N/A
N=32
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
Hallux Valgus Repairs · Medial or Lateral Instability Repairs/Reconstructions · Achilles Tendon Repairs/Reconstructions · Midfoot Reconstructions · Metatarsal Ligament/Tendon Repairs/Reconstructions
Bottom Line
View on ClinicalTrials.gov: NCT04186481 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative — 31 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MINITAC Ti 2.0 suture anchor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative |
31 | — |
| SECONDARY Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative |
4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04186481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.