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Longitudinal Analysis of Shoulder Arthroplasty Utilization, Clinical Outcomes, and Value: a Comparative Assessment of Changes in Improvement Over 15 Years with a Single Platform Shoulder Prosthesis
Roche, Christopher P; Jones, Richard; Routman, Howard; Marczuk, Yann; Flurin, Pierre-Henri; Wright, Thomas W; Zuckerman, Joseph D
BACKGROUND:The goal of this longitudinal analysis of aTSA and rTSA utilization from 2007-2021 is to quantify changes in clinical outcomes, cost, and value, resulting from the introduction and adoption of new shoulder arthroplasty technologies. METHODS:We analyzed an international database of a single shoulder arthroplasty prosthesis (Equinoxe; Exactech, Inc; Gainesville, FL, USA) for all clinical sites that have continuously enrolled cases from 2007 to 2021 to compare changes in primary aTSA and primary rTSA utilization and outcomes across three, 5-year cohorts based upon the date of implantation. A value analysis was conducted across the 5-year implantation cohorts, with value measured by the ratio of each postoperative outcome measure at 24-36 months and 36-60 months after surgery and the average implant selling price each year for the US sites in constant 2007 US dollars, these measures of value were compared between cohorts to quantify the impact of new technology introduced over the study period. RESULTS:A dramatic increase in rTSA utilization was observed across the 6 sites over the 15-year study period, along with a rapid adoption of new aTSA and rTSA technologies. The average patient receiving primary aTSA and primary rTSA changed over the 15-year study period, with significant shifts in diagnosis, comorbidities, and preoperative functional status. A comparison of postoperative results demonstrated that both aTSA and rTSA clinical and radiographic outcomes showed improvement relative to 2007-2011. Over this 15-year study period, the average aTSA implant selling price has been relatively stable while the average rTSA implant selling price has significantly declined. As a result, the value associated with the Equinoxe rTSA significantly increased for nearly every outcome measure at 24-36 months and 36-60 months after surgery, while value associated with the Equinoxe aTSA stayed relatively constant from 2007-2021. CONCLUSION/CONCLUSIONS:Our 6,042-patient longitudinal analysis quantified numerous changes in utilization, outcomes, and value across 6 clinical sites over the past 15-years. Rapid adoption of new aTSA and rTSA technologies was observed and clinical and radiographic outcomes improved relative to 2007-2011. These clinical improvements, in combination with steady aTSA and declining rTSA implant prices, have driven rTSA value to continuously increase while aTSA value has been maintained at a high-level over the 15-year study period with this particular shoulder arthroplasty system, even when considering the cost and adoption of new technologies.
PMID: 36681103
ISSN: 1532-6500
CID: 5419352
International Consensus Statement on the Management of Glenohumeral Arthritis in Patients ≤ 50 Years Old
Colasanti, Christopher A; Lin, Charles C; Simovitch, Ryan W; Virk, Mandeep S; Zuckerman, Joseph D
BACKGROUND:The purpose of this study was to implement a modified Delphi technique among a group of experts affiliated with American Shoulder and Elbow Surgeons (ASES) and European Society for Surgery of the Shoulder and Elbow (SECEC) to determine areas of consensus regarding what factors influence their decision to manage a patient surgically and what specific treatment modalities they utilize for patients ≤ 50 years of age with glenohumeral arthritis (GHA). METHODS:The panel of experts comprised 168 shoulder and elbow specialists, 138 ASES and 30 SECEC members. In the first round, an open-ended questionnaire was utilized to solicit features that are important in making decisions regarding treatment. The second round involved ranking the features identified in the first round as to their importance in helping decision making for surgery. The results of round two were then utilized and 18 complex surgical cases previously treated by one of the lead authors were provided for the study. One additional case was included to address the management of Cutibacterium acne (C.Acne) infection. RESULTS:159 (95.0%) participants completed the round one survey, 142 (89%) responded to the second and third round survey. In total 50 individual factors were positively associated with the decision to proceed with surgery. Ten of these were strongly supportive of surgery. Eight out of 18 clinical cases demonstrated >80% agreement on the surgical treatment modality chosen. Over 90% of respondents chose rTSA to manage pathology when an incompetent rotator cuff was present. Over 90% of respondents managed AVN with hemiarthroplasty (HA). Over 70% of respondents chose aTSA for inflammatory arthritis with low demand on their shoulder. 79% of respondents chose a stemless humeral component when a HA or aTSA was chosen in response to the proposed surgical cases. If arthroscopy was chosen there was good agreement on five core procedures. There was only fair consensus on the approach to C.acnes in patients with GH OA≤ 50 years of age. CONCLUSION/CONCLUSIONS:The optimal treatment of glenohumeral arthritis in patients ≤ 50 years of age remains controversial, and there are many treatment options to consider when responding to the variety of clinical presentations and anatomic pathologies. While physicians and patients engage in the shared decision-making process regarding the final choice for management, this consensus statement serves as a basis for discussion amongst colleagues and between patients and surgeons though it clearly demonstrates that the topic must be further investigated prospectively and with large cohorts.
PMID: 36736654
ISSN: 1532-6500
CID: 5420582
Impact of Accumulating Risk Factors on the Acromial and Scapular Fracture Rate after Reverse Total Shoulder Arthroplasty with a Medialized Glenoid/Lateralized Humerus Onlay Prosthesis
Roche, Christopher P; Fan, Wen; Simovitch, Ryan; Wright, Thomas; Flurin, Pierre-Henri; Zuckerman, Joseph D; Routman, Howard
BACKGROUND:Identifying risk factors for acromial and scapular fractures improves our understanding about which variables are relevant to this fracture complication; however, this data is difficult to integrate into clinical practice because the majority of rTSA patients have 1 or more risk factors. The goal of this study is to better facilitate preoperative identification of patients at-risk for acromial and scapular fracture and quantify the impact of accumulating risk factors on the incidence of fracture. METHODS:We retrospectively analyzed 9,079 rTSA patients from a multi-center database of a single medialized glenoid/lateralized humerus onlay rTSA prosthesis to quantify the rate of acromial and scapular fractures. A univariate and multivariate analysis was performed to identify risk factors for fracture. Next, we quantified the number of patients with one or multiple significant risk factors for fracture. Finally, to facilitate preoperative identification of patients most at-risk for fracture, we stratified our dataset by multiple combinations of age, gender, and diagnosis risk factors and calculated the odds ratio for each cohort to quantify the impact of accumulating risk factors on the incidence of fracture. RESULTS:138 of 9,079 patients were radiographically identified to have a fracture of the acromion or scapula for a rate of 1.52%. Patients with fractures were more likely older, female, more likely to have a RA diagnosis, CTA diagnosis, and less likely to have diabetes diagnosis. 85% of rTSA patients had at least 1 fracture risk factor. Individually, age, gender, or diagnosis failed to identify any patient cohort with an odds ratio >2.5. Use of multiple combinations of patient risk factors refined identification of at-risk patients better than any individual or 2-risk factor combination and demonstrated that the patients with the greatest fracture risk were females with RA diagnosis >70 years, >75 years, and >80 years. CONCLUSION/CONCLUSIONS:This 9,079 rTSA multi-center study demonstrated that 1.52% of patients experienced acromial and/or scapular fractures with single medialized glenoid/lateralized humerus onlay rTSA prosthesis. Our analysis identified numerous risk factors and quantified the impact of accumulating risk factors on fracture incidence. Patients considering rTSA with these age, gender, and diagnosis risk factors should be made aware of their elevated complication risk.
PMID: 36731625
ISSN: 1532-6500
CID: 5420492
High Intraoperative Accuracy and Low Complication Rate For Computer Assisted Navigation Of The Glenoid In Total Shoulder Arthroplasty
Larose, Gabriel; Greene, Alexander T; Jung, Amaury; Polakovic, Sandrine V; Davis, Noah Z; Zuckerman, Joseph D; Virk, Mandeep S
BACKGROUND:Preoperative planning software and intraoperative guidance technology is being increasingly used for managing complex glenoid deformity in anatomic and reverse total shoulder arthroplasty (aTSA; rTSA). The aim of this study is to review the intraoperative efficacy and complications of computer assisted navigation (CAN) surgery for treating glenoid deformity in TSA. METHODS:A retrospective review was performed of all the TSAs implanted using a single computer navigation shoulder system. All patients underwent preoperative planning using a CT based preoperative planning software. The starting point on the glenoid, and the final version and inclination of the central post (cage) of the glenoid component were reviewed on the intraoperative navigation guidance report and compared to these parameters on the preoperative plan for each patient. The intraoperative accuracy of CAN for the glenoid was determined by the deviation of the starting point and final position of the central cage drill in the glenoid compared to preoperative plan. Intraoperative complications and the number of times the navigation system was abandoned intraoperatively were collected. RESULTS:A total of 16,723 aTSAs and rTSAs performed worldwide with this navigation system were included in this review. 16,368 cases (98%) completed every step in the navigation procedure without abandoning use of the system intraoperatively. There was minimal deviation in the intraoperative execution of the preoperative plan with respect to version (0.6° ± 1.96°), inclination (0.2° ± 2.04°) and starting point on the glenoid face (1.90mm ± 1.2 mm). There were 9 coracoid fractures (0.05%) reported in this cohort. CONCLUSION/CONCLUSIONS:And Discussion: This study demonstrates the safety and efficacy of computer assisted navigation for glenoid implantation in TSA. Future studies should continue to focus on the impact of CAN on longevity and survival of the glenoid component and improve cost-effectiveness of this technology.
PMID: 36681107
ISSN: 1532-6500
CID: 5419362
The Shoulder Arthroplasty Smart Score Correlates Well With Legacy Outcome Scores Without a Ceiling Effect
King, Joseph J; Wright, Logan; Hao, Kevin A; Roche, Christopher; Wright, Thomas W; Vasilopoulos, Terrie; Zuckerman, Joseph D; Flurin, Pierre-Henri; Schoch, Bradley S
BACKGROUND:The Shoulder Arthroplasty Smart (SAS) score is a new, validated machine learning-derived outcome measure that requires six input parameters. The SAS score has the potential to replace legacy shoulder outcome scores. METHODS:We conducted a retrospective review of a multinational shoulder arthroplasty database of one platform shoulder prosthesis (used interchangeably for anatomic and reverse total shoulder arthroplasty). All primary shoulder arthroplasties with a minimum of two-year follow-up and an available SAS score were evaluated. Associations between scoring systems were assessed using Pearson correlations, with 95% confidence intervals stratified by time point (preoperatively and postoperatively at 2- and 5-year follow-ups, respectively) and procedure (anatomic verses reverse total shoulder arthroplasty). Conversion equations were developed using the best-fit line from linear regression analysis. Ceiling effects were assessed based on two definitions: (1) >15% of participants scoring the maximal possible score and (2) a standardized distance less than 1.0, whereby the standardized distance is calculated by subtracting the mean from the maximal score and dividing by the standard deviation. RESULTS:Two thousand four hundred six shoulders were evaluated at 4,553 clinical encounters. For preoperatively collected data, the SAS score correlated strongly with the Constant (R = 0.83), University of California at Los Angeles (R = 0.85), and Shoulder Pain and Disability Index (R = -0.70) scores and moderately with the American Shoulder and Elbow Surgeons (R = 0.69) and Simple Shoulder Test (R = 0.65) scores. The SAS score strongly correlated (R > 0.7) with all legacy outcome scores collected at 2- and 5-year postoperative visits. Score predictions made using the conversion equations between the SAS score and legacy outcome scores strongly correlated with their actual values. Neither the SAS nor the Constant score were influenced by ceiling effects. All other outcome scores evaluated demonstrated ceiling effects. CONCLUSION/CONCLUSIONS:The SAS score correlates well with legacy shoulder scores after primary shoulder arthroplasty while mitigating ceiling effects. Surgeons may decrease patient questionnaire burden by using the brief six-question SAS score.
PMID: 36580051
ISSN: 1940-5480
CID: 5409672
Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper extremity PROMIS scores following arthroscopic rotator cuff repairs
Alben, Matthew G; Gordon, Dan; Gambhir, Neil; Kim, Matthew T; Romeo, Paul V; Rokito, Andrew S; Zuckerman, Joseph D; Virk, Mandeep S
PURPOSE/OBJECTIVE:To calculate and determine what factors are associated with achieving the Minimal Clinically Important Difference (MCID) and the Substantial Clinical Benefit (SCB) of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Testing v2.0 (UE), Pain Interference (P-Interference), and Pain Intensity (P-Intensity) in patients undergoing arthroscopic rotator cuff repair (aRCR). METHODS:The change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve analysis was used to calculate the anchor-based MCID and SCB. To assess the responsiveness of each PROM, effect sizes and standardized response means (SRM) were calculated. To identify factors associated with attaining the MCID and SCB, univariate and multivariate logistic regression analyses were performed. RESULTS:A total of 323 patients with an average age of 59.9 ± 9.5 were enrolled in this study, of which, 187/323 [57.9%] were male and 136/323 [42.1%] were female. The anchor-based MCID for PROMIS UE, P-Interference, and P-Intensity was: 9.0, 7.5, and 11.2, respectively. The respective SCB was 10.9, 9.3, and 12.7. Effect size and SRM were: PROMIS UE (1.4, 1.3), P-Interference (1.8, 1.5), and P-Intensity (2.3, 2.0). Lower preoperative P-Intensity scores (p = 0.02), dominant arm involvement (p = 0.03), and concomitant biceps tenodesis (p = 0.03) were associated with patients achieving the SCB for PROMIS UE. CONCLUSION/CONCLUSIONS:A large responsiveness for each of the PROMIS instruments due to the majority of patients reporting great improvement after aRCR and a small standard deviation across all outcome measures was shown in our study. Lower preoperative P-Intensity scores and concomitant biceps tenodesis were associated with higher odds of achieving the SCB for PROMIS UE. The knowledge of MCID and SCB values for PROMIS instruments will allow the surgeon to determine whether the improvements in the PROMIS scores after aRCR are clinically meaningful. LEVEL OF EVIDENCE/METHODS:Level III.
PMID: 36622420
ISSN: 1433-7347
CID: 5399362
Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) of upper extremity PROMIS scores in idiopathic adhesive capsulitis
Alben, Matthew G; Gambhir, Neil; Shankar, Dhruv; Gordon, Dan; Zuckerman, Joseph D; Virk, Mandeep S
INTRODUCTION/BACKGROUND:The purpose of this study is to calculate the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Testing v2.0 (UE), Pain Interference (P-Interference), and Pain Intensity (P-Intensity) in patients treated nonoperatively for idiopathic adhesive capsulitis (IAC). METHODS:The anchor-based MCID, SCB, and PASS were calculated as the change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve (AUC) analysis. The distribution-based MCID was calculated as a range between the average standard error of measurement multiplied by two different constants: 1 and 2.77. Effect sizes and standardized response means (SRM) were calculated to assess the responsiveness of each PROMIS instrument while regression analyses were performed to identify factors associated with achieving these thresholds. RESULTS:This study enrolled 115 patients. The anchor-based MCID for PROMIS UE, P-Interference, and P-Intensity was 5.11, 4.16, and 8.16, respectively. The respective SCB was 8.44, 6.65, and 10.05. The respective PASS was 8.47, 7.01, and 10.41. The odds of achieving MCID values in adhesive capsulitis were negatively affected by gender (male), higher forward elevation at the time of presentation, higher pain scores (P-Interference), need for ≥ 2 corticosteroid injections, and a concomitant diagnosis of diabetes. CONCLUSION/CONCLUSIONS:The MCID, SCB, and PASS parameters for PROMIS scores can be utilized to determine the clinical meaningfulness of patient-reported improvements in these instruments during the nonoperative treatment and as a research tool to compare the efficacy of new treatments for adhesive capsulitis. LEVEL OF EVIDENCE/METHODS:Level III, basic science study, validation of outcome instruments. Key points • This is the first study to calculate the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for the Patient-Reported Outcome Measurement Information System (PROMIS) Upper Extremity and Pain instruments in patients with idiopathic adhesive capsulitis (IAC) of the shoulder.• This study determined the impact of symptom severity, demographics, and comorbidities on achieving the MCID, SCB, and PASS for PROMIS instruments in IAC patients treated nonoperatively.
PMID: 36547817
ISSN: 1434-9949
CID: 5399352
Augmented Baseplates Yield Optimum Outcomes When Compared to Bone Graft Augmentation for Managing Glenoid Deformity During Reverse Total Shoulder Arthroplasty-A Retrospective Comparative Study
Colasanti, Christopher A; Lin, Charles C; Ross, Keir; Luthringer, Tyler; Elwell, Josie A; Roche, Christopher; Virk, Mandeep S; Simovitch, Ryan W; Routman, Howard D; Zuckerman, Joseph D
PURPOSE/OBJECTIVE:The purpose of this study was to compare the outcomes of primary rTSA utilizing glenoid bone grafting (BG rTSA) to primary rTSA utilizing augmented glenoid baseplates (Aug rTSA) with a minimum 2-year follow-up. METHODS:520 primary rTSA patients treated with 8° posterior glenoid augments (n=246), 10° superior glenoid augments (n=97), or combined 10° superior/8° posterior glenoid augments (n=177) were compared to 47 patients undergoing glenoid bone grafting for glenoid bone insufficiency. Mean follow-up of 37.0(±16) and 53.0(±27) months. Outcomes were analyzed preoperatively and at the latest follow-up using conventional statistics and stratification by minimum clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds where applicable. Radiographs were analyzed for baseplate failure and the incidence of postoperative complications and revisions were recorded. RESULTS:The glenoid Aug rTSA cohort had greater improvements in patient reported outcome measures (PROMs) and ROM when compared to the BG rTSA group at a minimum of 2-year follow-up including: simple shoulder test (SST), Constant Score, American Shoulder and Elbow Surgeons (ASES)score, University of California Los Angeles (UCLA)score, Shoulder Pain and Disability Index (SPADI)score, Shoulder Function, Shoulder Arthroplasty Smart (SAS)score, abduction, and external rotation(p<0.05). Patient satisfaction was higher in Aug rTSA group compared to BG rTSA group(p=0.006). The utilization of an augmented glenoid component instead of glenoid bone grafting resulted in approximately 50% less total intraoperative time (p<0.001), nearly 33% less intraoperative blood loss volume (p<0.001), approximately threefold less scapular notching (p<0.01) and approximately fifteenfold less adverse events requiring revision (p<0.01) when compared to BG rTSA cohort. Aside from SCB for abduction, the Aug rTSA cohort achieved higher rates of exceeding MCID and SCB for every PROM compared to BG rTSA. More specifically, 77.6% and 70.2% of the Aug rTSA achieved SCB for ASES and SPADI versus 55% and 48.6% in the BG rTSA, respectively(p=0.003 and p=0.013). CONCLUSION/CONCLUSIONS:The present midterm clinical and radiographic study demonstrates that the utilization of an augmented base plate for insufficient glenoid bone stock is superior as judged by multiple PROMs and ROM metrics when compared to bone graft augmentation at minimum 2-year follow-up. Additionally, when analyzed according to MCID and SCB thresholds, the use of augmented baseplates outperforms the use of glenoid bone grafting. Complication and revision rates also favor the use of augmented glenoid baseplates over glenoid bone grafting. Long-term clinical and radiographic follow-up is necessary to confirm that these promising mid-term results are durable.
PMID: 36400341
ISSN: 1532-6500
CID: 5385052
Impact of Mental Health on Outcomes After Total Shoulder Arthroplasty
Colasanti, Christopher A; Lin, Charles C; Anil, Utkarsh; Simovitch, Ryan W; Virk, Mandeep S; Zuckerman, Joseph D
BACKGROUND:Anxiety and depression are the two most commonly diagnosed psychiatric disorders in the US. The effect of these disorders on total shoulder arthroplasty (TSA) outcomes must be appreciated. The purpose of this study was to examine the correlation between preoperative diagnosis of anxiety and depression and its association with postoperative outcomes after TSA. The secondary goals were to determine whether patients contemporaneously being treated with medicine for their mental health diagnosis fared better than a non-medicated cohort and to examine the degree to which PROMIS Mental Health (PROMIS-MH) scores correlate with patient outcomes. Our hypothesis is that a history of anxiety and/or depression will negatively impact patient outcomes after TSA. METHODS:A retrospective analysis was performed on a prospectively collected cohort at a single institution. Anatomic and reverse TSA patients (aTSA, rTSA) with either anxiety and/or depression (aTSApsych+, rTSApsych+) were identified and compared to a cohort of patients without a mental health diagnosis enrolled in an institutional registry from 2011 to 2020. Demographic characteristics, diagnoses, implant type, range of motion (ROM), adverse events (AE) and clinical outcome metric scores:PROMIS-MH, American Shoulder and Elbow Surgeons (ASES), Constant, Shoulder Arthroplasty Smart Score (SAS) were recorded. Outcomes between cohorts were analyzed using conventional statistics as well as stratification by MCID and SCB thresholds where applicable. RESULTS:218 patients (114 rTSA and 95 aTSA) had a diagnosis of either anxiety and/or depression and 378 (153 rTSA and 217 aTSA) had no history. Although both cohorts achieved MCID and SCB for postoperative ASES, the psych+ cohort resulted in lower postoperative outcomes scores (p<0.05), higher AE, and significantly lower Δ differences in all variables when compared to the psych negative cohort. There were no differences in outcome scores after rTSApsych+ or aTSApsych+ between patients being treated for anxiety/depression compared to not receiving treatment. PROMIS-MH score was positively correlated with postoperative outcomes and patient satisfaction. CONCLUSION/CONCLUSIONS:The current study demonstrates that patients with anxiety and/or depression who undergo TSA have inferior postoperative outcomes and higher rates of AE compared to a cohort without a mental health diagnosis. Additionally, patients on medications for treatment of depression and/or anxiety did not gain any significant benefit in terms of their postoperative shoulder outcomes or satisfaction rate compared to those with a diagnosis but not on medication. Additionally, we found that, independent of a patient's underlying shoulder pathology or psychiatric diagnosis, lower PROMIS-MH scores was correlated with worse postoperative outcomes.
PMID: 36460262
ISSN: 1532-6500
CID: 5374192
Fact or fiction: the "5Â mm Rule" in greater tuberosity fractures of the proximal humerus
Ryan, Devon J; Zuckerman, Joseph D; Egol, Kenneth A
PURPOSE/OBJECTIVE:The purposes of this study were 1) to assess the outcome of nonoperative management of GT fractures with > 5 mm of displacement and 2) to assess whether there is a correlation between degree of displacement and outcome. METHODS:This study was a retrospective review of consecutive low-energy GT fractures from 2011 to 2020. Radiographs from all visits were reviewed. The direction of maximal displacement was assessed. Subjects were stratified based on the amount of maximal displacement: Group 1: 0-5 mm, Group 2: 5-10 mm, Group 3: > 10 mm. Range of motion (ROM) at the time of final follow-up was assessed. The presence of persistent shoulder pain after healing was noted, as well as whether supplemental subacromial corticosteroid injection was provided as part of long-term treatment. RESULTS:A cohort of 93 fractures comprised the study group. Mean age was 62 years. Mean follow-up was 20 months. All fractures went on to union. Mean displacement was 6.2 mm. There were 43 patients in Group 1, 43 in Group 2, and 7 in Group 3. Maximal displacement was most commonly inferolateral or lateral, accounting for a combined 77% of all patients. There was no difference in final ROM between displacement groups, with at least 155 degrees of forward elevation and 45 degrees of ER in all three groups. There was no difference between Group 1 and Groups 2/3 in frequency of persistent pain or likelihood of receiving a steroid injection. CONCLUSION/CONCLUSIONS:Our findings do not support a discrete 5 mm displacement threshold for surgical repair of isolated greater tuberosity fractures.
PMID: 36346475
ISSN: 1432-1068
CID: 5357212