NCT03060928

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: ASST Gaetano Pini-CTO · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic Rotator Cuff Repair	Arthroscopic Rotator Cuff Repair
PROCEDURE	Micro-perforations	Biological stimulation with micro-perforations
PROCEDURE	Artelon®	Biological stimulation with Artelon® Tissue Reinforcement

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2017-02-23
• Last updated: 2017-02-28

Locations

1 site across 1 country: Italy