Safety and Performance of the TFCC FastFix in the Wrist

N/ACompletedNCT03756714

Smith & Nephew, Inc.88 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Miami Orthopedics & Sport Medicine Institute

Miami, Florida, United States

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

Data from ClinicalTrials.gov

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