Rotator Cuff TearNCT01467336
Supra-spinatus Rehabilitation Program Comparison
A study testing Arthroscopic rotator cuff repair in people with Rotator Cuff Tear, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Jan 2012to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient with a stiff shoulder
- previous surgery of the shoulder
- stage 3 or 4 fatty infiltration
- insufficient repair of the cuff
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy
Nancy, 54035
Centre Chirurgical Emile Gallé
Nancy, 54052
CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
Official title: Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair
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.
Read more
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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repairProcedure or surgery
Arthroscopic rotator cuff repair for all groups
| Study group | Role | What they receive |
|---|---|---|
| Passive group | Other | Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week. Receives: Procedure: Arthroscopic rotator cuff repair |
| Immobilization group | Other | No passive Rehabilitation program is started. An active protocol is started after the sixth week Receives: Procedure: Arthroscopic rotator cuff repair |
| Delayed group | Other | Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week. Receives: Procedure: Arthroscopic rotator cuff repair |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study start9 Jan 2012
- Primary completionFeb 2020
- Study completionFeb 2020
Why it stopped: Patient inclusion stopped since 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CLAVERT, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467336
- Sponsor's protocol ID
- 4964
- Status last verified
- Feb 2012
- First submitted
- 25 Oct 2011
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair
- ClinicalTrials.gov ID
- NCT01467336
- Acronym / sponsor ID
- 4964
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient inclusion stopped since 2019
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Jan 2012 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive group | Other | Procedure: Arthroscopic rotator cuff repairRehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week. |
| Immobilization group | Other | Procedure: Arthroscopic rotator cuff repairNo passive Rehabilitation program is started. An active protocol is started after the sixth week |
| Delayed group | Other | Procedure: Arthroscopic rotator cuff repairRehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- patient with a stiff shoulder
- previous surgery of the shoulder
- stage 3 or 4 fatty infiltration
- insufficient repair of the cuff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff repairArthroscopic rotator cuff repair for all groups | Procedure or surgery | Delayed group, Immobilization group, Passive group |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Patient inclusion stopped since 2019). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe CLAVERT, MD principal investigator
Hôpitaux Universitaires de Strasbourg, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair in people with Rotator Cuff Tear, run by University Hospital, Strasbourg, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient inclusion stopped since 2019). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.