Status:
COMPLETED
Safety and Performance of the TFCC FastFix in the Wrist
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair
Eligibility:
All Genders
18+ years
Brief Summary
Assess safety and performance post-market of the TFCC FastFix in the wrist.
Eligibility Criteria
Inclusion
- Patients who have undergone TFCC repair using the TFCC FastFix Device
- Patients aged 18 years and older
- Patients that are \> 12 months post-operative.
Exclusion
- Subjects who are \< 12 months post-operative
- Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
Key Trial Info
Start Date :
September 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03756714
Start Date
September 28 2018
End Date
September 29 2021
Last Update
October 5 2021
Active Locations (1)
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1
Miami Orthopedics & Sport Medicine Institute
Miami, Florida, United States, 33146