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

February 8, 2021 updated by: Smith & Nephew, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Ashtonfield, New South Wales, Australia, 2323
        • Maitland Hand and Othopaedic surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Minitac Ti 2.0 suture anchor
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
Time Frame: 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
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion (ROM)
Time Frame: 6 and 12 months
Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc), Maitland Hand and Othopaedic surgery
  • Study Chair: Stephan Mangin, Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Actual)

November 8, 2019

Study Completion (Actual)

November 8, 2019

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINI.PMCF.2018.11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hallux Valgus Repairs

Clinical Trials on MINITAC Ti 2.0 suture anchor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe