Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Официальное название

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

Обзор

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.

Подробное описание

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:

1. To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure. 2. 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.

Вмешательства

• Устройство Treatment of metatarsus adductus and hallux valgus with the 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.

Первичные конечные точки

• Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction [Срок оценки: 24 Months]

Вторичные конечные точки (11)

• Radiographic Recurrence [Срок оценки: 24 Months]
• Union vs non-Union [Срок оценки: 12 Months]
• Clinical Complications [Срок оценки: 60 Months]
• Weight-Bearing Recovery Time [Срок оценки: 12 Months]
• Time to Weight-Bear in Boot [Срок оценки: 6 Weeks]
• Time to Weight-Bear in Shoes [Срок оценки: 8 Weeks]
• Time to Return to Unrestricted Activity [Срок оценки: 6 weeks - 6 months, post Lapiplasty® Procedure]
• Change in Pain [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• Foot and Ankle Center of the Rockies — Greeley
• Foot and Ankle Center of Iowa — Ankeny
• Coastal Maine Foot and Ankle — Yarmouth
• JCMG - Jefferson City Medical Group — Jefferson City
• Duke Orthopaedics Arringdon — Morrisville
• Ohio Foot and Ankle Center — Canton
• Ohio Foot and Ankle Center — Stow
• Greater Pittsburgh Foot and Ankle Center — Wexford
• … и ещё 1 центр

Идентификаторы

NCT: NCT05587569 · CP2022-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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