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700 patients to be tracked after foot surgery in new safety registry

NCT ID NCT04715139

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a registry that will follow 700 people who need foot or ankle surgery using specific Arthrex products. The goal is to see how safe and effective these devices are over time by collecting patient-reported pain and function surveys. Participants must be 18 or older (or 2-17 for one implant) and willing to return for follow-up visits. No new treatment is being tested; this just gathers real-world data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 700 subjects (50 subjects per product/indication pair) will be enrolled. The subject population will be male and female,18 years of age or older, with the exception of ProStop®, which includes subjects aged \>2 to 17 years of age. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Orthopaedic Specialists

    RECRUITING

    Virginia Beach, Virginia, 23462, United States

  • Barrett Podiatry

    TERMINATED

    San Antonio, Texas, 78258, United States

  • Dr Haroun Mahomed Orthopaedic Practice

    TERMINATED

    Durban, 3629, South Africa

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • OrthoPedes

    TERMINATED

    Duisburg, 47169, Germany

  • TOA Research Foundation

    TERMINATED

    Nashville, Tennessee, 37209, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

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