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| Name | Class |
|---|---|
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.
Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brace | Experimental | After surgery the patient must wear the brace for 6 weeks, for the first 3 weeks during day and night and for the following 3 weeks only at night |
|
| Normal sling | Experimental | After surgery the patient must wear the normal sling for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brace | Procedure | A brace to be weared according to protocol |
| |
| Normal sling |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in the rehabilitative therapy | The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months | 6 months |
| re-rupture rate of the supraspinatus tendon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Candrian, MD | EOC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ente Ospedaliero Cantonale | Lugano | 6900 | Switzerland |
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| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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randomized 1:1
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| Procedure |
A normal sling to be weared according to protocol |
|
Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months
| 6 months |