The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study

Cross-cultural adaptation, reliability, and validity of the Italian version of the Western Ontario Rotator Cuff (WORC) Index in subjects with rotator cuff diseases.

No Functional Difference Between Three and Six Weeks of Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-Inferiority Trial

Influence of dominant- as compared with nondominant-side symptoms on Disabilities of the Arm, Shoulder and Hand and Western Ontario Rotator Cuff scores in patients with rotator cuff tendinopathy

Background: Despite advances in surgical techniques, the use of maximal repair to treat large or massive rotator cuff tears results in a high retear rate postoperatively. Currently, no randomized controlled trials have compared the outcomes of maximal repair with interposition dermal allograft bridging reconstruction. Hypothesis: We hypothesized that large or massive rotator cuff tendon tears reconstructed using bridging dermal allograft would have better clinical outcomes 2 years postoperatively, as measured using the Western Ontario Rotator Cuff (WORC) index, than would those receiving the current gold standard treatment of debridement and maximal repair alone. We also expected that patients treated via bridging reconstruction using dermal allograft would have fewer postoperative failures as assessed using postoperative magnetic resonance imaging scans. Study Design: Randomized controlled trial; Level of evidence 1. Methods: A sample size of 30 patients (determined using a priori sample size calculation) with massive, retracted rotator cuff tears were randomly allocated to 1 of 2 groups: maximal repair or bridging reconstruction using dermal allograft. All patients completed questionnaires (WORC and Disabilities of the Arm, Shoulder and Hand [DASH]) preoperatively and postoperatively at 3 months, 6 months, 1 year, and 2 years. The primary outcome of this study was the WORC index at 2 years. Secondary outcomes included healing rate, progression of rotator cuff arthropathy, and postoperative acromiohumeral distance in both groups. Results: Patients treated via bridging reconstruction using dermal allograft had better postoperative WORC and DASH scores (23.93 ± 24.55 and 15.77 ± 19.27, respectively) compared with patients who received maximal repair alone (53.36 ± 31.93 and 34.32 ± 23.31, respectively). We also noted increased progression to rotator cuff arthropathy in the maximal repair group with an increased retear rate when compared with the reconstruction group (87% and 21%, respectively; P < .001). The acromiohumeral distance was maintained in the reconstruction group but significantly decreased in the maximal repair group. Conclusion: Rotator cuff bridging reconstruction using a dermal allograft demonstrated improved patient-reported outcomes as measured using the WORC index 2 years postoperatively. This technique also showed favorable structural healing rates and decreased progression to arthropathy compared with maximal repair. Trial Registration: ClinicalTrials.gov (NCT01987973)

Background:Rotator cuff tears are common injuries that are reliably treated witharthroscopic repair, producing good to excellent results. The WesternOntario Rotator Cuff (WORC) index is a validated disease-specific instrumentused to assess patient outcomes; however, no study to date has correlatedWORC index with treatment failure.Purpose:To evaluate the WORC index as a predictor for successful treatment inarthroscopic rotator cuff repair. An additional purpose was to identifypatient and tear characteristics associated with risk of treatmentfailure.Study Design:Case-control study; Level of evidence, 3.Methods:This study reviewed a total of 500 patients who underwent arthroscopicrotator cuff repair with a minimum of 2-year follow-up. Patient charts werereviewed for treatment failures, defined as persistent or recurrent shoulderpain or weakness, leading to further workup and identification of a failureto heal or recurrent tear by magnetic resonance imaging. Patient demographicand comorbidity data were gathered and correlated with risk of failure. Allpatients completed WORC questionnaires, and scores were correlated with riskof treatment failure.Results:There were 28 (5.6%) treatment failures at a median 28 weeks (SD, 42 weeks)postoperatively. Patients claiming workers’ compensation were 3.21 timesmore likely (odds ratio; P = .018) to fail treatment.Posterior interval tears (those including infraspinatus) were 3.14 timesmore likely (P = .01) to fail than anterior interval tears.Tear size was associated with treatment failure; the odds of failure was3.24 for a 2-tendon tear and 5.83 for a 3-tendon tear (P =.03). Tears involving the nondominant arm were associated with an increasedrisk of failure by a factor of 3.04 (95% CI, 1.01-9.11; P =.047). A WORC score ≥80 was associated with a 95% probability of treatmentsuccess at 1 year.Conclusion:After arthroscopic rotator cuff repair, patients with WORC scores ≥80 at 1year have a 95% probability of successful treatment and likely do notbenefit from continued follow-up visits. Furthermore, several risk factorswere identified that may influence outcomes after rotator cuff repair,including workers’ compensation, location of tear, tear size, and handdominance.

Single Assessment Numeric Evaluation (SANE) correlates with American Shoulder and Elbow Surgeons score and Western Ontario Rotator Cuff index in patients undergoing arthroscopic rotator cuff repair

Comparison of computerized and paper versions of the Western Ontario Rotator Cuff (WORC) Index

Purpose We aimed to translate and cross-culturally adapt the Western Ontario Rotator Cuff index into Greek (WORC-GR) and evaluate its reliability and validity in a Greek speaking population with rotator cuff (RC) disorders. Materials and methods Translation and cross-cultural adaptation process followed published guidelines. Content and face validity were assessed by 9 experts and 16 patients with RC pathologies, respectively. Internal structure, reliability, measurement error, and convergent validity (correlation with the Disability of the Arm, Shoulder and Hand – DASH, Shoulder Pain and Disability Index – SPADI, and Short Form-36) of the index were evaluated in 104 participants (44.2% women, mean age ± SD: 44.9 ± 15.01 years) with RC related pain. Results The WORC-GR showed excellent item and scale content validity index (0.875–1.00 and 0.975, respectively), internal consistency (Cronbach’s alpha range 0.749 − 0.903) and test-retest reliability (intraclass correlation coefficient: 0.942, 95% CI: 0.913–0.961). Factorial validity testing revealed a 4-factor structure explaining 69.7% of the total variance. High positive correlations were found with DASH (r = 0.806) and SPADI (r = 0.852). Conclusions WORC-GR is a reliable and valid instrument to assess symptoms in patients with RC disorders. Further research on the content validity, internal structure, and responsiveness of the tool is required. Implications for rehabilitation The Greek version of WORC (WORC-GR) is a clear and comprehensible patient reported outcome measure. WORC-GR has excellent internal consistency, test-retest reliability and with no floor and ceiling effects. WORC-GR is a valid outcome measure for patients with rotator cuff disorders.

To compare responsiveness for the two region specific questionnaires Shoulder Disability Questionnaire (SDQ) and Shoulder Pain Disability Index (SPADI) and the disease specific Western Ontario Rotator Cuff (WORC) index in subacromial impingement syndrome (SIS) receiving physical therapy or subacromial corticosteroid injection. Sixty-four patients with SIS diagnosed participated in this study. All the patients were provided either physical therapy or subacromial corticosteroid injection treatment. The SDQ, the SPADI and WORC index were assessed both at the beginning and after the 3rd month of treatment. The responsiveness of the three questionnaires was compared by using the effect size (ES), the standardized responsiveness mean (SRM) and Guyatt's method. For both treatment groups there was no statistical difference observed between the pre- and post treatment measurement results versus improvement differences (p> 0.05). SDQ (ES=0.94; SRM=1.14; Guyatt value=0.95), SPADI (ES=1.55; SRM=2.14; Guyatt value=1.08), WORC index (ES=1.37; SRM=1.70; Guyatt value=1.15) were highly responsive for SIS. The SDQ, the SPADI and the WORC index are suitable for measuring changes in patients with SIS. Of these three indices, the SDQ and the SPADI are more suitable for a rapid assessment whereas the WORC index is better in cases where a more detailed assessment including the psychological impact created by the functional status needs to be assessed.

The aim of the present study was to investigate the effectiveness of prolotherapy injections in the treatment of failed rotator cuff repair surgery. Between May 2014 and March 2016, a total of 15 patients (5 males, 10 females; mean age 49.4±10.7 years; range, 33 to 71 years) with failed rotator cuff repair surgery who had at least six months of complaints and were refractory to at least of three months of conservative methods were included. Ultrasound-guided prolotherapy injections were performed under aseptic conditions, and the patients were instructed to carry out a home-based exercise program. Clinical assessment of shoulder function was performed using a visual analog scale (VAS) for pain, Shoulder Pain and Disability Index (SPADI), Western Ontario Rotator Cuff (WORC) Index, patient satisfaction and shoulder range of motion. All patients were examined at baseline, at Week 3, 6, and 12 and at the final follow-up visit. The intra-group comparison showed that the patients achieved significant improvements at all time points, compared to baseline as measured by VAS, SPADI, WORC index, and shoulder range of motion (p<0.001). Twelve patients (80%) reported excellent or good outcomes. Our study results show that prolotherapy is effective in the treatment of patients with failed rotator cuff repair surgery with significant improvements in the shoulder functions and pain relief.

To examine functional outcomes and radiographic shoulder findings at mid-term after superior capsular reconstruction for irreparable rotator cuff ruptures using a porcine dermal graft. Clinical results for patients not older than 70 years of age with a chronic irreparable superior or posterosuperior tendon defect, which included either a total defect of the supraspinatus tendon or a larger defect, including both the supraspinatus and infraspinatus tendons, treated with a xenograft superior capsular reconstruction technique during a 5-year period between October 2015 and January 2020. Patients were evaluated using the Constant score and Western Ontario Rotator Cuff (WORC) index over a minimum 5-year follow-up. All operated shoulders had magnetic resonance imaging of the injured shoulder after 1 year and after 5 years or later with a qualitative radiographic evaluation of graft integrity. Preoperative x-rays and x-rays at mid-term were classified according to the Hamada classification. Twenty-three patients were operated on. Twenty-one patients completed a mid-term follow-up (range, 60-101 months; mean, 71 months). Mean age was 57 years at the time of surgery. No correlation was found between functional outcome scores, graft durability, and Hamada grade. There was no correlation between functional outcome and any progression of radiographic rotator cuff arthropathy. Patients with a single-tendon defect or patients with no prior rotator cuff operation had better outcomes than patients with a 2-tendon defect and patients with a prior operation. At final follow-up for 21 patients, the mean Constant score improved from an average of 26 points to 68 points (P < .001). The mean WORC index increased from a percentage average of 29% to 76% (P < .001). Twenty-one of 21 patients exceeded recognized minimal clinically important difference (MCID) levels for their Constant scores, and 20 of 21 patients exceeded MCID levels for their WORC indices. At mid-term follow-up, no further complications in terms of graft tears, infections, or revisions were registered. The clinical failure rate was 1 patient out of 21. At the time of completed mid-term follow-up, a substantial number of patients (95%) achieved the MCID for the Constant scores and WORC indices, with no deterioration in functional improvement. No correlations between functional outcomes and radiographic shoulder findings at mid-term were identified. Level IV, retrospective case series.

PurposeRotator cuff (RC) tear is one of the most common injuries of the shoulder. Patients with RC tears often report a trauma initiating shoulder pain and impaired function. The aim of this retrospective analysis of a prospectively registered cohort was to elucidate whether the time interval between the trauma and RC repair, using a cut off of 3 months, affects the functional outcome after 2 years.MethodsIn a single orthopedic unit, 819 consecutive patients were treated with rotator cuff repair during the period from 2010 to 2014 and 733 of the patients completed the Western Ontario Rotator Cuff (WORC) index preoperatively and at 2-year follow-up. The Constant–Murley (CM) score was completed by trained physiotherapists after a clinical examination both preoperatively and at 2-year follow-up. Preoperative magnetic resonance imaging (MRI) was performed in all patients and postoperatively in 65% of the included patients. Re-tears and partial repairs were excluded, as were patients with pseudoparalysis who were given high priority and underwent surgery during the first 3 weeks after trauma.ResultsOf the 733 treated patients, 437 (60%) reported having had a shoulder trauma in their medical history initiating their shoulder symptoms, and of these, 358 met the inclusion criteria. 296 patients with non-traumatic tears, 9 repairs done within 3 weeks after trauma, 25 partial repairs, 33 re-tears and 12 others were excluded. At 2-year follow-up there was no significant difference in WORC index (n.s.) or CM score (n.s.) between patients who had their RC repaired within or more than 3 months after trauma. In patients where RC repair was performed within 3 months, the WORC index improved by 42.9%, and in the group of patients operated later than 3 months, the increase was 38.7%. This difference between the groups was neither statistically significant (n.s.) nor clinically relevant. On postoperative MRI, 80% of the repairs were healed in both groups.ConclusionIn this retrospective cohort study, no differences in clinical outcome were found when RC repair was performed between 3 weeks and 3 months or later than 3 months after injury in patients describing their onset of symptoms as traumatic.Level of evidenceIII.

Objectives:The objectives of this project are: (1) to compare the efficacy of surgical versus non-surgical management of full-thickness rotator cuff tears, and (2) to detect variables that predict success within each treatment group.Methods:Patients who presented to our care for management of symptomatic full-thickness rotator cuff tears were enrolled in our Shoulder Registry and clinical data were collected prospectively. In addition to baseline demographic information, the following outcome measures were collected at baseline, 6 months, 1 year and annually up to 3 years: Western Ontario Rotator Cuff (WORC) Index, American Shoulder and Elbow Surgeons (ASES) score, Modified Marx Shoulder Activity Level Scale, VR-12, 100-point Single Assessment Numeric Evaluation (SANE) rating, 100-point visual analog scale (VAS) for pain, and a patient satisfaction scale. All patients were allocated treatment as recommended by the attending surgeon. We described all patient demographic characteristics, and performed linear and logistic regression for variables associated with treatment allocation and with treatment effects. We also used Student’ t-tests and Wilcoxon rank-sum tests where appropriate, to explore differences in treatment effects between the groups for all outcome measures at all time points.Results:A total of 292 patients were included with 155 allocated to surgery and 137 to non-surgical treatment. Those allocated to surgery were younger (58.6 years vs 65.2 years; P<.0001), less likely to have diabetes (12% vs 21%; P=0.05), more likely to have a known traumatic injury (71% vs 55%; P=0.002), and tended to be worse off on all outcome measures at baseline then the non-surgical group. Both the surgical group and non-surgical group improved on all outcome measures across the follow up period with several variables predicting changes at each time point. Table 1 contains the list of specific variables that predicted improved outcomes separately for both treatment groups. Also, at one year the surgical group improvement was significantly greater than the non-surgical group on all outcome measures. At both two and three years the surgical group showed a significantly greater degree of improvement than the non-surgical group on both the WORC index and the ASES score.Conclusion:We found that patients with rotator cuff tears who undergo surgical or nonsurgical treatment tend to improve, with patients allocated to surgery improving to a greater degree across three years of follow-up. In addition, there appear to be important predictors of improved outcomes that may help us to tailor our treatments to individuals with specific characteristics.

BackgroundDegenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears.MethodsThe study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40–75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including—as indicated—bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.DiscussionThe ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears.Trial registrationThe trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).

To adapt the Western Ontario Rotator Cuff (WORC) index for use in Turkey and to investigate its reliability and validity; the Turkish version of the WORC was developed according to the guidelines in the literature. Seventy-two patients with rotator cuff disease were administered the questionnaire and were also evaluated by using the University of California Los Angeles (UCLA) shoulder rating scale, Constant score, and Short Form (SF)-36 to test validity. The WORC questionnaire was repeated in 35 patients after a mean interval of 2.9 days (range 2-7 days) to evaluate test-retest reliability. Cronbach's alpha was calculated as 0.92 for the total questionnaire. The intraclass correlation coefficients were very high and ranged between 0.96 and 0.98 for each section. There was a significant negative correlation between the Turkish version of WORC and UCLA (r = -0.598, P < 0.01), Constant score (r = -0.630, P < 0.01), and all subscales of SF-36 (P < 0.01). The Turkish version of the WORC index is a reliable and valid instrument for use in clinical trials in patients with rotator cuff disorders.