Rotator Cuff InjuriesPRO-CUFFNCT06371872
French Cohort of Patients With Rotator Cuff Lesions
An observational study of Rotator Cuff Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
Trial summary
The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- total transfixing injury to the rotator cuff
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Dec 2035
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients recruited during their first consultation for the management of a rotator cuff injury.
Who may be able to join
- Patient, male or female, over 18 years of age.
- Patient with a transfixing (total) rotator cuff lesion confirmed by imaging.
- A patient who has been informed and has expressed no oral objection to taking part in the research.
- Patient affiliated to or benefiting from a social security scheme.
Who cannot join
- Patients over 75 years of age.
- Patients with a history of shoulder surgery.
- Patients unable to receive emails and/or answer online questionnaires.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
About this study
Official title: French Cohort of Patients With Rotator Cuff Lesions: Changes in Shoulder Function and Quality of Life at 1, 2, 5, 8 and 10 Years, According to Their Care
The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment.
Read the detailed description
This is a non-interventional, prospective, longitudinal, multicentre cohort study.
The research procedure involves recruiting patients during their first consultation for the management of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment. Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction.
- Conditions
- Rotator Cuff Injuries
- Being tested
- total transfixing injury to the rotator cuff
- 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.
total transfixing injury to the rotator cuffProcedure or surgery
develop an appropriate prescription strategy with a view to improving patients' quality of life in the short, medium and long term in this condition
| Study group | Role | What they receive |
|---|---|---|
| patients with rotator cuff injuries | Patients will be recruited during their first consultation for treatment of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment.
Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction. These questionnaires will be accessible via a secure website. Receives: Procedure: total transfixing injury to the rotator cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index
Improved shoulder function (evolution of SPADI score, composed of a pain sub-score and a shoulder mobility sub-score ≥ 13 points compared with inclusion)
Measured: 5 years
European quality of life scale - EQ5D
Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startApr 2025 (estimated)
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Why it stopped: The sponsor, in consultation with the coordinating investigator, decided to stop the study prematurely on 01/10/2025. No patients were enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371872
- Sponsor's protocol ID
- 2024-A00173-44
- Acronym
- PRO-CUFF
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Cohort of Patients With Rotator Cuff Lesions: Changes in Shoulder Function and Quality of Life at 1, 2, 5, 8 and 10 Years, According to Their Care
- ClinicalTrials.gov ID
- NCT06371872
- Acronym / sponsor ID
- PRO-CUFF / 2024-A00173-44
- Conditions
- Rotator Cuff Injuries
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor, in consultation with the coordinating investigator, decided to stop the study prematurely on 01/10/2025. No patients were enrolled in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 17 Apr 2024 (actual)
- 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.
The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment.
Detailed description
This is a non-interventional, prospective, longitudinal, multicentre cohort study.
The research procedure involves recruiting patients during their first consultation for the management of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment. Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with rotator cuff injuries | – | Procedure: total transfixing injury to the rotator cuffPatients will be recruited during their first consultation for treatment of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment. Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction. These questionnaires will be accessible via a secure website. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients recruited during their first consultation for the management of a rotator cuff injury.
Key inclusion criteria (4 listed)
- Patient, male or female, over 18 years of age.
- Patient with a transfixing (total) rotator cuff lesion confirmed by imaging.
- A patient who has been informed and has expressed no oral objection to taking part in the research.
- Patient affiliated to or benefiting from a social security scheme.
Key exclusion criteria (4 listed)
- Patients over 75 years of age.
- Patients with a history of shoulder surgery.
- Patients unable to receive emails and/or answer online questionnaires.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
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 |
|---|---|---|
| total transfixing injury to the rotator cuffdevelop an appropriate prescription strategy with a view to improving patients' quality of life in the short, medium and long term in this condition | Procedure or surgery | patients with rotator cuff injuries |
Primary outcome
Shoulder Pain and Disability Index
Time frame: 5 years
Improved shoulder function (evolution of SPADI score, composed of a pain sub-score and a shoulder mobility sub-score ≥ 13 points compared with inclusion)
European quality of life scale - EQ5D
Time frame: 5 years
Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Related trials for Rotator Cuff Injuries
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
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 4 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: withdrawn, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Shoulder Pain and Disability Index (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 1 Apr 2026.