Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
50 participants
OBSERVATIONAL
2013-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BioFiber
Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
BioFiber
Subjects implanted with BioFiber or BioFiber-CM Scaffold
Interventions
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BioFiber
Subjects implanted with BioFiber or BioFiber-CM Scaffold
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Stryker Trauma and Extremities
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Brockmeier, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Timothy Reish, MD
Role: PRINCIPAL_INVESTIGATOR
Insall Scott Kelly Institute
Philippe Collin, MD
Role: PRINCIPAL_INVESTIGATOR
St. Gregoire, France
Locations
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Insall Scott Kelly Institute
New York, New York, United States
University of Virginia Sports Medicine and Shoulder Surgery
Charlottesville, Virginia, United States
St. Gregoire
Saint-Grégoire, , France
Countries
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Other Identifiers
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Tornier 2013-1
Identifier Type: -
Identifier Source: org_study_id
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