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

Achilles Tendon Repairs/Reconstructions Clinical Trial

— MINITAC  

Official title:

Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186481
• Other study ID #: MINI.PMCF.2018.11
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: February 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Repairs/Reconstructions
• Biceps Tendon Reattachment
• Hallux Valgus
• Hallux Valgus Repairs
• Lateral Epicondylitis Repair
• Medial or Lateral Instability Repairs/Reconstructions
• Metatarsal Ligament/Tendon Repairs/Reconstructions
• Midfoot Reconstructions
• Scapholunate Ligament Reconstructions
• Tennis Elbow
• Ulnar or Radial Collateral Ligament Reconstructions

Intervention

Device:
• MINITAC Ti 2.0 suture anchor
The MINITAC? Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.

Locations

Country	Name	City	State
Australia	Maitland Hand and Othopaedic surgery	Ashtonfield	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Range of Motion (ROM)	Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits	6 and 12 months
Primary	Clinical Success Rate (%) of the MINITAC? Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative	Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.	6 months
Secondary	Clinical Success Rate (%) of the MINITAC? Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative	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	12 months