Miami Orthopedics & Sport Medicine Institute
Miami, Florida, 33146, United States
Completed
NCT Number: NCT03756714
Safety and Performance of the TFCC FastFix in the Wrist
Assess safety and performance post-market of the TFCC FastFix in the wrist.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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
Sponsors and collaborators
Lead sponsor
Smith & Nephew, Inc.
Industry
Registry information
Important dates
- Study start
- 2018
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Nov 28, 2018
- Registry last updated
- Oct 5, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.