Evaluating combined Adductoplasty™ and Lapiplasty® procedures for foot correction

Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)

This study is testing if combining two foot surgeries can help people with foot deformities feel better and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Treace Medical Concepts, Inc. (industry)
• Locations: 9 sites (Greeley, Colorado and 8 other locations)
• Trial ID: NCT05587569 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter study aims to assess the outcomes of the Adductoplasty™ Procedure in conjunction with the Lapiplasty® Procedure for patients suffering from metatarsus adductus and hallux valgus. The study will involve up to 80 participants aged 14 and older, who will be treated across 13 clinical sites. Researchers will evaluate quality of life and pain scores post-surgery, as well as the effectiveness of the combined procedures in correcting and maintaining proper anatomical alignment of the metatarsals and hallux. Participants will be monitored for adherence to post-operative care and scheduled follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 14 and older with symptomatic metatarsus adductus and hallux valgus.

Not a fit: Patients who have previously undergone foot surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life and reduce pain for patients with foot deformities.

How similar studies have performed: While this approach is innovative, similar studies have shown promising outcomes with combined surgical techniques for foot deformities.

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

Where this trial is running

Greeley, Colorado and 8 other locations

• Foot and Ankle Center of the Rockies — Greeley, Colorado, United States (RECRUITING)
• Foot and Ankle Center of Iowa — Ankeny, Iowa, United States (RECRUITING)
• Coastal Maine Foot and Ankle — Yarmouth, Maine, United States (RECRUITING)
• JCMG - Jefferson City Medical Group — Jefferson City, Missouri, United States (RECRUITING)
• Duke Orthopaedics Arringdon — Morrisville, North Carolina, United States (RECRUITING)
• Ohio Foot and Ankle Center — Canton, Ohio, United States (RECRUITING)
• Ohio Foot and Ankle Center — Stow, Ohio, United States (RECRUITING)
• Greater Pittsburgh Foot and Ankle Center — Wexford, Pennsylvania, United States (RECRUITING)
• Foot and Ankle Associates of North Texas - Keller — Keller, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Paul Dayton, DPM — Foot and Ankle Center of Iowa
• Study coordinator: Cara Bethell

Conditions: Metatarsus Adductus, Hallux Valgus, MTA3D