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The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

L

Lovisenberg Diakonale Hospital

Status

Completed

Conditions

Rotator Cuff Rupture

Treatments

Device: Simple sling.
Device: Neutral brace

Study type

Interventional

Funder types

Other

Identifiers

NCT02050087
2012/2288

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

3 weeks with simple sling
Active Comparator group
Description:
Early motion after arthroscopic rotator cuff repair.
Treatment:
Device: Neutral brace
6 weeks with neutral brace
Active Comparator group
Description:
Delayed motion after arthroscopic rotator cuff repair.
Treatment:
Device: Simple sling.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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