Study Stopped
Patient inclusion stopped since 2019
Supra-spinatus Rehabilitation Program Comparison
Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair
1 other identifier
interventional
229
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedStudy Start
First participant enrolled
January 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedNovember 24, 2025
February 1, 2012
8.1 years
October 25, 2011
November 18, 2025
Conditions
Study Arms (3)
Passive group
OTHERRehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.
Immobilization group
OTHERNo passive Rehabilitation program is started. An active protocol is started after the sixth week
Delayed group
OTHERRehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.
Interventions
Arthroscopic rotator cuff repair for all groups
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient with a stiff shoulder
- previous surgery of the shoulder
- stage 3 or 4 fatty infiltration
- insufficient repair of the cuff
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy
Nancy, 54035, France
Centre Chirurgical Emile Gallé
Nancy, 54052, France
CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000, France
Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe CLAVERT, MD
Hôpitaux Universitaires de Strasbourg, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2011
First Posted
November 8, 2011
Study Start
January 9, 2012
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
November 24, 2025
Record last verified: 2012-02