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

NCT ID: NCT04186481

Last Updated: 2021-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-25

Study Completion Date

2019-11-08

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Minitac Ti 2.0 suture anchor

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

MINITAC Ti 2.0 suture anchor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc)

Role: PRINCIPAL_INVESTIGATOR

Maitland Hand and Othopaedic surgery

Stephan Mangin

Role: STUDY_CHAIR

Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew

Locations

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Maitland Hand and Othopaedic surgery

Ashtonfield, New South Wales, Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MINI.PMCF.2018.11

Identifier Type: -

Identifier Source: org_study_id

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