Actively Recruiting

Phase Not Applicable
Age: 14Years - 65Years
All Genders
Healthy Volunteers
ID05587569

Radiographic and Patient Reported Outcomes Following Combined Adductoplasty12 and Lapiplastyae Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)

Led by Treace Medical Concepts, Inc. · Updated on 2025-05-25

80

Participants Needed

9

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the outcomes of combining the Adductoplasty12 and Lapiplastyae Procedures for patients who need surgery to correct metatarsus adductus and hallux valgus. This study aims to assess how well these procedures improve quality of life and reduce pain, as well as to determine if they effectively correct and maintain the alignment of the first three metatarsals, hallux position, sesamoid position, and foot width. The trial is a prospective, multicenter, unblinded study involving up to 80 participants aged 14 years and older with symptomatic conditions. Participants will undergo the combined Adductoplasty12 and Lapiplastyae Procedures, which involve surgical correction of foot deformities. The study duration extends up to five years following the initial surgery. There are no comparator groups mentioned as this is a single arm intervention study conducted across multiple clinical sites. The procedures are performed under general anesthesia, and patients must be able to adhere to postoperative care instructions. During the study, participants will be assessed at various intervals up to 60 months after the procedure. Evaluations include radiographic imaging to check for recurrence of deformities, measurement of pain and quality of life changes, range of motion, foot width, and monitoring of clinical complications. Weight-bearing recovery times and return to unrestricted activity will also be tracked. These outcomes will help researchers understand the effectiveness and durability of the combined surgical approach.

CONDITIONS

Brief Title

Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Who Can Participate

Age: 14Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and females 14 years or older at the time of consent
  • Closed growth plates at the time of consent
  • Intermetatarsal angle of 8.0 degrees or greater; OR True IMA greater than 10 degrees
  • Hallux valgus angle of 12.0 degrees or greater
  • Metatarsus adductus angle of 15 degrees or greater based on Sgarlatos method
  • Willing and able to follow post-operative care instructions
  • Able to complete self-administered questionnaires
  • Suitable candidate for surgery including general anesthesia
  • Female participants must be non-childbearing or have a negative pregnancy test before surgery
  • Able to schedule surgery within 3 months of consent and attend follow-up visits
  • Willing and able to provide written informed consent
  • Agree to avoid reconstructive surgery on the opposite foot for at least 6 months after the procedure
Not Eligible

You will not qualify if you...

  • Previous hallux valgus surgery on the operative foot
  • Previous foot surgeries involving fusion of foot or ankle joints except certain toe or muscle procedures
  • Moderate to severe osteoarthritis outside the 1st, 2nd, or 3rd tarsometatarsal joints
  • Severe osteoarthritis of the 1st, 2nd, or 3rd tarsometatarsal joints
  • Deformities of the hindfoot or midfoot that affect alignment or need surgery
  • Body mass index over 40 kg/m2
  • Current nicotine use in any form including vaping or patches
  • Current diagnosis or treatment for diabetes
  • Diagnosed peripheral neuropathy
  • Diagnosed fibromyalgia
  • Diagnosed Complex Regional Pain Syndrome or Reflex Sympathetic Dystrophy
  • Uncontrolled hypothyroidism
  • Chronic dependent edema
  • Sensitivity to titanium
  • Current use of oral steroids or rheumatoid biologics
  • Use of immunosuppressant drugs
  • Poor bone quality or healing conditions
  • Active or suspected infection in the affected area
  • Use of synthetic or allogenic bone graft substitutes
  • Use of non-Treace products for the procedure
  • Need for additional bone procedures during surgery
  • Scheduled for same-day bilateral surgery
  • Previous enrollment in this study for the opposite foot
  • Scheduled for other procedures affecting weight-bearing post-surgery
  • Involvement in workman's compensation or litigation
  • Participation in another clinical study within 30 days or planned during this study except certain survey studies
  • Any condition that may affect safety, consent, or study completion as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Single day for surgery with recovery period

Participants undergo the combined Adductoplasty™ and Lapiplasty® surgical procedures to correct metatarsus adductus and hallux valgus, followed by immediate post-operative care.

1 surgery visit and several immediate post-operative visits

Post-operative Follow-up

Duration - Up to 5 years post-surgery

Participants attend follow-up visits to monitor healing, pain, quality of life, foot alignment, and recovery milestones such as weight-bearing and return to activity.

Multiple visits including assessments at 6 weeks, 8 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months

Trial Site Locations

Total: 9 locations

1

Foot and Ankle Center of the Rockies

Greeley, Colorado, United States, 80634

Actively Recruiting

2

Foot and Ankle Center of Iowa

Ankeny, Iowa, United States, 50023

Actively Recruiting

3

Coastal Maine Foot and Ankle

Yarmouth, Maine, United States, 04096

Actively Recruiting

4

JCMG - Jefferson City Medical Group

Jefferson City, Missouri, United States, 65019

Actively Recruiting

5

Duke Orthopaedics Arringdon

Morrisville, North Carolina, United States, 27560

Actively Recruiting

6

Ohio Foot and Ankle Center

Canton, Ohio, United States, 44708

Actively Recruiting

7

Ohio Foot and Ankle Center

Stow, Ohio, United States, 44224

Actively Recruiting

8

Greater Pittsburgh Foot and Ankle Center

Wexford, Pennsylvania, United States, 15090

Actively Recruiting

9

Foot and Ankle Associates of North Texas - Keller

Keller, Texas, United States, 76248

Actively Recruiting

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Research Team

C

Cara Bethell

S

Shana Zink

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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