What happens to patients when we do not repair their cuff tears? Five-year rotator cuff quality-of-life index outcomes following nonoperative treatment of patients with full-thickness rotator cuff tears.

BACKGROUND: The purpose of this study was to examine 5-year outcomes in a prospective cohort of patients previously enrolled in a nonoperative rotator cuff tear treatment program. METHODS: Patients with chronic (>3 months), full-thickness rotator cuff tears (demonstrated on imaging) who were referred to 1 of 2 senior shoulder surgeons were enrolled in the study between October 2008 and September 2010. They participated in a comprehensive, nonoperative, home-based treatment program. After 3 months, the outcome in these patients was defined as "successful" or "failed." Patients in the successful group were essentially asymptomatic and did not require surgery. Patients in the failed group were symptomatic and consented to undergo surgical repair. All patients were followed up at 1 year, 2 years, and 5 or more years. RESULTS: At 5 or more years, all patients were contacted for follow-up; the response rate was 84%. Approximately 75% of patients remained successfully treated with nonoperative treatment at 5 years and reported a mean rotator cuff quality-of-life index score of 83 of 100 (SD, 16). Furthermore, between 2 and 5 years, only 3 patients who had previously been defined as having a successful outcome became more symptomatic and underwent surgical rotator cuff repair. Those in whom nonoperative treatment had failed and who underwent surgical repair had a mean rotator cuff quality-of-life index score of 89 (SD, 11) at 5-year follow-up. The operative and nonoperative groups at 5-year follow-up were not significantly different (P = .11). CONCLUSION: Nonoperative treatment is an effective and lasting option for many patients with a chronic, full-thickness rotator cuff tear. While some clinicians may argue that nonoperative treatment delays inevitable surgical repair, our study shows that patients can do very well over time.

The rotator cuff quality-of-life index predicts the outcome of nonoperative treatment of patients with a chronic rotator cuff tear.

BACKGROUND: Chronic rotator cuff tears are prevalent and can be disabling. The existing literature is unclear regarding the effectiveness of nonoperative treatment. The purposes of this study were to determine whether the outcome of nonoperative treatment can be predicted on the basis of the presenting clinical characteristics and whether the outcome achieved at three months after treatment can be maintained at two years. METHODS: The prospective cohort included ninety-three patients with a documented chronic full-thickness rotator cuff tear. Patients underwent a three-month supervised program of nonoperative treatment and were then evaluated by an orthopaedic surgeon. The treatment outcome was defined as a success if surgical treatment was no longer deemed appropriate by both patient and surgeon because the patient had improved considerably and was predominantly asymptomatic. The outcome was defined as a failure if the patient elected to have surgery after failing to improve and remaining symptomatic. The presenting clinical characteristics that were analyzed included age, sex, smoking status, hand dominance, duration of symptoms, onset (traumatic etiology or insidious onset), shoulder motion, external rotation strength, tear size as documented by ultrasonography or magnetic resonance imaging, and the Rotator Cuff Quality-of-Life Index (RC-QOL). RESULTS: Seventy (75%) of the patients were successfully treated. Logistic regression analysis showed that the baseline RC-QOL score was a significant predictor of outcome (p = 0.017). Eighty-nine percent of patients maintained their three-month outcome at two years of follow-up. CONCLUSIONS: The RC-QOL was predictive of the outcome of nonoperative treatment of patients with a chronic full-thickness rotator cuff tear. Patients in whom the nonoperative treatment was deemed successful at the conclusion of three months of treatment had a very high chance of ongoing success at two years after the initiation of treatment.

Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial.

BACKGROUND: Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications. Reports of serious adverse events followed, leading to its abandonment. This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy (ETAC) compared with open inferior capsular shift (ICS) and reviews the role of randomized trials in adopting new technology. METHODS: Patients (>14 years) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled. Patients with bone lesions or labral, biceps anchor, or full-thickness rotator cuff tears were excluded intraoperatively. Outcomes included Western Ontario Shoulder Instability Index, function and recurrent instability at 2 years postoperatively, and surgical times. RESULTS: Fifty-four subjects (mean age, 23 years; 37 women) were randomized to ETAC (n = 28) or open ICS (n = 26). The groups were comparable at baseline, except for external rotation at the side. At 2 years postoperatively, there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index (P = .71), American Shoulder and Elbow Surgeons score (P = .43), Constant score (P = .43), and active range of motion. Recurrent instability was not statistically different (ETAC, 2; open, 4; P = .41). ETAC (23 minutes) was significantly shorter than open ICS (59 minutes) (P < .01) surgery. Three subjects (1 ETAC, 2 open) had stiff shoulders. CONCLUSIONS: At 2 years postoperatively, quality of life and functional outcomes between groups were not clinically different. ETAC had fewer complications and episodes of recurrence compared with open surgery. This evidence reinforces the need to critically evaluate new technology before widespread clinical use.

A randomized clinical trial comparing open and arthroscopic stabilization for recurrent traumatic anterior shoulder instability: two-year follow-up with disease-specific quality-of-life outcomes.

BACKGROUND: The literature comparing open and arthroscopic repair for glenohumeral instability is conflicting. We performed a prospective, expertise-based, randomized clinical trial to compare open shoulder stabilization with arthroscopic shoulder stabilization by measuring quality-of-life outcomes and recurrence rates at two years among patients treated for traumatic anterior shoulder instability. METHODS: Computer-generated, variable-block-size, concealed randomization allocated 196 patients to either the open-repair group (n = 98) or the arthroscopic-repair group (n = 98). An expertise-based randomization design was employed to avoid a differential bias in terms of physician experience. Outcomes were measured at baseline, at three and six months postoperatively, and at one and two years postoperatively with use of the Western Ontario Shoulder Instability Index (WOSI) and the American Shoulder and Elbow Surgeons (ASES) functional outcome scale. Recurrent instability was also analyzed. RESULTS: There were no significant differences in outcome scores at baseline. At two years, seventy-nine patients in the open group and eighty-three patients in the arthroscopic group were available for follow-up. There was no significant difference in mean WOSI scores between the groups; the mean WOSI score (and standard deviation) for the open group was 85.2 ± 20.4 (95% confidence interval [CI] = 80.5 to 89.8), and for the arthroscopic group, 81.9 ± 19.8 (95% CI = 77.4 to 86.4); p = 0.31. There was also no significant difference in mean ASES scores: 91.4 ± 12.7 (95% CI = 88.5 to 94.4) for the open group and 88.2 ± 15.9 (95% CI = 84.6 to 91.8) for the arthroscopic group; p = 0.17. Recurrence rates at two years were significantly different: 11% in the open group and 23% in the arthroscopic group (p = 0.05). Recurrent instability was more likely in patients with a preoperative Hill-Sachs lesion and in male patients who were twenty-five years old and younger. There was no significant difference in shoulder motion between the groups at two years. CONCLUSIONS: There was no difference between open and arthroscopic repair in terms of patient quality of life. Open repair resulted in a significantly lower risk of recurrence. Secondary outcome data from this trial suggest that open surgical repair may be recommended to reduce the risk of recurrent instability in younger male patients with a Hill-Sachs lesion.

A randomized clinical trial comparing open to arthroscopic acromioplasty with mini-open rotator cuff repair for full-thickness rotator cuff tears: disease-specific quality of life outcome at an average 2-year follow-up.

BACKGROUND: Rotator cuff tears affect patients' quality of life. The evolution toward less invasive operative techniques for rotator cuff repair requires appropriate comparisons with the standard open procedure, using validated outcomes in a randomized fashion. HYPOTHESIS: There is no difference in disease-specific quality of life outcomes at 2 years between an open surgical repair (open) versus an arthroscopic acromioplasty with mini-open (scope mini-open) repair for patients with full-thickness rotator cuff tears. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients with unremitting pain, failed nonoperative treatment, and imaging indicating full-thickness rotator cuff tears were included in the study. Massive irreparable cuff tears were excluded. Patients were assessed using the disease-specific Rotator Cuff-Quality of Life index, which produces a maximum score of 100, representing a high quality of life. Secondary shoulder-specific outcomes (American Shoulder and Elbow Society, Shoulder Rating Questionnaire, and Functional Shoulder Elevation Test) were also measured at baseline, 3 and 6 months, and 1 and 2 years. RESULTS: The mean Rotator Cuff-Quality of Life scores at an average follow-up of 28 months were not statistically different: open, 86.9 (95% confidence interval: 81.8-92.0); and scope mini-open, 87.2 (95% confidence interval: 80.6-93.8). At 3 months, the patients who underwent scope mini-open showed statistically significantly better outcomes (55.6 vs 71.3; P = .005). The baseline to 3-month difference in Rotator Cuff-Quality of Life scores between the scope mini-open and open groups was also statistically significant. CONCLUSION: Patient outcomes improved from baseline to all postoperative measurement intervals. There was no difference in outcome at 1 and 2 years after surgery between the scope mini-open and open procedures. The quality of life of patients undergoing the arthroscopic acromioplasty with mini-open rotator cuff repair improved statistically significantly and clinically at 3 months compared with the open group.

The inter-rater reliability of shoulder arthroscopy.

PURPOSE: The purpose of this study was to determine the inter-rater reliability of orthopaedic shoulder surgeons in evaluating the intra-articular structures involved in real-time diagnostic shoulder arthroscopy by use of a videotape model. METHODS: Twenty patients (nineteen male patients and one female patient) diagnosed with recurrent anterior shoulder instability with a mean age of 27.9 years (range, 15 to 44 years) consented to participate in the study. Standardized diagnostic shoulder arthroscopies (modified Snyder protocol) were done by a single experienced surgeon, and the procedures were videotaped. The patients' clinical information, radiographs, and videotape of the arthroscopy were sent to 6 experienced shoulder surgeons. The surgeons reviewed the clinical information, assessed the intra-articular structures shown on the videotape, and recorded their diagnoses on a standardized data collection form. The primary outcome was the median overall percent agreement for the video review surgeons by structure evaluated. RESULTS: The median values for overall agreement for the video review surgeons were as follows: anterior labrum, 90%; inferior labrum, 75%; superior labrum, 60%; posterior labrum, 65%; superior glenohumeral ligament, 50%; middle glenohumeral ligament, 50%; anterior inferior glenohumeral ligament, 25%; glenoid surface, 35%; detection of Hill-Sachs lesion, 85%; biceps tendon, 70%; supraspinatus tendon, 85%; infraspinatus tendon, 70%; and subscapularis tendon, 80%. CONCLUSIONS: The inter-rater reliability for orthopaedic shoulder surgeons' arthroscopic assessment of intra-articular anatomy in patients with anterior shoulder instability varied by structure examined. It was very good (>80%) for the anterior labrum and supraspinatus tendon and in detecting a Hill-Sachs lesion, poor (<40%) for the glenoid and anterior inferior glenohumeral ligament, and intermediate for all other structures examined. LEVEL OF EVIDENCE: Level V, diagnostic study, expert opinion.

Arthroscopic versus open repair for traumatic anterior shoulder instability: a meta-analysis.

PURPOSE: The purpose of this study was to critically evaluate the literature to determine whether open or arthroscopic surgical repair for traumatic recurrent anterior shoulder instability results in a better outcome. TYPE OF STUDY: Meta-analysis. METHODS: The search involved clinical studies in all languages in the MEDLINE database from 1966 to October 31, 2003. The following key words were used: (1) anterior shoulder instability, (2) Bankart lesion, (3) traumatic recurrent anterior shoulder instability, and (4) arthroscopic and open Bankart repair. All abstracts were reviewed and articles were included if there was a direct clinical comparison between arthroscopic and open repair for traumatic recurrent anterior shoulder instability. These articles were manually cross-referenced for additional abstracts. The final group of articles was independently critically appraised and the following outcomes were extracted: recurrent instability, return to activity, reoperation rate, and cause of recurrence. RESULTS: The search terms resulted in 677, 183, 68, and 51 hits respectively. From these, 18 articles were determined to be eligible for full review including 2 foreign-language articles. Cross-referencing identified 2 unpublished studies. Eleven studies were included in the final analysis: 1 randomized trial, 2 pseudo-experimental designs, 4 prospective cohorts, 3 retrospective studies, and 1 case control study. Pooled Mantel-Haenszel odds ratio for recurrent instability and return to activity were 2.04 ( P = .003; 95% confidence interval, 1.27, 3.29) and 2.85 ( P = .004; 95% confidence interval, 1.40, 5.78), respectively, in favor of the open repair. CONCLUSIONS: Based on this meta-analysis, open repair has a more favorable outcome with respect to recurrence and return to activity. LEVEL OF EVIDENCE: Level III, Systematic Review of Level III (and II/I) Studies.

The reliability between surgeons comparing arthroscopic and video evaluation of patients with shoulder impingement syndrome.

PURPOSE: To assess interobserver reliability between 2 surgeons, for real-time diagnostic arthroscopy and the corresponding videotape of shoulder pathology in patients with a clinical symptom complex consistent with shoulder impingement syndrome. TYPE OF STUDY: Prospective cohort. METHODS: Fifty-three patients with shoulder impingement syndrome underwent arthroscopic surgery by 1 of 2 experienced orthopaedic shoulder surgeons. All operations were videotaped. The surgeon who did not perform the surgery reviewed the videotaped procedure. The findings in the shoulder were independently documented by each surgeon on standardized shoulder information sheets. The video-review surgeon was blinded to the results of the arthroscopy and all preoperative workup information. The percentage agreement, kappa statistics, and correlations were calculated to assess the inter-rater reliability. RESULTS: The percentage agreement ranged from 100% for tendon ruptures to 39% when identifying acromion type. Interobserver kappa statistics were significant for all relevant structures with the exception of acromion type and coracoacromial ligament. CONCLUSIONS: There was satisfactory reliability between video and real-time arthroscopy. However, better objective definitions of pathology and standardization of arthroscopic techniques would improve these results. Videotaping of arthroscopy can be considered a useful educational tool, a way to improve communication between surgeons, and possibly a medicolegal tool when defining pathology in the shoulder. LEVEL OF EVIDENCE: Level II.

A prospective, double-blind comparison of magnetic resonance imaging and arthroscopy in the evaluation of patients presenting with shoulder pain.

The purpose of this study was to determine the diagnostic ability of magnetic resonance imaging (MRI) compared with a reference standard, arthroscopy, in patients presenting with shoulder pain consistent with the signs and symptoms of shoulder impingement. Fifty-eight patients in whom conservative management failed underwent standardized MRI with intravenous gadolinium enhancement and arthroscopic evaluation. The prevalence of supraspinatus tendon, long head of the biceps tendon, and acromioclavicular joint pathology in this population was high: 79.3%, 66%, and 56%, respectively. MRI was highly accurate in detecting full-thickness supraspinatus tears and acromioclavicular joint pathology. However, it had poor concordance with arthroscopy in diagnosing pathology in the biceps tendon and in classifying the curvature of the acromion. A smaller number of other abnormal structures were identified in this population of patients, including labral abnormalities (superior labral anterior-posterior and Bankart tears), Hill-Sachs lesions, and articular surface damage. Concordance between MRI and arthroscopy would increase with improved radiologist-surgeon communication, a more reliable classification of pathology, and possibly the use of intraarticular contrast. This study demonstrates that patients presenting with the clinical findings of shoulder impingement syndrome represent a heterogeneous population. Overall, MRI is a useful tool in the identification of shoulder pathology; however, the clinical correlation of this information and the assessment of outcomes remains unknown.

Creep behavior of a rabbit model of ligament laxity after electrothermal shrinkage in vivo.

Deformation of capsular tissue under constant load (creep) may lead to recurrent laxity after thermal shrinkage for shoulder instability. We investigated the effects of thermal shrinkage in a rabbit model in which the tibial insertion of the medial collateral ligament was elevated and shifted toward the joint line to create abnormal laxity. On the right side, radiofrequency electrothermal energy was applied to the shifted ligament, while the left side served as a control. Length, laxity, mass, cross-sectional area, water content, and creep behavior of the ligament were assessed at 0 (N = 8), 3 (N = 7), and 12 (N = 6) weeks postoperatively. Laxity was reduced with thermal treatment (0.65 +/- 0.31 compared with 3.33 +/- 0.25 mm). After 3 weeks, ligament mass, area, and water content were significantly increased in the thermally treated group compared with the untreated controls. At 12 weeks, cyclic creep strain remained greater than that in controls (1.25% +/- 0.65% compared with 0.93% +/- 0.22%). Although thermal shrinkage reduced laxity, there was increased potential to creep and failure at low physiologic stresses. These findings suggest that loading of thermally treated tissues should be carefully controlled during the early phase of rehabilitation after surgery.