Clinical trial Recruiting at 3 sites Observational Ages 2 and up

Evaluating the safety and performance of foot and ankle surgical products

Official title: A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Run by Arthrex, Inc. · NCT04715139 · Data updated 2026-11-12

This study is testing how safe and effective different foot and ankle surgical products are for people having surgery for issues like flat feet and bunions.

Quick facts

Study typeObservational
Ages2 Years and up
SexAll
Enrollment700 (estimated)
SponsorArthrex, Inc.
Industry-sponsored
Locations7 sites (Sacramento, California and 6 other locations)
StatusRecruiting
StartedDecember 1, 2020
Main results expectedDecember 1, 2027
Study endsDecember 31, 2027
Registry record updatedFebruary 11, 2026
Trial IDNCT04715139 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 2 years and older who require surgery for hyperpronated foot or other specified foot and ankle conditions.

Probably not a fit

Patients with insufficient bone quality, active infections, or those who are skeletally immature (except for specific cases) may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and effectiveness of various Arthrex foot and ankle products used in surgeries for conditions such as hyperpronated foot and bunionectomy osteotomies. Participants will undergo evaluations at multiple postoperative time points, including assessments of adverse events, physical exams, imaging, and patient-reported outcomes using standardized measures. The study will include patients aged 2 years and older, depending on the specific product used, and will monitor recovery and performance over a year.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of surgical treatments for foot and ankle conditions, leading to improved patient outcomes.

How similar studies have gone: While this study builds on existing knowledge of foot and ankle surgical products, its specific focus on the continued safety and performance of these devices is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Subject requires surgery using Arthrex foot and ankle products included in the registry.
2. Subject is 18 years of age or over (all products except ProStop®).
3. Subject age \>two to 17 years (ProStop® product only).
4. Capable of completing self-administered questionnaires.
5. Willing and able to return for all study-related follow-up visits.
6. Subject or subject's representative signed informed consent and assent, when applicable, and is willing and able to comply with all study requirements.

   (ArthroFLEX® subjects only):
7. Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.
8. Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.

   DualCompression Hindfoot Nail subjects only:
9. The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.
10. The participant should be undergoing treatment with the Arthrex DualCompression Hindfoot Nail, either as a primary procedure or as a revision surgery, per standard of care

Exclusion Criteria:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections, which may retard healing.
3. Foreign-body sensitivity.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Subjects that are skeletally immature (except for ProStop®).
7. Subject is considered from vulnerable population (i.e., child, prisoner, pregnant).
8. Subjects who are contraindicated for these devices.
9. Subject is currently receiving compensation or benefits due to a work-related injury or illness under any applicable occupational injury or disability program.
10. Subject has a planned or scheduled additional surgery on the affected or contralateral lower extremity within the course of the study.

    (® Nitinol Staple Subjects only):
11. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.
12. Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite® Nitinol Staples directions for use.

    (ArthroFLEX® subjects only):
13. Additional ipsilateral lower limb pathology that requires active treatment.
14. Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.
15. Diagnosis of gout.
16. Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (\>1cm) of the 1st MTP joint.
17. Lesions greater than 10mm in size.
18. Hallux varus to any degree, or hallux valgus \>20 degrees.

    (DualCompression Hindfoot Nail subjects only):
19. Requiring only a tibiotalar or subtalar arthrodesis
20. Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage

Where it's running

  • UC Davis Medical Center
    Sacramento, California, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • Atlantic Orthopaedic Specialists
    Virginia Beach, Virginia, United States
    Recruiting
  • TOA Research Foundation
    Nashville, Tennessee, United States
    Terminated
  • Barrett Podiatry
    San Antonio, Texas, United States
    Terminated
  • OrthoPedes
    Duisburg, Germany
    Terminated
Show 1 more location
  • Dr Haroun Mahomed Orthopaedic Practice
    Durban, South Africa
    Terminated

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.