Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D) (MTA3D)

May 22, 2025 updated by: Treace Medical Concepts, Inc.

Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)

Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction.

Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery:

  1. To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure.
  2. To determine whether the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, effectively corrects and maintains triplane anatomical alignment of the 1st, 2nd and 3rd metatarsals, the hallux position, the sesamoid position, and the foot width.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • Foot and Ankle Center of Iowa
        • Principal Investigator:
          • Paul Dayton, DPM
        • Sub-Investigator:
          • Mindi Dayton, DPM
        • Sub-Investigator:
          • Jesseka Kaldenberg-Leppert, DPM
        • Contact:
    • Maine
      • Yarmouth, Maine, United States, 04096
        • Recruiting
        • Coastal Maine Foot and Ankle
        • Contact:
        • Principal Investigator:
          • Barry White, DPM
    • Missouri
      • Jefferson City, Missouri, United States, 65019
        • Recruiting
        • JCMG - Jefferson City Medical Group
        • Contact:
        • Principal Investigator:
          • Jody McAleer, DPM
        • Contact:
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Duke Orthopaedics Arringdon
        • Sub-Investigator:
          • Mark Easley, MD
        • Contact:
        • Principal Investigator:
          • Cesar de Cesar Netto, MD
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Ohio Foot and Ankle Center
        • Contact:
        • Principal Investigator:
          • Aaron Chokan, DPM
      • Stow, Ohio, United States, 44224
        • Recruiting
        • Ohio Foot and Ankle Center
        • Principal Investigator:
          • Aaron Chokan, DPM
        • Contact:
    • Pennsylvania
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Greater Pittsburgh Foot and Ankle Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • William DeCarbo, DPM
    • Texas
      • Keller, Texas, United States, 76248
        • Recruiting
        • Foot and Ankle Associates of North Texas - Keller
        • Contact:
        • Principal Investigator:
          • Paul Steinke, DPM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and females ≥14 years old at the time of consent
  2. Closed physeal plates at the time of consent
  3. Intermetatarsal angle is ≥8.0˚; OR True IMA of >10°, (IMA+MTA-15=True IMA)
  4. Hallux valgus angle is ≥12.0˚
  5. Metatarsus adductus angle based on Sgarlatos method ≥15°
  6. Willing and able to adhere to post-op care instructions
  7. Capable of completing self-administered questionnaires
  8. Acceptable surgical candidate, including use of general anesthesia
  9. Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure
  10. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits
  11. Willing and able to provide written informed consent
  12. Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure

Exclusion Criteria:

  1. Previous surgery for hallux valgus on operative side
  2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
  3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
  4. Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
  5. Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction
  6. BMI >40 kg/m²
  7. Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
  8. Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
  9. Current clinical diagnosis of peripheral neuropathy
  10. Current clinical diagnosis of fibromyalgia
  11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
  12. Current uncontrolled hypothyroidism
  13. Current clinical diagnosis of chronic dependent edema
  14. Previously sensitized to titanium
  15. Currently taking oral steroids or rheumatoid biologics
  16. Currently taking immunosuppressant drugs
  17. Insufficient quantity or quality of bone to permit stabilization, conditions that inhibit healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease
  18. Active, suspected, or latent infection in the affected area
  19. Use of synthetic or allogenic bone graft substitutes
  20. Use of non-Treace products for Index Procedure
  21. Additional bone procedure needed during the index procedure to complete correction [first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion (other than Weil osteotomies)];
  22. Scheduled to undergo a same-day bilateral procedure
  23. Patient has previously been enrolled into this study for a contralateral procedure
  24. Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure
  25. Patient is actively involved with a workman's compensation case or is currently involved in litigation
  26. Patient is currently in, or has participated in, a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE
  27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
Time Frame: 24 Months
Successful correction is defined as two of the following three criteria: measured IMA <9.0°, HVA <15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA >15.0°.
24 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Complications
Time Frame: 60 Months
Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.
60 Months
Weight-Bearing Recovery Time
Time Frame: 12 Months
Assessment of weight-bearing recovery time following the procedures. Weight-bearing will be measured in days and recorded based upon individual surgeon recovery protocol.
12 Months
Time to Weight-Bear in Boot
Time Frame: 6 Weeks
Time to start of weight-bearing in boot, in days.
6 Weeks
Time to Weight-Bear in Shoes
Time Frame: 8 Weeks
Time to start of weight-bearing in shoes, in days.
8 Weeks
Change in Pain
Time Frame: 0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.
Change in pain at the base of the big toe (bunion related), as well as the midfoot region for the operative foot only, assessed via the Visual Analog Scale (VAS) with 0-10 minimum and maximum values - with 0 being a better outcome and 10 being a worse outcome.
0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.
Change in Quality of Life
Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Quality of Life, (PROMIS-29/PROMIS-25 and MOxFQ) defined as the total domain score measured.
6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Range of Motion
Time Frame: 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion
12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Osseous Foot Width
Time Frame: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in osseous foot width - radiographically
12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Time to Return to Unrestricted Activity
Time Frame: 6 weeks - 6 months, post Lapiplasty® Procedure
Time to return to full unrestricted activity, in days.
6 weeks - 6 months, post Lapiplasty® Procedure
Radiographic Recurrence
Time Frame: 24 Months
Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA >20°.
24 Months
Union vs non-Union
Time Frame: 12 Months
Evaluate clinical/radiographic healing (union vs non-union). Non-union is defined as pain and lucency at the 1st, 2nd, and/or 3rd TMT joint at 12 months post- Adductoplasty® Procedure and Lapiplasty® Procedure.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Treace Medical Concepts, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Dayton, DPM, Foot and Ankle Center of Iowa
  • Principal Investigator: Mark Easley, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP2022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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