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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.
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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total transfixing injury to the rotator cuff | Procedure | develop an appropriate prescription strategy with a view to improving patients' quality of life in the short, medium and long term in this condition |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 5 years |
| European quality of life scale - EQ5D | Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline) | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients recruited during their first consultation for the management of a rotator cuff injury.
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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