Cavus FootNCT07644078
Clinical Examination of Cavovarus Feet
An observational study of Cavus Foot, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavus Foot
- What is being tested?
- Clinical Examination
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2026to 31 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CMT and cavovarus feet
Who may be able to join
- 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:
Show all 9Show fewer
- Previously assessed for cavovarus feet at RNOH
- Forefoot morphotype previously identified using Disior Bonelogic software
- Clinical examination findings documented in medical notes.
Who cannot join
- 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- Participant has previously withdrawn consent for use of their data in line with NHS Opt-out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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
Ira Jakupovic, ira.jakupovic1@nhs.net
About this study
Official title: 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.
Read more
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.
- Conditions
- Cavus Foot
- Being tested
- Clinical Examination
- Medical subject headings
- Talipes Cavus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ExaminationOther
Clinical examination as part of routine care
| Study group | Role | What they receive |
|---|---|---|
| Cavovarus Feet | Patients with cavovarus feet and Charcot Marie Tooth Receives: Other: Clinical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of reproducibility of clinical examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start28 May 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavus FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karan Malhotra, Principal investigator, Consultant Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644078
- Sponsor's protocol ID
- 26/PR/0552
- Other IDs
- 371432
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Forefoot Morphotypes in Cavovarus Feet Without the Need for Specialised Software
- ClinicalTrials.gov ID
- NCT07644078
- Acronym / sponsor ID
- 26/PR/0552
- Conditions
- Cavus Foot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal National Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cavovarus Feet | – | Other: Clinical ExaminationPatients with cavovarus feet and Charcot Marie Tooth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CMT and cavovarus feet
Key inclusion criteria (9 listed)
- 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.
- Capacity to provide written informed consent
- Previously assessed for cavovarus feet at RNOH
Key exclusion criteria (7 listed)
- Previous surgery to the hindfoot or midfoot
- Age under 18 years
- Unable to consent
- Participant has previously withdrawn consent for use of their data in line with NHS Opt-out
- Insufficient clinical examination data recorded in medical notes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical ExaminationClinical examination as part of routine care | Other | Cavovarus Feet |
Primary outcome
Assessment of reproducibility of clinical examination
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karan Malhotra principal investigator
Consultant Orthopaedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cavus Foot, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 United Kingdom. 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 Karan Malhotra (+442039470272, k.malhotra@nhs.nbet), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of reproducibility of clinical examination (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.