Safety and Performance of the TFCC FastFix in the Wrist

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03756714

Enrollment

Registered

2018-11-28

Start date

2018-09-28

Completion date

2021-09-29

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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	6 months

Countries

United States

Outcome results