Safety and Performance of the TFCC FastFix in the Wrist
October 1, 2021 updated by: Smith & Nephew, Inc.
Assess safety and performance post-market of the TFCC FastFix in the wrist.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33146
- Miami Orthopedics & Sport Medicine Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who had TFCC repair using TFCC FastFix device
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 28, 2018
Primary Completion (ACTUAL)
September 29, 2021
Study Completion (ACTUAL)
September 29, 2021
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
November 27, 2018
First Posted (ACTUAL)
November 28, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2021
Last Update Submitted That Met QC Criteria
October 1, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- TFCCFF.PMCF.2017.12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.