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Not yet recruitingNCT07515170Updated Apr 7, 2026

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.

An interventional study of Weight-Bearing CT scan in Flat Foot, sponsored by Istituto Ortopedico Rizzoli. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Flat Foot

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Keywords

  • Subtalar Arthrodesis
  • Weight-Bearing CT
  • Progressive Collapsing Foot Deformity (PCFD)
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    enrolled patients

    Patients of both sexes, aged between 18 and 80 years, affected by grade A2 Progressive Collapsing Foot Deformity (PCFD).

    Diagnostic Test: Weight-Bearing CT scan

Interventions

  • Diagnostic testWeight-Bearing CT scan

    Weight-Bearing CT scan after surgery

05

What researchers measure

Primary outcomes

  1. Foot and Ankle Offset

    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.

    Time frame: At baseline; After 6 months post op

Secondary outcomes

  1. Talo-navicular congruency angle

    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.

    Time frame: At baseline; After 6 months post op

  2. Middle facet Incongruency angle

    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.

    Time frame: At baseline; After 6 months post op

  3. Forefoot arch angle

    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.

    Time frame: At baseline; After 6 months post op

  4. Hindfoot moment arm

    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).

    Time frame: At baseline; After 6 months post op

  5. Calcaneofibular distance and subtalar impigemen

    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).

    Time frame: At baseline; After 6 months post op

06

Study locations

1 site
  • Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
07

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 38398256 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07515170
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
May 2026 (estimated)
Primary completion
Nov 2028 (estimated)
Completion
May 2029 (estimated)
Last update
Apr 7, 2026

Study contacts

Massimiliano Mosca, MD
Contact
massimiliano.mosca@ior.it
3355881233 ext. +39

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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