BioFiber Scaffold Post-Market Observational Study

Stryker Trauma and Extremities

Status: Completed

Conditions: Full Thickness Rotator Cuff Tear

Treatments: Device: BioFiber

Study type: Observational

Funder types: Industry

Identifiers

NCT01849458

Tornier 2013-1

Details and patient eligibility

About

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.

Full description

Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

BioFiber

Description:

Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold

Treatment:

Device: BioFiber