Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation

Study Overview
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Brief Summary
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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 Artelon® 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.

Official Title
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Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Arthroscopic Rotator Cuff Repair
* Procedure: Micro-perforations
* Procedure: Artelon®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair signed informed consensus Exclusion Criteria: previous fractures diabetes subscapularis tears tears < 1cm or > 3 cm reduced passive range of motion infections known mental or neurological disorders unwilling or unable to follow the post-surgery instructions conditions that contraindicate arthroscopic rotator cuff surgery patients without complete osteogenesis pregnant or breastfeeding women
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Arthroscopic Rotator Cuff Repair with standard treatment | Procedure: Arthroscopic Rotator Cuff Repair<br>* Arthroscopic Rotator Cuff Repair<br>|
| Experimental: Experimental 1<br>Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations | Procedure: Arthroscopic Rotator Cuff Repair<br>* Arthroscopic Rotator Cuff Repair<br>Procedure: Micro-perforations<br>* Biological stimulation with micro-perforations<br>|
| Experimental: Experimental 2<br>Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of Artelon® Tissue Reinforcement | Procedure: Arthroscopic Rotator Cuff Repair<br>* Arthroscopic Rotator Cuff Repair<br>Procedure: Micro-perforations<br>* Biological stimulation with micro-perforations<br>Procedure: Artelon®<br>* Biological stimulation with Artelon® Tissue Reinforcement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retear rate | Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging | 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Tear, Artelon®