- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07644078
Clinical Examination of Cavovarus Feet
Identification of Forefoot Morphotypes in Cavovarus Feet Without the Need for Specialised Software
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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Karan Malhotra
- Phone Number: +442039470272
- Email: k.malhotra@nhs.nbet
Study Contact Backup
- Name: Ira Jakupovic
- Phone Number: 3041 +442039470272
- Email: ira.jakupovic1@nhs.net
Study Locations
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Stanmore, United Kingdom, HA7 4LP
- Recruiting
- Royal National Orthopaedic Hospital
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Contact:
- Ira Jakupovic
- Email: ira.jakupovic1@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cavovarus Feet
Patients with cavovarus feet and Charcot Marie Tooth
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Clinical examination as part of routine care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assessment of reproducibility of clinical examination
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karan Malhotra, Consultant Orthopaedic Surgeon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Talipes Cavus
- Investigative Techniques
- Therapeutics
- Behavior Control
- Immobilization
- Restraint, Physical
Other Study ID Numbers
- 26/PR/0552
- 371432 (Registry Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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