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Clinical Trials/NCT01467336
NCT01467336
Terminated
Not Applicable

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

University Hospital, Strasbourg, France4 sites in 1 country229 target enrollmentJanuary 9, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tear
Sponsor
University Hospital, Strasbourg, France
Enrollment
229
Locations
4
Status
Terminated
Last Updated
5 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2012
End Date
February 1, 2020
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (4)

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