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

Last updated: June 23, 2025
Sponsor: Arthrex, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bunion

Treatment

Products listed in Group/Cohort Description

Clinical Study ID

NCT04715139
AIRR-0006
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject requires surgery using Arthrex foot and ankle products included in theregistry.

  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, whenapplicable, and is willing and able to comply with all study requirements.

(ArthroFLEX® subjects only):

  1. Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.

  2. Subjects who require surgical intervention or are medically indicated for anarthrodesis or arthroplasty of the 1st MTP. DualCompression Hindfoot Nail subjects only:

  3. The participant must have instability, arthritis, rigid deformity, or severe foot orankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred toas TTC arthrodesis.

  4. The participant should be undergoing treatment with the Arthrex DualCompressionHindfoot Nail, either as a primary procedure or as a revision surgery, per standardof care

Exclusion

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 restrictactivities 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 injuryor illness under any applicable occupational injury or disability program.

  10. Subject has a planned or scheduled additional surgery on the affected orcontralateral lower extremity within the course of the study.

(® Nitinol Staple Subjects only):

  1. Subjects who have a comminuted bone surface that would not allow for stapleplacement as required by the DynaNite® Nitinol Staples directions for use.

  2. Subjects who have pathologic bone conditions such as osteopenia that would impairthe ability to securely fix the implant as required by the DynaNite® Nitinol Staplesdirections for use.

(ArthroFLEX® subjects only):

  1. Additional ipsilateral lower limb pathology that requires active treatment.

  2. Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that wouldrequire simultaneous treatment of both MTP joints.

  3. Diagnosis of gout.

  4. Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (>1cm) of the 1st MTP joint.

  5. Lesions greater than 10mm in size.

  6. Hallux varus to any degree, or hallux valgus >20 degrees.

(DualCompression Hindfoot Nail subjects only):

  1. Requiring only a tibiotalar or subtalar arthrodesis

  2. Patient requires bulk allograft or metal spacer implant to fill large bony defectand aid in limb salvage

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: Products listed in Group/Cohort Description
Phase:
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • OrthoPedes

    Duisburg, 47169
    Germany

    Active - Recruiting

  • Dr Haroun Mahomed Orthopaedic Practice

    Durban, 3629
    South Africa

    Active - Recruiting

  • Life Westville Hospital

    Durban, 3629
    South Africa

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • TOA Research Foundation

    Nashville, Tennessee 37209
    United States

    Terminated

  • Barrett Podiatry

    San Antonio, Texas 78258
    United States

    Terminated

  • Atlantic Orthopaedic Specialists

    Virginia Beach, Virginia 23462
    United States

    Active - Recruiting

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