Safety and Performance of the TFCC FastFix in the Wrist

Smith & Nephew

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03756714

TFCCFF.PMCF.2017.12

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.