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Flat FootNCT07515170

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.

A study testing Weight-Bearing CT scan in people with Flat Foot, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Flat Foot
What is being tested?
Weight-Bearing CT scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
Nov 2026to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Massimiliano Mosca, MD contact

3355881233 ext. +39

massimiliano.mosca@ior.it

Italy1 site

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

Other trials in Italy

About this study

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.

Conditions
Flat Foot
Being tested
Weight-Bearing CT scan
Keywords
Subtalar Arthrodesis, Weight-Bearing CT, Progressive Collapsing Foot Deformity (PCFD)
Medical subject headings
Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight-Bearing CT scanDiagnostic test

    Weight-Bearing CT scan after surgery

Study groups in NCT07515170
Study groupRoleWhat they receive
enrolled patientsExperimentalPatients of both sexes, aged between 18 and 80 years, affected by grade A2 Progressive Collapsing Foot Deformity (PCFD).
Receives: Diagnostic Test: Weight-Bearing CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline; After 6 months post op

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: At baseline; After 6 months post op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07515170
Sponsor's protocol ID
SAMBB-WBCT
Status last verified
Oct 2026
First submitted
31 Mar 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Weight-Bearing CT scan in people with Flat Foot, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Massimiliano Mosca, MD (3355881233 ext. +39, massimiliano.mosca@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Foot and Ankle Offset (time frame: At baseline; After 6 months post op). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07515170, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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