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BioFiber Scaffold Post-Market Observational Study | Clinical Trials | Clareo Health

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COMPLETEDNCT01849458

BioFiber Scaffold Post-Market Observational Study

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 ...

Lead sponsor: Stryker Trauma and Extremities•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Stryker Trauma and Extremities

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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COMPLETEDEARLY Phase 1

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 22, 2017Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment50

Start dateMar 2013

Last updatedJun 22, 2017

Condition

Full Thickness Rotator Cuff Tear

Locations shown

Insall Scott Kelly Institute

New York, New York

University of Virginia Sports Medicine and Shoulder Surgery

Charlottesville, Virginia

St. Gregoire

Saint-Grégoire

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2017Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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