This trial is active, not recruiting.

Condition full thickness rotator cuff tear
Treatment biofiber
Sponsor Wright Medical Group
Start date June 2013
End date June 2015
Trial size 50 participants
Trial identifier NCT01849458, Tornier 2013-1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
biofiber BioFiber Scaffold
Subjects implanted with BioFiber or BioFiber-CM Scaffold

Primary Outcomes

time frame: 12 Months

Secondary Outcomes

Clinical Functional Outcome
time frame: 6 & 12 Months
time frame: 6 & 12 Months
Clinical Functional Outcome
time frame: 6 & 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
Principal investigator Stephen Brockmeier, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Wright Medical Group.