Supra-spinatus Rehabilitation Program Comparison

NCT ID: NCT01467336

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-09

Study Completion Date

2020-02-29

Brief Summary

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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

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Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Passive group

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

Group Type OTHER

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair for all groups

Immobilization group

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

Group Type OTHER

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair for all groups

Delayed group

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

Group Type OTHER

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair for all groups

Interventions

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Arthroscopic rotator cuff repair

Arthroscopic rotator cuff repair for all groups

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe CLAVERT, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg, France

Locations

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Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy

Nancy, , France

Site Status

Centre Chirurgical Emile Gallé

Nancy, , France

Site Status

CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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4964

Identifier Type: -

Identifier Source: org_study_id

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