BioFiber Scaffold Post-Market Observational Study

NCT01849458 | Completed Results

• 1 other identifier: Tornier 2013-1
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 3

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 Union.

Conditions

Full Thickness Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device Associated Adverse Events

  The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.

  12 Months

Secondary Outcomes (6)

• Clinical Functional Outcome - Adjusted Constant-Murley Score

  6 Months

• Clinical Functional Outcome - Adjusted Constant-Murley Score

  12 Month

• Clinical Functional Outcome - WORC Index

  6 Months

• Clinical Functional Outcome - WORC Index

  12 Months

• Number of Study Participants With Re-tears

  6 Months

Study Arms (1)

BioFiber

Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold

Device: BioFiber

Interventions

BioFiber DEVICE

Subjects implanted with BioFiber or BioFiber-CM Scaffold

Also known as: BioFiber Scaffold, BioFiber-CM Scaffold

BioFiber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopedic referral clinic

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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (3)

Insall Scott Kelly Institute

New York, New York, 10065, United States

Location

University of Virginia Sports Medicine and Shoulder Surgery

Charlottesville, Virginia, 22908, United States

Location

St. Gregoire

Saint-Grégoire, France

Location

Results Point of Contact

• Title: Marcela Bravo
• Organization: Tornier Inc.

marcela.bravo@tornier.com

9526837481

Study Officials

• Stephen Brockmeier, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Timothy Reish, MD

  Insall Scott Kelly Institute

  PRINCIPAL INVESTIGATOR

• Philippe Collin, MD

  St. Gregoire, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 22, 2017
• Results First Posted: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); FR (1)