Aseptic Glenoid Baseplate Loosening after Reverse Total Shoulder Arthroplasty with a Single Prosthesis
Schell, Lauren; Roche, Christopher P; Eichinger, Josef K; Flurin, Pierre Henri; Wright, Thomas W; Zuckerman, Joseph D; Friedman, Richard J
INTRODUCTION/BACKGROUND:Early reverse total shoulder arthroplasty (rTSA) designs had high failure rates, mainly from loosening of the glenoid baseplate. The purpose of this study is to determine the incidence of aseptic glenoid baseplate loosening after primary rTSA using a contemporary medialized glenoid/lateralized humeral system and identify significant risk factors associated with loosening. METHODS:7,162 primary rTSA were treated with a single platform rTSA system between April 2007 and August 2021, from which 3,127 primary rTSA patients with a minimum 2-year follow-up were identified. Patients with aseptic glenoid baseplate loosening were compared to all other primary rTSA without loosening. Univariate and multivariate analyses were performed to compare these cohorts and identify the demographic, comorbidities, operative, and implants associated aseptic glenoid loosening after rTSA. Odds ratios were calculated for each significant risk factor and for multiple combinations of risk factors. RESULTS:Irrespective of minimum follow-up, fifty-three (31F/22M) of 7,162 primary rTSA shoulders experienced aseptic glenoid loosening, for an overall rate of 0.74%. At latest 2-year minimum follow-up, thirty of 3,127 patients experienced aseptic glenoid loosening and had significantly lower clinical scores, function, active ROM, and higher pain scores as compared to patients without loosening. Univariate analysis identified that patients with rheumatoid arthritis (RA, p=0.029, OR = 2.74) and diabetes (p=0.028, OR=1.84) and multivariate analysis identified Walch glenoid types B2 (p=0.002, OR= 4.513) and B3 (p=0.002, OR=14.804), use of expanded lateralized glenospheres (p=0.025, OR=2.57) and use of augmented baseplates (p=0.001, OR=2.50) as significant risk factors for aseptic glenoid loosening after rTSA. CONCLUSION/CONCLUSIONS:The incidence of aseptic glenoid baseplate loosening was 0.74% for this medialized glenoid/lateralized humeral rTSA system. Numerous risk factors for aseptic loosening were identified, including: RA, diabetes, Walch B2 and B3 glenoids, posterior/superior augmented baseplates, and expanded lateralized glenospheres. Finally, analysis of multiple combinations of risk factors identified patients and implant configurations with the greatest risk of aseptic glenoid loosening.
Analysis of Patient Factors Associated with Selection of Corticosteroid Injection in the Freezing Phase of Idiopathic Adhesive Capsulitis
Adekanye, David; Papalia, Aidan G; Romeo, Paul V; Kingery, Matthew T; Ben-Ari, Erel; Bustamante, Sebastian; Zuckerman, Joseph D; Virk, Mandeep S
BACKGROUND:Primary idiopathic adhesive capsulitis (AC) is characterized by shoulder pain and global limitations in range of motion (ROM). The aim of this study was to determine (1) if a spectrum of symptom severity exists during the freezing phase of AC and (2) identify factors associated with patient selection of corticosteroid injection (CSI) for treatment. METHODS:Patients presenting within 6-months of symptom onset of AC (freezing phase) were enrolled in this single-site retrospective case control study. Visual analog pain score (VAS), shoulder ROM, American Shoulder and Elbow Surgeons (ASES) scores, and Patient-Reported Outcomes Measurement Information System (PROMIS function and pain) scores were collected. Each patient was offered oral anti-inflammatory medication, physical therapy, and intraarticular corticosteroid injection (CSI). Patients were divided into two cohorts: those electing versus those deferring CSI. Multivariable logistic regression was performed to identify patient or symptom characteristics predictive of electing CSI. RESULTS:A total of 112 patients [mean age=54.7+/-8.8, female=76 (67.9%), mean symptom duration in weeks=13.2+/-7.9, elected CSI=74 (66.1%)] were included in our analysis. The overall study population demonstrated a wide spectrum of VAS pain scores [6.0+/-2.8 (range: 0-10)] and ROM: forward elevation (FE) [99.1°+/-27.0° (range: 30°-150°)], abduction (Abd) [81.5°+/-23.5° (range: 30°-130°)], external rotation (ER) [46.6°+/-13.0° (range: 0°-90°)], internal rotation (IR) [38.47°+/- 25.9° (range: 5°-90°)]. The CSI group had higher mean VAS pain score [6.6+/-2.5 versus 4.9+/-3.0, p=0.005] and greater limitations in ROM for FE [91.9°+/-26.9° versus 112.9°+/- 24.6°, p = 0.001] and Abd [77.2°+/- 23.6° versus 89.9°+/- 21.1°, p = 0.005] compared to the non-CSI cohort. The CSI group demonstrated significantly worse shoulder function based on Constant (p<.05), ASES (P=0.001), P-UE (P=0.016), P-Intensity (p=0.002), and P-Interference (p=0.004). Logistic regression demonstrated decreased total shoulder ROM in FE and Abd plains [OR=0.98 (95% CI=0.97-0.99), p=0.004)], Hispanic ethnicity and increased VAS pain score [OR=1.20 (95% CI=1.01-1.43), p=0.04] were associated with increased likelihood of electing CSI. CONCLUSION/CONCLUSIONS:A spectrum of symptom severity exists during the freezing phase of primary AC, despite similar etiology. AC patients with greater pain severity, and greater limitations in ROM at initial evaluation were associated with patient selection of CSI.
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.
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.
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.
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.
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.
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.
Patterns of limitations in activities of daily living, sleep, and pain in the early postoperative period following total shoulder arthroplasty: a prospective study
Kolade, Oluwadamilola; Ghosh, Niloy; Buchalter, Daniel; Rosenthal, Yoav; Zuckerman, Joseph D.; Virk, Mandeep S.
Background: The aim of this study is to investigate the pattern of changes in activities of daily living (ADLs), sleep disturbance, and pain in the early postoperative period following a total shoulder arthroplasty (TSA). Methods: Prospective data on patterns of limitation in ADLs, sleep disturbance, and pain were collected from patients undergoing elective TSA preoperatively and at specific time points postoperatively (2, 6, and 12 weeks). At each time point, patients were asked regarding the major limitation affecting their shoulder. Limitations in ADLs and sleep disturbances were scored on a 3-point scale (0 = unable to do, 3 = no difficulty) modeled after the ADL which require active external rotation score and visual analog scale scores were used for pain. Patient responses were analyzed with respect to patient factors (demographics, arm dominance, function of opposite arm, and ambulation status), and living situation (alone, or with caregiver). Results: Shoulder pain (43%) and inability to perform ADLs (38%) were the 2 most commonly reported limitations prior to undergoing TSA. Patients noticed progressive improvements in pain with 37% reductions in visual analog scale scores at 2 weeks and 67% reduction at 3 months. At 2 weeks after TSA, sleep disturbances were the most disabling issue in 33% of the cohort, with considerable improvements (104%) in sleep scores at 3 months compared to pre-op. The ADLs involving forward elevation and working at the waist level improved considerably between 6 weeks and 3 months, but activities involving rotation including reaching behind the back, across the chest, and use of strength showed mild improvements by 3 months. Conclusion: This prospective study demonstrates the chronology of improvements in pattern of limitations experienced by patients with respect to pain, sleep, and ADLs in the early postoperative period after TSA. Majority of patients can expect to have 2/3 resolution of pain, improved sleep, and improvement in ADLs involving forward elevation and waist level function by 3 months.
Radiographic and clinical characterization of coracoid fractures: a retrospective cohort analysis
Ben-Ari, Erel; Pines, Yaniv; Gordon, Dan; Zuckerman, Joseph D; Petchprapa, Catherine; Virk, Mandeep S
PURPOSE/OBJECTIVE:Coracoid fracture is a rare injury. The aim of this study is to present the demographics, clinical and radiologic characteristics, and outcomes of coracoid fracture in a cohort of 32 patients. METHODS:We queried our institutional electronic medical record database (years 2012-2020) to identify patients with coracoid fractures using specific International Classification of Disease-10 codes. Demographic data, injury details including mechanism of injury and associated injuries, imaging performed, and treatment outcomes were obtained from retrospective chart review. A radiologist reviewed all available imaging studies (radiographs/CT/MRI) and classified the fractures according to Ogawa and Eyres classifications. Missed diagnoses were determined by comparing initial imaging reports with the follow-up imaging obtained in the office. RESULTS:Thirty-two patients with coracoid fractures were identified during the study period. Sixteen fractures (50%) occurred in the setting of low-energy trauma. Twelve fractures were missed on initial radiographs, and diagnosis with three-view radiographs (AP, scapular-Y and axillary) was 88% compared to 33% (pâ€‰<â€‰0.03) with two views (AP, scapular-Y). The majority of fractures were non-displaced (94%), and 56% were Ogawa Type-II fractures. Associated injuries were seen in 81% of patients. Most fractures (94%) were treated without surgery with excellent outcomes. CONCLUSION/CONCLUSIONS:Coracoid fractures continue to be a rare injury. In contrast to previous studies, in this case series of 32 patients, half of the fractures were associated with low-energy trauma, which correlated with higher percentage of non-displaced fractures and Ogawa Type-II fractures. Addition of the axillary view in the trauma radiographic series significantly improved the initial fracture detection rate. LEVEL IV/UNASSIGNED:Retrospective study.