Evaluating the safety and performance of foot and ankle surgical products

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

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 type: Observational
• Enrollment: 700 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: Arthrex, Inc. (Industry-sponsored)
• Locations: 7 sites (Sacramento, California and 6 other locations)
• Trial ID: NCT04715139 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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 performed: 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.

Eligibility 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 this trial is running

Sacramento, California and 6 other locations

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

Study contacts

• Study coordinator: Justin Moss, DHSc

Conditions Hyperpronated Foot; Reconstruction Surgeries of the Foot; Fixation of Fractures and Fusion of the Foot/Ankle; Fixation of Small Bone Fragments of the Foot/Ankle; Lisfranc Arthrodesis; Mono or Bi-cortical Osteotomies in the Forefoot; First Metatarsophalangeal Arthrodesis; Akin Osteotomy