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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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07515170
Enrollment
20
Registered
2026-04-07
Start date
2026-05-01
Completion date
2029-05-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flat Foot

Keywords

Subtalar Arthrodesis, Weight-Bearing CT, Progressive Collapsing Foot Deformity (PCFD)

Brief summary

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_TESTWeight-Bearing CT scan

Weight-Bearing CT scan after surgery

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Foot and Ankle OffsetAt baseline; After 6 months post opA three-dimensional parameter derived from weight-bearing CT (WBCT) acquisitions that allows objective quantification of the global alignment of the foot-ankle unit. It measures the spatial relationship between the functional tripod of the foot (first metatarsal, fifth metatarsal, and calcaneus) and the geometric center of the tibiotalar joint, effectively representing a synthetic index of the morpho-functional balance of the hindfoot-midfoot complex.

Secondary

MeasureTime frameDescription
Talo-navicular congruency angleAt baseline; After 6 months post opA three-dimensional parameter that assesses talonavicular joint alignment and quantifies the degree of midfoot abduction (PCFD class B). It reflects the extent to which the talar head is "uncovered" relative to the navicular, indicating external rotation and lateral translation of the midfoot typical of PCFD. An increased TNCA corresponds to greater talonavicular incongruity and represents a three-dimensional marker of the transverse component of the deformity.
Middle facet Incongruency angleAt baseline; After 6 months post opThe degree of incongruity between the talus and calcaneus at the level of the middle facet of the subtalar joint. It is a direct indicator of peritalar subluxation, one of the key features of PCFD (class A/D). Increased values suggest instability of the subtalar complex, loss of joint congruency, and three-dimensional hindfoot malalignment, with impairment of the subtalar joint's rotational function and load distribution.
Forefoot arch angleAt baseline; After 6 months post opA three-dimensional parameter that evaluates the stability and morphology of the medial and transverse arches at the level of the midfoot (PCFD class C). It reflects the behavior of the medial cuneiform and the first ray under load, describing the ability of the medial column to maintain adequate structural support.
Hindfoot moment armAt baseline; After 6 months post opA three-dimensional measure of calcaneal alignment relative to the tibial axis, representing a direct index of hindfoot valgus. It quantifies the lateral displacement of the calcaneus under the tibial load, objectively describing the hindfoot deviation that characterizes the coronal component of PCFD (class A).
Calcaneofibular distance and subtalar impigemenAt baseline; After 6 months post opIt evaluates the three-dimensional distance between the lateral surface of the calcaneus and the medial aspect of the fibula, serving as an indirect indicator of subfibular impingement (SFI). A reduction in this distance suggests mechanical conflict due to the combination of calcaneal valgus, lateral displacement of the hindfoot, and instability of the subtalar ligamentous complex. SFI is typical of advanced, rigid PCFD and is associated with progressive lateral load alteration (PCFD class D).

Countries

Italy

Contacts

CONTACTMassimiliano Mosca, MD
massimiliano.mosca@ior.it3355881233

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026