Dataset Information

All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076].

ABSTRACT: Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair.This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate-sized rotator cuff tears. A national consensus meeting of investigators in the Joint Orthopaedic Initiative for National Trials of the Shoulder (JOINTS Canada) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC)) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, Constant score), secondary dimensions of health (general health status (SF-12) and work limitations), and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12, and 24 months post-operatively by blinded research assistants and musculoskeletal radiologists. Patients (n = 250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to statistically detect a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score (alpha = 0.05). A central methods centre will manage randomization, data management, and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. We will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2 years post-operatively. As a secondary analysis, we will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2 years. The trial will commence when funding is in place.These results will have immediate impact on the practice behaviors of practicing surgeons and surgical trainees at JOINTS centres across Canada. JOINTS Canada is actively engaged in knowledge exchange and will publish and present findings internationally to facilitate wider application. This trial will establish definitive evidence on this question at an international level.

SUBMITTER: MacDermid JC

PROVIDER: S-EPMC1421402 | biostudies-literature | 2006 Mar

REPOSITORIES: biostudies-literature

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Publications

All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076].

MacDermid Joy C JC Holtby Richard R Razmjou Helen H Bryant Dianne D

BMC musculoskeletal disorders 20060310

<h4>Background</h4>Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair.<h4>Methods/design</h4>This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate-sized rotator cuff tears. A national consens ...[more]

PMID: 16529658

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Project description:The aim of the study was to compare the clinical outcomes of patients undergoing all-arthroscopic (AA) or mini-open (MO) rotator cuff repair.The present study evaluated 50 patients who had undergone AA repair and 50 patients who had undergone MO repair with a minimum 1-year follow-up. Every patient was asked to complete the Disabilities of the Arm, Shoulder and Hand (DASH) and visual analog scale (VAS) questionnaires. Constant-Murley score (CMS) and active ranges, forward flexion and external rotation, were also evaluated and documented. One year after surgery, ultrasound evaluation was done to determine the integrity of the rotator cuff for each patient.The average age of enrolled patients at the time of surgery was 53.0 years (range, 40-59 years), and average follow-up was 16.6 months (range, 12-24 months). At 2 weeks, the range of forward flexion in the AA group was larger than that in the MO group (136.5?±?10.2 vs 132.5?±?7.7, P?=?0.03). On postoperative day 1, the VAS in the MO group was significantly higher than that in the AA group (6.5?±?0.6 vs 6.1?±?0.6, P?<?0.01). At 1 month, the difference in VAS between both groups reappeared (2.9?±?0.6 vs 2.6?±?0.6, P?=?0.03). At 1 month, the CMS score of patients in the AA group was higher than that in the MO group (52.8?±?3.6 vs 50.9?±?5.0, P?=?0.03). At 3 and 6 months, the DASH score of patients in the AA group was lower than that in the MO group (43.8?±?8.2 vs 47.8?±?4.4, P?<?0.01 and 38.6?±?4.3 vs 42.7?±?9.9, P?<?0.01, respectively). Mean operative time was longer in the AA group compared with that in the MO group (71.9?±?17.6 vs 64.7?±?12.7 minutes, P?<?0.01). Five patients (10.0%) in the AA group and 4 patients (8.2%) in the MO group had rotator cuff retear, and 6 patients (12.0%) in the AA group and 8 patients (16.3%) in the MO group had adhesive capsulitis by the end of follow-up. There is no significant difference between the 2 groups in the incidence of complications. We also found that joint exercising at least 3 times per week was associated with better short- and long-term joint function recovery.The AA approach was associated with less pain and lower DASH score as well as higher CMS score in the early recovery period. No difference was found between the 2 groups in primary and secondary outcomes in the long term, or incidence of complications such as adhesive capsulitis and rotator cuff retear. In conclusion, we consider that the AA procedure has better recovery at short-term follow-ups, while both techniques are equivalent regarding long-term outcomes.

Dataset Information

All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076].

Publications

All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076].

Similar Datasets

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