Rotator Cuff TearNCT02510352
Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair
An observational study of Rotator Cuff Tear, run by Centre Hospitalier Universitaire de Saint Etienne at 12 sites in France.
Trial summary
In accordance with national guidelines surgical repair of rotator cuff tear is the first-line strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff muscles and articular status. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 150 participants
- Where
- 12 sitesFrance
- Study dates
- Apr 2006to Oct 2014
- Phase
- Observational
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a full-thickness tear of the rotator cuff confirmed by MRI
Who may be able to join
- Having a clinical symptoms suggesting a rotator cuff tear.
- Having a full-thickness tear of the rotator cuff confirmed by MRI.
- Covered by the Social Security system.
Who cannot join
- Being included in another clinical trial with a potential alteration of shoulder pathology management.
- Having a partial tear of the rotator cuff.
- Having a single lesion of the bicipital tendon.
- Having a traumatic tear of the rotator cuff less than 3-month old.
- Having surgery for rotator cuff tear planned within 3 months.
- Unable to understand the study protocol.
- Having a contra-indication to MRI.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hopital Ambroise Pare
Boulogne-Billancourt, 92100
Centre de Rhumatologie
Grenoble, 38000
Clinique Orthocèdres
Grenoble, 38130
Hopital Corentin-Celton
Issy-les-Moulineaux, 92130
Clinique Du Parc
Lyon, 69006
Centre Orthopedique Santy
Lyon, 69008
Cabinet de Rhumatologie
Marseille, 13006
Hopital Lariboisiere
Paris, 75010
Hopital Cochin
Paris, 75014
Chu de Saint Etienne
Saint-Etienne, 42055
Chu de Strasbourg
Strasbourg, 67000
Chu de Tours
Tours, 37000
About this study
In accordance with national guidelines surgical repair of rotator cuff tear is the first-line strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff muscles and articular status. In appropriate situations, a satisfactory result is expected in more than 80% of cases with a very good long-term outcome. On the other hand, the first-line strategy in older patients is conservative as the main objective is the treatment of pain and stiffness of the shoulder which can be achieved at least in the short-term with general and local medications and physiotherapy. In addition, poor prognostic factors such as massive tears and muscle fatty infiltration or atrophy, are more frequently present in those patients, leading to poor results of surgical treatment and a high risk of iterative tear after repair.
Because of a lack of evaluation, there is currently no identified prognostic factor of medical treatment and on the other hand no clinical situation in which a surgical repair is mandatory. Therefore, investigator designed this study as an observatory with the follow up of patients with a symptomatic rotator cuff tear treated conservatively.
Read the detailed description
Patients are regularly monitored in rheumatology consultation at 3 months, 6 months, 1 year, 2 years, 30 months, 3 Years, 42 months, 4 years, 54 months and 5 years supplemented by simple radiological monitoring and an MRI followed by 1 year, 2 years and 5 years.
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff tear, MRI
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff tear | patients with a symptomatic rotator cuff tear treated without surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional evolution of patients with a rotator cuff tear
Score to the Algo functional Constant score
Measured: at 5 years
Secondary outcomes (3)
Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
lesion size measured by RMI
Measured: at 2 years
Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
lesion size measured by RMI
Measured: at 5 years
Functional evolution of patients with a rotator cuff tear
Score to the Algo functional Constant score
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startApr 2006
- Primary completionOct 2009
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Thomas, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510352
- Sponsor's protocol ID
- 0501079
- Other IDs
- DGOS
- Status last verified
- Jul 2015
- First submitted
- 24 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neel T, Tavernier T, Lefevre-Colau MM, Goupille P, Favard L, Noel E, Godeneche A, Nove-Josserand L, Walch G, Thomas T. Clinical stability despite progressive fatty infiltration in patients over 50 years old with full-thickness rotator cuff tears. Joint Bone Spine. 2026 Jul 21:106116. doi: 10.1016/j.jbspin.2026.106116. Online ahead of print.
PubMed 42480798
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair
- ClinicalTrials.gov ID
- NCT02510352
- Acronym / sponsor ID
- 0501079
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff tear, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Jul 2015 (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.
In accordance with national guidelines surgical repair of rotator cuff tear is the first-line strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff muscles and articular status. In appropriate situations, a satisfactory result is expected in more than 80% of cases with a very good long-term outcome. On the other hand, the first-line strategy in older patients is conservative as the main objective is the treatment of pain and stiffness of the shoulder which can be achieved at least in the short-term with general and local medications and physiotherapy. In addition, poor prognostic factors such as massive tears and muscle fatty infiltration or atrophy, are more frequently present in those patients, leading to poor results of surgical treatment and a high risk of iterative tear after repair.
Because of a lack of evaluation, there is currently no identified prognostic factor of medical treatment and on the other hand no clinical situation in which a surgical repair is mandatory. Therefore, investigator designed this study as an observatory with the follow up of patients with a symptomatic rotator cuff tear treated conservatively.
Detailed description
Patients are regularly monitored in rheumatology consultation at 3 months, 6 months, 1 year, 2 years, 30 months, 3 Years, 42 months, 4 years, 54 months and 5 years supplemented by simple radiological monitoring and an MRI followed by 1 year, 2 years and 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff tear | – | –patients with a symptomatic rotator cuff tear treated without surgical repair |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a full-thickness tear of the rotator cuff confirmed by MRI
Key inclusion criteria (3 listed)
- Having a clinical symptoms suggesting a rotator cuff tear.
- Having a full-thickness tear of the rotator cuff confirmed by MRI.
- Covered by the Social Security system.
Key exclusion criteria (7 listed)
- Being included in another clinical trial with a potential alteration of shoulder pathology management.
- Having a partial tear of the rotator cuff.
- Having a single lesion of the bicipital tendon.
- Having a traumatic tear of the rotator cuff less than 3-month old.
- Having surgery for rotator cuff tear planned within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional evolution of patients with a rotator cuff tear
Time frame: at 5 years
Score to the Algo functional Constant score
3 secondary outcomes
Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
Time frame: at 2 years
Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
Time frame: at 5 years
Functional evolution of patients with a rotator cuff tear
Time frame: at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Derived from this study: PubMed 42480798Neel T, Tavernier T, Lefevre-Colau MM, Goupille P, Favard L, Noel E, Godeneche A, Nove-Josserand L, Walch G, Thomas T. Clinical stability despite progressive fatty infiltration in patients over 50 years old with full-thickness rotator cuff tears. Joint Bone Spine. 2026 Jul 21:106116. doi: 10.1016/j.jbspin.2026.106116. Online ahead of print.
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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.
Thierry Thomas, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Centre Hospitalier Universitaire de Saint Etienne at 12 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 7 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: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Functional evolution of patients with a rotator cuff tear (time frame: at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510352, which also lists 1 linked publication.
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 29 Jul 2015.