Supra-spinatus Rehabilitation Program Comparison

Not Applicable

• Conditions: Rotator Cuff Tear

• Registration Number: NCT01467336
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Study Start: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (4)

CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Illkirch, France

Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy; 🇫🇷 Nancy, France

Centre Chirurgical Emile Gallé; 🇫🇷 Nancy, France

Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France