Supra-spinatus Rehabilitation Program Comparison

Not Applicable

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Arthroscopic rotator cuff repair

• 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

Arm && Interventions

Group	Intervention	Description
Passive group	Arthroscopic rotator cuff repair	Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.
Immobilization group	Arthroscopic rotator cuff repair	No passive Rehabilitation program is started. An active protocol is started after the sixth week
Delayed group	Arthroscopic rotator cuff repair	Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.

Trial Locations

Locations (4)

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

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

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

Centre Chirurgical Emile Gallé; 🇫🇷 Nancy, France