Safety and Performance of the TFCC FastFix in the Wrist

Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair Clinical Trial

Official title:

Safety and Performance of the TFCC FastFix in the Wrist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756714
• Other study ID #: TFCCFF.PMCF.2017.12
• Status: Completed
• Start date: September 28, 2018
• Est. completion date: September 29, 2021

Study information

• Verified date: October 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assess safety and performance post-market of the TFCC FastFix in the wrist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair

Locations

Country	Name	City	State
United States	Miami Orthopedics & Sport Medicine Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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