The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

May 30, 2017 updated by: Lovisenberg Diakonale Hospital

The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0446
        • Lovisenberg Diaconal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 weeks with simple sling
Early motion after arthroscopic rotator cuff repair.
Device: Neutral brace
Active Comparator: 6 weeks with neutral brace
Delayed motion after arthroscopic rotator cuff repair.
Device: Simple sling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint
Time Frame: 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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Investigators

  • Study Chair: Sigbjørn Dimmen, MD, Phd, Lovisenberg Diaconal Hospital, Oslo, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/2288

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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