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Recruiting NCT07644078

Clinical Examination of Cavovarus Feet

Observational Cavus Foot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical Examination.
Who it may be relevant to
Registry conditions: Cavus Foot. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Identification of Forefoot Morphotypes in Cavovarus Feet Without the Need for Specialised Software

Overview

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.

Interventions

  • Other Clinical Examination
    Clinical examination as part of routine care

Primary outcome measures

  • Assessment of reproducibility of clinical examination [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Royal National Orthopaedic Hospital — Stanmore

Identifiers

NCT: NCT07644078 · 26/PR/0552 · 371432

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗