NCT01025037

Outcomes in Rotator Cuff Repair Using Graft Reinforcement

A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.

Detailed description

Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff. Conexa will be used in accordance with its labeling for this clinical study.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Conexa Reconstructive Tissue Matrix	Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2009-12-03
• Last updated: 2015-01-26
• Results posted: 2015-01-26

Locations

6 sites across 1 country: United States