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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Combined Adductoplasty™ and Lapiplasty® Surgery for Bunions?

The research suggests that correcting combined foot deformities, like metatarsus adductus and hallux valgus, using surgical techniques similar to those in the Combined Adductoplasty™ and Lapiplasty® procedures, can lead to good clinical and radiographic outcomes, reducing the chance of recurrence. ^{1 2 3 4 5}

How is the Combined Adductoplasty™ and Lapiplasty® treatment for bunions different from other treatments?

The Combined Adductoplasty™ and Lapiplasty® treatment is unique because it combines two surgical procedures to correct bunions by addressing both the alignment of the toe and the underlying bone structure, potentially offering a more comprehensive correction compared to traditional bunion surgeries that may only focus on one aspect. ^{6 7 8 9 10}

Research Team

Mark Easley, MD

Principal Investigator

Duke University

Paul Dayton, DPM

Principal Investigator

Foot and Ankle Center of Iowa

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. France pubmed.ncbi.nlm.nih.gov

Metatarsus adductus setting in adult patients: Results of a treatment algorithm with shortening arthrodesis tarsometatarsal joints two and three. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Modification of the Kalish osteotomy to correct the proximal articular set angle. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

A Systematic Approach to the Surgical Correction of Combined Hallux Valgus and Metatarsus Adductus Deformities. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Primary Triple Arthrodesis for Management of Rigid Flatfoot Deformity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Correction of Unicoronal Synostosis With Springs: Two Patients With Improved Facial Symmetry. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Spring-mediated cranioplasty for sagittal craniosynostosis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Endoscopic treatment of combined metopic-sagittal craniosynostosis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Improved Facial and Skull-base Symmetry Following Osteotomy and Distraction of Unilateral Coronal Synostosis. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Outcome analysis of morcellation craniotomy with distraction osteogenesis for scaphocephaly. [2019]