N/A
N=50
BioFiber Scaffold Post-Market Observational Study
Full Thickness Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT01849458 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Device Associated Adverse Events — 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BioFiber (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Trauma and Extremities
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Device Associated Adverse Events |
4 | — |
| SECONDARY Clinical Functional Outcome - Adjusted Constant-Murley Score |
97.1 | 0.0001 sig |
| SECONDARY Clinical Functional Outcome - Adjusted Constant-Murley Score |
97.1 | 0.0001 sig |
| SECONDARY Clinical Functional Outcome - WORC Index |
86.8 | 0.0001 sig |
| SECONDARY Clinical Functional Outcome - WORC Index |
86.8 | 0.0001 sig |
| SECONDARY Number of Study Participants With Re-tears |
2 | — |
| SECONDARY Number of Study Participants With Re-tears |
2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01849458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.