Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Recruiting now · Not applicable

Conditions studied: Metatarsus Adductus, Hallux Valgus

In brief

Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction. Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Key facts

Study ID

NCT05587569

Run by

Treace Medical Concepts, Inc.

People needed

80

Starts

2022-09-28

Expected to finish

2030-12-31

Last updated by the study team

2025-05-25

Who can join

Age: 14 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and females ≥14 years old at the time of consent
• Closed physeal plates at the time of consent
• Intermetatarsal angle is ≥8.0˚; OR True IMA of >10°, (IMA+MTA-15=True IMA)
• Hallux valgus angle is ≥12.0˚
• Metatarsus adductus angle based on Sgarlatos method ≥15°
• Willing and able to adhere to post-op care instructions
• Capable of completing self-administered questionnaires
• Acceptable surgical candidate, including use of general anesthesia
• Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure
• Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits
• Willing and able to provide written informed consent
• Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure

You may not qualify if…

• Previous surgery for hallux valgus on operative side
• Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
• Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
• Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
• 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
• BMI >40 kg/m²
• Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
• Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
• Current clinical diagnosis of peripheral neuropathy
• Current clinical diagnosis of fibromyalgia
• Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
• Current uncontrolled hypothyroidism
• Current clinical diagnosis of chronic dependent edema
• Previously sensitized to titanium
• Currently taking oral steroids or rheumatoid biologics
• Currently taking immunosuppressant drugs
• 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
• Active, suspected, or latent infection in the affected area
• Use of synthetic or allogenic bone graft substitutes
• Use of non-Treace products for Index Procedure
• 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)];
• Scheduled to undergo a same-day bilateral procedure
• Patient has previously been enrolled into this study for a contralateral procedure
• Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure
• Patient is actively involved with a workman's compensation case or is currently involved in litigation

Where it is running

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

Full record on ClinicalTrials.gov

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