Safety and Performance of the TFCC FastFix in the Wrist
Completed
- Conditions
- Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair
- Registration Number
- NCT03756714
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
Assess safety and performance post-market of the TFCC FastFix in the wrist.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate (%) of clinical success of six months post-operative. Clinical success is defined as wrists without signs of device failure and/or re-intervention after assessment by surgeon 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Miami Orthopedics & Sport Medicine Institute
🇺🇸Miami, Florida, United States