Metatarsus AdductusMTA3DNCT05587569
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
A study testing Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure in people with Metatarsus Adductus and Hallux Valgus, run by Treace Medical Concepts, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metatarsus Adductus, Hallux Valgus
- What is being tested?
- Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Sep 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Currently taking immunosuppressant drugs
- 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
- Active, suspected, or latent infection in the affected area
- Use of synthetic or allogenic bone graft substitutes
- Use of non-Treace products for Index Procedure
- 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)];
- Scheduled to undergo a same-day bilateral procedure
- Patient has previously been enrolled into this study for a contralateral procedure
- Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure
- Patient is actively involved with a workman's compensation case or is currently involved in litigation
- 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
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Foot and Ankle Center of Iowa
Ankeny, Iowa, 50023
Mindi Dayton, DPM, 515-639-3775, mdayton@footanklecenteriowa.com
Paul Dayton, DPM
- Recruiting
Ohio Foot and Ankle Center
Canton, Ohio, 44708
Aaron Chokan, DPM, 330-447-4400, drchokan@gmail.com
Aaron Chokan, DPM
- Recruiting
Foot and Ankle Center of the Rockies
Greeley, Colorado, 80634
Michael D Vaardahl, DPM, 970-351-0900, michaelvaardahlDPM@ankleandfootcenters.com
Lauren Shodrock, (970) 351-0900, laurenshodrock@AnkleAndFootCenters.com
- Recruiting
JCMG - Jefferson City Medical Group
Jefferson City, Missouri, 65019
Jody McAleer, DPM, 573-556-7724, jmcaleer@jcmg.org
Christy Kidwell, (573) 556-7724, christy.kidwell@avacare.com
- Recruiting
Foot and Ankle Associates of North Texas - Keller
Keller, Texas, 76248
Paul Steinke, DPM, 817-416-6155, steinke@faant.com
Paul Steinke, DPM
- Recruiting
Duke Orthopaedics Arringdon
Morrisville, North Carolina, 27560
Jacob Carpenter, 919-744-8166, jacob.carpenter@duke.edu
Jennifer Friend, (919) 668-4373, jennifer.friend@duke.edu
- Recruiting
Ohio Foot and Ankle Center
Stow, Ohio, 44224
Aaron Chokan, DPM, 330-929-3331, drchokan@gmail.com
Aaron Chokan, DPM
- Recruiting
Greater Pittsburgh Foot and Ankle Center
Wexford, Pennsylvania, 15090
William DeCarbo, DPM, 724-799-8727, wdecarbo@yahoo.com
Shannon Litton, (724) 799-8727, slitton@gpfootankle.com
- Recruiting
Coastal Maine Foot and Ankle
Yarmouth, Maine, 04096
Barry White, DPM, 207-888-3640, Footdocbmw@outlook.com
Barry White, DPM
About this study
Official title: 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.
Read the 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:
- To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure.
- 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.
- Conditions
- Metatarsus Adductus, Hallux Valgus
- Being tested
- Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
- Keywords
- Metatarsus Adductus, Hallux Valgus, MTA3D
- Medical subject headings
- Metatarsus Varus, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® ProcedureDevice
Also called Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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°.
Measured: 24 Months
Secondary outcomes (11)
Radiographic Recurrence
Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA >20°.
Measured: 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.
Measured: 12 Months
Clinical Complications
Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.
Measured: 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.
Measured: 12 Months
Time to Weight-Bear in Boot
Time to start of weight-bearing in boot, in days.
Measured: 6 Weeks
Time to Weight-Bear in Shoes
Time to start of weight-bearing in shoes, in days.
Measured: 8 Weeks
Time to Return to Unrestricted Activity
Time to return to full unrestricted activity, in days.
Measured: 6 weeks - 6 months, post Lapiplasty® Procedure
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.
Measured: 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.
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
Measured: 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
Measured: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start28 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metatarsus AdductusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treace Medical Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Dayton, DPM, Principal investigator, Foot and Ankle Center of IowaMark Easley, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587569
- Sponsor's protocol ID
- CP2022-1
- Acronym
- MTA3D
- Status last verified
- May 2025
- First submitted
- 10 Oct 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)
- ClinicalTrials.gov ID
- NCT05587569
- Acronym / sponsor ID
- MTA3D / CP2022-1
- Conditions
- Metatarsus Adductus, Hallux Valgus
- Keywords
- Metatarsus Adductus, Hallux Valgus, MTA3D
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Treace Medical Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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°
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® ProcedureAlso: Adductoplasty™ Procedure in combination with the Lapiplasty® ProcedurePatients 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. | Device | – |
Primary outcome
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°.
11 secondary outcomes
Radiographic Recurrence
Time frame: 24 Months
Union vs non-Union
Time frame: 12 Months
Clinical Complications
Time frame: 60 Months
Weight-Bearing Recovery Time
Time frame: 12 Months
Time to Weight-Bear in Boot
Time frame: 6 Weeks
Time to Weight-Bear in Shoes
Time frame: 8 Weeks
Time to Return to Unrestricted Activity
Time frame: 6 weeks - 6 months, post Lapiplasty® Procedure
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 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 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 Osseous Foot Width
Time frame: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Metatarsus Adductus
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Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus
Club Foot
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Dayton, DPM principal investigator
Foot and Ankle Center of Iowa
Mark Easley, MD principal investigator
Duke University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure in people with Metatarsus Adductus and Hallux Valgus, run by Treace Medical Concepts, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cara Bethell ((904) 373-5940 ext. 1317, cbethell@treace.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.