Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Study Overview
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Brief Summary
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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 10 clinical sites. Patients 14 years through 65 years 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
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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.

Official Title
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Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)

Conditions
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Metatarsus Adductus, Hallux Valgus

Intervention / Treatment
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* Device: Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females between the ages 14 and 65 years at the time of consent Closed physeal plates at the time of consent Intermetatarsal angle is between 8.0˚ - 22.0˚; OR True IMA of >10°, (IMA+MTA-15=True IMA) Hallux valgus angle is between 12.0˚ - 50.0˚ Metatarsus adductus angle based on Sgarlatos method >15° and <40° 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 Exclusion Criteria: Previous surgery for hallux valgus on operative side Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits) Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints Moderate-severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5˚and talonavicular subluxation/uncovering >50%) 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 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 (additional metatarsal or tarsal bone osteotomy or fusion, first MTP fusion, calcaneal osteotomy, traditional medial eminence resection); 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure|Patients 14 years through 65 years 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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Radiographic Correction of the Following: Intermetatarsal Angle (IMA), Hallux Valgus Angle (HVA), Tibial Sesamoid Position (TSP), and Metatarsus Adductus Angle (MAA) | Sustained radiographic correction of hallux valgus deformity with metatarsus adductus. Sustained correction is defined by measured Intermetatarsal Angle (IMA) <12.0 degrees, Hallux Valgus Angle (HVA) <20.0 degrees, Tibial Sesamoid Position (TSP) as ≤3 and ≥50 percent Metatarsus Adductus (MAA) correction (compared to baseline) at 24 months. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union vs non-Union | Evaluate clinical/radiographic healing (union vs non-union). | 12 Months | 
| 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 | 
| Time to Return to Unrestricted Activity | Time to return to full unrestricted activity, in days. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metatarsus Adductus, Hallux Valgus, MTA3D