The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.

Обзор

Progressive Collapsing Foot Deformity (PCFD) is a complex, multiplanar condition characterized by hindfoot valgus, peritalar subluxation, midfoot abduction, and collapse of the medial arch, which may progress to rigid deformity with pain and functional impairment. In advanced stages, subtalar arthrodesis is a well-established surgical option to restore hindfoot alignment and stability. Subtalar Arthrodesis with Mini/Medial Bone Block (SAMBB) is an evolution of the Grice-Green technique, using an autologous bone graft to achieve stable correction of talocalcaneal alignment and improve joint congruency, with favorable clinical and radiographic outcomes. This study aims to evaluate the three-dimensional corrective effect of SAMBB using weight-bearing CT (WBCT), focusing on hindfoot alignment and talocalcaneal and talonavicular relationships.

Вмешательства

• Диагностический тест Weight-Bearing CT scan
  Weight-Bearing CT scan after surgery

Первичные конечные точки

• Foot and Ankle Offset [Срок оценки: At baseline; After 6 months post op]

Вторичные конечные точки (5)

• Talo-navicular congruency angle [Срок оценки: At baseline; After 6 months post op]
• Middle facet Incongruency angle [Срок оценки: At baseline; After 6 months post op]
• Forefoot arch angle [Срок оценки: At baseline; After 6 months post op]
• Hindfoot moment arm [Срок оценки: At baseline; After 6 months post op]
• Calcaneofibular distance and subtalar impigemen [Срок оценки: At baseline; After 6 months post op]

Критерии участия

Критерии включения

• Patients of both sexes, aged between 18 and 80 years
• Patients affected by grade A2 Progressive Collapsing Foot Deformity (PCFD)
• Patients who have provided informed consent to participate in the study

Критерии исключения

• Patients who have previously undergone corrective surgery on the deformity under study.
• Patients with prior lower limb fractures resulting in altered biomechanics.
• Patients affected by PCFD of grade A1, B2, C2, E1, or E2 according to the PCFD classification \[2\].
• Patients with active acute or chronic infections.
• Patients with chronic inflammatory joint diseases.
• Patients with significant lower limb trauma occurring after the surgical intervention.
• Patients with pre-existing gait abnormalities (e.g., amputations, neuromuscular diseases, poliomyelitis, hip dysplasia).
• Patients with cognitive deficits.
• Patients with concomitant neurological disorders.
• Patients affected by cancer.
• Pregnant patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• Polichetti C, Borruto MI, Lauriero F, Caravelli S, Mosca M, Maccauro G, Greco T, Perisano C. Adult Acquired Flatfoot Deformity: A Narrative Review about Imaging Findings. Diagnostics (Basel). 2023 Jan 7;13(2):225. doi: 10.3390/diagnostics13020225. PMID 36673035
• Myerson MS, Thordarson DB, Johnson JE, Hintermann B, Sangeorzan BJ, Deland JT, Schon LC, Ellis SJ, de Cesar Netto C. Classification and Nomenclature: Progressive Collapsing Foot Deformity. Foot Ankle Int. 2020 Oct;41(10):1271-1276. doi: 10.1177/1071100720950722. Epub 2020 Aug 28. PMID 32856474
• Cai Y, Zhao Z, Huang J, Yu Z, Jiang M, Kang S, Yuan X, Liu Y, Wu X, Ouyang J, Li W, Qian L. Morphological changes in flatfoot: a 3D analysis using weight-bearing CT scans. BMC Med Imaging. 2024 Aug 19;24(1):219. doi: 10.1186/s12880-024-01396-0. PMID 39160476
• Mosca M, Caravelli S, Vannini F, Pungetti C, Catanese G, Massimi S, Fuiano M, Faldini C, Giannini S. Mini Bone Block Distraction Subtalar Arthrodesis (SAMBB) in the Management of Acquired Adult Flatfoot with Subtalar Arthritis: A Modification to the Grice-Green Procedure. Joints. 2019 Dec 13;7(2):64-70. doi: 10.1055/s-0039-3400452. eCollection 2019 Jun. PMID 31879733
• Mosca M, Caravelli S, Vocale E, Massimi S, Fuiano M, Grassi A, Ceccarelli F, Zaffagnini S. Outcome After Modified Grice-Green Procedure (SAMBB) for Arthritic Acquired Adult Flatfoot. Foot Ankle Int. 2020 Nov;41(11):1404-1410. doi: 10.1177/1071100720938665. Epub 2020 Aug 11. PMID 32779535
• de Cesar Netto C, Schon LC, Thawait GK, da Fonseca LF, Chinanuvathana A, Zbijewski WB, Siewerdsen JH, Demehri S. Flexible Adult Acquired Flatfoot Deformity: Comparison Between Weight-Bearing and Non-Weight-Bearing Measurements Using Cone-Beam Computed Tomography. J Bone Joint Surg Am. 2017 Sep 20;99(18):e98. doi: 10.2106/JBJS.16.01366. PMID 28926392
• Pasapula CS, Choudkhuri MR, Monzo ERG, Dhukaram V, Shariff S, Pasterse V, Richie D, Kobezda T, Solomou G, Cutts S. Review of Classification Systems for Adult Acquired Flatfoot Deformity/Progressive Collapsing Foot Deformity and the Novel Development of the Triple Classification Delinking Instability/Deformity/Reactivity and Foot Type. J Clin Med. 2024 Feb 6;13(4):942. doi: 10.3390/jcm13040942. PMID 38398256

Идентификаторы

NCT: NCT07515170 · SAMBB-WBCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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