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Safety and Performance of PEEK Anchors in Extremities

NCT03782298 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-10-01

Study results available
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Summary

Safety and performance of the study devices in extremities up to 12 months post-surgery

Conditions

  • Medial or Lateral Instability Repairs/Reconstructions
  • Hallux Valgus Repairs
  • Achilles Tendon Repairs/Reconstructions
  • Midfoot Reconstructions
  • Metatarsal Ligament/Tendon Repairs/Reconstructions
  • Bunionectomy
  • Scapholunate Ligament Reconstructions
  • Ulnar
  • Lateral Epicondylitis Repair
  • Bicep Tendon Reattachments

Interventions

DEVICE

Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

PEEK Suture Anchors, which include: * SPYROMITE™ 2.0 PK Suture Anchor with Needles * DYNOMITE™ 2.0 PK Suture Anchor with Needles * RAPTORMITE™ 3.0 Suture Anchor with Needles * FOOTPRINT™ Ultra PK SL Suture Anchor

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Judth Horner · Smith & Nephew, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2019-10-10
Completion
2019-10-10

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782298 on ClinicalTrials.gov