Supra-spinatus Rehabilitation Program Comparison

November 18, 2025 updated by: University Hospital, Strasbourg, France

Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair

Through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the Optimization of the post-operative clinical and anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):

  • strict immobilization for 6 weeks then active rehabilitation,
  • or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation,
  • or immediate passive motion for 6 weeks and then active rehabilitation.

Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-CT will be performed at 1 year.

The investigators will evaluate: constant score and rate of tendon healing.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

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

  • France
      • Nancy, France, 54035
        • Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy
      • Nancy, France, 54052
        • Centre Chirurgical Emile Gallé
      • Strasbourg, France, 67000
        • CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67098
        • Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female between 40 and 65 years old
  • non-retracted supra-spinatus tendon tear-pre-operative clinical examination and ct
  • scan-arthroscopic single-row tendon repair

Exclusion Criteria:

  • patient with a stiff shoulder
  • previous surgery of the shoulder
  • stage 3 or 4 fatty infiltration
  • insufficient repair of the cuff

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Passive group
Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups
Other: Immobilization group
No passive Rehabilitation program is started. An active protocol is started after the sixth week
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups
Other: Delayed group
Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Philippe CLAVERT, MD, Hôpitaux Universitaires de Strasbourg, France

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 (Actual)

January 9, 2012

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimated)

November 8, 2011

Study Record Updates

Last Update Posted (Estimated)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4964

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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