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)
1 other identifier
interventional
80
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2022
CompletedFirst Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
May 25, 2025
May 1, 2025
4.3 years
October 10, 2022
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Radiographic Recurrence
24 Months
Union vs non-Union
12 Months
Clinical Complications
60 Months
Weight-Bearing Recovery Time
12 Months
Time to Weight-Bear in Boot
6 Weeks
- +6 more secondary outcomes
Interventions
Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated study duration will be 5 years post index procedure.
Eligibility Criteria
You may qualify if:
- Male and females ≥14 years old at the time of consent
- Closed physeal plates at the time of consent
- Intermetatarsal angle is ≥8.0˚; OR True IMA of \>10°, (IMA+MTA-15=True IMA)
- Hallux valgus angle is ≥12.0˚
- Metatarsus adductus angle based on Sgarlatos method ≥15°
- Willing and able to adhere to post-op care instructions
- Capable of completing self-administered questionnaires
- Acceptable surgical candidate, including use of general anesthesia
- Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the 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
- Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure
You may not qualify if:
- Previous surgery for hallux valgus on operative side
- Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
- Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
- Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
- 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
- BMI \>40 kg/m²
- Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
- Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
- Current clinical diagnosis of peripheral neuropathy
- Current clinical diagnosis of fibromyalgia
- Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
- Current uncontrolled hypothyroidism
- Current clinical diagnosis of chronic dependent edema
- Previously sensitized to titanium
- Currently taking oral steroids or rheumatoid biologics
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Foot and Ankle Center of the Rockies
Greeley, Colorado, 80634, United States
Foot and Ankle Center of Iowa
Ankeny, Iowa, 50023, United States
Coastal Maine Foot and Ankle
Yarmouth, Maine, 04096, United States
JCMG - Jefferson City Medical Group
Jefferson City, Missouri, 65019, United States
Duke Orthopaedics Arringdon
Morrisville, North Carolina, 27560, United States
Ohio Foot and Ankle Center
Canton, Ohio, 44708, United States
Ohio Foot and Ankle Center
Stow, Ohio, 44224, United States
Greater Pittsburgh Foot and Ankle Center
Wexford, Pennsylvania, 15090, United States
Foot and Ankle Associates of North Texas - Keller
Keller, Texas, 76248, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Dayton, DPM
Foot and Ankle Center of Iowa
- PRINCIPAL INVESTIGATOR
Mark Easley, MD
Duke University
Central Study Contacts
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
October 10, 2022
First Posted
October 20, 2022
Study Start
September 28, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2030
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share