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

Launched by ARTHREX, INC. · Jan 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of various foot and ankle products made by Arthrex, including implants and screws used in surgeries for conditions like hyperpronated foot, bunion correction, and other foot and ankle surgeries. The goal is to ensure these products continue to perform well and are safe for patients. If you or a loved one is considering surgery for these conditions, you might be eligible to participate in this study if you are over 18 years old (or between 2 to 17 years old for a specific product) and meet certain health criteria.

Participants in this trial can expect to have their surgery using the Arthrex products and will be monitored for safety and performance outcomes during their recovery. It's important to note that individuals with certain medical conditions, such as infections, poor bone quality, or those who may struggle to follow recovery instructions, may not be eligible. By participating, you can help contribute to our understanding of these treatments, which may lead to improved care for future patients.

Gender

ALL

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