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NCT Number: 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.

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight-Bearing CT scan

Diagnostic Test

Weight-Bearing CT scan after surgery

Primary outcomes

  1. Foot and Ankle Offset

    Time frame: At baseline; After 6 months post op

    A 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 outcomes

  1. Talo-navicular congruency angle

    Time frame: At baseline; After 6 months post op

    A 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.

  2. Middle facet Incongruency angle

    Time frame: At baseline; After 6 months post op

    The 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.

  3. Forefoot arch angle

    Time frame: At baseline; After 6 months post op

    A 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.

  4. Hindfoot moment arm

    Time frame: At baseline; After 6 months post op

    A 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).

  5. Calcaneofibular distance and subtalar impigemen

    Time frame: At baseline; After 6 months post op

    It 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Massimiliano Mosca, MD

CONTACT

[email protected]

3355881233 ext. +39

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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