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Clinical Trials in the USA / NCT03740282
Active, not recruiting Not applicable

Early Weight-Bearing After the Lapiplasty Procedure

NCT03740282 · tracked via the Priya Life Science USA tracker
Sponsor
Treace Medical Concepts, Inc.
Phase
Not applicable
Started
2018-11-06
Last updated
2026-04-06

Condition(s) studied

Hallux ValgusBunion

Investigational drug(s) / intervention(s)

Lapiplasty

Lapiplasty: Patients 14 years through 58 years with symptomatic hallux valgus who are treated with the Lapiplasty System will begin weight-bearing by 3 weeks and follow a defined post-operative protocol.

Study summary

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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
58 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (7)

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

More Treace Medical Concepts, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03740282 on ClinicalTrials.gov ↗ ← All trials in the USA