NCT01256242

Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: BioMimetic Therapeutics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient. Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.

Conditions

• Full Thickness Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Augment Rotator Cuff	rhPDGF-BB and bovine collagen matrix
PROCEDURE	Standard Suture Repair	standard suture repair

Timeline

• Start date: 2010-11-24
• Primary completion: 2012-11-16
• Completion: 2012-11-16
• First posted: 2010-12-08
• Last updated: 2019-02-19

Locations

4 sites across 1 country: Canada