Rotator Cuff Tear
Conditions
Keywords
Rotator Cuff Tear, Artelon®
Brief summary
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.
Interventions
PROCEDUREArthroscopic Rotator Cuff Repair
Arthroscopic Rotator Cuff Repair
PROCEDUREMicro-perforations
Biological stimulation with micro-perforations
PROCEDUREArtelon®
Biological stimulation with Artelon® Tissue Reinforcement
Sponsors
ASST Gaetano Pini-CTO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retear rate | 12 months post-operatively | Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley | 3, 6, 12 months post-operatively | Comparison of Constant-Murley Score in each group |
| DASH | 1, 3, 6, 12 months post-operatively | Comparison of DASH Score in each group |
| VAS | 1, 3, 6, 12 months post-operatively | Comparison of Visual Analogue Scale (VAS) in each group |
| Passive ROM | 1, 3, 6, 12 months post-operatively | Comparison of passive range of motion in each group |
| Adverse events | 1, 3, 6, 12 months post-operatively | Adverse events for any cause |
Countries
Italy
Outcome results
None listed