Western Ontario Rotator Cuff Scores Research Articles

Effectiveness of abduction brace versus simple sling rehabilitation following rotator cuff repair: systematic review and meta-analyses.

To date, no conclusions have been reached regarding the type of brace worn after arthroscopic rotator cuff repair. To this end, a systematic review and meta-analysis of randomized controlled trials was conducted. According to the updated guidelines of the preferred reporting items of systematic review and meta-analysis (PRISMA), all related literature in PubMed, Embase, and Cochrane Central Register of Controlled Trials (Central), from their establishment to March 1, 2022, were searched systematically. Outcome measures included the Constant score, Western Ontario Rotator Cuff (WORC) index, visual analog scale (VAS) score, shoulder joint range of motion (ROM), and failure events of rotator cuff healing. The Cochrane risk-of-bias tool was used to evaluate the quality of randomized controlled trials (RCT). Two independent reviewers (Chen, Wu) reviewed 275 articles, of which only five met the inclusion criteria, and four were included in the meta-analysis, with a total of 302 patients. The overall risk of bias was high in two RCTs, unclear in one, and low in two. Considering the clinical outcomes, the Constant score (P = 0.08 MD, 3.06; 95% confidence interval [CI], -0.42 to 6.53), WORC (P = 0.23; MD, 3.32; 95%CI,-2.15 to 8.79) , visual analog scale (VAS) score (P=0.09; MD -1.27; 95%CI, -2.75 to 0.21), ROM (P = 0.1; MD, 4.75; 95%CI, -0.98 to 10.48), and failure events of rotator cuff healing (P = 0.78; odds ratio[OR], 0.86; 95%CI, 0.32 to 2.37) did not significantly differ between the abduction brace and simple sling after arthroscopic rotator cuff repair. The findings of this systematic review and meta-analysis suggest that wearing abduction braces after rotator cuff repair neither improved the Constant score , VAS, and WORC scores, and ROM of the shoulder joint, nor did it reduce the risk of retearing . Therefore, a simple sling may be a better option in terms of cost-effectiveness. It is expected that studies with larger and more homogeneous samples will help verify our results.

Paper 49: Bridging Reconstruction for Large-to-Massive Rotator Cuff Tears Has a Low Rate of Cuff Arthropathy Progression at A Minimum Five-Year Follow-Up

Objectives: Rotator cuff tears cause pain, muscle weakness, and difficulty with overhead activity. While smaller tears are easier to repair, large-to-massive cuff tears (>3 cm in size) are considered irreparable. For patients with large-to-massive cuff tears, surgical options include maximal repair, superior capsular reconstruction, bridging reconstruction, tendon transfers and reverse total shoulder arthroplasty (rTSA). Bridging reconstruction was developed to improve outcomes and to avoid the morbidity associated with other technique. Bridging reconstruction, also known as graft interposition, has been shown to have superior outcomes as compared to maximal repair with better patient-reported outcomes at two-years post-operatively as recently demonstrated in a randomized controlled trial. These positive results are maintained at five years, however the midterm changes in progression of rotator cuff arthropathy and conversion to rTSA have not been assessed. The purpose is to assess the progression of rotator cuff arthropathy in bridging reconstruction patients at a five-year follow-up. Methods: Forty-four patients who underwent bridging reconstruction between 2012 and 2017 for large-to-massive rotator cuff tears were included. All patients had a minimum five-year follow-up. Data collected included demographics, pre- and post-operative Western Ontario Rotator Cuff (WORC) Index, conversion to rTSA, and X-ray readings (including acromiohumeral distance (as measured on anterior-posterior pre/post-operative radiographs) and Hamada grades for rotator cuff arthropathy). Furthermore, a sub-group analysis was performed on post-operative MRIs for graft status. Results: The mean age at surgery was 59.9± 10.8 years with a mean follow-up of 7.3±1.4 years. The population was mostly male (70.5%). Pre-operatively, seven patients had mild rotator cuff arthropathy with Hamada grade 2-3, and one patient had Hamada grade 4B. The rest of the patients had Hamada grade one preoperatively. At a minimum five-year postoperative follow-up, only one patient had a rTSA, resulting in a survivorship rate of 98%. Two patients (4.6%) had post-operative Hamada grade 4. One patient had progression of cuff arthropathy from pre-operative Hamada 3 to post-operative Hamada 4A. The other patient maintained Hamada grade 4B from pre-operative to post-operative. Patients with progression of cuff arthropathy (i.e. higher post-operative Hamada grade) appear to have a higher possibility of complete post-operative graft tears. [SS1] [JM2] There were no correlations between progression of cuff arthropathy and WORC score at five years. Conclusions: At a minimum 5-year with a mean follow-up of 7.3 years, bridging reconstruction showed 98% survivorship rate with a low rate of conversion to rTSA and a low progression of cuff arthropathy with only 4.6% of patients having advanced RCA with Hamada grade 4.

The single assessment numeric evaluation correlates with the western ontario rotator cuff score in non-traumatic shoulder disease

Patient-reported outcome measures (PROMs) are essential clinical instruments used for assessing patient function and assisting in clinical decision making. The Western Ontario Rotator Cuff (WORC) index is the PROM for shoulder pathology with the most psychometric properties but is very time consuming. The Single Assessment Numeric Evaluation (SANE) method is a PROM that takes less time to answer and to analyze. The aim of the study is to evaluate the intra- class correlation between these two outcome scores in establishing shoulder function in patients with non-traumatic rotator cuff pathologies. Fifty five subjects of both genders and different ages presenting with non-traumatic shoulder pain for more than 12 weeks had a physical examination and ultrasound as well as MRI arthrogram scan findings that were consistent of a non-traumatic rotator cuff (RC) based pathology. On the same moment a WORC index and a SANE score questionnaire were filled in by the subject. The intra class correlation of both PROMs was statistically analyzed. The WORC index score and the SANE score show a moderate correlation with an Intra Class Coefficient (ICC) of r = 0.60 (95% CI:0.40-0.75). This study demonstrates a moderate correlation between the WORC index score and the SANE score in rating the disability of patients with atraumatic RC disease. The SANE score is applicable in research and clinical practice and is for the patient and the researcher an almost no time consuming PROM.

Effectiveness of Ultrasound-Guided Corticosteroid Injections, Prolotherapy, and Exercise Therapy on Partial-Thickness Supraspinatus Tears.

To investigate the effects of steroid injection (STE), prolotherapy (PRO), and exercise therapy in the treatment of partial tears of the supraspinatus. A retrospective cohort study. A total of 64 patients with clinically and radiologically diagnosed partial-thickness supraspinatus tear who received either a cortisone injection (STE), dextrose PRO, or physical therapy combined with home-based exercise therapy were included. Main outcome measures were patients' visual analog scale scores, Western Ontario Rotator Cuff (WORC) Index scores, and the Shoulder Pain and Disability Index scores at the baseline, 3weeks, and 3months. The effect of group, time, and group-time interaction on visual analog scale, WORC, and Shoulder Pain and Disability Index scores was statistically significant (P < .001). Visual analog scale and Shoulder Pain and Disability Index scores were the lowest in the STE group at week 3, and the lowest in the PRO group at month 3 (P < .001). WORC scores of the STE group were the highest at week 3 (P < .001). At month 3, WORC scores of STE and PRO groups were similar (P = .089), but significantly higher than exercise therapy. Corticosteroids provide a fast pain-relieving effect and improvement in function in partial-thickness rotator cuff tears, but these effects diminish over time, whereas PRO provides a long-lasting effect.

Graft Healing Is More Important Than Graft Technique: Superior Capsular Reconstruction Versus Bridging Grafts—A Prospective Randomized Controlled Trial

To compare superior capsular reconstruction (SCR) versus bridging graft (BG) for massive irreparable rotator cuff tears (RCTs). A prospective double-blind randomized study was conducted to compare SCR versus BG for massive irreparable RCTs. Fifty patients (mean age: 60.2 ± 6.0 years) with chronic tears (mean duration of symptoms: 5 ± 5.2 years) were intraoperatively randomized following partial repair to SCR or BG using human dermal allograft. All patients underwent standardized rehabilitation and were followed at 3, 6, 12, and 24 months clinically and radiographically. Magnetic resonance imaging were obtained at 12 months to determine graft integrity. At 2 years, 46 patients were available for follow-up. Mean American Shoulder and Elbow Surgeons (ASES), Western Ontario Rotator Cuff (WORC), and Quick Disabilities of the Arm, Shoulder and Hand scores were 74.8 ± 23.9, 66.0 ± 28.3, and 24.7 ± 26.1 for the SCR group, and 77.9 ± 19.9, 69.5 ± 24.5, and 25.0 ± 19.1 for the BG group, respectively, with no significant difference between groups. Magnetic resonance imaging demonstrated 18 of 24 (75%) in the SCR group and 14 of 22 (64%) in the BG group were intact at 12 months (P= .53). Patients with intact grafts compared with those with retorn grafts, whether SCR or BG, had greater ASES and WORC scores at 24 months (ASES 81.0 ± 18.7 vs 65.7 ± 24.4, P= .021 and WORC 72.3 ± 24.6 vs 53.7 ± 26.7, P= .04) and greater acromiohumeral intervals on radiographs at all follow-up time points. When performing arthroscopic reconstruction using human dermal allograft for an irreparable RCT, whether the proximal edge of the graft is attached on the glenoid bone or to the torn tendon does not significantly change short-term clinical and radiographic outcomes. I, therapeutic.

Paper 65: Arthroscopic rotator cuff repair with and without acromioplasty in the treatment of full-thickness rotator cuff tears: long term follow-up of a multicenter, randomized controlled trial

Objectives:In our previous trial of 86 patients randomized to undergo rotator cuff repair with or without acromioplasty, no differences in functional and quality-of-life indices at 24-months post-operative were observed. At that time point, four patients (9%) in the group without acromioplasty required reoperation due to persistent symptoms (1 with a type-II acromion and 3 with type-III acromion) while no patients that underwent acromioplasty had follow-up surgery. This is consistent with other short-term studies; however, no long-term follow-up of a randomized clinical trial has been conducted. The aim of this study was to re-evaluate the patients from the original trial determine the long-term efficacy of performing a subacromial decompression in cases of full thickness rotator cuff tears.Methods:This is a secondary study based on a previous multi-centre, double-blind, balanced randomization (1:1), parallel-group study with patients allocated to arthroscopic rotator cuff repair with (ACR) or without acromioplasty (No ACR). Recruitment for the original study was conducted between June 2003 and February 2009 with 24-month follow-up taking place between 2005 and 2011. This secondary study was conducted between April 2015 and March 2021 with all patients randomized in the main study comprising the study sample. Additional exclusion criteria were those who were unable or unwilling to provide informed consent. Patients from the original study were invited by a blinded assessor to return for a follow-up visit involving the same methodology as their previous visits. The visit included completion of a patient-reported outcome, the Western Ontario Rotator Cuff score (WORC) and clinical assessment. If a participant was unable to return for a clinical evaluation, they were asked to complete the WORC by mail.Results:Eighty-six patients were randomized in the original trial. Fifty-seven of those completed the long-term follow-up, 31 of 45 from the No ACR group and 25 of 41 from the ACR group. Sixty-one percent in the No ACR group and 64% in the ACR group were male. The mean (SD) duration of follow-up was 11.2 (2.4) years for No ACR and 11.5 (2.6) years for ACR, respectively. Mean (SD) age of patients at the time of initial surgery for the No ACR group was 58.5 (8.4) and for the ACR group was 56.2 (7.8), while mean age at the most recent follow-up was 69.0 (9.3) for No ACR and 67.7 (7.7) for ACR. Mean (SD) WORC scores at pre-operative, 24-months and long-term follow-up are presented by group in Table 1. There was no significant difference in WORC between the No ACR and ACR groups at the time of long-term follow-up (p=0.30). WORC score maintained a significant improvement from pre-operative scores in both groups (p < 0.001). In the initial study at 24-months post-operative, four patients were identified in the No ACR group who underwent revision surgery. Of those, 2 returned for long-term follow-up and 2 did not. In long term follow-up, another 6 patients were identified that underwent additional surgery on their study shoulder since the 24-month follow-up, including 3 rotator cuff revisions, 1 total shoulder arthroplasty, and 2 unknown shoulder surgeries (patient-reported). Therefore, 10 (22%) of the 45 patients in the No ACR group underwent further shoulder surgery. One participant, 2% of the initial 41 patients allocated to ACR, underwent a revision shoulder surgery.Conclusions:The main finding of this study was that at long-term (mean 11 years post-operative) follow-up of patients randomized to undergo rotator cuff repair with or without acromioplasty, there was no difference in patient-reported outcome, specifically WORC scores. Both groups maintained improved outcomes from their pre-operative status. However, revision rate was significantly higher in those that did not undergo acromioplasty at the time of their initial surgery.Figure 1.Patient flow through study.Figure 2.WORC scores over time by group.

Rotator cuff outcomes and mental health indices: Correlation or causation?

Psychological factors such as catastrophizing, anxiety, and depression influence clinical outcomes in many conditions. Our purpose was to examine trends and associations between these and outcomes of rotator cuff surgery. 148 patients (76 W:72 M, 55.1 ± 8.2 years) with unilateral symptomatic rotator cuff syndrome were followed for 1 year after surgery. The Western Ontario Rotator Cuff Score (WORC), the Pain Catastrophizing Score (PCS), and the Hospital Anxiety and Depression Score (HADS) were administered. Evolution and associations of WORC, HADS and PCS scores were examined using uni- and multivariate analyzes. At 1 year, PCS, HADS-A, and HADS-D scores negatively correlated with WORC score (R = -0.6, -0.61, -0.69). The strength of correlation was lower between baseline PCS, HADS-A, and HADS-D scores and 1-year WORC score (R = -0.38, -0.43, -0.42). Prior anxiety diagnosis was associated with higher HADS-A scores at 2- and 6- weeks post-op (p = 0.013, 0.011). 106 participants experienced an improving HADS-D over the year of follow-up. Worse pre-op pain, WORC, PCS, HADS-A, HADS-D, cardiovascular disease and current smoking were associated with non-improving HADS-D. Patient-reported outcomes of rotator cuff surgery are associated with patient-reported anxiety, depression, and pain catastrophizing. In many, all outcome scores improved over time suggesting a two-way association between shoulder condition and psychological parameters. II.

Measurement of value in rotator cuff repair: patient-level value analysis for the 1-year episode of care.

Rotator cuff repair (RCR) is one of the most common elective orthopedic procedures, with predictable indications, techniques, and outcomes. As a result, this surgical procedure is an ideal choice for studying value. The purpose of this study was to perform patient-level value analysis (PLVA) within the setting of RCR over the 1-year episode of care. Included patients (N = 396) underwent RCR between 2009 and 2016 at a single outpatient orthopedic surgery center. The episode of care was defined as 1-year following surgery. The Western Ontario Rotator Cuff index was collected at both the initial preoperative baseline assessment and the 1-year postoperative mark. The total cost of care was determined using time-driven activity-based costing (TDABC). Both PLVA and provider-level value analysis were performed. The average TDABC cost of care was derived at $5413.78 ± $727.41 (95% confidence interval, $5341.92-$5485.64). At the patient level, arthroscopic isolated supraspinatus tears yielded the highest value coefficient (0.82; analysis-of-variance F test, P = .01). There was a poor correlation between the change in the 1-year Western Ontario Rotator Cuff score and the TDABC cost of care (r2 = 0.03). Provider-level value analysis demonstrated significant variation between the 8 providers evaluated (P < .01). RCR is one of the most common orthopedic procedures, yet the correlations between cost of care and patient outcomes are unknown. PLVA quantifies the ratio of functional improvement to the TDABC-estimated cost of care at the patient level. This is the first study to apply PLVA over the first-year episode of care. With health care transitioning toward value-based delivery, PLVA offers a quantitative tool to measure the value of individual patient care delivery over the entire episode of care.

Does statin-treated hyperlipidemia affect rotator cuff healing or muscle fatty infiltration after rotator cuff repair?

Hyperlipidemia is linked to poor tendon-to-bone healing and progression of fatty infiltration after rotator cuff repair. Statins effectively treat hyperlipidemia, but it is unknown if they have any potential detrimental effects following rotator cuff repair. The aim of this study was to evaluate the effect of statins on rotator cuff healing and fatty infiltration following repair. A total of 77 patients undergoing arthroscopic rotator cuff repair were recruited prospectively, 38 patients who were prescribed a statin for hyperlipidemia (statin group) and 39 patients who were not taking a statin (control group). Patients who did not have both preoperative and 1-year postoperative magnetic resonance imaging (MRI) scans were excluded from the study. Patient-reported outcome measures, namely the Western Ontario Rotator Cuff (WORC) index, Constant-Murley score, American Shoulder and Elbow Surgeons (ASES) score, and Disabilities of the Arm, Shoulder and Hand (DASH) score, were collected preoperatively and at 1 year. Fatty infiltration was assessed on MRI according to the Goutallier grade preoperatively and at 12 months; rotator cuff healing was assessed at 12 months according to the Sugaya classification. Following propensity score weighting to adjust for baseline imbalances, 12-month outcomes were compared between the 2 groups. At 12 months, all patient-reported outcome measures had improved significantly compared with baseline (WORC score, 85.9 vs. 32.5, P < .001; ASES score, 87.3 vs. 37.5, P < .001; Constant-Murley score, 77 vs. 31, P < .001; and DASH score, 13.6 vs. 61.4, P < .001). There was no significant difference in postoperative scores in the statin group vs. the control group (WORC score, 84.9 vs. 89.6, P = .94; ASES score, 87.5 vs. 86.6, P = .40; Constant-Murley score, 77 vs. 81, P = .90; and DASH score, 14.4 vs. 11.4, P = .14), and for 3 of these scores, the 95% confidence intervals excluded a clinically meaningful difference. Similarly, rotator cuff healing at 12 months and Goutallier fatty infiltration grades were comparable between the 2 groups. Retears were seen in 6 patients (15.8%) in the statin group and 8 (20.5%) in the control group. Progression of fatty infiltration was seen in 4 patients (10.5%) in the statin and 4 (10.3%) in the control group. Statin use did not demonstrate a significant association with either retear risk (P = .41) or progression of fatty atrophy (P = .69). Patient-reported outcomes, rotator cuff retear rate, and fatty infiltration on MRI at 12 months after rotator cuff repair in patients with hyperlipidemia treated with statins are similar to those in a control group.

Primary versus revision arthroscopic bridging reconstruction using dermal allograft: a clinical and radiographic analysis (243)

Objectives:Large or massive rotator cuff tears make up between 10-40% of all rotator cuff tears, yet there is no agreement on the best treatment. Previous studies have shown that acellular human dermal allograft (AHDA) can be used for bridging reconstruction with positive patient outcomes. The use of this surgical technique has not been extensively studied in the primary or revision surgical setting. The main objective of this study was to compare the clinical and radiographic outcomes of patients who received primary or revision arthroscopic bridging reconstruction.Methods:This study is a retrospective review of a sequential series of patients who underwent arthroscopic bridging reconstruction (ABR) using AHDA by the primary author (IW). A total of 130 patients underwent ABR between 2010 and 2018. The inclusion criteria were patients with completed Western Ontario Rotator Cuff (WORC) questionnaire, Disabilities of the Arm, Shoulder, and Hand (DASH) score, or both pre-operatively and at multiple post-operative timepoints. Patients with missing WORC scores were excluded from the study. Eighty-three patients were included following chart review. Patients with available post-operative MRIs were also used for radiological assessment by an independent MSK-trained radiologist. Post-operative MRIs were reviewed to assess for graft integrity and changes to rotator cuff muscle atrophy (using the Warner classification) and fatty degeneration (using the Goutallier classification).Results:There were 46 patients who received primary ABR and 37 who received revision ABR. Forty-eight patients had a post-operative MRI available for review (Primary: 25; Revision: 23). The demographics are summarized in Table 1. Both groups showed a significant improvement in WORC score post-operatively (p<0.001). Primary ABR resulted in higher post-operative WORC scores as compared to revision ABR (p=0.015; Figure 1). The incidence of complete re-tears in the primary group was 8% and 17.4% in the revision group. More than 35% of patients in the primary group showed improvement in fatty infiltration of the infraspinatus and supraspinatus muscles. There was a higher progression in muscle atrophy in the revision group as compared to the primary group (74% and 30%, respectively).Conclusions:Arthroscopic primary arthroscopic bridging reconstruction for large/massive rotator cuff tears using acellular human dermal allograft had better improvement in their WORC scores compared to revision group at the final follow-up. Although the revision group had improved at the two-year follow-up, these changes in WORC score were not sustained at the final follow-up while the improvements were maintained for the primary group. The primary group had a smaller re-tear rate, better fatty infiltration and muscle atrophy as compared to the revision group. This suggests that primary bridging reconstruction provides better outcomes than a revision surgery.

Massive Rotator Cuff Tear Bridging Reconstruction Using Acellular Dermal Matrix: Mid-term Results (219)

Objectives:Management of massive rotator cuff tears remains a challenge despite development of different surgical techniques. Bridging reconstruction was developed to improve clinical outcomes and to avoid the morbidity associated with tendon transfers and arthroplasty. To date, there have been no studies assessing the mid-term clinical outcome for patients undergoing this procedure. The objective of this study was to evaluate the mid-term clinical outcomes of patients who underwent bridging reconstruction using acellular dermal matrix for large/massive rotator cuff tears (> 3 cm).Methods:A retrospective chart review was conducted for patients who underwent bridging reconstruction between 2010 and 2018 by one surgeon (IW). Patients with a minimum follow-up of two years were included. All patients completed self-reported questionnaires (Western Ontario Rotator Cuff (WORC) Index and the Disabilities of the Shoulder, Arm and Hand (DASH) score) pre-operatively and post-operatively at six months, one year and annually thereafter.Results:One hundred charts were reviewed, and 20 patients were excluded due to lack of pre- or post-operative outcome scores. This cohort of patients consisted of 80 patients mean age of 58.6 ± 9.1 years and an average follow-up of 5.1 ± 1.6 years. The mean pre- and post-operative WORC scores (± SD) were 61.4 ± 20.6 and 28.1 ± 25.5 (p < 0.001), respectively. The mean pre- and post-operative DASH scores were 52.2 ± 19.7 and 23.1 ± 22.4 (p < 0.001), respectively. There was an improvement in WORC and DASH over time with the most significant improvement during the first year post-operatively (Figure 1). Seventy-eight percent of patients met the minimal clinically important difference (MCID) for WORC while 77% of patients met the MCID for DASH. Our results show significant mid-term clinical improvement in WORC and DASH scores that is similar to previously published data that showed significant improvements in other patient-reported outcome scores. We believe these positive outcomes to be a result of better force coupling within the shoulder as compared to other surgical treatments such as maximal repair, superior capsular reconstruction, and reverse total shoulder arthroplasty.Conclusions:Arthroscopic bridging reconstruction for the treatment of massive rotator cuff tears results in significant improvement of patient reported outcomes (as measured using the WORC and DASH scores) at a mean follow up of five years. This may suggest that bridging reconstruction is a good treatment alternative as compared to superior capsular reconstruction or reverse total shoulder arthroplasty. Longer follow-up with a prospective study design is necessary to determine the longevity of these outcomes.

Patient gender and rotator cuff surgery: are there differences in outcome?

BackgroundAlthough rotator cuff syndrome is common and extensively studied from the perspective of producing healed tendons, influence of gender on patient-reported outcomes is less well examined. As activity and role demands may vary widely between men and women, clarity on whether gender is an important factor in outcome would enhance patient education and expectation management. Our purpose was to determine if differences exist in patient-reported outcomes between men and women undergoing rotator cuff surgery.MethodsOne hundred forty-eight participants (76 W:72 M) aged 35–75 undergoing surgery for unilateral symptomatic rotator cuff syndrome were followed for 12 months after surgery. Demographics, surgical data, and the Western Ontario Rotator Cuff (WORC) scores were collected. Surgery was performed by two fellowship-trained shoulder surgeons at a single site.ResultsThere were no gender-based differences in overall WORC score or subcategory scores by 12 months post-op. Pain scores were similar at all time points in men and women. Women were more likely to have dominant-arm surgery and had smaller rotator cuff tears than men. Complication rates were low, and satisfaction was high in both groups.ConclusionPatient gender doesn’t appear to exert an important effect on patient-reported rotator cuff outcomes in this prospective cohort. Further work examining other covariates as well as the qualitative experience of going through rotator cuff repair should provide greater insight into factors that influence patient-reported outcomes.

Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial

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)

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry

PurposeThe purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing.MethodsSeventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of ≥21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected.ResultsOf 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively; P < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n = 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n = 1), and adhesive capsulitis (n = 1).ConclusionsThe safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size.Level of EvidenceLevel IV, therapeutic case series.

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry

Background:Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears.Purpose:Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears.Study Design:Case series; Level of evidence, 4.Methods:A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study.Results:The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections.Conclusion:This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive “take-down and repair” approach.

Effect of Age, Gender, And BMI on the Incidence and Satisfaction of A Popeye Deformity Following Biceps Tenotomy or Tenodesis: Outcomes of A Multicenter Randomized Controlled Trial

Objectives:The purpose of this study was to 1) determine the rates of popeye deformity following biceps tenotomy versus tenodesis 2) identify predictors for developing a deformity, and 3) report the subjective and objective outcomes in patients with a popeye deformity.Methods:Data for this study were collected as part of a randomized clinical trial comparing tenodesis versus tenotomy in the treatment of lesions of the long head of biceps tendon. Patients 18 years of age or older undergoing arthroscopic shoulder surgery with intraoperative confirmation of a lesion of the long head of the biceps tendon randomized to one of these techniques were included. The primary outcome measure for this sub-study was the rate of a popeye deformity at 24-months post-operative as determined by an evaluator blinded to group allocation. Secondary outcomes were presence/absence of a popeye deformity based on patients responding to the following question: “Do you notice a bulge on the front of your upper arm above your elbow?” If yes, patients indicated their satisfaction with the appearance of their arm on a 10 cm visual analog scale (VAS) with 0=“Unsatisfactory” and 10=“Satisfactory” as the anchors. Patients were also asked to indicate if they experienced pain or cramping on a VAS, and complete the American Shoulder and Elbow Score (ASES) and the Western Ontario Rotator Cuff score (WORC). Isometric elbow flexion and supination strength (ratio of affected and unaffected) were also measured. Kappa was calculated to measure interrater reliability between patient and evaluator on the presence of a deformity, and logistic regression was used to identify possible predictors of its occurrence. Pearson correlations were performed to identify factors associated with dissatisfaction in appearance.Results:Fifty-seven participants were randomly assigned to each group of which 42 in the tenodesis group and 45 in the tenotomy group completed a 24-month follow-up. The overall incidence of popeye deformity based on clinical assessment was 21%, 9.5% (4/42) in the tenodesis group and 33% (15/45) in the tenotomy group. The odds of a popeye deformity resulting from a tenotomy was 4.3 times that of tenodesis (OR 4.3, 95% CI: 1.25-14.76; p=0.018). Gender was tending towards significance with males having 7.3 greater odds of a perceived deformity (p=0.067), while age and BMI were not predictive. There were no differences between those with and without a perceived deformity with respect to subjective and functional outcome measures. Based on patient self-assessment, the overall incidence of a deformity was 18%, 25% in the tenotomy group and 10% in the tenodesis group. The odds of a patient reporting a popeye deformity following tenotomy was 3.66 relative to tenodesis (OR=3.66, CI 95% 1.08-12.44; p=0.038). Gender, BMI, and age were not predictive of self-report of a popeye. Those with and without a self-reported popeye deformity differed with respect to pain (p=0.001), cramping (0.039), and WORC scores (p<0.006), there was no difference in ASES or elbow strength.Of those who reported having a deformity, mean (SD) satisfaction score reported on the appearance of their arm was 7.3 (2.6). Increasing satisfaction score was significantly correlated with increasing patient age (r=0.640; p=0.025) but there was no association with gender or BMI.Inter-rater agreement between clinical assessment and self-reported popeye deformity was substantial with a kappa of 0.635 (p<0.001). However, 8% (7/87) of patients with a popeye deformity did not perceive it and 3% (3/87) of patients reported a popeye deformity that was not detected by the clinical assessor.Conclusions:The odds of observing a popeye deformity based on clinical assessment following tenotomy was 4.3 times higher than tenodesis at 24-months post-operative. Male gender may contribute to increased incidence, while age and BMI were not major contributors to the presence/absence of a popeye. In patients who reported a popeye deformity, increasing age was associated with increased satisfaction in the appearance of the arm.

POS0020 EFFICACY AND SAFETY OF SECUKINUMAB IN PATIENTS WITH ROTATOR CUFF TENDINOPATHY: A 24-WEEK, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II PROOF-OF-CONCEPT TRIAL

Background:Rotator cuff tendinopathy (RC TP) is a multifactorial condition and one of the most common causes of musculoskeletal burden. Current standard of care (SoC) is limited to pain relief with NSAIDs and physiotherapy. Recent evidence indicates that IL-17A-expressing tendon-resident immune cells are present in human overuse tendinopathy, and IL-17A levels are increased in early human tendinopathic tissue samples [1, 2]. Secukinumab (SEC) is a fully human, monoclonal antibody that binds to and neutralises IL-17A.Objectives:To evaluate the efficacy and safety of SEC in patients with active overuse RC TP refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections.Methods:96 patients with symptomatic RC TP with no or &lt;50% rupture were randomly assigned to receive seven subcutaneous injections of SEC 300 mg or placebo (PBO) at baseline and Weeks 1, 2 and 3, followed by every 4 weeks starting at Week 4. The primary endpoint was change from baseline in the Western Ontario Rotator Cuff (WORC) index score at Week 14 for SEC vs PBO (two-sided p&lt;0.1). Secondary endpoints included, visual analogue scale (VAS) pain score, Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) score, American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES), EQ-5D-5L score and patient global assessment (PGA) score. All endpoints were assessed through 24 weeks.Results:Clinically relevant improvement in both SEC and PBO groups on top of SoC treatment was observed, with no statistically significant difference demonstrated in the full study population on physical symptoms and function (Table 1). Similar results were observed in the secondary endpoints with marked improvement in both groups over time. Exploratory post-hoc analyses in a subpopulation of 39% of the study subjects with non-acute, moderate to severe disease, SEC provided significant and clinically relevant improvements vs PBO through Week 24 in total WORC score (overall treatment difference: 19.2, p &lt;0.01) and pain (VAS, overall treatment difference: 15, p = 0.02) with early effect observed after two weeks (Figure 1). A favourable treatment effect in the more severe subgroup was demonstrated in other patient-reported outcomes. No serious adverse events were reported.Conclusion:Although SEC did not demonstrate a significant benefit vs PBO in the overall patient population with active overuse RC TP, SEC did provide benefit in the subpopulation with non-acute, moderate to severe disease. Larger clinical trials of SEC in this area are warranted.

Preoperative bone marrow stimulation does not improve functional outcomes in arthroscopic cuff repair: a prospective randomized controlled trial.

Despite recent advances in arthroscopic rotator cuff repair, re-tear rates remain high. New methods to improve healing rates following rotator cuff repair must be sought. Our primary objective was to determine if adjunctive bone marrow stimulation with channelling five to seven days prior to arthroscopic cuff repair would lead to higher Western Ontario Rotator Cuff (WORC) scores at 24 months postoperatively compared with no channelling. A prospective, randomized controlled trial was conducted in patients undergoing arthroscopic rotator cuff repair. Patients were randomized to receive either a percutaneous bone channelling of the rotator cuff footprint or a sham procedure under ultrasound guidance five to seven days prior to index surgery. Outcome measures included the WORC, American Shoulder and Elbow Surgeons (ASES), and Constant scores, strength, ultrasound-determined healing rates, and adverse events. Overall, 94 patients were randomized to either bone channelling or a sham procedure. Statistically significant improvements in all clinical outcome scores occurred in both groups from preoperative to all timepoints (p < 0.001). Intention-to-treat analysis revealed no statistical differences in WORC scores between the two interventions at 24 months postoperatively (p = 0.690). No differences were observed in secondary outcomes at any timepoint and healing rates did not differ between groups (p = 0.186). Preoperative bone channelling one week prior to arthroscopic rotator cuff repair was not associated with significant improvements in WORC, ASES, Constant scores, strength, or ultrasound-determined healing rates. Cite this article: Bone Joint J 2021;103-B(1):123-130.

Stephen S. Burkhart, M.D. Shoulder Innovation Research Award Paper: Balloon Subacromial Spacer vs. Partial Repair for Massive Rotator Cuff Tears: A Randomized Trial

Limited options exist for the treatment of massive rotator cuff tears (MRCTs). Surgical repair may be technically challenging and require prolonged rehabilitation with variable outcomes. The present study was designed to assess the safety and efficacy of an arthroscopically-deployed inflatable biodegradable subacromial spacer balloon (InSpaceTM, OrthoSpace, Israel) as an alternative to partial repair in patients with MRCTs. A non-inferiority, prospective, single-blinded, multicenter, randomized, controlled, pivotal study was conducted to compare the outcomes of arthroscopic subacromial balloon spacer implantation to partial repair in the treatment of MRCTs. Patients ≥ 40-years of age with full thickness MRCTs (≥ 5 cm, ≥ 2 tendons) were included. Baseline and follow-up data were collected to identify patients that had reached a primary composite endpoint consisting of the minimal clinically important difference (MCID) for the Western Ontario Rotator Cuff (WORC) score (275 points) and American Shoulder and Elbow Society (ASES) score (6.4 points) by 6-weeks and maintained at 12-months without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). 184 patients were randomized, 176 (88/group) of which completed the required 12-month follow-up per protocol. At 12-months, 45 (51%) patients in the spacer implant group and 35 patients (39.8%) in the partial repair group, had reached and maintained the primary composite endpoint, corresponding to a difference between groups of 11.4% (non-inferiority margin 10%; p = 0.0049). Additionally, the spacer implant group demonstrated superior improvement (p = 0.0224) when evaluating the following combined efficacy timepoints of ASES score at 6-weeks and WORC score at 12-weeks, both maintained at 12-months in the absence of SSSI or SADEs, compared to the partial repair group. Arthroscopic subacromial balloon spacer implantation is a viable alternative to partial repair in the treatment of symptomatic MRCTs with comparable clinical outcomes at one year.

Normative values of the Western Ontario Rotator Cuff (WORC) Index for the general population in the USA

ObjectivesThere are limited data on Western Ontario Rotator Cuff (WORC) Index scores in a population without shoulder pathology. The primary purpose was to provide normative reference values for the WORC in an adult population with healthy shoulders. The secondary purpose was to identify demographic factors and comorbidities that may impact WORC scores.MethodsThe WORC survey was completed by patients and family members at a suburban outpatient orthopaedic centre. Patients with current shoulder injury or former upper extremity surgery were excluded. Percentage scores were calculated for total and subscale measures. Demographic factors and comorbidities were evaluated to identify possible risk factors for an abnormal baseline score (less than 100).ResultsThere were 988 participants (434 men, 554 women). Overall WORC median (IQR) was 98.64 (94.3 to 100). Each subscale was greater than 96 for all sex-based and age-based subgroups. Median WORC scores were greater than those reported in previous literature following surgery for shoulder pathology. Demographic risk factors for poor WORC scores included body mass index (BMI) greater than 30 (p<0.05), tobacco use (p<0.05), a history of shoulder problems (p<0.001) and a history of shoulder injections (p<0.001).ConclusionsThis study provides baseline values for the WORC survey in a US suburban population across a range of age groups, demonstrating that surgery for shoulder pathology often results in improved WORC scores, but may not return patients to baseline. Demographic risk factors for lower scores include smoking, BMI above 30, history of shoulder problems or history of shoulder injection.Level of evidenceDescriptive epidemiology study; Level of evidence: III.