NCT03756714CompletedNot Applicable
Safety and Performance of the TFCC FastFix in the Wrist
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
Assess safety and performance post-market of the TFCC FastFix in the wrist.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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