The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-operative Mobilisation After Rotator Cuff Repair

NCT02943005

Rotator Cuff

UNKNOWN NA

Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

NCT01502098

Rotator Cuff Tear

UNKNOWN NA

Immobilization in External Rotation of Acute Shoulder Dislocations

NCT00196560

Anterior Shoulder Dislocation

COMPLETED PHASE3

Post-op Rehabilitation's Influence on Tendon Healing & Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

NCT00756015

Rotator Cuff Tear

COMPLETED NA

Early Mobilization Following Arthroscopic Rotator Cuff Repair

NCT01333527

Rotator Cuff Tear

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Rupture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3 weeks with simple sling

Early motion after arthroscopic rotator cuff repair.

Group Type ACTIVE_COMPARATOR

Neutral brace

Intervention Type DEVICE

6 weeks with neutral brace

Delayed motion after arthroscopic rotator cuff repair.

Group Type ACTIVE_COMPARATOR

Simple sling.

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simple sling.

Intervention Type DEVICE

Neutral brace

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

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.

\-

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes