700 patients to be tracked after foot surgery in new safety registry
NCT ID NCT04715139
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Locations
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Atlantic Orthopaedic Specialists
RECRUITINGVirginia Beach, Virginia, 23462, United States
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Barrett Podiatry
TERMINATEDSan Antonio, Texas, 78258, United States
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Dr Haroun Mahomed Orthopaedic Practice
TERMINATEDDurban, 3629, South Africa
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
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OrthoPedes
TERMINATEDDuisburg, 47169, Germany
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TOA Research Foundation
TERMINATEDNashville, Tennessee, 37209, United States
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UC Davis Medical Center
RECRUITINGSacramento, California, 95817, United States
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