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Evaluate the Continued Safety and Performance of the Foot and Ankle Products

NCT04715139 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2026-02-11

No results posted yet for this study

Summary

The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.

Conditions

  • Hyperpronated Foot
  • Reconstruction Surgeries of the Foot
  • Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle
  • Fixation of Small Bone Fragments of the Foot/Ankle
  • Lisfranc Arthrodesis
  • Mono or Bi-cortical Osteotomies in the Forefoot
  • First Metatarsophalangeal Arthrodesis
  • Akin Osteotomy
  • Midfoot and Hindfoot Arthrodeses or Osteotomies
  • Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)
  • Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus
  • Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)
  • Medial Ankle Stabilization
  • Tibiotalocalcaneal Arthrodesis

Interventions

DEVICE

Products listed in Group/Cohort Description

Depending on approved indication per product

Sponsors & Collaborators

  • Arthrex, Inc.

    lead INDUSTRY

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2027-12-01
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • South Africa

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 NCT04715139 on ClinicalTrials.gov