Combined Adductoplasty™ and Lapiplasty® Surgery for Bunions

(MTA3D Trial)

Recruiting at 8 trial locations

Overseen By Paul Steinke, DPM

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Treace Medical Concepts, Inc.

Must not be taking: Oral steroids, Rheumatoid biologics, Immunosuppressants

Disqualifiers: Diabetes, Peripheral neuropathy, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effects of combining two surgeries, Adductoplasty™ and Lapiplasty®, to correct bunions and metatarsus adductus (a curve in the middle of the foot). Researchers aim to determine the effectiveness of these combined procedures for individuals needing both conditions addressed. It suits those aged 14 and older with noticeable bunions and a curved foot, who are prepared to follow post-surgery instructions.

As an unphased trial, this study allows patients to contribute to innovative surgical solutions for foot conditions.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently taking oral steroids, rheumatoid biologics, or immunosuppressant drugs, you may not be eligible to participate.

What prior data suggests that the Combined Adductoplasty™ and Lapiplasty® Procedure is safe?

Research has shown that the Adductoplasty™ and Lapiplasty® procedures have yielded good results in past studies. These procedures are used together to correct foot problems such as a curved foot and bunions.

Patients in earlier studies generally tolerated the combined treatment well, with no major safety issues reported. This is encouraging for anyone considering participation in a clinical trial. Although the current study doesn't specify its phase, these procedures have been used elsewhere without significant safety problems.

For those considering this trial, the safety evidence so far appears reassuring. It's always advisable to discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined Adductoplasty™ and Lapiplasty® surgery for bunions because it offers a unique approach to correcting the underlying causes of bunion deformities. Unlike traditional bunion surgeries that often focus solely on removing the bony bump, this treatment addresses both the metatarsal alignment and rotational deformities, potentially leading to more lasting results. Additionally, by combining these two techniques, the surgery aims to provide better stability and reduce the likelihood of recurrence, which is a common issue with conventional procedures. This innovative approach could offer patients a more effective and long-term solution for bunion correction.

What evidence suggests that the Combined Adductoplasty™ and Lapiplasty® Procedure is effective for bunion correction?

Research has shown that combining the Adductoplasty™ and Lapiplasty® procedures can effectively correct bunions, especially in cases involving foot conditions like metatarsus adductus and hallux valgus. Traditional bunion surgeries often result in a high recurrence rate, sometimes up to 30%, particularly when certain midfoot issues are present. However, patients who underwent the combined Adductoplasty™ and Lapiplasty® procedures reported positive outcomes, with their foot alignment remaining corrected. These procedures also receive high satisfaction ratings from patients. Overall, early research suggests that this combined approach might offer a more reliable and lasting solution for bunion problems. ^{1 2 5 6 7}

Who Is on the Research Team?

Paul Dayton, DPM

Principal Investigator

Foot and Ankle Center of Iowa

Mark Easley, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals aged 14 to 65 with symptomatic metatarsus adductus and hallux valgus, which are conditions affecting the alignment of the foot and big toe. Participants must have specific angles of deformity, be able to follow post-op care instructions, complete questionnaires, not be pregnant or planning other foot surgeries soon. Exclusions include severe arthritis in certain joints, very high BMI, diabetes, neuropathy among others.

Inclusion Criteria

Closed physeal plates at the time of consent

Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits

I am not able to have children or have a negative pregnancy test.

Exclusion Criteria

Previously sensitized to titanium

I have moderate to severe foot or ankle arthritis, not in the toe joints.

Patient has previously been enrolled into this study for a contralateral procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for correction of metatarsus adductus and hallux valgus

6 weeks

1 visit (surgical procedure)

Initial Recovery

Participants begin weight-bearing in a boot and start recovery

6 weeks

Follow-up visits as per surgeon's protocol

Follow-up

Participants are monitored for safety, effectiveness, and recurrence of hallux valgus deformity

24 months

Regular follow-up visits at 6, 12, and 24 months

Long-term Follow-up

Participants are monitored for long-term outcomes including quality of life and clinical complications

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Combined Adductoplasty™ and Lapiplasty®

Trial Overview The study is testing a combined surgical approach using Adductoplasty™ and Lapiplasty® procedures for correcting foot deformities like bunions and inwardly curved metatarsal bones. Up to 80 patients at up to 10 sites will undergo this prospective (looking forward), multicenter study without being blinded to treatment.

Combined Adductoplasty™ and Lapiplasty® is already approved in United States for the following indications:

Approved in United States as Combined Adductoplasty and Lapiplasty Procedure for:

• Metatarsus adductus correction
• Hallux valgus correction

Who Is Running the Clinical Trial?

Treace Medical Concepts, Inc.

Lead Sponsor

Trials

4

Recruited

590+

Published Research Related to This Trial

In a study of 14 infants with unilateral coronal synostosis, a surgical technique combining osteotomy and distraction osteogenesis significantly improved facial symmetry and corrected orbital dystopia, with notable reductions in the orbital dystopia angle and cranial fossa deviations.

The procedure was associated with low blood loss (average 6.1 mL/kg) and a short hospital stay (average 4.4 days), indicating a favorable safety profile and suggesting it may enhance the surgical management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Facial and Skull-base Symmetry Following Osteotomy and Distraction of Unilateral Coronal Synostosis. Mellgren, J., Säljö, K., Tarnow, P., et al.[2023]

The new bunion procedure effectively reduces the intermetatarsal angle and corrects the proximal articular set angle, which are important for proper foot alignment.

This technique combines elements from established bunion surgeries (Kalish modification of the Austin bunionectomy and Green-Laird modification of the Reverdin bunionectomy) while utilizing compressive rigid internal fixation for improved stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the Kalish osteotomy to correct the proximal articular set angle. Hill, RS., Marek, LJ.[2016]

Metatarsus adductus (MTA) complicates the diagnosis and treatment of hallux valgus (HV), leading to challenges in achieving complete correction and a higher chance of recurrence.

The study proposes a surgical option involving multiplanar angular correction arthrodesis of the first, second, and third tarsometatarsal joints to effectively address both HV and MTA deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Approach to the Surgical Correction of Combined Hallux Valgus and Metatarsus Adductus Deformities. McAleer, JP., Dayton, P., DeCarbo, WT., et al.[2021]

In a study involving 111 patients, primary triple arthrodesis demonstrated a high union rate of 98% after a minimum follow-up of 2 years, indicating its efficacy in stabilizing and correcting rigid flatfoot deformities.

The procedure is associated with a low complication rate and a high patient satisfaction rate, with 91% of patients expressing willingness to undergo the surgery again if needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Triple Arthrodesis for Management of Rigid Flatfoot Deformity. Seybold, JD., Coetzee, JC.[2022]

The use of springs in combination with linear osteotomy for surgical correction of unicoronal synostosis (UCS) effectively corrected facial scoliosis, achieving near-perfect symmetry in orbital dystopia angles postoperatively.

This innovative dynamic technique showed significant improvements in both facial symmetry and skull base angles, suggesting that it may be a superior alternative to traditional extensive cranioplasties for UCS correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction of Unicoronal Synostosis With Springs: Two Patients With Improved Facial Symmetry. Bhatti-Søfteland, M., Mellgren, J., Säljö, K., et al.[2023]

The morcellation craniotomy with distraction osteogenesis (MoD) procedure for treating sagittal synostosis in older children resulted in shorter operation times and less blood transfusion compared to total cranial remodeling, indicating a safer surgical option.

Over a 10-year follow-up of 7 patients, the MoD procedure achieved satisfactory cranial shape without serious complications, demonstrating its efficacy and reliability for dynamic skull remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome analysis of morcellation craniotomy with distraction osteogenesis for scaphocephaly. Sakamoto, Y., Nakajima, H., Tamada, I.[2019]

The Keller procedure, a century-old technique for treating issues in the first metatarsophalangeal joint, has seen various modifications, particularly in the challenging step of capsular interposition.

This article introduces a new, simplified method for capsular interposition using a dorsal capsular flap and soft-tissue anchors, potentially improving the surgical process and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capsular interposition for the Keller bunionectomy with the use of soft-tissue anchors. Cook, KD.[2019]

Endoscope-assisted craniectomy combined with helmet therapy is an effective single-stage treatment for combined metopic-sagittal craniosynostosis, showing significant improvements in cranial shape and morphology in three patients, with no need for reoperation.

Postoperative measurements indicated normalization of the cranial index and interfrontal divergence angle, with a mean blood loss of only 100 mL and a short hospital stay of 1.7 days, suggesting a safe and efficient surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic treatment of combined metopic-sagittal craniosynostosis. Zubovic, E., Skolnick, GB., Naidoo, SD., et al.[2022]

A treatment algorithm involving shortening arthrodesis of the 2nd and 3rd tarsometatarsal joints in 46 adult patients with metatarsus adductus and hallux abducto-valgus showed significant improvements in clinical and radiographic outcomes after one year.

The procedure effectively realigned the forefoot and hindfoot, leading to better overall foot function, although the talus-first metatarsal angle did not show significant change post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metatarsus adductus setting in adult patients: Results of a treatment algorithm with shortening arthrodesis tarsometatarsal joints two and three. Pauli, W., Dopke, K., Straehl, C., et al.[2022]

Spring-mediated cranioplasty is an effective and less invasive treatment for correcting scaphocephalic head shape in patients with sagittal craniosynostosis, providing durable results.

The authors present a multimedia demonstration of various surgical techniques for performing spring-mediated cranioplasty, highlighting its advantages over traditional whole-vault cranioplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spring-mediated cranioplasty for sagittal craniosynostosis. Kalmar, CL., Swanson, JW., Shakir, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05587569?term=AREA%5BConditionSearch%5D(%22Metatarsus%20Varus%22)&rank=3

Outcomes Following Combined Adductoplasty™ and ... The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux ...

2. lapiplasty.com lapiplasty.com/clinical-studies/mta3d-adductoplasty-clinical-study/

MTA3D™ Adductoplasty® Clinical Study - Treace “Recurrence rates following traditional hallux valgus correction are found to be as high as 30% when certain deformities of the midfoot are present.1 With the ...

3. investors.treace.com investors.treace.com/news-releases/news-release-details/treace-announces-clinical-study-data-demonstrating-positive

Treace Announces Clinical Study Data Demonstrating ... The study will evaluate for consistent, maintained radiographic correction and patient reported outcome scores following combined Adductoplasty® ...

4. investors.treace.com investors.treace.com/news-releases/news-release-details/treace-announces-peer-reviewed-publication-four-year-results

Treace Announces Peer-Reviewed Publication of Four-Year ... The study evaluates consistency and reliability of correction of all three dimensions of the bunion deformity with the Lapiplasty® Procedure, as ...

5. clinicaltrial.be clinicaltrial.be/en/details/12?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Outcomes Following Combined Adductoplasty™ and ... The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients ...

6. biospace.com biospace.com/press-releases/treace-announces-clinical-study-data-demonstrating-positive-lapiplasty-and-adductoplasty-outcomes-at-the-2025-acfas-annual-scientific-conference

Treace Announces Clinical Study Data Demonstrating ... Treace Announces Clinical Study Data Demonstrating Positive Lapiplasty® and Adductoplasty® Outcomes at the 2025 ACFAS Annual Scientific ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05587569/outcomes-following-combined-adductoplastytm-and-lapiplastyr-mta3d

Outcomes Following Combined Adductoplasty™ and ... The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in ...