Category: Commentary

New Study Doubles Down on Debridement vs. Balloon

Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multi-centre randomized controlled trial

[us_separator]
[us_iconbox icon=”fas|fas fa-user-md-chat” style=”circle” size=”20px” iconpos=”left” title=”Contributor” title_size=”20px” title_tag=”h3″ alignment=”left” css=”%7B%22default%22%3A%7B%22font-family%22%3A%22Roboto%22%7D%7D”]Gregory Gilot, MD
Cleveland Clinic Florida[/us_iconbox][us_separator]

Andrew Metcalfe, Helen Parsons, Nicholas Parsons, Jaclyn Brown, Josephine Fox, Elke Gemperlé Mannion, Aminul Haque, Charles Hutchinson, Rebecca Kearney, Iftekhar Khan, Tom Lawrence, James Mason, Nigel Stallard, Martin Underwood*, Stephen Drew*, on behalf of the START:REACTS team

To review is to opine 

Rotator cuff tears are a common cause for shoulder pain and disability.  While the majority of rotator cuff tears are amenable to surgical repair, a third of tears cannot be repaired to its original site of attachment. Massive irreparable rotator cuff tears remain a challenge for the shoulder surgeon in any age range.  Patients with irreparable tears have worse outcomes from traditional rotator cuff surgery and have fewer treatment options.  As a result, novel surgical procedures have been introduced as options for these complex situations. The InSpace subacromial balloon spacer device (Stryker, USA) is a saline-filled biodegradable balloon inserted into the subacromial space. The device maintains this space with the goal of improving the mechanics of the shoulder and aid rehabilitation.

Summary

The purpose of the study was to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. The authors recognize the potential harm patients are exposed to when a new surgical procedure is introduced. In addition, the authors recognize the need for careful evaluation of new surgical procedures before widespread use.

The purpose of the study was to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.

Materials and Methods

A double-blind multi-centre, superiority randomized controlled trial across 24 hospitals in the UK was performed using a group sequential adaptive design with two preplanned interim analyses. Adults with symptomatic irreparable rotator cuff tears and for whom conservative management had been unsuccessful were included. The control group (debridement only) underwent arthroscopic debridement of the subacromial space and biceps tenotomy. The intervention group (debridement and device) underwent the same procedure with the insertion of the InSpace balloon using the manufacturer’s recommended technique. All participants were offered the same rehabilitation. All primary (Oxford Shoulder Score) and secondary outcomes (Constant Score, flexion and abduction, WORC Index, EuroQol, EQ-5D-5L, change in symptoms, Participant Global Impression of Chane, resource use, and adverse events) were assessed at 3, 6, and 12 months.

Results

One hundred seventeen participants were randomly allocated to a treatment group, 61 to the debridement only group and 56 to the debridement with device group. The average age of the debridement only group was 67·3 (+/-9·0) 66·4 (+/-7·6) for the debridement with device group. Fifty-seven percent of all participants were male, the average duration of symptoms was4·9 (6·7) years, and 21% had previous surgery. The mean tear size was similar between groups (debridement only 4.3cm versus debridement with device 4.2cm).

[us_separator]
Results at 12 months
Outcome Mean Difference or

Adjusted Odds Ratio

Adjusted mean difference* (95% CI)

*Negative values favour the debridement-only group

**OR with 95% CI with Fishers exact test.

Comment
Oxford Shoulder Score –4·2 (–7·8 to –0·6) Not significant,

favoring debridement only

WORC Index –8·4 (–16·8 to –0·1) Not significant,

favoring debridement only

EQ-5D-5L –0·056 (–0·150 to 0·035) Not significant,

favoring debridement only

 Participant Global Impression of Change, since the operation 0·5 (0·3 to 1·1)|| Not significant,

 

Analgesia Use  0·8 (0·4 to 1·8)**

 

Safety Events
 Debridement

only (n=61)

 Debridement

with device

(n=56)

Overall 9 (15%) 11 (20%)
Any Serious Adverse Events 2 (3%) 4 (7%)
Unrelated to Surgery 1 (pain after fall) 2 (pain after fall, proximal humerus fracture after fall)
Related to Surgery 1 (pain) 2 (pain, 1 converted to RSP)

Discussion

A blinded randomized controlled trial design with predefined stopping boundaries allowed the study to be stopped at more than half the maximum potential sample size of 221 participants allowing the authors to report their findings early. During the time of the study the COVID-19 restrictions limited face-to-face assessments therefore there was a high amount of missing data. In the primary analysis the authors found that arthroscopic debridement only was superior to arthroscopic debridement with the InSpace device based on the Oxford Shoulder Score at 12 months. In addition, secondary outcomes were similar to the primary outcome.

Conclusions

Through this adaptive design methodology with interim analyses the authors concluded that the InSpace device is unlikely to be of benefit and may be harmful to this patient population. The authors recommended against the use of the InSpace subacromial balloon spacer device for the treatment of irreparable rotator cuff tears.

Reviewer Comments

Lancet is one of the most prestigious medical journals with an impact factor of ~80, and the authors’ conclusions are strongly worded and in sharp contrast to that of the recent JBJS study on the balloon. Additional clinical research is required on this device, and it will be interesting to see in the coming years which of these studies on the balloon more accurately describes the clinical performance of the InSpace for treatment of irreparable rotator cuff tears.

[us_separator show_line=”1″]

Metcalfe A, Parsons H, Parsons N, Brown J, Fox J, Gemperlé Mannion E, Haque A, Hutchinson C, Kearney R, Khan I, Lawrence T, Mason J, Stallard N, Underwood M, Drew S; START:REACTS team. Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial. Lancet. 2022 May 21;399(10339):1954-1963. doi: 10.1016/S0140-6736(22)00652-3. Epub 2022 Apr 21. PMID: 35461618.

Verma N, Srikumaran U, Roden CM, Rogusky EJ, Lapner P, Neill H, Abboud JA; SPACE GROUP. InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears: A Multicenter, Single-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2022 Apr 22. doi: 10.2106/JBJS.21.00667. Epub ahead of print. PMID: 35777921.

Tags:

Anatomic versus Reverse, the Debate Continues

A commentary on “Comparison of complication types and rates associated with anatomic and reverse total shoulder arthroplasty” by Parada et al from JSES 2021

[us_separator]
[us_iconbox icon=”fas|fas fa-user-md-chat” style=”circle” size=”20px” iconpos=”left” title=”Contributor” title_size=”20px” title_tag=”h3″ link=”url:https%3A%2F%2Fstaging.exac.com%2Fsurgeon%2F16954%2Fshoulder%2Flexington%2Fky%2F40509%2Fsajadi-kaveh%2F” alignment=”left” css=”%7B%22default%22%3A%7B%22font-family%22%3A%22Roboto%22%7D%7D”]Kaveh R. Sajadi, MD
Kentucky Bone & Joint Surgeons[/us_iconbox][us_separator]

There can be no doubt that total shoulder arthroplasty (TSA) is a successful operation that improves the lives of patients. Shoulder arthroplasty is increasing in frequency due in part to its success as well as the introduction of the reverse shoulder replacement (rTSA), which offers solutions to problems without previous good options. In fact, rTSA is now performed more frequently than anatomic TSA (aTSA), and sometimes the indications for one versus the other (previously quite distinct) may overlap, leading to debates about optimal implant choice. Unfortunately, with any surgery comes complications which can certainly impact outcomes and negatively effect quality of life. The authors of this study, Drs. Parada et al, sought to determine the types of failure modes of shoulder replacement and the differences in these between aTSA and rTSA.

This study is a retrospective cohort comparison using an international database of patients who received a single-platform shoulder arthroplasty system. Patients were treated by 40 different fellowship-trained surgeons and 2224 aTSAs and 4158 rTSAs were included, while revisions were excluded. These were reviewed for the incidence, type, and timing of complications. Complications and revisions were separately analyzed. Overall, the mean age of aTSA patients was significantly younger than rTSA, as would be expected. For aTSA, the overall complication rate was 10.7% with a 5.6% revision rate. The most common complications were rotator cuff tear/subscapularis failure in 3.1%, aseptic glenoid loosening in 2.5%, infection in 1.3%, and pain in 1.1%. For aTSA, the most common reasons for revision were aseptic glenoid loosening, rotator cuff/subscapularis failure, and infection. For rTSA, the overall complication rate was 8.9% with a 2.5% revision rate. The most common complications were acromial/scapular stress fractures in 1.7%, instability in 1.4%, pain in 1.2%, and infection in 0.9%. The most common reasons for revision were instability, infection, and aseptic glenoid loosening.

When compared head to head, rTSA had significantly fewer complications (aTSA 10.7% v rTSA 8.9%, p=0.0434), due to significantly fewer rates of aseptic glenoid loosening despite higher rates of instability and humeral fracture. The overall revision rate was also significantly less in rTSA (aTSA 5.6% v rTSA 2.5%, p<0.0001). There was a significantly lower rate of aseptic glenoid loosening but a higher rate of instability.

Patients were treated by 40 different fellowship-trained surgeons and 2224 aTSAs and 4158 rTSAs were included, while revisions were excluded.

The authors are to be commended for this study which adds greatly to the knowledge base on the incidence and types of shoulder arthroplasty complications. This is very helpful when discussing the potential risks and benefits of shoulder arthroplasty with patients. The authors note in their discussion that the complication rates in this paper compare very favorably with older reports of high complication rates with rTSA, in part due to increased surgeon experience and improved implant design.

Historically, rTSA was introduced as a treatment option for patients with rotator cuff tear arthropathy, or end-stage osteoarthritis combined with an irreparable rotator cuff tear as aTSA in these patients is contraindicated due to high failure rates. With its great success, indications for rTSA have expanded to include revision shoulder arthroplasty, proximal humeral fractures and fracture/dislocations, inflammatory arthropathies, and even patients with an intact rotator cuff but advanced glenoid wear or in elderly patients. It is generally held that a well-performed aTSA with an intact rotator cuff will outperform a rTSA, but subscapularis healing does not always occur and rotator cuff tears develop even without trauma as the shoulder (and patient) ages.

In some clinical settings, aTSA and rTSA are both a viable option for the patient and understanding the different complication rates and their frequencies will help surgeons better counsel their patients to determine the appropriate implant. Predictive analytics, utilizing machine learning and large patient databases such as this, may further help with this decision-making. Predict+ is such a software. Predict+ utilizes a few simple questions regarding the patient’s pain, their demographics, diagnoses, comorbidities, and range of motion to apply algorithms tested through machine learning to “predict” the patient’s expected improvement in range of motion and function with aTSA and rTSA and provides their predicted complication rates and types. This, in effect, personalizes the results of this paper to an individual patient. This information, combined with preoperative planning and intraoperative navigation to optimize implant placement, can lead to reproducibly improving outcomes and reducing complications. The future of shoulder arthroplasty may be upon us.

[us_separator]

References

  1. “Comparison of complication types and rates associated with anatomic and reverse total shoulder arthroplasty.” Stephen A. Parada, MD, Pierre-Henri Flurin, MD, Thomas W. Wright, MD, Joseph D. Zuckerman, MD, Josie A. Elwell, PhD, Christopher P. Roche, MSE, MBA, Richard J. Friedman, MD. J Shoulder Elbow Surg, (2021) 30, 811-818.
Tags:

3D CT Preoperative Planning in Shoulder Arthroplasty: Differences in Industry Technician and Surgeon Planning

Given the increased use and availablilty of preoperative planning in shoulder arthroplasty, improved knowledge of how surgeons plan, the ability to execute the plan, and factors associated with planning is needed.

[us_separator]
[us_iconbox icon=”fas|fas fa-user-md-chat” style=”circle” size=”20px” iconpos=”left” title=”Contributor” title_size=”20px” title_tag=”h3″ alignment=”left” css=”%7B%22default%22%3A%7B%22font-family%22%3A%22Roboto%22%7D%7D”]Joseph J. King, MD
UF Health Orthopaedics and Sports Medicine Institute[/us_iconbox][us_separator]

Hartzler and colleagues1 evaluated the rates of surgeon agreement compared to an industry technician team regarding the 3-dimensional preoperative plan for placement of shoulder arthroplasty components in 6,483 cases (aTSA and rTSA).  The industry technicians used some general principles to follow when creating the plan and were trained in this process.  Aditionally, all plans underwent a peer-reviewed process prior to be accepted by the team.  The patient-specific instrumentation used in this study utilized a reusable device with 5 points of contact on the glenoid surface.  This device targets the central glenoid pin used in this system.  This study focused on the central glenoid pin placement regarding version and inclination.

The authors demonstrated that there was a moderate rate of surgeon acceptance of the plan (66% version, 72% inclination, and 55% for both).  Notably, 45% of plans showed at least version or inclination were not accepted by the surgeon with 18% of cases having neither plan accepted by the surgeon.  While in a “majority” of cases the plan was accepted, this still shows a relatively high lack of acceptance of the plan that was generated using general guidelines.

Interestingly, the authors noted that on univariate analysis, as the surgeon’s case count increased, their acceptance of technician planned version decreased.  This suggests that with experience using the preoperative planning system or just surgeon experience caused the surgeons to not accept the standardized plan.  This highlights the fact that experienced surgeons likely use other factors besides the general guidelines when considering preoperative glenoid planning.  This study adds to the literature regarding surgeon variability in preoperative planning in differing clinical scenarios. 2,3

The authors demonstrated that there was a moderate rate of surgeon acceptance of the plan (66% version, 72% inclination, and 55% for both). 6

Increasing native glenoid version was another factor on univariate analysis that caused decreased surgeon agreement with the technician planned implant version.  Again, this shows that in difficult cases (with significant glenoid wear), other factors besides the general guidelines are used by surgeons for planning implant version.

Limitations of this study include the fact that only glenoid version and inclination were assessed.  Change in the inferior/ superior or anterior/ posterior position of the central pin as well as the planned depth of reaming was not assessed.  In addition, while understanding planning is important, in vivo execution of the plan and/or intraoperative acceptance of the patient specific instrumentation guide was not assessed.  Studies have shown that even with preoperative planning, the in vivo execution of the plan still can be off a significant amount of the time.4,5

Of note, some of the same authors found that different preoperative planning software leads to different measurements in native version and inclination whereas the surgeons in that study had relatively high inter-observer reliability, demonstrating that measurements of even native version and inclination by preoperative planning softwares differ.6

The authors do mention the risks of anchoring bias and authority bias when accepting or changing the plan in these scenarios.  They make a good point that maybe it is better to let the surgeon plan from the beginning without industry input to avoid these biases, although this was not evaluated in this study.  The authors caution surgeons to avoid blind acceptance of the industry technician preoperative plan in shoulder arthroplasty given the findings of this study.  I agree with this assessment as there are many factors to consider when planning including remaining glenoid bone stock, location of central pin vault penetration, backside support of the implant, ease of implant placement, and availablilty of glenoid augments, amongst other factors all play a role in surgeon preoperative planning.

[us_separator]

References

  1. Hartzler RU, Denard PJ, Griffin JW, Werner BC, and Romeo AA. “Surgeon acceptance of an initial 3D glenoid preoperative plan: rates and risk factors.”  J Should Elb Surg.   30: 787-94.
  2. Greene A, Cheung E, Polakovic S, Hamilton M, Jones R, Youderian A, et al. Inter-surgeon variability in using 3D planning software for reverse total shoulder arthroplasty: an analysis of 360 cases. Orthop Proc. 101-B:64.
  3. Parsons M, Greene A, Polakovic S, Byram I, Cheung E, Jones R, Papandrea R, Youderian R, Wright T, Flurin PH, Zuckerman JD. Assessment of surgeon variability in preoperative planning of reverse total shoulder arthroplasty: a quantitative comparison of 49 cases planned by 9 surgeons. J Should Elbow Surg.  29(10): 2080-88.
  4. Hao KA, Sutton CD, Wright TW, Schoch BS, Wright JO, Struk AM, Haupt ET Leonor T, King JJ. Influence of glenoid wear pattern on glenoid component placement accuracy in shoulder arthroplasty.  JSES Int.  6(2): 200-8.
  5. Schoch BS, Haupt E, Leonor T, Farmer KW, Wright TW, King JJ. Computer navigation leads to more accurate glenoid targeting during total shoulder arthroplasty compared with 3-dimensional preoperative planning alone. J Should Elbow Surg.  29(11): 2257-63.
  6. Erickson BJ, Chalmers P, Denard P, Lederman E, Horneff G, Werner BC, Provencher M, Romeo AA. Does commercially available shoulder arthroplasty preoperative planning software agree with surgeon measurements of version, inclination, and subluxation?  J Should Elbow Surg.  30(2): 413-20.
Tags: , , ,

Diversity, Equality and Inclusion in Orthopaedics

The lack of diversity within the orthopaedics industry has been well documented over the past several years.

[us_separator]
[us_iconbox icon=”fas|fas fa-user-md-chat” style=”circle” size=”20px” iconpos=”left” title=”Contributor” title_size=”20px” title_tag=”h3″ alignment=”left” css=”%7B%22default%22%3A%7B%22font-family%22%3A%22Roboto%22%7D%7D”]Stephanie Muh, MD
Deputy Chief of Service in the Department of Orthopaedics Henry Ford Hospital West Bloomfield[/us_iconbox][us_separator]

Since the 1970s the percentage of women entering medicine has steadily increased, and currently 51% of matriculating medical students are female. The number of females entering surgical specialties has also steadily increased. While the many surgical subspecialties including neurosurgery, plastic surgery, urology, and others have seen continued growth of female surgeons, orthopaedics unfortunately has not seen the same growth.1,2,3 Orthopaedics has only seen a 2-3% increase since 1990.

Overall, orthopaedic surgery ranks last (5.8%) in the percentage of practicing female physicians, and that percentage has not dramatically changed when discussing training programs where it continues to rank last in the percentage of female residents (16% as of 2020) and underrepresented minorities (URMs)(7.7% in 2020).2,4,5,6 At the current rate of 3% growth per year, it would take 217 years to reach parity in orthopaedics.6 This reflects the lack of growth in diversity.

At the current rate of 3% growth per year, it would take 217 years to reach parity in orthopaedics.6

Of concern, recent work has identified the American Shoulder and Elbow Surgery society (ASES) as having one of the lowest percentages of female members.7 Only the scoliosis research society, the knee society, cervical spine research society, and hip society rank lower. Clearly, there is much room for improvement for inclusion with Orthopaedics as well as within our specialty. While there are many factors that influence the advancement of diversity, a few important topics will be discussed.

Why Do We Need to Improve Diversity? 

An abundance of literature demonstrates underrepresented minorities have worse outcomes compared to Caucasian patients even when accounting for socio-economic factors. Additionally, patients want to be treated by those who look like them as patient satisfaction improves with communication among people who share similar social, cultural, and linguistic experiences.2

Finally, recent evidence suggests that patients who are treated by physicians of the same race, ethnicity, cultural background, or gender feel more comfortable with their care and tend to have better outcomes.8 With 12.4% of the U.S. population identifying as African American and 51% of the population being women, clearly the orthopaedic community does not reflect the current population.

Ways to Improve Diversity 

Bias (explicit, implicit)

Bias can be both implicit and explicit through a variety of ways including personal interactions, institutional cultures, recruitment and hiring processes, as well as professional evaluation processes.9,10 All of these processes have the potential to subtly disadvantage underrepresented minorities and women.

Explicit biases are demonstrated by those who believe that women should simply not be orthopaedic surgeons because they do not possess the strength, intelligence, temperament, or other characteristics. Those are often easily identified within society. However, implicit bias, which is likely much more prevalent but difficult to identify, has been defined as a reflection of unconscious attitudes or stereotypes that affect individual decisions and actions. Correction of implicit bias centers on self-awareness of the problem and a desire for change. To improve diversity, leaders must first recognize that bias exists (often within themselves as well) and then have the desire to eliminate it. Only then can leaders work to gain “buy-in” from fellow members (partners, colleagues, and faculty).

To achieve this, bias literacy (the uncovering, defining, and understanding of implicit bias so it may be made explicit) is a necessity. The Harvard Implicit Association Tests (IAT) is a free online tool used to detect and measure implicit bias. This test should be required of all participants to evaluate bias among team members.

The hiring process is just one example of how implicit bias perpetuates the lack of diversity within our profession. Within the recruitment and evaluation process, bias tends to flourish when such processes are unstructured or informal. Additionally, evidence suggests that interviewers preferred men, Caucasian-sounding names, a lighter skin tone, taller individuals, and personality traits most associated as male attributes. To counteract this implicit bias, it has been recommended that during the recruiting process committees establish a specific set of criteria and commit to the value of credentials before evaluating individual applicants.

Mentors and Advocates 

Mentors and advocates are critical to the development and advancement of surgeons, especially in academic medicine.9 While they are often used interchangeably, and can be the same person, they are in fact two separate qualities.

A mentor is an individual who provides guidance through the process of navigating a career path from past experiences of the mentor. An advocate actively creates opportunities for promotion and progression to leadership positions are more closely tied to the concepts of advocacy and sponsorship than to mentorship.

The difference between these roles is clear: a mentor helps one think through the process of navigating his or her career, whereas an advocate is a person with influence and who creates opportunities for others toward promotion and career advancement. Women and URMs are in need of more mentors and advocates in order to improve diversity within our profession. Increasing exposure of women and URM surgeons on podiums and major speaking roles at conferences, meetings, and teaching events is just one way an advocate can help with progress.

When an audience sees a diverse faculty at events it helps cultivate the principle of being a diverse organization. It should be noted that not all mentors or advocates need to be of the same race or gender. Especially in the current state with the limited number of active female and URM surgeons, strong male leaders can provide both mentorship and act as advocates. My personal experience has seen several male orthopaedic colleagues provide crucial mentorship as well as become an advocate for my professional development.

Several organizations have been created to help address this issue (Perry Initiative, Ruth Jackson Society, J Robert Gladden Society, Orthopaedic Diversity Leadership Consortium, Nth Dimension), and evidence suggests that these organizations are making an impact. URM and women who attended a medical school at an institution with high URM and female representation on the faculty and residency were more likely to apply to orthopaedics. However, more support and recognition are necessary to continue to diversify our profession. It has also been identified that early exposure to orthopaedics has increased awareness of the specialty to women and URMs.

Many subspecialities have recently organized Diversity, Equality, and Inclusion (DEI) committees. ASES leadership organized a DEI subcommittee, and with executive board mentorship and advocacy our committee has accomplished several impressive achievements within only a few years. The list of achievements includes sponsorship of a Nth dimension summer intern in shoulder/elbow, the creation of an ASES scholars program introducing local medical students to the field of shoulder and elbow surgery, and junior resident scholarships for ASES/AAOS shoulder/elbow courses, and a medical student/resident webinar to expose the specialty of shoulder and elbow surgery to a younger group of future physicians.

The recent increased recognition regarding the need for diversity is encouraging. While recent progress is promising, there needs to be a continued long-term effort to change the culture of diversity within our specialty and orthopaedics as a whole. Without a sustained focused goal of change in culture, the progress made to date is at risk for failure.

Finally, the topic of diversity in orthopaedics should not be limited to surgeons. Diversity within our industry as well as support from staff should also be targeted. As a female surgeon, I want to also work and collaborate with companies who have demonstrated a clear dedication for improving diversity within our workforce.

The mentioned topics are just a small subset of many additional factors not mentioned in this blog post, but they are meant as a possible catalyst for discussion as well as achievable actionable items. While the overall goal is to increase membership of women and URMs, we also must be cognizant of these individuals’ qualifications and if they can uphold the standards of professional care that should be expected of every orthopaedic surgeon.

[us_separator]

References

  1. Poon S, Kiridly D, Mutawakkil M, Wendolowski S, Gecelter R, Kline M, Lane LB. Current Trends in Sex, Race, and Ethnic Diversity in Orthopaedic Surgery Residency. J Am Acad Orthop Surg. 2019 Aug 15;27(16):e725-e733. doi: 10.5435/JAAOS-D-18-00131. PMID: 30676512.
  2. Ramirez RN, Franklin CC. Racial Diversity in Orthopedic Surgery. Orthop Clin North Am. 2019 Jul;50(3):337-344. doi: 10.1016/j.ocl.2019.03.010. PMID: 31084836.
  3. American Association of Medical Colleges. 2020 facts: applicants and matriculants data. 2020.https://www.aamc.org/data-reports/workforce/report/physician-specialty-data-report
  4. Vij N, Singleton I, Bisht R, Lucio F, Poon S, Belthur MV. Ethnic and Sex Diversity in Academic Orthopaedic Surgery: A Cross-sectional Study. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 8;6(3):e21.00321. doi: 10.5435/JAAOSGlobal-D-21-00321. PMID: 35258489; PMCID: PMC8906469.
  5. Okike K, Phillips DP, Johnson WA, O’Connor MI. Orthopaedic Faculty and Resident Racial/Ethnic Diversity is Associated With the Orthopaedic Application Rate Among Underrepresented Minority Medical Students. J Am Acad Orthop Surg. 2020 Mar 15;28(6):241-247. doi: 10.5435/JAAOS-D-19-00076. PMID: 31305355.
  6. Haffner MR, Van BW, Wick JB, Le HV. What is the Trend in Representation of Women and Under-represented Minorities in Orthopaedic Surgery Residency? Clin Orthop Relat Res. 2021 Dec 1;479(12):2610-2617. doi: 10.1097/CORR.0000000000001881. PMID: 34180873; PMCID: PMC8726541.
  7. Saxena S, Cannada LK, Weiss JM. Does the Proportion of Women in Orthopaedic Leadership Roles Reflect the Gender Composition of Specialty Societies? Clin Orthop Relat Res. 2020 Jul;478(7):1572-1579. doi: 10.1097/CORR.0000000000000823. PMID: 31180910; PMCID: PMC7310307.
  8. Hill A, Jones D, Woodworth L. Physician-patient race-match and patient outcomes. Available at: https://papers.ssrn.com/abstract=3211276. Accessed May 5, 2020.
  9. Scerpella TA, Spiker AM, Lee CA, Mulcahey MK, Carnes ML. Next Steps: Advocating for Women in Orthopaedic Surgery. J Am Acad Orthop Surg. 2021 Nov 10. doi: 10.5435/JAAOS-D-21-00932. Epub ahead of print. PMID: 34780383.
  10. Samora JB, Ficke JR, Mehta S, Weber K. True Grit in Leadership: 2018 AOA Critical Issues Symposium Addressing Grit, Sex Inequality, and Underrepresented Minorities in Orthopaedics. J Bone Joint Surg Am. 2019 May 15;101(10):e45. doi: 10.2106/JBJS.18.01276. PMID: 31094992.
Tags: , , ,

Creating Efficiency in the O.R. with Streamlined Instrument Sets

Clinical Contributor

Matthew R. Price, MD
Ellis & Badenhausen Orthopaedics, PSC
Louisville, KY

The number of total joint replacements is growing rapidly, and the current trend suggests that the number of total joints performed will double by 2030.1 As the population ages in the United States, and the older generations graduate to more advanced stages of arthritis, the need for joint arthroplasty surgery will expand. In addition, the transition to outpatient total joint arthroplasties over the past five years has caused a shift toward shortened hospital stays and increased outpatient procedures. In 2017, only 15 percent of joint replacements were performed in the outpatient setting, and current estimates suggest that by 2026 that number will be closer to 50 percent.2

Considering these statistics, we answered the following questions regarding the implementation of the Exactech ExacSETS into our hospital and ambulatory surgery settings and cannot overstate the opportunities it afforded.

How did the O.R. experience change from the standard setup to the two-tray setup?

I operate in two different settings—an Ambulatory Surgery Center (ASC) and traditional hospital surgical suites. In the hospital setting, the rooms are typically larger and more spacious. While it is an advantage to conserve space in any setting, there is a difference in space saving in a hospital versus an ASC. Orthopedic surgery requires a great deal of instrumentation, and the room configurations are oftentimes more complicated and more cluttered than other service lines. With that in mind, most hospitals accommodate orthopedic services with larger rooms.  However, in an ASC setting, room size and maneuverability are usually confined. While an extra table or mayo stand in a hospital O.R. may not affect the space allocation, it would absolutely affect the available space in an ASC setting.

With the two-tray ExacSETS, we have been able to go from two large back tables to one large back table (Figures 1 and 2). When accounting for surgical side space, in addition to the scrub tech and fellow, this modification makes a small O.R. feel much larger.

[us_separator size=”small”]

Figure 1. One table room set-up using ExacSETS.

[us_separator size=”small”]

Figure 2. View of one table set-up using an ExacSETS tray.

Did you feel that you had to compromise anything from your standard surgical flow?

Actually, we felt the exact opposite. The flow seemed to be more efficient, and the time from room breakdown to opening felt much easier. Some systems require four to six pans to be opened for each case (Figure 3). With the switch to the ExacSETS, the room staff almost immediately noticed a difference. While it might not seem like a big difference to the surgeon waiting in the lounge for the room to be opened, our ASC staff was ecstatic to open only two pans for each case (Figure 4). When we transferred the ExacSETS to the hospital setting, the staff took notice as well.

Figure 3. Six-tray instrument system.

Figure 4. Two-tray ExacSETS kit.

[us_separator size=”small”]

Needless to say, the number of trays opened can make a vast difference in the room morale and workload to the staff. Our scrub techs and room nurses were excited about the decrease in trays being opened. I didn’t appreciate the numbers until one of my scrub techs noted that on a five-case day, we drastically cut the opening time down possibly because of a decrease in about 10 to 20 pans. Over the course of a day, those increments of time add up.

Was there a learning curve for you or your O.R. staff?

Honestly, not really. The pans are stacked a bit differently than the standard tray sets, but we quickly figured out that the instruments we needed were all available. The reamer sizes for a total hip range from 44mm to a 60mm. Head sizes range from 28mm to 40mm, with all plus and minus sizes available. In addition, all stem sizes in each grouping are available in standard and extended options. It’s a wonder we haven’t done this sooner.

Did you notice a difference in your Sterile Processing Department (SPD)?

Our SPD may have noticed the biggest difference. In addition to processing total joint tray sets, they also prepare and arrange other service lines. The task can be daunting, and the amount of work is demanding. Making sure the instruments are scrubbed, washed, and cleaned takes an enormous amount of time and effort. And that doesn’t include sterilization time. It was immediately obvious that our SPD staff preferred the two pan ExacSETS. The difference between preparing a two-tray system versus a four- to six-tray system is significant not only for the day of surgery, but also when preparing for the next day’s cases.

Overall, what did you experience as the benefits of using ExacSETS for your practice?

As an owner in an ASC, the cost savings is the biggest difference when comparing ExacSETS to the competition. The cost of preparing a tray of instruments includes scrubbing, washing, and sterilizing. That doesn’t include the overhead associated with the upkeep for sterile processors, employee salaries and benefits, and the cost of chemical supplies. It has been estimated that the cost to sterilize one pan can be anywhere from $125 to $200 per tray. If we take the median of the expected cost at $150 per tray, used for 200 joints per year, the average cost savings would be $60,000 a year for a two-tray system versus a four-tray system for a total hip. When comparing the same savings for a six-tray total knee system, the savings are $120,000 per year. Those are real numbers that can significantly reduce the overhead of running an ACS.

In the future, I believe that one of the largest responsibilities for surgeons will be cost containment. Reducing overhead costs and increasing O.R. efficiency could be accomplished using the ExacSETS for total hip and knee arthroplasties.

[us_separator size=”small”]

REFERENCES

  1. Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020–2040 Using the National Inpatient Sample. The Journal of Rheumatology September 2019,46(9)1134-1140;org/10.3899/jrheum.170990
  2. Armocida F, Hazen B, Samii N. Moving toward success with outpatient total joint replacement surgeries. Becker’s ASC Review. September 2019. https://www.beckersasc.com/orthopedics-tjr/moving-toward-success-with-outpatient-total-joint-replacement-surgeries.html?em=mrpric02@gmail.com
Tags: , ,

The Impact of Preoperative Patient Education on Clinical Outcomes

Clinical Contributor

Ari Youderian, MD
SCOS Orthopedic Specialists
Laguna Woods, CA

Introduction

A 2017 study published in the Current Reviews on Musculoskeletal Medicine stated that patient education prior to joint replacement surgery has been shown to decrease anxiety, improve post-operative pain control, provide more realistic expectations of surgery, and increase the patient’s understanding of their surgery. As a result, the incorporation of preoperative education programs for elective joint replacement can lead to lower hospital length of stay, higher home discharge, lower readmission, and improved cost.1

In this article, Ari Youderian, MD shares his personal experience with preoperative patient education and provides valuable insights for fellow orthopaedic surgeons to expand their preop protocols and incorporate patient discussions of advanced technology. 

Talk us through your preoperative protocols and your expectations of patients prior to surgery?

We must recognize that all patients are different in their expectations, knowledge, background, and education. To that end, I have created a multi-modal approach to my patients’ preoperative education, with a lot of reinforcing repetition.

My patients initially meet with me to discuss their condition, previous treatments, medical history, and candidacy for shoulder replacement. We review their initial imaging studies as well as the overall treatment process from preoperative to full recovery six to 12 months later. I also present an initial recommendation for either outpatient or inpatient surgery, based on their health status.

All patients attend a preoperative visit guided by my physician assistant. They review the process, day of surgery details, wound care, obtain DME, and sign paperwork. I then answer any remaining questions and obtain informed consent. We also provide and review a set of initial post-operative exercises.

Inpatient surgical patients are recommended to attend a shoulder-specific joint class provided by the hospital’s joint surgery coordinators. We have tailored and simplified the program (which I helped develop) for my shoulder patients with specific protocols and expectations. Approximately 90 percent of my patients attend these classes.

Outpatient surgical patients are linked with a nurse navigator who provides preoperative shoulder replacement education, preoperative testing, day of surgery details, and outpatient return-to-home planning. The navigator follows up with the patients after surgery via phone calls. All outpatient patients are required to participate.

My expectations for my patients are centered on understanding what their disease is and the procedure that I am planning to perform. After surgical decision making and planning is complete, the expectations shift toward preparation for surgery and, most importantly, after surgery. Setting the goals for length of stay, typically 0-1 night, is critical. Patients must understand their rehabilitation plans, post-operative medications, and prepare for any post-operative restrictions. The ultimate goal is to have them comfortable when they return home to alleviate any anxiety and eliminate any surprises.

What do you think the impact of preoperative education has been on your overall clinical outcomes?

Clinical outcomes are a combination of both patient satisfaction and physical assessment.  I believe that in both of these categories preoperative education is a winner.

We know that early range of motion after shoulder replacement is most important for a successful outcome.  The patients learn early on that exercises starting on post-operative day one are expected. These are taught and reviewed by my physician assistant as well as reviewed at the preoperative education class. Handouts are provided in both instances, and patients are ready to perform these from the start.

The patient satisfaction outcome scores are typically based on patient perception of post-operative pain and function.  When the process is clear, the people they meet are helpful and informative, and their expectations are met or exceeded; their outcomes are mostly positive. I am confident that as the preoperative expectations are set early on and repeated often, they drive higher patient satisfaction scores.

We have minimized the hospital length of stay to under one day, as well as lessened the need for post-operative home health requirements.  My findings are anecdotal at this point but in addition to these truths, we see less patients calling after surgery with questions.

Do you have any tips for explaining complex surgeries or advanced technologies to your patients in a way that’s easy to understand?

Tip #1 Keep it Simple

Promoting advanced technology doesn’t mean explaining the gritty details (unless the patient wants or asks for them).  It does mean getting the points across but with simple language. For example, when I explain to patients that I like to use the ExactechGPS® shoulder preoperative planning application, I don’t say, “I am planning to use a software optimization program that incorporates your DICOM images from a computed tomography scan.”  I typically say, “I plan your surgery to be more accurate2 with a computer program that lets me see your bone in 3D and figure out what size implants would be best for your shoulder.”

Tip #2 Keep an Open Dialogue

Some patients can follow what you are saying and like the details and some would rather not know them all.  Ask your patients throughout the process about their level of understanding and if they are satisfied with the information that you have provided during their visit.  Remember – Long, one-way lectures are rarely well-absorbed.

Tip #3 Use Visual Aids

Some patients may learn better with visual aids such as joint models, images or videos. I often use models and even compare them to the patient’s 3D reconstructions while explaining shoulder replacement. There are many aids that can be used, and I often refer them to my own website and the company website for more detailed videos and procedural guides.

What advice would you give to a new orthopaedic surgeons on first developing preoperative education plans?

Tip #1 Don’t try to reinvent the wheel. Most hospitals and surgery centers have developed some of these processes already. You can easily implement some of your own ideas and practices as well as guidelines from your training programs into these programs. New surgeons do not have to do this alone. Partnership with a hospital or surgery center can help provide the resources you need. They typically want the business and will make efforts to provide services for your patients, including joint classes and materials.

Tip #2 Spend the extra time yourself with your patient. Especially in the beginning of your practice, your patients will trust you and appreciate the extra time and effort that they might not get from other, busier surgeons. You can tailor your education efforts to be more efficient as you yourself become busier.

Tip #3 Gather appropriate brochures, handouts, or leverage corporate vendors to help provide materials for your patients to reiterate and expand upon the information you provide.

Tip #4 Continue to connect with your patients after surgery to gain feedback on the entire process. This way you can adjust your education programs or processes to maximize your patient satisfaction and clinical outcomes. 

 

Interview conducted by Allison Downey, APR, CPRC, Exactech, Inc.

DISCLAIMER: The opinions expressed in this article are that of one surgeon. Individual results vary. With any surgery, there are potential risks and recovery times may differ depending on the patient. Exactech, as the manufacturer, does not practice medicine, and is not responsible for recommending the appropriate surgical technique for use on a particular patient. These guidelines are intended to be solely informational and each surgeon must evaluate the appropriateness of these guidelines based on his or her personal medical training and experience.

[us_separator size=”small”]

REFERENCES

  1. Edwards, PK, Mears, SC, Lowry Barnes, C. Preoperative Education for Hip and Knee Replacement: Never Stop Learning. Curr Rev Musculoskelet Med 10, 356–364 (2017). doi.org/10.1007/s12178-017-9417-4
  2. Data on file at Exactech.
Tags:

The Power of Data Collection

American astrophysicist Dr. Neil deGrasse Tyson once said, “Any time scientists disagree, it’s because we have insufficient data. Then we can agree on what data to get; we get the data; and the data solves the problem. Either I’m right, you’re right or we’re both wrong.” In orthopaedics, data is king.

Since the inception of the Equinoxe® Shoulder System in 2004, Exactech and its surgeon partners have made the science of data collection part of their mission. With 35 collection sites across the United States and Europe, the Equinoxe database includes information on demographics, comorbidities, implant specifics, 7 PROMs, ROM, radiographic data, and complications—all using standardized forms—for more than 10,000 shoulder cases.  This multi-center collection using standardized forms creates the volume of evidence needed to produce the necessary statistical power for accurate analysis of the data; otherwise, the data would not be generalizable to a large patient population or to surgeons in different countries.

Some implant manufacturers and their consultants take non-standardized or under-powered data, such as individual user experience or small groups of surgeons’ outcomes, and present it as generalizable evidence. This makes it difficult for surgeons to know what they can and can’t trust. Accurate analysis of robust data is what surgeons need to make informed decisions about which implant to use and what surgical techniques to employ to do what is best for the patient.

The Journal of Bone & Joint Surgery recently published an article titled “Acromial and Scapular Fractures After Reverse Total Shoulder Arthroplasty with a Medialized Glenoid and Lateralized Humeral Implant: An Analysis of Outcomes and Risk Factors” by Routman et al. In this study, 4,125 shoulders from 3,995 patients were treated for primary reverse total shoulder arthroplasty using only one design of a reverse shoulder prosthesis1—the Equinoxe rTSA System, a medialized glenoid and lateralized humeral implant. The Equinoxe reverse acromial and scapular fracture rate is 1.48 percent, which is more than two times lower than the prosthesis designs, whether inlay or onlay, referenced in this study.2-5

Despite the comprehensive and extensive data, surgeons continue to disagree on whether implant design is associated with acromial and scapular fractures. One possible reason is that previous studies tend to lack the necessary statistical power for accurate data analysis to make the resulting claims and surgeons must depend on comparisons drawn from meta-analyses to try to answer this important question.

With the ever-increasing number of medical journals and online outlets available for publication, there should be an increased amount of scrutiny placed on editorial submissions that are accepted—and the underlying data within them—but that does not always seem to be the case.

Creating products for patients that solve clinical challenges requires dedication and investment. Over the last 17 years, Exactech surgeon collaborators and their research staffs have invested countless hours alongside Exactech’s multi-million-dollar investment to ensure that the Equinoxe Shoulder System is the most studied and published shoulder arthroplasty system on the market. The original medial glenoid lateral humerus design has not changed since its introduction—a feat that is truly unique within the industry. With over 430 literature references since 2004 and 27 peer-reviewed papers in 2020 alone, the Equinoxe database is a benchmark for new product development. It has also paved the way for continued use of the Equinoxe Shoulder System in Europe under the new EU Medical Device Regulations and enabled the use of machine learning to create predictive modeling applications and shoulder scoring systems, which will change and challenge the current way we approach shoulder surgery. The continuum of care is expanding, and data will support this growth. This is the power of the Equinoxe database.

Without clean, generalizable, sufficiently powered data, the conversation will continue to be “I’m right, you’re right or we’re both wrong”; and while this provides a platform for heated debate within the orthopaedic community and for capitalism, to prosper, the question of what is right for the patient will continue to be our guide.

Thoughts contributed by Jessica DeGrasse, Exactech, Inc.

[us_separator size=”small”]

REFERENCES

  1. Routman, HD, et al. Acromial and Scapular Fractures After Reverse Total Shoulder Arthroplasty with a Medialized Glenoid and Lateralized Humeral Implant, J Bone Joint Surg. 2020 Aug 26.
  2. Teusink MJ, et al. What is the effect of postoperative scapular fracture on outcomes of reverse shoulder arthroplasty? J Shoulder Elbow Surg. 2014 Jun;23(6):782-90. Epub 2013 Dec 8.
  3. Ascione F, et al. Increased scapular spine fractures after reverse shoulder arthroplasty with a humeral onlay short stem: an analysis of 485 consecutive cases. J Shoulder Elbow Surg. 2018 Dec;27(12):2183-90. Epub 2018 Aug 8.
  4. Levy JC, Blum S. Postoperative acromion base fracture resulting in subsequent instability of reverse shoulder replacement. J Shoulder Elbow Surg. 2012 Apr;21(4):e1 4-8. Epub 2011 Dec 21.
  5. Haidamous G, et al. The risk of postoperative scapular spine fracture following reverse shoulder arthroplasty is increased with an onlay humeral stem. J Shoulder Elbow Surg. 1-8.
Tags: , ,

If Computer-Assisted Surgery is More Accurate, Why Isn’t it More Prevalent?

Jefferson Morrison, MD
Southern Joint Replacement Institute

There are two things that all total knee surgeons can agree on when it comes to imageless computer navigation: It is more accurate than mechanical instrumentation in obtaining coronal alignment of the limb, and it is painful to adopt into one’s practice. Countless studies looking at different computer assisted orthopaedic surgery (CAOS) systems have shown improvement in alignment, but full adoption of this technology into surgeon’s operating rooms is uncommon.1 Most of us can easily list the reasons we tried and ultimately gave up on navigation. The cameras take up too much space. The lines of sight to the arrays are hard to keep open with assistants in the sterile field. The work flows are set and not customizable. The interface is outside of the sterile field so the surgeon has to rely on a company representative or nurse to “run” the system. The arrays require extra pins, sometimes outside of the incision. The reflective spheres quit working when they get blood on them or someone gets in between the array and the camera. Registration takes too long. The cutting blocks and instruments are specific to navigation, so if the case starts to go off the rails, converting back to conventional instruments is difficult and time consuming.

We should not, however, ignore the first point. CAOS is more accurate. The question, of course, is does this matter? There is plenty of evidence in the literature that alignment improves longevity.2-4 There is even good registry data that navigated total knees have a lower revision rate in one of the more high-risk demographics.5 There is even some literature to suggest that functional outcomes are better in navigated total knees.6

If we believe that navigation is more accurate, and that accuracy improves longevity and functional outcomes, what will it take to get us to fully adopt navigation into our operating rooms? Assume cost is not the roadblock. The system would have to be smaller and be fully incorporated into the surgical field. The software interface would have to be intuitive, run by the surgeon in the sterile field and customizable in real time. The arrays would have to be placed inside the incision, unaffected by blood and fluid and minimally affected by line of sight issues.

The ExactechGPS® computer assisted surgery system does all of this, and its accuracy has been validated in thousands of cases. I personally have used this system on and off for five years. Its accuracy allows me to do away with the intraoperative x-ray I typically take of my tibia cut. This saves me time, but the registration and “fiddle factor” still adds nine minutes on average to my navigated tourniquet times. While I am very accustomed to the extra pins needed to fix the arrays to the femur and tibia as well as the navigation-specific adjustable cutting blocks, I remember that the learning curve was frustrating. So, when Exactech asked me to work with its team to come up with an easier way to navigate that incorporates the power of CAOS into the simplicity of mechanical instruments without extra pins I was intrigued and agreed to participate.

The initial offering from this work group is ExactechGPS TKA Plus. TKA Plus uses familiar Truliant® mechanical instruments to guide TKA Plus specific cutting guides into an initial position for cutting the distal femur and proximal tibia. The cutting blocks, once fixed to the bone, then become foundations for the arrays that allow bone registration and cut guidance. For the distal femoral cut, an intramedullary guide is still utilized. While this eliminates one of the purported advantages of navigation, it is familiar and will place the block within the range of adjustment to allow for a perfectly planned resection. Intramedullary distal femoral cuts fall outside an acceptable varus/valgus angle up to fourteen percent of the time.7,8 The ability to adjust the cut to the desired valgus angle, flexion, and resection depth will improve alignment. The block offers plus/minus four degrees of varus/valgus adjustment, plus/minus four degrees of flexion/extension, and plus four/minus two millimeters of resection. Registration is six quick points. Only the distal medial and lateral femur require painting, so registration takes about one minute.

The tibial side uses the familiar extramedullary guide. Once pinned to the bone, it takes six quick points to register without any painting. Registration is fast! The intended cut is then verified and adjustments can be made on the block before resection. Much like the femoral block adjustment is plus four/minus four degrees of varus/varus, plus four/minus four degrees of tibial slope, and minus two/plus four millimeters of resection depth.

What I have found is that I’m not that accurate with mechanical instruments. Probably none of us are.

Lab testing has shown that when the blocks are pinned with the appropriate technique (threaded headed pins) for stable, secure fixation that angular play of the block with attempted movement is only 0.2 degrees. So the trackers are stable. In surgery, I have found the system to be very intuitive. Registration and block adjustment only adds three to five minutes compared to my mechanical instruments if I don’t need to recut. Recuts do not happen when I use the TKA Plus navigation so I may save time over many cases.

What I have found is that I’m not that accurate with mechanica instruments. Probably none of us are. In a sawbones study at Stanford in which 36 tibia and 36 distal femoral cuts were made by surgeons with varying levels of training, all cuts required at least one of the three adjustments to get to the intended cut angles and depths. Many times all three parameters were adjusted. I have found a similar trend. Prior to using navigation, I x-rayed all of my tibia cuts to ensure a 90 degree cut the mechanical axis. Twenty three percent of the time I was more than two degrees off and had to recut the tibia. In my TKA Plus cases I have had to adjust at least one parameter two thirds of the time! On the femoral side I have always taken it for granted that my cut was accurate. I was wrong. Studies show that an improperly placed starting point, a femur with medial to lateral bow, or a patulous intramedullary canal can all lead our cuts to be outside of an acceptable range.7,8 In my TKA Plus cases I have adjusted one of the three parameters twenty five percent of the time!

We all agree that CAOS makes us better. After using TKA Plus, I know it is making me better without disrupting my normal workflow. It adds very little additional time, and if it prevents recuts, will probably save time in the long run. ExactechGPS navigation already gets past many of the hurdles to the adoption of CAOS. Its accuracy has been validated. TKA Plus takes the next step toward mainstream use of navigation by incorporating it into our standard mechanical instrumentation. Future plans with TKA Plus may incorporate sizing and femoral rotation.


References

1. Hetaimish BM et al. Meta-analysis of navigation versus conventional total knee arthroplasty. Journal of Arthroplasty, 2012 Jun;27(6):1177-82.
2. Jeffery RS et al. Coronal alignment after total knee replacement. Journal of Bone and Joint Surgery Br, 1991 Sep;73(5):709-14.
3. Berend ME et al. Tibial component failure mechanisms in total knee arthroplasty. Clinical Orthopaedics and Related Research, 2004 Nov;(428):26-34.
4. Collier MB et al. Factors associated with the loss of thickness of polyethylene tibial bearings after knee arthroplasty. Journal of Bone and Joint Surgery Am, 2007 Jun;89(6):1306-14.
5. Australian Orthopedic Association, National Joint Replacement Registry, Annual Report 2013 – Hip and Knee Arthroplasty.
6. Rebal BA et al. Imageless computer navigation in total knee arthroplasty provides superior short term functional outcomes: a meta-analysis. Journal of Arthroplasty, 2014 May;29(5):938-44.
7. Cates HE et al. Intramedullary versus extramedullary femoral alignment systems in total knee arthroplasty. Clinical Orthopaedics and Related Research, 1993 Jan;(286):32-9.
8. Teter KE et al. The efficacy of intramedullary femoral alignment in total knee replacement. Clinical Orthopaedics and Related Research, 1995 Dec;(321):117-21.

Tags: , ,

A New Perspective in Total Ankle Arthroplasty

Mark Easley, MD
Duke Health

I have had the distinct privilege serving on the Exactech total ankle design team with three other surgeons, my Duke University partners Jim DeOrio, MD and Jim Nunley, MD and our Swiss colleague, Victor Valderrabano, MD. Over the past 25 years we have had extensive experience with most every major total ankle system, including fixed- and mobile-bearing designs. Jim, Jim and Victor are unequivocally international thought leaders in total ankle arthroplasty (TAA). As a group, arguably we have unparalleled clinical and research experience with TAA.1-5 Each of us has formulated potential improvements to the existing body of knowledge of TAA and has had some hand in the improvement of existing total ankle systems or development of potential new systems. Roughly five years ago, we realized that our collective efforts would be far more effective.

Exactech offered the perfect opportunity for the four of us to optimize our contributions to optimal treatment of patients with end-stage ankle arthritis. The Exactech team of Matt Hamilton, PhD (Manager of Lower Extremity Engineering), Steve Norton (Product Development Engineer), Medhut Alnadi (Product Design Engineer), Phong Diep (Sr. Designer), Emery Patton (Director of Marketing), and Rick Andrews (Sr. Product Manager), with its experience in Exactech’s other joint arthroplasty systems, provided us with the engineering and implant development expertise needed to convert our visions into a superior and practical total ankle implant. The combination of our surgical experience and the Exactech’s team’s talent for implant development proved to be ideal.

The Vantage® Total Ankle System incorporates numerous features favored in currently used total ankle designs while introducing several new ones. What especially stands out for the Vantage is that rather than use imaging or cadaver specimens of physiologic normal ankles, 73 CT scans of arthritic ankles served as the template to optimize the tibial and talar implant backside designs.6 The Vantage is available in both fixed- and mobile-bearing designs. The fixed-bearing implant is cleared for sale in the United States, and the mobile-bearing implant is cleared for sale in Europe, as of this writing.

 

Figure 1. The Vantage tibial component features a recessed area to accommodate the fibula while maximizing tibial component cortical support.

Figure 1. The Vantage tibial component features a recessed area to accommodate the fibula while maximizing tibial component cortical support.

The Vantage tibial component maximizes the contact area on the prepared tibial plafond surface, featuring a recessed area to accommodate the fibula while maximizing tibial component cortical support. (Figure 1) To diminish joint fluid gaining access to the tibial component’s backside and creating component loosening, recent trends in TAA technique favor not violating the anterior tibial cortex.

Figure 2. Recent trends in TAA technique favor not violating the anterior tibial cortex.

Figure 2. Recent trends in TAA technique favor not violating the anterior tibial cortex.

(Figure 2) The Vantage’s technique confers the advantage of vertically oriented tibial component fixation in contrast to most other modern systems that utilize obliquely orientated tibial pegs to avoid violating the anterior tibial cortex or traditional horizontally oriented tibial fixation that require anterior tibial cortex penetration.

Figure 3. The Vantage’s technique confers the advantage of vertically oriented tibial component fixation.

Figure 3. The Vantage’s technique confers the advantage of vertically oriented tibial component fixation.

(Figure 3) Finite element modeling suggests that vertically oriented pegs provide ideal loading characteristics on the tibial bone-implant interface, thereby diminishing the risk of eccentric stresses, stress shielding and the chance of tibial component loosening.

Figure 4. Finite element modeling suggests that vertically oriented pegs provide ideal loading characteristics on the tibial bone-implant interface.

Figure 4. Finite element modeling suggests that vertically oriented pegs provide ideal loading characteristics on the tibial bone-implant interface.

(Figure 4) Moreover, the Vantage tibial component’s central cage, similar to the cage featured on the Exactech reverse total shoulder system, affords not only reliable press-fit fixation but adds the potential for bone ingrowth and superior long-term fixation.

Figure 5. The Vantage tibial component’s central cage affords not only reliable press-fit fixation but adds the potential for bone ingrowth and superior long-term fixation.

Figure 5. The Vantage tibial component’s central cage affords not only reliable press-fit fixation but adds the potential for bone ingrowth and superior long-term fixation.

Figure 6. The instrumentation to prepare the tibia for vertical peg and cage orientation is unique and simple to use.

Figure 6. The instrumentation to prepare the tibia for vertical peg and cageorientation is unique and simple to use.

(Figure 5) The instrumentation to prepare the tibia for vertical peg and cage orientation is unique and simple to use (Figure 6); the Exactech engineering team was brilliant in creating this impaction system disproving many doubters, including myself, that such an impactor could be safely introduced despite the ankle joint’s relatively limited access. The Vantage talar component’s backside has a uniform curve that optimizes compressive forces on the prepared dome-shaped talus throughout the ankle’s full range of motion. In contrast, nearly all competitors’ talar components provide alarm component stability via chamfer cuts that tend to create the potential for shear stresses. (Figure 5) One recently released total ankle system, features a uniform dome-shaped talar preparation like that of the Vantage but requires a lateral approach and fibular osteotomy for component implantation. The Vantage’ talar component confers the same talar component advantages via the far more commonly used anterior approach and does not require a fibular osteotomy. Unique to the Vantage total ankle system, a simple manual rasp is used to complete the uniform talar dome preparation.

Figure 7. A simple manual rasp is used to complete the uniform talar dome preparation.

Figure 7. A simple manual rasp is used to complete the uniform talar dome preparation.

(Figure 7) Two anterior pegs designed to provide initial component stability do not detract from the uniformly compressive forces throughout the range of motion. The central talar component sulcus on the components articulating surface maintains the Vantage’s coronal plane stability for the polyethylene and ankle.

Based on the successful Exactech total knee polyethylene implant, the Vantage’s polyethylene component, affords high fracture toughness and low wear rates. The polyethylene, with its congruent articulation on the talar component, affords satisfactory coronal plane ankle stability without creating undue constraint. (Figure 2) Unique to the Vantage fixed-bearing total ankle system is the locking clip technology that secures the polyethylene to the tibial tray. (Figure 8) Through exhaustive stress and cyclic load testing, the Vantage team of engineers confirmed that the locking clip maintains satisfactory polyethylene fixation to the tibial tray; yet, extraction is easy should the polyethylene need to be exchanged.

Figure 8. Unique to the Vantage fixed-bearing total ankle system is the locking clip technology that secures the polyethylene to the tibial tray.

Figure 8. Unique to the Vantage fixed-bearing total ankle system is the locking clip technology that secures the polyethylene to the tibial tray.

Our ankle design team spent the better part of four years devising and perfecting the Vantage surgical technique. Our initial thoughts favored sophistication and complexity to confer advantages over the competitors’ ankles. However, complexity and its accompanying frustrations soon gave way to simplicity. The current surgical technique and instrumentation is remarkably straightforward. I recently taught a Vantage cadaver lab to a group of residents; none of the residents had prior experience performing a total ankle replacement. I can confidently state that the residents’ implanted Vantage ankles were on par with the first Vantage cadaveric ankle implantations of nearly every experienced foot and ankle surgeon at our training labs. The external tibial alignment guide is reliable in properly orienting the tibial cut, and punching the relief areas for the tibial component pegs and cage is easily learned. Talar preparation is uncomplicated, with reproducible positioning of the talar component in both the coronal and sagittal planes (Figure 9); creating the uniform talar dome arc is facilitated by the user-friendly manual rasp.

Figure 9. Talar preparation is uncomplicated, with reproducible positioning of the talar component in both the coronal and sagittal planes.

Figure 9. Talar preparation is uncomplicated, with reproducible positioning of the talar component in both the coronal and sagittal planes.

 

September 30, 2017 was the one-year anniversary of the first Vantage total ankle implantation, a fixed-bearing ankle that Dr. Nunley and I performed at Duke University Medical Center. Since then my Duke colleagues and I have performed more than 100 Vantage total ankles, have trained numerous foot and ankle specialists throughout the United States and have seen the first wave of successful Vantage implantations by a talented group of surgeons that now favor the Vantage for treating end-stage ankle arthritis. Dr. Valderrabano will soon begin implanting the mobile-bearing Vantage in Switzerland and train many European foot and ankle specialists.

Figure 8. Unique to the Vantage fixed-bearing total ankle system is the locking clip technology that secures the polyethylene to the tibial tray.

Figure 8. Unique to the Vantage fixed-bearing total ankle system is the
locking clip technology that secures the polyethylene to the tibial tray.

 

 

 

 

 

 

 

 

 

Follow-up is too short at this point to report outcomes for the Vantage. However, my colleagues and I have been collecting data on every Vantage that we implant, including validated patient-reported outcomes, accepted objective outcomes measures and standardized radiographic evaluations. (Fig 10 A and B) To date, our observations reflect high patient satisfaction, low complication rates and a trend toward favorable range of motion confirmed with objective postoperative radiographic dorsiflexion and plantarflexion measurements. While my colleagues and I initially limited the Vantage to end-stage ankle arthritis with minimal deformity, more recently we expanded indications to include varus and valgus ankle arthritis. At early follow-up our results are equally favorable for end-stage ankle arthritis with and without deformity.

The future of the Vantage is, in my mind, rather bright. Within the next six months the Exactech team of engineers anticipates completion of a dome-replacing “flat top” talus that will allow surgeons to safely perform TAA for ankle arthritis associated with talar dome cysts, focal AVN, and extensive talar dome wear.* The dome-replacing talar component will also be used in revision TAA.* We have also begun designing an augmented tibial component for ankle arthritis associated with a deficient distal tibia or for revision surgery. Although some competitors have similar augmented or revision components, they lack the advantages of the Vantage total ankle design. Computer-assisted orthopaedic surgery and patient-specific options for the Vantage are planned. Drs. DeOrio, Nunley, Valderrabano and I look forward to the continued success working with Exactech’s ankle design team.


References

1.Stewart MG, Green CL, Adams SB Jr, DeOrio JK, Easley ME, Nunley JA. Midterm Results of the Salto Talaris Total Ankle Arthroplasty. Foot Ankle Int. 2017 Jul 1:1071100717719756. doi: 10.1177/1071100717719756. [Epub ahead of print]
2. Adams SB Jr, Demetracopoulos CA, Queen RM, Easley ME, DeOrio JK, Nunley JA. Early to mid-term results of fixed-bearing total ankle arthroplasty with a modular intramedullary tibial component. J Bone Joint Surg Am. 2014 Dec 3;96(23):1983-9. doi: 10.2106/JBJS.M.01386.
3. Queen RM, Sparling TL, Butler RJ, Adams SB Jr, DeOrio JK, Easley ME, Nunley JA. Patient-Reported Outcomes, Function, and Gait Mechanics After Fixed and Mobile-Bearing Total Ankle Replacement. J Bone Joint Surg Am. 2014 Jun 18;96(12):987-993.                              4. Nunley JA, Caputo AM, Easley ME, Cook C. Intermediate to long-term outcomes of the STAR Total Ankle Replacement: the patient perspective. J Bone Joint Surg Am. 2012 Jan 4;94(1):43-8. doi: 10.2106/JBJS.J.01613.
5. Brunner S, Barg A, Knupp M, Zwicky L, Kapron AL, Valderrabano V, Hintermann B. The Scandinavian total ankle replacement: long-term, eleven to fifteen-year, survivorship analysis of the prosthesis in seventytwo consecutive patients. J Bone Joint Surg Am. 2013 Apr 17;95(8):711-8. doi: 10.2106/JBJS.K.01580.
6. Wiewiorski M, Hoechel S, Anderson AE, Nowakowski AM, DeOrio JK, Easley ME, Nunley JA, Valderrabano V, Barg A. Computed Tomographic Evaluation of Joint Geometry in Patients With End-
Stage Ankle Osteoarthritis. Foot Ankle Int. 2016 Jun;37(6):644-51. doi: 10.1177/1071100716629777. Epub 2016 Feb 3.

Tags:

Additive Manufacturing Technology for Orthopaedic Implants

Laurent Angibaud, Dipl. Ing.
Exactech, Inc.

Additive manufacturing, also known as 3D printing, is a process that creates a three-dimensional object by building successive layers of raw material, such as metal, plastic, tissue scaffolds, concrete and even food. Each new layer is attached to the previous one until the object is complete, as opposed to subtractive manufacturing methodologies, such as traditional machining. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or an MRI image.

IS ADDITIVE MANUFACTURING A “NEW” TECHNOLOGY?

The first 3D printing processes were developed in the 1980s, patents were developed in the 1990s and with the first metal 3D technologies were introduced in the early 2000s. Low-cost 3D printing companies started to emerge in 2005, and the technology has grown exponentially since. In 2005, additive manufacturing was a $750 million market; today it has grown to more than $5 billion.1 The number of 3D technology manufacturers has grown from 14 in January 2012 to 431 as of September 2016.1

 

The application of 3D printing for orthopedic implants can provide many benefits, including: the customization and personalization of implants, cost effectiveness, increased productivity as well as the democratization of design and manufacturing.

IS ADDITIVE MANUFACTURING FOR PROTOTYPES ONLY?

This technology has moved well beyond prototyping, rapid tooling and toys. Additive manufacturing is creating durable and safe products for sale to real customers in moderate to large quantities. For example, one out of every 30 hip surgeries involves components that come from an Arcam Electron Beam Melting (EBM) system.2 Patient specific cutting blocks or pin guides are manufactured at a quantity of almost 100,000 per year.3,4 More than 10,000,000 hearing aid components have been manufactured by additive manufacturing.5

WHAT ARE THE ADVANTAGES OF ADDITIVE MANUFACTURING?

The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures (e.g., porous structure). An engineer can design the surgeon’s part as he or she envisions it without manufacturing constraints. This “manufacturing on demand” process streamlines the supply chain and can save hospitals on the cost of inventory. Additive manufacturing is a green technology. Because only the material that is needed is used, there is very little (if any) material wasted. These capabilities have sparked huge interest in 3D printing of medical devices.

EXACTECH EXPERIENCE WITH ADDITIVE MANUFACTURING

In 2016, Exactech confirmed the purchase of two Arcam Q10plus machines to expand its in-house manufacturing capabilities. This investment will advance Exactech’s long-term commitment to additive manufacturing technology. “Integrating the Arcam Q10plus technology into our operations will bring numerous benefits to our already robust manufacturing systems,” said Raymond Cloutier, Exactech vice president of engineering & development for spine. “In 2010, Exactech became the first company to receive FDA clearance for a 3-D printed orthopaedic implant and has since received multiple additional clearances for other implants. We will now be able to leverage this knowledge and experience to enhance the design of our hip, knee, extremities and spine implants, reduce product development lead times and further supplement supply.” The Arcam Q10plus is Arcam’s latest Electron Beam Melting (EBM) machine that has been designed specifically for cost-efficient production of orthopaedic implants. Studies have shown that build times can be reduced up to 25 percent with improved surface finishes, compared to previous generations of EBM systems.6 “Exactech was the first company in the U.S. to mass-produce medical implants using additive manufacturing. We are happy to see their confidence in our EBM technology and in the Arcam Q10plus as a volume production system for the medical device industry. We truly look forward to partnering with Exactech to grow production of their joint restoration products,” said Arcam Chief Executive Officer Magnus René.

WHAT ARE THE LIMITATIONS?

The application of 3D printing for orthopedic implants can provide many benefits, including: the customization and personalization of implants, cost-effectiveness, increased productivity as well as the democratization of design and manufacturing.

However, it should be cautioned that despite recent significant and exciting medical advances involving 3D printing, notable scientific and regulatory challenges remain and the most transformative applications for this technology will need time to evolve. Design complexity makes post process inspection and qualification challenging. The FDA has cleared more than 85 3D printed medical devices, but from a Regulatory perspective, it is difficult to keep up with the pace of this fast-moving technology.

The additive manufacturing process occurs “layer by layer”; which introduces anisotropy in mechanical properties resulting in high strength in the transverse plane, but lower strength along the vertical axis. This aspect is mainly a concern for small implant under substantial loading.

An engineer can design the surgeon’s part as he or she envisions it without manufacturing constraints.

CONCLUSION

Additive manufacturing is both the present and the future. It is likely to have an enormous impact on all our lives, but that doesn’t mean it is going to be good for every business. As the technology continues to evolve, the orthopaedic industry will be paying attention to its benefits as well as its limitations.


References

1. Espen Sivertsen. A Brief History of Additive Manufacturing. www.typeamachines.com
2. Michael Petch. 3D Printing Metal Interview with Arcam CEO Magnus René. www.3dprintingindustry.com
3. Thienpoint E et al. Patient-specific instruments: industry’s innovation with a surgeon’s interest. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2227-33
4. Gabelli & Company, Inc. Inside 3D printing conference and industry review. www.gabelli.com
5. Rakesh Sharma. The 3D Printing Revolution You Have Not Heard About. www.forbes.com
6. Data on file at Arcam

Tags: