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Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of ArtelonĀ® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.
The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Arthroscopic Rotator Cuff Repair with standard treatment |
|
| Experimental 1 | Experimental | Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations |
|
| Experimental 2 | Experimental | Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of ArtelonĀ® Tissue Reinforcement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Rotator Cuff Repair | Procedure | Arthroscopic Rotator Cuff Repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retear rate | Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging | 12 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Constant-Murley | Comparison of Constant-Murley Score in each group | 3, 6, 12 months post-operatively |
| DASH | Comparison of DASH Score in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roberto Leo | Milan | Italy |
|
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| C044690 | polyetherurethane urea |
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Double Blind
| Micro-perforations | Procedure | Biological stimulation with micro-perforations |
|
| ArtelonĀ® | Procedure | Biological stimulation with ArtelonĀ® Tissue Reinforcement |
|
| 1, 3, 6, 12 months post-operatively |
| VAS | Comparison of Visual Analogue Scale (VAS) in each group | 1, 3, 6, 12 months post-operatively |
| Passive ROM | Comparison of passive range of motion in each group | 1, 3, 6, 12 months post-operatively |
| Adverse events | Adverse events for any cause | 1, 3, 6, 12 months post-operatively |