A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor

Smith & Nephew

Status: Completed

Conditions: Hallux Valgus Repairs; Medial or Lateral Instability Repairs/Reconstructions; Ulnar or Radial Collateral Ligament Reconstructions; Lateral Epicondylitis Repair; Midfoot Reconstructions; Biceps Tendon Reattachment; Scapholunate Ligament Reconstructions; Metatarsal Ligament/Tendon Repairs/Reconstructions; Achilles Tendon Repairs/Reconstructions

Treatments: Device: MINITAC Ti 2.0 suture anchor

Study type: Observational

Funder types: Industry

Identifiers

NCT04186481

MINI.PMCF.2018.11

Details and patient eligibility

About

This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.

Full description

Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
2. Subject was ≥ 18 years of age at time of surgery.
3. Subject status is > 12 months post-operative.

Exclusion criteria

Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Trial design

32 participants in 1 patient group

Minitac Ti 2.0 suture anchor

Description:

Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor

Treatment:

Device: MINITAC Ti 2.0 suture anchor