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

Completed

• Conditions: Lateral Epicondylitis Repair; Ulnar or Radial Collateral Ligament Reconstructions; Hallux Valgus Repairs; Achilles Tendon Repairs/Reconstructions; Midfoot Reconstructions; Scapholunate Ligament Reconstructions; Biceps Tendon Reattachment; Metatarsal Ligament/Tendon Repairs/Reconstructions; Medial or Lateral Instability Repairs/Reconstructions
• Interventions: Device: MINITAC Ti 2.0 suture anchor

• Registration Number: NCT04186481
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-25
• Primary Completion: 2019-11-08
• Study Completion: 2019-11-08
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Status Verified: 2021-02
• Results First Submitted: 2021-02-08
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-26
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minitac Ti 2.0 suture anchor	MINITAC Ti 2.0 suture anchor	Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor

Primary Outcome Measures

Name	Time	Method
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative	6 months	Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.

Secondary Outcome Measures

Name	Time	Method
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative	12 months	Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon for all participants that completed the 12-month visit

Trial Locations

Locations (1)

Maitland Hand and Othopaedic surgery; 🇦🇺 Ashtonfield, New South Wales, Australia