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

NCT04186481 | Completed Results DMC

• 1 other identifier: MINI.PMCF.2018.11
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative

  12 months

Other Outcomes (1)

• Range of Motion (ROM)

  6 and 12 months

Study Arms (1)

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

Interventions

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.

Minitac Ti 2.0 suture anchor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Maitland Hand and Othopaedic surgery

Ashtonfield, New South Wales, 2323, Australia

Location

Limitations and Caveats

Due to the nature of the study design, retrospective data was collected to the extent it was available.

Results Point of Contact

• Title: Alison Walker, Regional Operation Manager ANZ
• Organization: Smith+Nephew, Inc.

Alison.walker@smith-nephew.com

+61 466 322 200

Study Officials

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

  Maitland Hand and Othopaedic surgery

  PRINCIPAL INVESTIGATOR

• Stephan Mangin

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: October 25, 2019
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)