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Early Weight-Bearing After the Lapiplasty Procedure

NCT03740282 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2026-04-06

No results posted yet for this 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.

Conditions

  • Hallux Valgus
  • Bunion

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Treace Medical Concepts, Inc.

    lead INDUSTRY

Principal Investigators

  • Dane Wukich, MD · UTSW

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2023-05-01
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740282 on ClinicalTrials.gov