Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Launched by TREACE MEDICAL CONCEPTS, INC. · Oct 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a combined surgical approach called Adductoplasty™ and Lapiplasty® to treat two foot conditions: metatarsus adductus (a foot deformity where the front part of the foot turns inward) and hallux valgus (commonly known as a bunion). The goal is to see how well this combined treatment works for patients aged 14 and older who have noticeable symptoms from these conditions. Up to 80 participants will be included from various clinical sites.

To be eligible for the study, participants need to be at least 14 years old, have certain angles in their foot measurements that indicate the severity of their conditions, and be willing to follow post-surgery care instructions. Participants can expect to undergo the combined procedure and will need to attend follow-up visits to track their recovery. It’s important to note that individuals with certain medical conditions or previous surgeries on the affected foot may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and females ≥14 years old at the time of consent
• • 2. Closed physeal plates at the time of consent
• • 3. Intermetatarsal angle is ≥8.0˚; OR True IMA of \>10°, (IMA+MTA-15=True IMA)
• • 4. Hallux valgus angle is ≥12.0˚
• • 5. Metatarsus adductus angle based on Sgarlatos method ≥15°
• • 6. Willing and able to adhere to post-op care instructions
• • 7. Capable of completing self-administered questionnaires
• • 8. Acceptable surgical candidate, including use of general anesthesia
• • 9. Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure
• • 10. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits
• • 11. Willing and able to provide written informed consent
• • 12. Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure
• Exclusion Criteria:
• • 1. Previous surgery for hallux valgus on operative side
• • 2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
• • 3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
• • 4. Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
• • 5. Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction
• • 6. BMI \>40 kg/m²
• • 7. Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
• • 8. Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
• • 9. Current clinical diagnosis of peripheral neuropathy
• • 10. Current clinical diagnosis of fibromyalgia
• • 11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
• • 12. Current uncontrolled hypothyroidism
• • 13. Current clinical diagnosis of chronic dependent edema
• • 14. Previously sensitized to titanium
• • 15. Currently taking oral steroids or rheumatoid biologics
• • 16. Currently taking immunosuppressant drugs
• • 17. Insufficient quantity or quality of bone to permit stabilization, conditions that inhibit healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease
• • 18. Active, suspected, or latent infection in the affected area
• • 19. Use of synthetic or allogenic bone graft substitutes
• • 20. Use of non-Treace products for Index Procedure
• • 21. Additional bone procedure needed during the index procedure to complete correction \[first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion (other than Weil osteotomies)\];
• • 22. Scheduled to undergo a same-day bilateral procedure
• • 23. Patient has previously been enrolled into this study for a contralateral procedure
• • 24. Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure
• • 25. Patient is actively involved with a workman's compensation case or is currently involved in litigation
• • 26. Patient is currently in, or has participated in, a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE
• • 27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up