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

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: Recruiting
• Conditions: Hallux Valgus; Metatarsus Adductus
• Intervention / Treatment: Device: Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure

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: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cara Bethell; Phone Number: 1317 (904) 373-5940; Email: cbethell@treace.net
• Study Contact Backup: Name: Shana Zink; Phone Number: (513) 265-0621; Email: szink@treace.net

Study Locations

• United States
  • Colorado
    • Greeley, Colorado, United States, 80634
      • Recruiting
      • Foot and Ankle Center of the Rockies
      • Contact: Michael D Vaardahl, DPM; Phone Number: 970-351-0900; Email: michaelvaardahlDPM@ankleandfootcenters.com
      • Contact: Lauren Shodrock; Phone Number: (970) 351-0900; Email: laurenshodrock@AnkleAndFootCenters.com
      • Principal Investigator: Michael D Vaardahl, DPM
  • 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: Mindi Dayton, DPM; Phone Number: 515-639-3775; Email: mdayton@footanklecenteriowa.com
  • Maine
    • Yarmouth, Maine, United States, 04096
      • Recruiting
      • Coastal Maine Foot and Ankle
      • Contact: Barry White, DPM; Phone Number: 207-888-3640; Email: Footdocbmw@outlook.com
      • Principal Investigator: Barry White, DPM
  • Missouri
    • Jefferson City, Missouri, United States, 65019
      • Recruiting
      • JCMG - Jefferson City Medical Group
      • Contact: Jody McAleer, DPM; Phone Number: 573-556-7724; Email: jmcaleer@jcmg.org
      • Principal Investigator: Jody McAleer, DPM
      • Contact: Christy Kidwell; Phone Number: (573) 556-7724; Email: christy.kidwell@avacare.com
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Recruiting
      • Duke Orthopaedics Arringdon
      • Sub-Investigator: Mark Easley, MD
      • Contact: Jennifer Friend; Phone Number: (919) 668-4373; Email: jennifer.friend@duke.edu
      • Principal Investigator: Cesar de Cesar Netto, MD
      • Contact: Jacob Carpenter; Phone Number: 919-744-8166; Email: jacob.carpenter@duke.edu
  • Ohio
    • Canton, Ohio, United States, 44708
      • Recruiting
      • Ohio Foot and Ankle Center
      • Contact: Aaron Chokan, DPM; Phone Number: 330-447-4400; Email: drchokan@gmail.com
      • Principal Investigator: Aaron Chokan, DPM
    • Stow, Ohio, United States, 44224
      • Recruiting
      • Ohio Foot and Ankle Center
      • Principal Investigator: Aaron Chokan, DPM
      • Contact: Aaron Chokan, DPM; Phone Number: 330-929-3331; Email: drchokan@gmail.com
  • Pennsylvania
    • Wexford, Pennsylvania, United States, 15090
      • Recruiting
      • Greater Pittsburgh Foot and Ankle Center
      • Contact: William DeCarbo, DPM; Phone Number: 724-799-8727; Email: wdecarbo@yahoo.com
      • Contact: Shannon Litton; Phone Number: (724) 799-8727; Email: slitton@gpfootankle.com
      • Principal Investigator: William DeCarbo, DPM
  • Texas
    • Keller, Texas, United States, 76248
      • Recruiting
      • Foot and Ankle Associates of North Texas - Keller
      • Contact: Paul Steinke, DPM; Phone Number: 817-416-6155; Email: steinke@faant.com
      • Principal Investigator: Paul Steinke, DPM

Participation Criteria

Eligibility Criteria

• 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

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

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	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

Outcome Measure	Measure Description	Time Frame
Clinical Complications	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	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 to start of weight-bearing in boot, in days.	6 Weeks
Time to Weight-Bear in Shoes	Time to start of weight-bearing in shoes, in days.	8 Weeks
Change in 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	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	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	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 to return to full unrestricted activity, in days.	6 weeks - 6 months, post Lapiplasty® Procedure
Radiographic Recurrence	Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA >20°.	24 Months
Union vs non-Union	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

• Sponsor: Treace Medical Concepts, Inc.
• Investigators: Principal Investigator: Paul Dayton, DPM, Foot and Ankle Center of Iowa; Principal Investigator: Mark Easley, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Hallux Valgus; Metatarsus Adductus; MTA3D
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Bunion; Metatarsus Varus; Hallux Valgus
• Other Study ID 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