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Not yet recruiting NCT07515170

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.

No phase Interventional Flat Foot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Weight-Bearing CT scan.
Who it may be relevant to
Registry conditions: Flat Foot. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Weight-Bearing CT scan
    Weight-Bearing CT scan after surgery

Primary outcome measures

  • Foot and Ankle Offset [Time frame: At baseline; After 6 months post op]
Secondary outcome measures (5)
  • Talo-navicular congruency angle [Time frame: At baseline; After 6 months post op]
  • Middle facet Incongruency angle [Time frame: At baseline; After 6 months post op]
  • Forefoot arch angle [Time frame: At baseline; After 6 months post op]
  • Hindfoot moment arm [Time frame: At baseline; After 6 months post op]
  • Calcaneofibular distance and subtalar impigemen [Time frame: At baseline; After 6 months post op]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituto Ortopedico Rizzoli — Bologna

Publications

  • 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

Identifiers

NCT: NCT07515170 · SAMBB-WBCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗