Supra-spinatus Rehabilitation Program Comparison

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Rotator Cuff Tear

Treatments: Procedure: Arthroscopic rotator cuff repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01467336

4964

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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229 participants in 3 patient groups

Passive group

Other group

Description:

Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.

Treatment:

Procedure: Arthroscopic rotator cuff repair

Immobilization group

Other group

Description:

No passive Rehabilitation program is started. An active protocol is started after the sixth week

Treatment:

Procedure: Arthroscopic rotator cuff repair

Delayed group

Other group

Description:

Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.

Treatment:

Procedure: Arthroscopic rotator cuff repair