Management of irreparable massive rotator cuff tears: a systematic review and meta-analysis of patient-reported outcomes, reoperation rates, and treatment response.

BACKGROUND: There is no consensus on the treatment of irreparable massive rotator cuff tears. The goal of this systematic review and meta-analysis was to (1) compare patient-reported outcome scores, (2) define failure and reoperation rates, and (3) quantify the magnitude of patient response across treatment strategies. METHODS: The MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and Scopus databases were searched for studies including physical therapy and operative treatment of massive rotator cuff tears. The criteria of the Methodological Index for Non-randomized Studies were used to assess study quality. Primary outcome measures were patient-reported outcome scores as well as failure, complication, and reoperation rates. To quantify patient response to treatment, we compared changes in the Constant-Murley score and American Shoulder and Elbow Surgeons (ASES) score with previously reported minimal clinically important difference (MCID) thresholds. RESULTS: No level I or II studies that met the inclusion and exclusion criteria were found. Physical therapy was associated with a 30% failure rate among the included patients, and another 30% went on to undergo surgery. Partial repair was associated with a 45% retear rate and 10% reoperation rate. Only graft interposition was associated with a weighted average change that exceeded the MCID for both the Constant-Murley score and ASES score. Latissimus tendon transfer techniques using humeral bone tunnel fixation were associated with a 77% failure rate. Superior capsular reconstruction with fascia lata autograft was associated with a weighted average change that exceeded the MCID for the ASES score. Reverse arthroplasty was associated with a 10% prosthesis failure rate and 8% reoperation rate. CONCLUSION: There is a lack of high-quality comparative studies to guide treatment recommendations. Compared with surgery, physical therapy is associated with less improvement in perceived functional outcomes and a higher clinical failure rate.

Performance of PROMIS Global-10 compared with legacy instruments in patients with shoulder arthritis.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 measures physical and mental health and provides an estimated EuroQol-5 Dimension (EQ-5D) score. The purpose of this study was to determine the correlation between the PROMIS Global-10 and several gold-standard legacy measures to validate its overall performance and usefulness in patients with shoulder arthritis. METHODS: The study prospectively enrolled 161 patients with shoulder arthritis before treatment. Each patient completed the PROMIS, EQ-5D, American Shoulder and Elbow Surgeons (ASES) Assessment Form, Single Assessment Numeric Evaluation (SANE), and Western Ontario Osteoarthritis of the Shoulder (WOOS) Index. Spearman correlations were calculated, and Bland-Altman agreement tests were conducted between estimated EQ-5D scores from the PROMIS and actual EQ-5D scores. Ceiling and floor effects were determined. RESULTS: Correlation between the PROMIS and EQ-5D was excellent (0.72, P < .001). However, agreement for estimated EQ-5D ranged from 0.37 below to 0.36 above actual EQ-5D scores. Correlation of the PROMIS physical score was good with the ASES score (0.57, P < .001) and poor with the SANE score (0.23, P = .0045) and WOOS score (0.11, P = .3743). Correlation of the PROMIS mental score was poor when compared with all patient-reported outcome instruments investigated (ASES score, 0.26 [P = .0012]; SANE score, 0.13 [P = .1004]; and WOOS score, 0.09 [P = .4311]). No floor or ceiling effects were observed. CONCLUSION: PROMIS Global-10 physical scores show excellent correlation with the EQ-5D. However, the PROMIS Global-10 cannot replace actual EQ-5D scores for cost-effectiveness assessment in this population because of the large variance in agreement between actual and PROMIS Global-10-estimated EQ-5D scores. PROMIS Global-10 physical scores showed good correlation with the ASES score but poor correlation with other gold-standard patient-reported outcome instruments, suggesting that it is an inappropriate instrument for outcome measurement in populations with shoulder arthritis.

Augmentation of Rotator Cuff Healing With Orthobiologics.

The limited regenerative capacity of the tendon-bone enthesis after surgical repair poses a significant challenge to achieving desired clinical outcomes. Biologic augmentation of the repair site has the potential to enhance the biomechanical and histological integrity of the enthesis, leading to lower retear rates and greater patient satisfaction. Platelet-rich plasma, stem cells and bone marrow aspirate concentrate, growth factors, biodegradable or biomimetic scaffolds, and amniotic products have been investigated in preclinical and, in some cases, clinical studies aimed at augmenting tendon-bone healing. Although many of these therapies have achieved some degree of success in improving structural, histological, and clinical outcomes after surgical tendon-bone enthesis repair, none have reliably and consistently lead to clinical improvement. High-quality randomized controlled clinical studies are needed to definitively evaluate the efficacy of these biologic therapies and ultimately determine which, if any, are capable of achieving a tendon-bone repair that is structurally noninferior to the native enthesis before injury.

Validation of PROMIS Global-10 compared with legacy instruments in patients with shoulder instability.

BACKGROUND: Outcomes instruments are used to measure patients' subjective assessment of health status. The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 was developed to be a concise yet comprehensive instrument that provides physical and mental health scores and an estimated EuroQol-5 Dimension (EQ-5D) score. METHODS: A total of 175 prospectively enrolled patients with shoulder instability completed the PROMIS Global-10, EQ-5D, American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Western Ontario Shoulder Instability Index. Spearman correlations between PROMIS scores and the legacy instruments were calculated. Bland-Altman analysis assessed agreement between estimated and actual EQ-5D scores. Floor and ceiling effects were recorded. RESULTS: Correlation between actual and estimated EQ-5D was excellent-good (0.64/p < 0.0005), but Bland-Altman agreement revealed high variability for estimated EQ-5D scores (95% CI: -0.30 to +0.34). Correlation of PROMIS physical scores was excellent-good with ASES (0.69/p < 0.0005), good with SANE (0.43/p<0.0005), and poor with WOSI (0.17/p = 0.13). Correlation between PROMIS mental scores and all legacy instruments was poor. CONCLUSIONS: PROMIS Global-10 physical function scores show high correlation with ASES but poor correlation with other legacy instruments, suggesting it is an unreliable outcomes instrument in populations with shoulder instability. The PROMIS Global-10 cannot replace actual EQ-5D scores for cost-effectiveness assessment in this population. LEVEL OF EVIDENCE: Level II, study of diagnostic test.