- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Karan Malhotra
- Telefonnummer: +442039470272
- E-post: k.malhotra@nhs.nbet
Studer Kontakt Backup
- Navn: Ira Jakupovic
- Telefonnummer: 3041 +442039470272
- E-post: ira.jakupovic1@nhs.net
Studiesteder
-
-
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Stanmore, Storbritannia, HA7 4LP
- Rekruttering
- Royal National Orthopaedic Hospital
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Ta kontakt med:
- Ira Jakupovic
- E-post: ira.jakupovic1@nhs.net
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Cavovarus Feet
Patients with cavovarus feet and Charcot Marie Tooth
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Clinical examination as part of routine care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assessment of reproducibility of clinical examination
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Karan Malhotra, Consultant Orthopaedic Surgeon
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Talipes
- Muskel- og skjelettsykdommer
- Muskuloskeletale abnormiteter
- Medfødte abnormiteter
- Deformiteter i nedre ekstremiteter, medfødt
- Lemdeformiteter, medfødt
- Fotdeformiteter
- Fotdeformiteter, ervervet
- Fotdeformiteter, medfødt
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Talipes Cavus
- Undersøkelsesteknikker
- Terapeutikk
- Atferdskontroll
- Immobilisering
- Tilbakeholdenhet, fysisk
Andre studie-ID-numre
- 26/PR/0552
- 371432 (Registeridentifikator: IRAS)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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