Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)

Stopped early · Not applicable

Conditions studied: Hallux Valgus, Bunion

In brief

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Key facts

Study ID

NCT05082012

Run by

Treace Medical Concepts, Inc.

People needed

123

Starts

2021-09-17

Expected to finish

2024-05-09

Last updated by the study team

2026-04-20

Who can join

Age: 14 and older, up to 58. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
• 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…

• Patients satisfying the following criteria will not be eligible for participation:
• 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 concomitant procedures outside of the 1st ray;
• 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 HbA1c ≥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˚);
• Known keloid and hypertrophic scar forming;
• Scheduled to undergo a same-day 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 requires an incision >4.0 cm to complete the procedure (determined pre-operatively or intra-operatively);

Where it is running

• DOC - Decatur Orthopaedic Clinic — Decatur, Alabama, United States
• DOC - Decatur Orthopaedic Clinic — Hartselle, Alabama, United States
• Phoenix Foot and Ankle Institute — Scottsdale, Arizona, United States
• Orlando Foot and Ankle Clinic - Waterford Lakes Office — Orlando, Florida, United States
• JCMG - Podiatry — Jefferson City, Missouri, United States
• Desert Orthopaedic Center — Las Vegas, Nevada, United States
• University of Pennsylvania / Penn Medicine — Philadelphia, Pennsylvania, United States
• Stonebriar Foot and Ankle — Frisco, Texas, United States
• Foot & Ankle Associates of North Texas - Keller — Keller, Texas, United States
• Sports Medicine Associates of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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