Status:
COMPLETED
BioFiber Scaffold Post-Market Observational Study
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Full Thickness Rotator Cuff Tear
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01849458
Start Date
March 1 2013
End Date
April 1 2015
Last Update
June 22 2017
Active Locations (3)
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1
Insall Scott Kelly Institute
New York, New York, United States, 10065
2
University of Virginia Sports Medicine and Shoulder Surgery
Charlottesville, Virginia, United States, 22908
3
St. Gregoire
Saint-Grégoire, France