The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

Not Applicable

Completed

• Conditions: Rotator Cuff Rupture
• Interventions: Device: Neutral brace; Device: Simple sling.

• Registration Number: NCT02050087
• Lead Sponsor: Lovisenberg Diakonale Hospital

Brief Summary

The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

Detailed Description

Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Primary Completion: 2015-12
• Study Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -

Exclusion Criteria

Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.

Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 weeks with simple sling	Neutral brace	Early motion after arthroscopic rotator cuff repair.
6 weeks with neutral brace	Simple sling.	Delayed motion after arthroscopic rotator cuff repair.

Primary Outcome Measures

Name	Time	Method
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint	One year	We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.

Trial Locations

Locations (1)

Lovisenberg Diaconal Hospital; 🇳🇴 Oslo, Norway