Early Weight-Bearing After the Lapiplasty Procedure

Running, not enrolling · Not applicable

Conditions studied: Hallux Valgus, Bunion

In brief

The objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery: * The study will determine the radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. * The study will determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. * The study will assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. * The study will evaluate the quality of life and pain scores following the Lapiplasty® Procedure.

Key facts

Study ID

NCT03740282

Run by

Treace Medical Concepts, Inc.

People needed

183

Starts

2018-11-06

Expected to finish

2026-05-31

Last updated by the study team

2026-04-06

Who can join

Age: 14 and older, up to 58. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and females between the ages 14 and 58 years at the time of consent
• Closed physeal plates at the time of consent
• Intermetatarsal angle is between 10.0 ̊ - 22.0 ̊
• Hallux valgus angle is between 16.0 ̊ - 40.0 ̊
• Willing and able to adhere to early weight-bearing instructions post-operatively
• Capable of completing self - administered questionnaires
• Acceptable surgical candidate, including use of general anesthesia
• Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to 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

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 or lesser toes/digits)
• Additional arthrodesis outside the first tarsometatarsal joint (other than: arthrodesis between the medial cuneiform and intermediate cuneiform and/or base of 2nd metatarsal; arthrodesis of hammertoe proximal interphalangeal joint or lesser toes/digits)
• Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test
• Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5 ̊and talonavicular subluxation/uncovering >50%)
• BMI >40 kg/m²
• Current nicotine user, including current use of nicotine patch
• Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or HbA 1c ≥7.0
• Current clinical diagnosis of peripheral neuropathy or by assessment on 4 - point monofilament test
• Current clinical diagnosis of fibromyalgia
• Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
• Current uncontrolled hypothyroidism
• 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 retard 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
• Current diagnosis of metatarsus adductus (defined as MAA ≥ 23 ̊)
• Scheduled to undergo a same - bilateral procedure. Patient agrees to refrain from the Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for minimum of 6 months post index 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 early weight-bear post-procedure
• Patient is actively involved with a workman's compensation case or is currently involved in litigation
• Patient is currently or has participated in a clinical study in the last 30 days prior to signing
• 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 it is running

• Foot & Ankle Center of Northern Colorado — Greeley, Colorado, United States
• Foot & Ankle Center of Iowa — Ankeny, Iowa, United States
• Jefferson City Medical Group, P.C. — Jefferson City, Missouri, United States
• Desert Orthopaedic Center — Las Vegas, Nevada, United States
• University of Pennsylvania/Penn Medicine — Philadelphia, Pennsylvania, United States
• UT Southwestern — Dallas, Texas, United States
• Stonebriar Foot & Ankle — Frisco, Texas, United States

Full record on ClinicalTrials.gov

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