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

NCT05082012 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-04-20

Study results available
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Summary

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.

Conditions

  • Hallux Valgus
  • Bunion

Interventions

DEVICE

Treatment of Hallux Valgus

Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.

Sponsors & Collaborators

  • Treace Medical Concepts, Inc.

    lead INDUSTRY

Principal Investigators

  • Jody McAleer, DPM, FACFAS · JCMG - Podiatry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2024-05-09
Completion
2024-05-09
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 NCT05082012 on ClinicalTrials.gov