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

February 9, 2026 updated by: Arthrex, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Device-related adverse events will be continuously assessed and summarized at three months, six months, one year, and two years postoperatively to evaluate safety. A physical exam of the target area will be conducted three months postoperatively to evaluate performance. Range of motion (ROM) will be assessed preoperatively, at three months, six months, and one year postoperatively for the ArthroFLEX® dermal allograft only. Patient-reported outcomes (PROs) will be evaluated for all products at three months, six months, and one year. Additionally, PROs will be assessed at two years postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only. PROs include the Foot and Ankle Ability Measures (FAAM), Visual Analogue Scale (VAS), Single Assessment Numeric Evaluation (SANE) score, and Veterans Rand 12-Item Health Survey (VR-12). DualCompression X-rays will be evaluated at six months and one year postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only, and CT scans will be assessed at three months postoperatively for DualCompression Hindfoot Nail only.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Duisburg, Germany, 47169
        • Terminated
        • OrthoPedes
  • South Africa
      • Durban, South Africa, 3629
        • Terminated
        • Dr Haroun Mahomed Orthopaedic Practice
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Contact:
          • Gaby Zumaran
        • Principal Investigator:
          • Christopher Kreulen, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Muhammad Mutawakkil, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Terminated
        • TOA Research Foundation
    • Texas
      • San Antonio, Texas, United States, 78258
        • Terminated
        • Barrett Podiatry
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Atlantic Orthopaedic Specialists
        • Contact:
        • Principal Investigator:
          • Blake Moore, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Products listed in Descriptions
  • ProStop
  • BioCompression Screw
  • TRIM-IT Drill Pin/TRIM-IT Spin Pin
  • Headless Compression Screw/Compression FT Screw
  • DynaNite Nitinol Staple
  • BioComposite SutureTak Anchor
  • Beveled Headed FT Screw
  • KreuLock Screws
  • ArthroFLEX dermal allograft
  • DualCompression Hindfoot Nail
Device: Products listed in Group/Cohort Description
Depending on approved indication per product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess change in Visual Analogue Scale (VAS) survey
Time Frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported pain scale 0-10 point scale (0 min, 10 max)
preoperatively, 3 months, 6 months and 12 months post operative
To assess changes in Veterans RAND Health (VR-12) survey
Time Frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
preoperatively, 3 months, 6 months and 12 months post operative
To assess changes in Foot and Ankle Ability Measures (FAAM) survey
Time Frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function
preoperatively, 3 months, 6 months and 12 months post operative
To assess change in Single Assessment Numeric Evaluation (SANE) survey
Time Frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.
preoperatively, 3 months, 6 months and 12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRR-0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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