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Completed

NCT Number: NCT04186481

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maitland Hand and Othopaedic surgery

Ashtonfield, New South Wales, 2323, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
  • Subject was ≥ 18 years of age at time of surgery.
  • 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.

Treatment and study plan

MINITAC Ti 2.0 suture anchor

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Acronym: MINITAC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2019
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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