BACKGROUND:This study aimed to investigate the associations of general patient and disease-specific factors with baseline patient-reported outcome measures (PROMs) in patients undergoing revision rotator cuff repair (RCR). Baseline characteristics were also compared to those of patients undergoing primary RCR. METHODS:Patients undergoing revision RCR of recurrent superior-posterior rotator cuff tears were included. Preoperative characteristics in the cohort were compared to a primary RCR cohort with identical selection criteria. Multivariable modeling and Akaike's Information Criterion comparisons were used to investigate the associations and relative importance of 21 preoperative factors in explaining variations in baseline PENN Shoulder Score (PSS) and its subscores in the revision RCR cohort. RESULTS:A total of 305 revision RCRs were included. Compared to the primary RCR cohort, patients undergoing revision RCR were more likely to be White (91% vs. 84%, P = .001), have a lower Charlson Comorbidity Index (0 vs. 1, P < .001), lower Veterans Rand-12 Mental Component Scores (VR-12 MCS; 50 vs. 53, P = .005), and were more likely to have a full-thickness (90% vs. 76%, P < .001), large/massive (54% vs. 37%, P < .001) tear with complete long head biceps rupture (37% vs. 10%, P < .001), and significant glenohumeral cartilage changes (19% vs. 7%, P < .001). Eight variables were significantly associated with baseline PSS or its subscores in the revision cohort. Lower VR-12 MCS was associated with lower PSS total, pain and function, while female sex was associated with lower PSS total and function. Medicare and Medicaid insurance status and higher body mass index were associated with lower PSS function, non-White race with lower PSS pain, and lower education, lower Charlson Comorbidity Index, and absence of significant glenohumeral cartilage degeneration with lower PSS satisfaction. Baseline VR-12 MCS, insurance status and sex were the top 3 factors in the baseline PSS model. Notably, rotator cuff tear type and size were not associated with baseline PSS or its subscores in the revision cohort. CONCLUSIONS:Both general patient and disease-specific factors were associated with baseline PROMs in patients undergoing revision RCR, with mental health status showing the strongest association. Compared to primary RCR patients, the revision cohort were more commonly White, had lower mental health status and more severe rotator cuff pathology, though tear severity was not associated with baseline PROMs. Further studies are needed to investigate if factors associated with poor baseline PROMs predict poor postoperative PROMs following revision RCR.

BACKGROUND:Patient-reported outcome measures (PROMs) are routinely used to assess pain, function, and quality of life in shoulder care. Although rotator cuff repair (RCR) is a highly effective treatment for symptomatic tears, the relationship between structural healing and PROM responsiveness remains unclear. This study aimed to evaluate and compare the responsiveness of 5 common shoulder PROMs-the Penn Shoulder Score, modified American Shoulder and Elbow Surgeons score, Single Assessment Numeric Evaluation, Shoulder Activity Level (SAL), and Patient-Reported Outcome Measure Information System Upper Extremity-as well as individual items from these measures and the Western Ontario Rotator Cuff Index, to RCR surgery and healing at 1 year postoperatively, with secondary analyses at 6 months and 2 years. METHODS:A prospective cohort of 117 patients undergoing arthroscopic RCR for fully reparable 1-5 cm supraspinatus/infraspinatus tears was analyzed. PROMs were collected preoperatively and at 6 months, 1 year, and 2 years postoperatively. RCR healing was assessed using magnetic resonance imaging-based Sugaya classification and computed tomography-measured tendon retraction. Responsiveness was evaluated using standardized response means, with subgroup analyses comparing healed and nonhealed patients. Correlations between PROMs and structural healing were analyzed. RESULTS:All PROMs and their individual items (except SAL) demonstrated high responsiveness to RCR surgery (standardized response mean >0.8) during the first 2 postoperative years, regardless of structural healing status, with the majority of gains occurring within the first 6 months. However, neither total PROMs nor select high-function items demonstrated correlations with structural healing (r < 0.3), indicating PROMs improvements primarily reflected reduced pain and enhanced daily function rather than RCR integrity. At 1 year, 92% of patients reported an acceptable symptom state (Patient Acceptable Symptom State "yes"), including all patients meeting stringent criteria for failed RCR. SAL was unresponsive to RCR surgery in the overall cohort and demonstrated limited utility in assessing functional differences in this patient population. Penn Shoulder Score, American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, and Patient-Reported Outcome Measure Information System Upper Extremity demonstrated progressively increasing ceiling effects postoperatively. CONCLUSION:Shoulder PROMs are highly responsive to RCR surgery but even their highest function items lack sensitivity to structural healing during the first 2 postoperative years. PROM improvements primarily reflect subjective gains in pain relief and daily function, highlighting the need for alternate outcome measures incorporating objective functional assessments to better define the impact of RCR healing in the early term. Future research should focus on developing PROMs with lesser ceiling effects postoperatively and evaluating the longer-term clinical consequences of failed structural RCR healing.

BACKGROUND:The optimal management of posterior glenoid bone loss in glenohumeral osteoarthritis with anatomic total shoulder arthroplasty (aTSA) remains unknown, as the degree of bone loss and retroversion can vary across a wide spectrum in glenoids with Walch B2 and B3 morphology. The objectives of the current study were to evaluate the clinical and radiographic outcomes of utilizing standard, all-polyethylene, nonaugmented anchor-peg glenoid (APG) components in aTSA for patients with mild to moderate B2 or B3 morphology. METHODS:Between January 2010 and September 2019, we identified 79 shoulders with mild to moderate B2 or B3 glenoid morphology that underwent aTSA with use of a nonaugmented APG glenoid component and minimum 2 years clinical and radiographic follow-up. In each case, the surgeon had access to an augmented glenoid component but chose to use a standard component based upon the presence of mild to moderate deformity, defined as the ability to template components within 10° of premorbid glenoid vault retroversion and within 3 mm of premorbid glenoid vault joint line based on preoperative 3-dimensional computed tomography planning. The Penn Shoulder Score (PSS), glenoid anchor-peg osteolysis (APO) (grade 1 vs. 2 and 3), and humeral head subluxation (HHS) were the main outcomes of interest. RESULTS:The cohort included 63/79 (80%) B2 glenoids and 17/79 (21%) B3 glenoids. Median patient age at surgery was 64.2 years [interquartile range {IQR} 59.6; 68.5]; median preoperative retroversion was 13.0° [IQR 9.8; 15.4]; and median preoperative joint line medialization was 1.4 mm [IQR 0.4; 2.4]. Median follow-up duration was 4.3 years [IQR 2.5; 6.8]; The PSS and HHS were improved amongst all patients postoperatively (P < .0001), with a median PSS at latest follow-up of 96.0 [IQR 88.5; 99.0] and posterior HHS present in 11.8% at final follow-up. There were 4 complications in the cohort (5.0%), one of which required reoperation due to persistent posterior HHS. Postoperative grade 1 APO was present on latest radiographs in 8/79 (10.1%) cases. Walch classification, preoperative glenoid version, inclination, and joint line medialization as measured on 3-dimensional computed tomography were not significantly associated with PSS or APO at final follow-up. Higher PSS at final follow-up was associated with better shoulder range of motion. APO at final follow-up was not associated with lower PSS. DISCUSSION:The use of nonaugmented polyethylene APG components in patients undergoing aTSA with mild to moderate B2 and B3 glenoids results in significant improvements in clinical and radiographic outcomes with low complication and reoperation rates at short-term follow-up. Further follow-up of this cohort is needed to better understand the implications of glenoid component APO on loosening patterns and failure rates in the long-term.

BACKGROUND:Rotator cuff disease affects over 50% of individuals over age 70, with more than 250,000 rotator cuff repair (RCR) surgeries performed annually in the U.S. Despite its benefits, 20%-30% of repairs fail, and patient-reported outcome measures (PROMs) are widely used to assess recovery, though none are fully validated for RCR-specific use. OBJECTIVE:This study evaluates the psychometric properties of the PENN Shoulder Score (PSS), modified American Shoulder and Elbow Surgeons (ASES) score, and Single Assessment Numeric Evaluation (SANE) in RCR patients to determine their validity, reliability, responsiveness, and interpretability. METHODS:A retrospective analysis was conducted using the Cleveland Clinic's Outcomes Measurement and Evaluation database, including 4,909 patients who underwent primary arthroscopic RCR for superior-posterior tears between 2015 and 2024. A subset of 112 patients participated in an NIH R01 study, enabling test-retest reliability analysis. Measurement properties were assessed per COSMIN guidelines, including internal consistency (McDonald's ω ≥ 0.70), test-retest reliability (intraclass correlation coefficient, ICC ≥ 0.70), known-groups and convergent validity, structural validity, responsiveness, and interpretability (Patient Acceptable Symptom State, minimal clinically important difference, minimum detectable change). RESULTS:ASES score and PSS demonstrated high internal consistency (ω = 0.86-0.97). Test-retest reliability was strong, except for PSS-Satisfaction (ICC = 0.34-0.42), SANE at baseline (ICC = 0.38), and ASES-Pain at 1 year (ICC = 0.28). Known-groups validity confirmed that larger tears were associated with worse pain and function scores preoperatively. Convergent validity showed strong correlations between ASES and PSS scores (r = 0.83-0.98), while SANE had weaker correlations at baseline (r = 0.46-0.56). Structural validity analyses indicated acceptable model fit for ASES and PSS function items. Responsiveness was excellent across all PROMs (standardized response means= 1.34-2.05). PSS outperformed other PROMs, meeting all validation criteria at baseline and 75% at 1 year. CONCLUSION:This study provides a comprehensive psychometric evaluation of three widely used shoulder PROMs in RCR patients. While ASES and PSS were valid, reliable, and responsive, SANE's single-item format limited its effectiveness. The PSS demonstrated superior measurement properties, making it the most robust PROM for assessing RCR outcomes. These findings guide PROM selection for clinical and research applications, though unexamined factors such as patient response burden should also be considered.

BACKGROUND:It is unclear if there are significant changes in clinical and radiographic outcomes between 1 and 2 years postoperatively after total shoulder arthroplasty (TSA). The current multicenter study sought to compare patient-reported outcome measures (PROMs), range of motion, and radiographic analysis of glenoid and humeral loosening between 1 and 2-years postoperatively in a cohort of patients after primary anatomic TSA (aTSA). METHODS:A retrospective cohort of patients who underwent primary aTSA between 2017 and 2018 at 2 high-volume shoulder arthroplasty centers and had baseline, 1 and 2-year PROMs were included in the study. The American Shoulder and Elbow Surgeons (ASES) and Single Assessment Numerical Evaluation scores were collected. Radiographs were evaluated at 1- and 2- years for humeral calcar resorption and glenoid component radiolucent lines and osteolysis. RESULTS:Two hundred eleven patients were included. Median preoperative version was -5° [IQR -8; -2] and inclination was 6° [IQR 4; 9]. There was no statistically significant difference between 1 and 2-years total ASES score (92.6 [IQR 86.7; 97.9] vs. 95 [IQR 85; 98.3], P = .71), ASES pain sub-score (50 [IQR 45; 50] vs. 50 [IQR 45; 50], P = .05), Single Assessment Numerical Evaluation score (90 [IQR 83.5; 98] vs. 93 [IQR 85; 98.3], P = .60) and external rotation (55° [IQR 50; 60] vs. 60° [IQR 50; 60], P = .66). There was a statistically significant difference in the ASES function sub-score (43.3 [IQR 38.9; 48.2] vs. 46.3 [IQR 41.2; 48.3], P = .03, respectively), and forward elevation (150° [IQR 135; 160] vs. 155° [IQR 143.8; 165], P = .002). One hundred forty-five of 211 (69%) patients had complete radiographic data. There was no statistically significant difference in the incidence of glenoid component osteolysis (3.4% vs. 5.4%, P = .25), radiolucent lines (36.1% vs. 29.9%, P = .15), or humeral calcar resorption (58.5% vs. 49.7%, P = .06) between 1 and 2 years. There were 2 (0.9%) complications in the cohort, both of which occurred within the first 12 months postoperatively. CONCLUSION:The present study demonstrates no changes in most PROMs and all measured radiographic findings between 1 and 2-years postoperatively after primary aTSA. This data can help drive clinical decision-making with regard to the need for visits at both 1 and 2 years postoperatively for the collection of PROMs, which add cost for the health care system and patients. Additionally, this may support lowering the minimum threshold required for reporting of "short term" follow-up in clinical research for aTSA.

Background Patient-reported outcomes vary following rotator cuff repair surgery, yet the preoperative factors associated with patient outcomes are not fully understood. This study aimed to assess associations of preoperative patient, disease and surgical factors with 1-year Penn Shoulder Score (PSS) in patients undergoing primary arthroscopic rotator cuff repair (ARCR). Methods Patients who underwent ARCR for superior-posterior rotator cuff tendon tears at Cleveland Clinic from February 2015-February 2022 with completed baseline PSS were included. We used multivariable identity-link beta regression and proportional odds models to fit 1-year PSS-Total and subscores to 23 prospectively identified patient, disease, and surgical factors and used R2, Nagelkerke's pseudo-R2, and incremental changes in Akaike Information Criterion to respectively assess model overall predictive capacities and predictor relative importances, multiply-imputing missing data. Results Of 3,483 cases of mean age of 58.8 ± 9.7 (standard deviation) years, 59% were males, 13% current smokers, 24% had chronic pain, 46% had used opioids within the prior year, 32% had at least one psychiatric diagnosis, and 5% had Worker's Compensation insurance. Median (quartiles) preoperative Veterans Rand 12-Item Health Survey Mental Component Score (VR-12-MCS) and PSS were 53.2 (43.9, 60.5) and 40.0 (29.5, 52.0), respectively. 1-year PSS was provided by 2,491 patients (72%) with median 90.0 (76.0, 97.0) reflecting significant improvement. Lower preoperative PSS, VR-12-MCS, and nonprivate insurance (particularly Workmen's Compensation) were the most important predictors of lower 1-year PSS and all subscores. Other (neither White nor Black) self-reported race, a chronic pain diagnosis, glenohumeral cartilage degeneration, and no acromioplasty were also statistically significantly associated with lower 1-year PSS. Model R2 was 20%. Sensitivity analyses showed that inclusion of preoperative PSS and VR-12-MCS as predictors suppressed the statistical significance of several other patient factors. Conclusion Patients generally reported excellent 1-year outcomes following primary ARCR. The most important predictors of 1-year PSS were baseline PSS, VR-12-MCS, and insurance type, with race and acromioplasty also among top predictors. However, the 23 factors examined in this study only account for a modest fraction of the variability in 1-year PSS, suggesting that other factors, for example, strength, structural healing, and patient biology, may contribute as well.

Background: Prognostic factors for total shoulder arthroplasty (TSA) clinical outcomes are incompletely understood. This study investigates the associations of preoperative patient, disease -specific, and surgical factors with 1 -year postoperative PENN Shoulder Score (PSS) in patients undergoing primary TSA. Methods: Cleveland Clinic patients undergoing primary anatomic TSA (aTSA) or reverse TSA (rTSA) for glenohumeral osteoarthritis (GHOA) or rotator cuff tear arthropathy (CTA) between February 2015 and August 2019, and having complete preoperative and 1 -year postoperative patient -reported outcome measures (PROMs), were included. Twenty preselected preoperative patient, disease -specific, and surgical factors were used to fit multivariable models for 1 -year PSS and its subscores. Results: Of 1427 eligible primary TSAs, 1174 had 1 -year follow-up by PROMs (82%), with 1042 analyzed after additional exclusions, including 30% rTSAs for CTA (n = 308), 26% rTSAs for GHOA (n = 275), and 44% aTSAs for GHOA (n = 459). All PROMs showed statistically significant improvements postoperatively, with 89% of patients reaching an acceptable symptom state. Lower 1 -year PSS was associated with younger age, female sex, current smoking, chronic pain diagnosis, history of prior surgery, worker's compensation claim, lower preoperative mental health, lower baseline PSS, absence of glenoid bone loss, and diagnosis-arthroplasty type (CTArTSA < GHOA-rTSA < GHOA-aTSA). The most important prognostic factors associated with 1 -year PSS were diagnosisarthroplasty type, baseline mental health status, and insurance status. Conclusions: Disease diagnosis, arthroplasty type, and several other baseline factors are strongly and individually associated with PROMs following primary TSA, with patients undergoing aTSA for GHOA demonstrating the highest PROM scores at 1 -year follow-up. Patient, disease -specific, and surgical factors can be used to guide postoperative prognosis following primary TSA for improved preoperative patient counseling regarding expected outcomes of these procedures. Level of evidence: Level II; Prospective Cohort Comparison; Prognosis Study (c) 2024 The Author(s). This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/ 4.0/).

BackgroundGlenoid component loosening remains the most common reason for revision of anatomic total shoulder arthroplasty (aTSA). We assessed early clinical and radiographic outcomes, following aTSA using a press-fit short stem and peripherally enhanced fixation glenoid.Methods275 consecutive patients with end-stage glenohumeral arthritis and Walch A- or B-type glenoid morphology who underwent primary aTSA in 2017-2018 at two high-volume shoulder arthroplasty institutions were evaluated, and patient-reported outcomes (PROMs) and radiographic findings were studied in those with completed baseline and minimum 2-year follow-up, respectively. Patient demographics, glenoid morphology, body mass index (BMI), Charlson Comorbidity Index (CCI), Range of Motion (ROM), American Shoulder and Elbow Surgeons (ASES) score, and Simple Assessment Numeric Evaluation (SANE) score were collected. Radiographic analysis of glenoid and humeral components was performed. Multivariable logistic, equal adjacent odds ordinal, and beta regression were respectively used to identify predictors of glenoid radiolucent lines, humeral calcar resorption, and total ASES score.ResultsPatients were 43% female with mean age 66, median BMI 30, and median follow-up 28.4 months. ASES and SANE scores improved by respective medians of 54.4 and 55.0 points, forward elevation by median 35° and external rotation by median 30° (all P<0.001 for preoperative to postoperative change). Postoperative radiographs of 177 cases showed 10 (5.7%) glenoid osteolysis, 51 (28.8%) glenoid radiolucent lines, and 81 (45.8%) calcar resorption. Follow-up duration (median 40.1 vs. 27.2 months; P<0.001), BMI (median 27.5 vs. 30.7; P<0.001), and CCI (Q3 0 vs. 1; P=0.02) were associated with glenoid osteolysis in bivariate analyses. In multiple logistic regression, surgeon (C vs. A/B) was the only statistically significant predictor of glenoid radiolucent lines [OR 0.27, 95% CI (0.1, 0.8)]. By descending importance, Surgeon C [OR 6.5 (2.0, 20.5)], humeral canal filling ratio [upper vs. lower quartile OR 2.3 (1.3, 4.0)], mediolateral humeral head deviation [upper vs. lower quartile OR 1.9 (1.0, 3.5)] and glenoid osteolysis [OR 13.5 (2.6, 71.6)] significantly predicted greater calcar resorption. Longer follow-up duration marginally statistically significantly predicted lower ASES score [upper vs. lower quartile OR 0.8 (0.6, 1.0)].ConclusionsFollowing aTSA with a peripherally enhanced fixation glenoid, pain, ROM, and PROMs significantly improved at minimum 2 years with only 5.7% glenoid osteolysis despite heterogeneous preoperative glenoid pathologies.

Background: This study’s purpose was to investigate the extent to which differences among operating surgeons may influence 1-year patient-reported outcome measures (PROMs) in patients undergoing rotator cuff repair (RCR) surgery, after controlling for general and disease-specific patient factors. We hypothesized that surgeon would be additionally associated with 1-year PROMs, specifically the baseline to 1-year improvement in Penn Shoulder Score (PSS). Methods: We used mixed multivariable statistical modeling to assess the influence of surgeon (and alternatively surgical case volume) on 1-year PSS improvement in patients undergoing RCR at a single health system in 2018, controlling for eight patient- and six disease-specific preoperative factors as possible confounders. Contributions of predictors to explaining variation in 1-year PSS improvement were measured and compared using Akaike’s Information Criterion. Results: 518 cases performed by 28 surgeons met inclusion criteria, with median (quartiles) baseline PSS of 41.9 (31.9, 53.9) and 1-year PSS improvement of 42 (29.1, 55.3) points. Contrary to expectation, surgeon and surgical case volume were neither statistically significantly nor clinically meaningfully associated with 1-year PSS improvement. Baseline PSS and mental health status (VR-12 MCS) were the dominant and only statistically significant predictors of 1-year PSS improvement, with lower baseline PSS and higher VR-12 MCS predicting larger 1-year PSS improvement. Conclusion: Patients generally reported excellent 1-year outcomes following primary RCR. This study did not find evidence that the individual surgeon or surgeon case volume influences 1-year PROMs, independently of case-mix factors, following primary RCR in a large employed hospital system.

BACKGROUND:Most orthopaedic journals currently require reporting outcomes of surgical interventions for at least 2 postoperative years, but there have been no rigorous studies on this matter. Various patient-reported outcome (PRO) measures (PROMs) have been used to assess the status of the shoulder after rotator cuff repair (RCR).HYPOTHESIS:We hypothesized that the mean shoulder-specific PROMs at 1 year improve substantially over baseline but that there is no clinically meaningful difference between the mean 1- and 2-year PROMs after RCR.STUDY DESIGN:Meta-analysis; Level of evidence, 2.METHODS:We conducted a systematic review of published randomized controlled trials (RCTs) and prospective cohort studies (level of evidence 1 and 2) reporting the shoulder-specific American Shoulder and Elbow Surgeons (ASES), the Constant, or the Western Ontario Rotator Cuff (WORC) Index scores at baseline, 1 year, and 2 years after RCR. The methodologic quality of studies was assessed. Also, the random effects meta-analyses of changes in PROMs for each of the first and second postoperative years were conducted.RESULTS:Fifteen studies (n = 11 RCTs; n = 4 cohort studies) with a total of 1371 patients were included. Studies were highly heterogeneous, but no visual evidence of major publication bias was observed. The weighted means of the baseline PROMs were 46.2 points for the ASES score, 46.4 points for the Constant score, and 38.8 points for the WORC Index. The first-year summary increments were 41.1 (95% CI, 36.0-46.2) points for the ASES score, 34.2 (95% CI, 28.8-39.6) points for the Constant score, and 42.9 (95% CI, 37.3-48.4) points for the WORC Index. In contrast, the second-year summary increments were 2.3 (95% CI, 1-3.6) points for the ASES score, 3.2 (95% CI, 1.9-4.4) points for the Constant score, and 2 (95% CI, -0.1 to 4) points for the WORC Index.CONCLUSION:All PROMs improved considerably from baseline to 1 year, but only very small gains that were below the minimal clinically important differences were observed between 1 year and 2 years after RCR. This study did not find any evidence for requiring a minimum of 2 years of follow-up for publication of PROs after RCR. Our results suggest that focusing on 1-year PROMs after RCR would foster more timely reporting, better control of selection bias, and better allocation of research resources.

Background:Magnetic resonance imaging (MRI)-based rotator cuff assessment is often qualitative and subjective; few studies have tried to validate such preoperative assessments. This study investigates relationships of preoperative MRI assessments made by conventional approaches to intraoperative findings of tear type, location, and size or MRI-assessed muscle occupation ratio.Methods:Intraoperatively, surgeons assessed tear type, location, anterior-posterior (AP) width, and medial-lateral length in 102 rotator cuff repair patients. Two musculoskeletal radiologists independently assessed the preoperative MRI scans for these same parameters and supraspinatus muscle atrophy by both Warner classification and quantitative occupation ratio. Exact agreement proportions, kappa statistics, and correlation coefficients were used to quantify agreement relationships.Results:Agreement between MRI readers' and surgeons' observations of tear status averaged 93% with κ = 0.38, and that of tear location averaged 77% with κ = 0.50. Concordance correlations of MRI and intraoperative measures of anterior-posterior and medial-lateral tear length averaged 0.59 and 0.56 across readers, respectively. Despite excellent interrater agreement on Warner classification (exact agreement proportion 0.91) and occupation ratio (concordance correlation 0.93) separately, correlations between these 2 measures were -0.54 and -0.64 for the 2 readers, respectively. Patients with Warner grade 0 had occupation ratios ranging from 0.5 to 1.5.Conclusion:Correlations of preoperative MRI tear dimensions and muscle atrophy assessed by conventional approaches with intraoperatively measured tear dimensions and quantitative occupation ratio, respectively, were only fair. Since tear size and muscle atrophy are known strong predictors of outcomes following rotator cuff repair that may influence treatment decisions, surgeons need to be aware of the limitations of MRI methods. Continued development and validation of quantitative preoperative imaging methods to accurately assess these parameters are needed to improve surgical planning and prognosis.

BACKGROUND:The purpose of this study was to demonstrate the validity and efficiency of the Outcomes Management and Evaluation (OME) system, a prospectively designed electronic data collection tool, for collecting comprehensive and standardized surgical data in shoulder arthroplasty.METHODS:Surgical data from the first 100 cases of shoulder arthroplasty that were collected into the OME database were analyzed. Surgeons completed a traditional narrative operative note and also an OME case report using an encrypted smartphone. A blinded reviewer extracted data from the operative notes and implant logs in the electronic medical records (EMR) by manual chart review. OME and EMR data were compared with regard to data counts and agreement between 39 variables related to preoperative pathology, including rotator cuff status and glenoid wear, and surgical procedures. Data counts were assessed using both raw percentages and with McNemar's test (with continuity correction). Agreement of nominal variables was analyzed using Cohen's unweighted kappa (κ) and of ordinal variables using the linearly weighted Cohen's test. Efficiency was assessed by calculating the median time needed to complete OME.RESULTS:Compared to the EMR, the OME database had significantly higher data counts for 56% (22 of 39) of the variables assessed. A high level of proportional and statistical agreement was demonstrated between the data in the two datasets. 10 of 39 variables had 100% agreement but could not be statistically compared because both datasets had the same single response under those variables. Among the 29 variables that were compared, 79% (23 of 29) of variables had >80% raw proportional agreement, and 69% (20 of 29) of variables showed at least substantial agreement (κ > 0.6). The median time for completing OME surgery data entry was 92 seconds (IQR 70 - 126).CONCLUSION:The prospectively designed, electronic data entry system (OME) is an efficient and valid tool for collecting comprehensive and standardized surgical data on shoulder arthroplasty.LEVEL OF EVIDENCE:Level IV.

Background: Magnetic resonance imaging (MRI) is standard of care for rotator cuff evaluation, with clinical interpretation usually limited to qualitative judgments. The reliability of MRI-based measurements and scoring systems has been evaluated only preoperatively or >6 months following rotator cuff repair, when repairs are in the later stages of healing. This study describes the MRI assessments and inter-rater agreement of various rotator cuff tendon and muscle parameters evaluated preoperatively and 4 times during the first postoperative year. Methods: Two musculoskeletal radiologists independently assessed MRI scans of 42 patients preoperatively and 3, 12, 26, and 52 weeks after rotator cuff repair. Using standardized reading rules, readers assessed tendon integrity (5-point Sugaya classification), tear dimensions, muscle fat (5-point Goutallier classification) and atrophy (4-point Warner classification), muscle cross-sectional areas, and myotendinous junction distance. Raw exact agreement proportions, K statistics, and correlation coefficients were used to quantify inter-rater agreement. Results: Readers showed moderate to substantial above-chance agreement in scoring rotator cuff tendon integrity and supraspinatus muscle atrophy and good to excellent agreement on tear dimensions and muscle cross-sectional areas but only fair to moderate agreement for fatty infiltration and myotendinous junction distance. Only fatty infiltration grades evidenced observer bias. Inter-rater agreement did not appear time dependent. Conclusion: By use of defined reading rules in a research setting, MRI evaluations of rotator cuff tendon integrity, tear dimensions, muscle atrophy, and cross-sectional areas have reasonable reliability at all time points in the first postoperative year. However, the presence of clinically significant disagreements, even in such favorable circumstances, indicates the need for improved imaging tools for precise rotator cuff evaluation. (C) 2021 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.

Background: Shoulder pain and dysfunction are common indications for rotator cuff repair surgery, yet the factors that are associated with these symptoms are not fully understood. Purpose/Hypothesis: This study aimed to investigate the associations of patient and disease-specific factors with baseline patient-reported outcome measures (PROMs) in patients undergoing rotator cuff repair. We hypothesized that tear size and mental health status, as assessed by the Veterans RAND 12-Item Health Survey mental component score (VR-12 MCS), would be associated with baseline total Penn Shoulder Score (PSS) and its pain, function, and satisfaction subscale scores. Study Design: Cross-sectional study; Level of evidence, 3. Methods: We prospectively identified 12 patient factors and 12 disease-specific factors as possible statistical predictors for baseline PROMs in patients undergoing surgical repair of superior-posterior rotator cuff tears at a single institution over a 3-year period. Multivariable statistical modeling and Akaike information criterion comparisons were used to investigate the unique associations with, and relative importance of, these factors in accounting for variation in baseline PSS and its subscale scores. Results: A total of 1442 patients who had undergone surgery by 23 surgeons met inclusion criteria, with a baseline median total PSS of 38.5 (pain, 12; function, 24.2; satisfaction, 2). Adjusted R2 in multivariable models demonstrated that the 24 general patient and disease-specific factors accounted for 22% to 24% of the variability in total PSS and its pain and function subscale scores. Large/massive tear size was significantly associated with worse PSS total score and function score but not pain or satisfaction scores. Lower VR-12 MCS was significantly associated with worse total PSS and all 3 subscale scores. Among other factors significantly associated with baseline PROMs were sex, race, preoperative opioid use, years of education, employment status, acromion status, and adhesive capsulitis. Lower VR-12 MCS, preoperative opioid use, female sex, and black race were the factors most strongly associated with baseline PROMs. Conclusion: Large/massive tear size, lower VR-12 MCS, and several additional patient and disease-specific factors are associated with baseline PROMs in patients undergoing rotator cuff repair. Further studies are needed to investigate whether these factors will also predict poor postoperative PROMs.

Hypothesis and background: Shoulder pain and dysfunction are common indications for shoulder arthroplasty, yet the factors that are associated with these symptoms are not fully understood. This study aimed to investigate the associations of patient and disease-specific factors with preoperative patient-reported outcome measures (PROMs) in patients undergoing primary shoulder arthroplasty. We hypothesized that worse mental health status assessed by the Veterans RAND 12-Item Health Survey (VR-12) mental component score (MCS), glenoid bone loss, and increasing rotator cuff tear severity would be associated with lower values for the preoperative total Penn Shoulder Score (PSS) and its pain, function, and satisfaction subscores. Methods: We prospectively identified 12 patient factors and 4 disease-specific factors as possible statistical predictors of preoperative PROMs in patients undergoing primary shoulder arthroplasty at a single institution over a 3-year period. Multivariable statistical modeling and Akaike information criterion comparisons were used to investigate the unique associations with, and relative importance of, these factors in accounting for variation in the preoperative PSS and its subscores. Results: A total of 788 cases performed by 12 surgeons met the inclusion criteria, with a preoperative median total PSS of 31 points (pain, 10 points: function, 18 points; and satisfaction, 1 point). As hypothesized, a lower VR-12 MCS was associated with lower preoperative PSS pain, function, and total scores, but patients with intact status or small to medium rotator cuff tears had modestly lower PSS pain subscores (ie, more pain) than patients with large to massive superior-posterior rotator cuff tears. Glenoid bone loss was not associated with the preoperative PSS. Female sex and fewer years of education (for all 4 outcomes), lower VR-12 MCS and preoperative opioid use (for all outcomes but satisfaction), and rotator cuff tear severity (for pain only) were the factors most prominently associated with preoperative PROMs. Conclusion: In addition to mental health status and rotator cuff tear status, patient sex, years of education, and preoperative opioid use were most prominently associated with preoperative PROMs in patients undergoing shoulder arthroplasty. Further studies are needed to investigate whether these factors will also predict postoperative PROMs. (C) 2020 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.

BackgroundTo address the need for more objective and quantitative measures of tendon healing in research studies, we intend to use computed tomography (CT) with implanted radiopaque markers on the repaired tendon to measure tendon retraction following rotator cuff repair. In our small prior study, retraction at 1-year follow-up averaged 16.1± 5.3 mm and exceeded 10.0 mm in 12 of 13 patients, and thus tendon retraction appears to be a common clinical phenomenon. This study's objectives were to assess, using 5 longitudinal CT scans obtained over 1 year following rotator cuff repair, the variability in glenohumeral positioning because of pragmatic variations in achieving perfect arm repositioning and to estimate the associated measurement variability in bone-to-tendon marker length measurements.MethodsForty-eight patients underwent rotator cuff repair with intraoperative placement of radiopaque tendon markers at the repair site. All patients had a CT scan with their arms at the side on the day of surgery and at 3, 12, 26, and 52 weeks postoperatively. Glenohumeral position (defined by the orientation and distance of the humerus with respect to the scapula) and bone-to-tendon marker lengths were measured from each scan. Within-patient variation in glenohumeral position measurements was described by their pooled within-patient standard deviations (SDs), and variation in bone-to-tendon marker lengths by their standard errors of measurement (SEMs) and 95% confidence level minimally detectable distances (MDD95) and changes (MDC95).ResultsThe mean glenohumeral orientation from the 5 longitudinal CT scans averaged across the 48 patients was 12.6° abduction, 0.4° flexion, and –0.1° internal rotation. Within-patient SDs (95% confidence intervals) of glenohumeral orientation were 3.0° (2.7°-3.4°) in extension/flexion, 5.2° (4.6°-5.8°) in abduction/adduction, and 8.2° (7.3°-9.2°) in internal/external rotation. The SDs of glenohumeral distances were less than 1 mm in any direction. The estimated SEMs of bone-to-tendon lengths were consistent with a common value of 2.4 mm for any of the tendon markers placed across the repair, with MDD95 of 4.7 mm and MDC95 of 6.7 mm.ConclusionApparent tendon retraction of 5 mm or more, when measured as the distance from a tendon marker's day of surgery location to its new location on a volumetrically registered longitudinal CT scan, may be considered above the usual range of measurement variation. Tendon retraction measured using implanted radiopaque tendon markers offers an objective and sufficiently reliable means for quantifying the commonly expected changes in structural healing following rotator cuff repair.

Biologic grafts used in hernia repair undergo rapid cellular infiltration and remodeling, but their premature degradation often results in hernia recurrence. We hypothesize that a temporary barrier that prevents infiltration of acute inflammatory cells into the graft during the initial 4 weeks of implantation could mitigate graft degradation. The purpose of this study is to design tyramine-substituted hyaluronan (THA) hydrogel coatings with tunable degradation properties, as a means to develop a resorbable barrier for human acellular dermis grafts (HADM). THA plugs prepared at different cross-linking densities, by varying cross-linking agent concentration (0.0001-0.0075% H2 O2 ), demonstrated varying rates of in vitro degradation (25 U/mL hyaluronidase, 48 h). Based on these results, HADM grafts were coated with THA at three cross-linking densities (0.0001%, 0.00075%, and 0.003% H2 O2 ) and THA coating degradation was evaluated in vitro (25 U/mL hyaluronidase, 48 h) and in vivo (rat intraperitoneal implantation, 1-4 weeks). THA coatings degraded in vitro and in vivo with the lowest cross-linking density (0.0001% H2 O2 ), generally showing greater degradation as evidenced by significant decrease in coating cross-sectional area. However, all three coatings remained partially degraded after 4 weeks of in vivo implantation. Alternate strategies to accelerate in vivo degradation of THA coatings are required to allow investigation of the study hypothesis. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B:2664-2672, 2019.

PURPOSE:The purpose of the study was to describe the characteristics and demonstrate proof-of-concept and clinical use of a barium sulfate infused polypropylene radiopaque tissue marker for soft tissue localization and in vivo measurement of lengths and areas.METHODS:Marker mechanical properties were evaluated by tensile tests. Biocompatibility was evaluated following 8-12 weeks' implantation in a pig model. Proof-of-concept of marker application was performed in a human cadaveric shoulder model, and methods for CT imaging and measurement of dimensions were established. Lastly, the method of clinical use of the markers was described in one patient undergoing arthroscopic rotator cuff repair (RCR).RESULTS:The radiopaque markers had a tensile strength of 28 ±4.7 N and were associated with minimal to mild inflammatory tissue reaction similar to polypropylene control. CT-based measurements showed relatively high precisions for lengths (0.66 mm), areas (6.97 mm2), and humeral orientation angles (2.1°) in the cadaveric model, and demonstrated 19 ±3 mm medio-lateral tendon retraction and 227 ±3 mm2 increase in tendon area in the patient during 26 weeks following RCR. No radiographic leaching, calcification or local adverse events were observed.CONCLUSIONS:The radiopaque tissue marker was biocompatible and had adequate strength for handling and affixation to soft tissues using standard suturing techniques. The marker could be used with low-dose, sequential CT imaging to quantitatively measure rotator cuff tendon retractions with clinically acceptable accuracy. We envision the radiopaque tissue marker to be useful for soft tissue localization and in vivo measurement of tissue and organ dimensions following surgery.