NCT07644078

Brief Summary

Cavovarus feet are complex deformities in multiple planes. There is little consensus on the best way to address deformities. Furthermore there are various different phenotypes and we have previously described 4 distinct forefoot morphotypes that exist. It has been hypothesised that the various morphotypes could benefit from differing surgical strategies. However, identification of forefoot morphotypes has only been possible thus far using specialised semi-automated software and 3D animating software to manually identify morphotypes. It is therefore not straightforward to identify which patients may benefit from which surgery and this is not translatable to surgeons outside of a specialist centre. The utility of this classification has been thus far limited to research. There is a burning need to explore ways in which identification of forefoot morphotypes can be translated to other centres using techniques such as basic imaging or clinical examination to identify patients with different morphotypes. At Royal National Orthopaedic Hospital (RNOH) we have a large, complex cohort of patients with neuromuscular foot and ankle deformity and cavovarus feet. We also have access to advanced imaging techniques which we employ in routine care of our patients. We further have access to the software and previous research tools used to identify forefoot morphotypes. We have for many years been examining cavovarus feet and documenting the various clinical findings. We also run teaching clinics combined with registrars where patients are routinely examined as part of routine care and pre-operative work up. Therefore we are ideally and uniquely placed to carry out this research which is an extension of our previous work. Our primary aim is to identify a reproducible method of distinguishing between the various forefoot morphotypes in cavovarus feet in patients with Charcot Marie Tooth disease (CMT). This will include investigating the utility of clinical examination and manual measurements (without specialised software) on weightbearing CT (WBCT). We will also aim to examine the reproducibility of any techniques such as clinical examination.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2027

Study Start

First participant enrolled

May 28, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of reproducibility of clinical examination

    6 months

Study Arms (1)

Cavovarus Feet

Patients with cavovarus feet and Charcot Marie Tooth

Other: Clinical Examination

Interventions

Clinical examination as part of routine care

Cavovarus Feet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CMT and cavovarus feet

You may qualify if:

  • Adult patients aged ≥ 18 years
  • Clinical diagnosis of cavovarus foot deformity, AND confirmed Charcot-Marie-Tooth disease or other hereditary sensorimotor neuropathy
  • Already under the care of the Foot \& Ankle Unit at RNOH.
  • Additionally, for PROSPECTIVE element:
  • Capacity to provide written informed consent
  • Additionally, for the RETROSPECTIVE element:
  • Previously assessed for cavovarus feet at RNOH
  • Forefoot morphotype previously identified using Disior Bonelogic software
  • Clinical examination findings documented in medical notes.

You may not qualify if:

  • Previous surgery to the hindfoot or midfoot
  • Age under 18 years
  • For the PROSPECTIVE element:
  • Unable to consent
  • For the RETROSPECTIVE element:
  • Participant has previously withdrawn consent for use of their data in line with NHS Opt-out
  • Insufficient clinical examination data recorded in medical notes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Talipes Cavus

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Karan Malhotra

    Consultant Orthopaedic Surgeon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start

May 28, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations