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

NCT05082012 | Terminated Results DMC FDA Device

• 1 other identifier: CP2021-1
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Radiographic Recurrence

  Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) \<9.0°, Hallux Valgus Angle (HVA)\<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4

  24 months

Secondary Outcomes (16)

• Radiographic Angular Measurements

  pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure

• Number Of Patients With Radiographic Non-Union

  12 months post Lapiplasty® Procedure

• Clinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data

  24 months post Lapiplasty® Procedure

• Time to Start Weight-bearing in a Boot, in Days

  0-3 weeks, post Lapiplasty® Procedure

• Time to Start Weight-bearing in a Shoe

  From time of procedure up to 6 weeks

Interventions

Treatment of Hallux Valgus DEVICE

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.

Also known as: Lapiplasty® Mini-Incision™ Procedure

Eligibility Criteria

• Age: 14 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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;

Sponsors & Collaborators

• Treace Medical Concepts, Inc.: lead

Study Sites (10)

DOC - Decatur Orthopaedic Clinic

Decatur, Alabama, 35601, United States

Location

DOC - Decatur Orthopaedic Clinic

Hartselle, Alabama, 35640, United States

Location

Phoenix Foot and Ankle Institute

Scottsdale, Arizona, 85251, United States

Location

Orlando Foot and Ankle Clinic - Waterford Lakes Office

Orlando, Florida, 32825, United States

Location

JCMG - Podiatry

Jefferson City, Missouri, 65109, United States

Location

Desert Orthopaedic Center

Las Vegas, Nevada, 89121, United States

Location

University of Pennsylvania / Penn Medicine

Philadelphia, Pennsylvania, 19106, United States

Location

Stonebriar Foot and Ankle

Frisco, Texas, 75034, United States

Location

Foot & Ankle Associates of North Texas - Keller

Keller, Texas, 76248, United States

Location

Sports Medicine Associates of San Antonio

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: Treace Medical Concepts, Inc.

hmarshall@treace.net

904-597-6269

Study Officials

• Jody McAleer, DPM, FACFAS

  JCMG - Podiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 18, 2021
• Study Start: September 17, 2021
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)