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

ASST Gaetano Pini-CTO

Status: Unknown

Conditions: Rotator Cuff Tear

Treatments: Procedure: Artelon®; Procedure: Arthroscopic Rotator Cuff Repair; Procedure: Micro-perforations

Study type: Interventional

Funder types: Other

Identifiers

NCT03060928

753_2016

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups

Control

Active Comparator group

Description:

Arthroscopic Rotator Cuff Repair with standard treatment

Treatment:

Procedure: Arthroscopic Rotator Cuff Repair

Experimental 1

Experimental group

Description:

Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations

Treatment:

Procedure: Arthroscopic Rotator Cuff Repair

Procedure: Micro-perforations

Experimental 2

Experimental group

Description:

Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of Artelon® Tissue Reinforcement

Treatment:

Procedure: Arthroscopic Rotator Cuff Repair

Procedure: Micro-perforations

Procedure: Artelon®