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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Arthroscopic Rotator Cuff Repair
Biological stimulation with micro-perforations
Biological stimulation with Artelon® Tissue Reinforcement
Roberto Leo
Milan, Italy
Retear rate
Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging
Time frame: 12 months post-operatively
Constant-Murley
Comparison of Constant-Murley Score in each group
Time frame: 3, 6, 12 months post-operatively
DASH
Comparison of DASH Score in each group
Time frame: 1, 3, 6, 12 months post-operatively
VAS
Comparison of Visual Analogue Scale (VAS) in each group
Time frame: 1, 3, 6, 12 months post-operatively
Passive ROM
Comparison of passive range of motion in each group
Time frame: 1, 3, 6, 12 months post-operatively
Adverse events
Adverse events for any cause
Time frame: 1, 3, 6, 12 months post-operatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.