A randomized trial of arthroscopic surgery for osteoarthritis of the knee.

BACKGROUND: The efficacy of arthroscopic surgery for the treatment of osteoarthritis of the knee is unknown. METHODS: We conducted a single-center, randomized, controlled trial of arthroscopic surgery in patients with moderate-to-severe osteoarthritis of the knee. Patients were randomly assigned to surgical lavage and arthroscopic débridement together with optimized physical and medical therapy or to treatment with physical and medical therapy alone. The primary outcome was the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (range, 0 to 2400; higher scores indicate more severe symptoms) at 2 years of follow-up. Secondary outcomes included the Short Form-36 (SF-36) Physical Component Summary score (range, 0 to 100; higher scores indicate better quality of life). RESULTS: Of the 92 patients assigned to surgery, 6 did not undergo surgery. Of the 86 patients assigned to control treatment, all received only physical and medical therapy. After 2 years, the mean (+/-SD) WOMAC score for the surgery group was 874+/-624, as compared with 897+/-583 for the control group (absolute difference [surgery-group score minus control-group score], -23+/-605; 95% confidence interval [CI], -208 to 161; P=0.22 after adjustment for baseline score and grade of severity). The SF-36 Physical Component Summary scores were 37.0+/-11.4 and 37.2+/-10.6, respectively (absolute difference, -0.2+/-11.1; 95% CI, -3.6 to 3.2; P=0.93). Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show superiority of surgery. CONCLUSIONS: Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy. (ClinicalTrials.gov number, NCT00158431.)

Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for osteoarthritis of the shoulder: a prospective, randomized, double-blind clinical trial-A JOINTs Canada Project.

BACKGROUND: Although cemented humeral fixation is recognized as the standard of care in total shoulder arthroplasty (TSA), uncemented fixation has the potential to provide stable fixation, decrease operative time, and simplify potential revision procedures. This prospective, randomized, double-blind clinical trial compared cemented and uncemented humeral fixation in TSA for primary shoulder osteoarthritis. METHODS: Patients with primary shoulder osteoarthritis requiring replacement were screened for eligibility. After providing informed consent, subjects received baseline clinical and radiologic assessments, computed tomography scans, and standardized TSA. After glenoid component insertion, patients were randomized to either a cemented or uncemented humeral component. The primary outcome was the WOOS (Western Ontario Arthritis of the Shoulder Index) score at 2 years. Other outcomes included the Short Form 12 score, American Shoulder and Elbow Surgeons score, McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, operative time, complications, and revisions. Patients were assessed by a blinded evaluator at 2 and 6 weeks and 3, 6, 12, 18, and 24 months postoperatively. RESULTS: In total, 161 patients consented to be included and were randomized: 80 in the cemented group and 81 in the uncemented group. There were no significant differences in demographics or baseline evaluations between groups, except for gender. The 12-, 18-, and 24-month WOOS scores showed a significant difference in favor of the cemented group. The cemented group also had better strength and forward flexion. As expected, the operative time was significantly less for the uncemented group. CONCLUSIONS: These findings provide level I evidence that cemented fixation of the humeral component provides better quality of life, strength, and range of motion than uncemented fixation.

Cross-cultural adaptation and validation of the Arabic version of the Western Ontario Shoulder Instability Index (WOSI-Arabic).

BACKGROUND: One of the self-assessment tools used in shoulder instability to evaluate patient's quality of life is the Western Ontario Shoulder Instability (WOSI) Index. It is a valid and reliable disease-specific tool that has been translated into many languages. The aim of this study is to cross-culturally adapt the Western Ontario Shoulder Instability (WOSI) Index into Arabic and assess its psychometric properties in patients diagnosed with shoulder instability in order to help surgeons and physical therapists assess patients following an intervention. PATIENTS AND METHODS: Forty-four patients with shoulder instability participated in the study. For validity and reliability, the WOSI, Disability of Arm, Shoulder and Hand questionnaire (DASH) and the American Shoulder and Elbow Surgeons (ASES) questionnaire were completed at baseline and the WOSI again within 1 week. For responsiveness the WOSI was completed 1 week postoperative and again 6 months following the completion of a rehabilitation program. RESULTS: Cronbach's alpha (Internal Consistency) of the WOSI was 0.91 and the intraclass correlation coefficient (ICC) was 0.96 indicating high reliability. The standard error of measurement was 90.2 with the scale 0-2100 and the minimal detectable change was 250 out of 2100 (11.9%). For construct validity, there was a moderate significant correlation between the Arabic WOSI, the DASH and the ASES with r=0.60 and 0.62 respectively. The WOSI was highly responsive with an effect size of 3.17 and a standardized response mean of 2.94. CONCLUSION: The Arabic version of the WOSI is a valid, reliable and responsive tool that can be used to assess patients with shoulder instability. LEVEL OF EVIDENCE: I, Validity and reliability study.

Cross-cultural adaptation and measurement properties of an Italian version of the Western Ontario Shoulder Instability Index (WOSI).

STUDY DESIGN: Clinical measurement study. OBJECTIVES: To translate and cross-culturally adapt the Western Ontario Shoulder Instability Index (WOSI) into Italian, and to evaluate its measurement properties in patients with shoulder instability secondary to a first-time traumatic anterior dislocation. BACKGROUND: The WOSI was developed for English-speaking patients. To date, no Italian version of the WOSI exists. METHODS: The WOSI was cross-culturally adapted to Italian according to established guidelines. Sixty-four (16 women, 48 men) patients with unilateral shoulder anterior instability were prospectively recruited for the purposes of this study. Internal consistency, test-retest reliability, construct validity, and responsiveness of the WOSI were evaluated. RESULTS: The Italian version of the WOSI showed a high degree of internal consistency, with a Cronbach alpha of .93 (95% confidence interval [CI]: 0.91, 0.96). The test-retest reliability was high for both short-term (3 days, 64 patients) and medium-term (14 weeks, 20 patients) test-retest, with intraclass correlation coefficients of 0.95 (95% CI: 0.90, 0.97) and 0.92 (95% CI: 0.89, 0.95), respectively. The WOSI was more closely correlated to the Disabilities of the Arm, Shoulder and Hand questionnaire than to the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.794 and 0.113, respectively). The receiver-operating-characteristic curve analysis revealed that the WOSI was more responsive than the Disabilities of the Arm, Shoulder and Hand questionnaire (P = .03), with an area under the curve of 0.90 (95% CI: 0.78, 0.97) for the WOSI and 0.76 (95% CI: 0.61, 0.88) for the Disabilities of the Arm, Shoulder and Hand questionnaire. CONCLUSION: The Italian version of the WOSI is a valid, reliable, and responsive tool that can be used to measure function in Italian-speaking patients with shoulder instability due to a first-time traumatic anterior dislocation.