BioFiber Scaffold Post-Market Observational Study

Completed

Conditions studied: Full Thickness Rotator Cuff Tear

In brief

The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.

Key facts

Study ID

NCT01849458

Run by

Stryker Trauma and Extremities

People needed

50

Starts

2013-03-01

Expected to finish

2015-04-01

Last updated by the study team

2017-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older
• Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
• Patients willing and able to comply with the requirements of the study protocol and provide informed consent.

You may not qualify if…

• Patients with active or latent infection
• Patients with decreased vascularity
• Patients with pathological soft tissue conditions
• Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
• Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
• Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager

Where it is running

• Insall Scott Kelly Institute — New York, New York, United States
• University of Virginia Sports Medicine and Shoulder Surgery — Charlottesville, Virginia, United States
• St. Gregoire — Saint-Grégoire, France

Full record on ClinicalTrials.gov

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