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Active, not recruiting Not applicable Interventional

Early Weight-Bearing After the Lapiplasty Procedure

ClinicalTrials.gov ID: NCT03740282

Public ClinicalTrials.gov record NCT03740282. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 30, 2026, 3:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesIs With Early WeiGht-BeariNg After Lapiplasty ProcDure (ALIGN3D)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03740282
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Treace Medical Concepts, Inc.
Industry
Enrollment
183 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
14 Years to 58 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 5, 2018
Primary completion
Apr 30, 2023
Completion
May 30, 2026
Last update posted
Apr 5, 2026

2018 – 2026

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Foot & Ankle Center of Northern Colorado Greeley Colorado 80634
Foot & Ankle Center of Iowa Ankeny Iowa 50023
Jefferson City Medical Group, P.C. Jefferson City Missouri 65109
Desert Orthopaedic Center Las Vegas Nevada 89121
University of Pennsylvania/Penn Medicine Philadelphia Pennsylvania 19106
UT Southwestern Dallas Texas 75390
Stonebriar Foot & Ankle Frisco Texas 75034

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03740282, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 5, 2026 · Synced Jul 30, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03740282 live on ClinicalTrials.gov.

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