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

Not Applicable

• Conditions: Rotator Cuff Tear

• Registration Number: NCT03060928
• Lead Sponsor: ASST Gaetano Pini-CTO

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28
• Study Start: 2017-03-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retear rate	12 months post-operatively	Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Roberto Leo; 🇮🇹 Milano, Italy