Charcot-Marie-Tooth DiseaseNCT02001038
Survey of Current Management of Orthopaedic Complications in CMT Patients
An observational study of Charcot-Marie-Tooth Disease, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot deformities are frequent complications in CMT patients and orthopaedic surgery is often required. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Charcot-Marie-Tooth Disease
- What is being tested?
- Survey
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in INC.
Who may be able to join
- Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropatheis Consortium (INC)
- Willing to complete survey
Who cannot join
- Does not read or speak English
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
About this study
Official title: Survey of Current Management of Orthopaedic Complications in Charcot Marie Tooth Disease Patients
Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot deformities are frequent complications in CMT patients and orthopaedic surgery is often required. As yet there are no systematic studies on the management of orthopaedic complications in CMT patients and the current approach varies between centres. This study is a survey with the aim of understanding the current surgical approach to orthopaedic complications in CMT.
The target population includes orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropathies Consortium (INC).
Read the detailed description
The study protocol consists of a survey addressed to orthopaedic surgeons. The survey will be completed once and it includes two different scenarios of typical CMT patients (one adult and one child).
The orthopaedic surgeons will be asked which surgical procedures they would apply to each scenario:
- forefoot cavus,
- clawtoes and
- hindfoot varus
No medications or therapeutic agents are a component of this project.
- Conditions
- Charcot-Marie-Tooth Disease
- Being tested
- Survey
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| Orthopaedic surgeons | Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients at participants centres. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot-Marie-Tooth DiseaseStudies 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
- Case only
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital for Neurology and Neurosurgery, University of Iowa, Children's Hospital of Philadelphia, University of Pennsylvania, University of Rochester, Dubowitz Neuromuscular Centre, Sydney Children's Hospitals Network, Carlo Besta Neurological Institute, Johns Hopkins University, Vanderbilt University, University of Washington, National Institutes of Health (NIH), Stanford University, Data Management and Coordinating Center (DMCC), Federal, State foundation and industry support: National Institute of Health (NIH), Muscular Dystrophy Association, Charcot Marie Tooth Association
- Responsible party
- Principal investigator, Prof Mary Reilly, University College London Hospitals
- Investigators
- Prof Mary Reilly, Study chair, National Hospital for Neurology and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001038
- Sponsor's protocol ID
- INC 6608
- Status last verified
- Jan 2015
- First submitted
- 27 Nov 2013
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Current Management of Orthopaedic Complications in Charcot Marie Tooth Disease Patients
- ClinicalTrials.gov ID
- NCT02001038
- Acronym / sponsor ID
- INC 6608
- Conditions
- Charcot-Marie-Tooth Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- National Hospital for Neurology and Neurosurgery, University of Iowa, Children's Hospital of Philadelphia, University of Pennsylvania, University of Rochester, Dubowitz Neuromuscular Centre, Sydney Children's Hospitals Network, Carlo Besta Neurological Institute, Johns Hopkins University, Vanderbilt University, University of Washington, National Institutes of Health (NIH), Stanford University, Data Management and Coordinating Center (DMCC), Federal, State foundation and industry support: National Institute of Health (NIH), Muscular Dystrophy Association, Charcot Marie Tooth Association
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- 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.
Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot deformities are frequent complications in CMT patients and orthopaedic surgery is often required. As yet there are no systematic studies on the management of orthopaedic complications in CMT patients and the current approach varies between centres. This study is a survey with the aim of understanding the current surgical approach to orthopaedic complications in CMT.
The target population includes orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropathies Consortium (INC).
Detailed description
The study protocol consists of a survey addressed to orthopaedic surgeons. The survey will be completed once and it includes two different scenarios of typical CMT patients (one adult and one child).
The orthopaedic surgeons will be asked which surgical procedures they would apply to each scenario:
- forefoot cavus,
- clawtoes and
- hindfoot varus
No medications or therapeutic agents are a component of this project.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopaedic surgeons | – | Other: SurveyOrthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients at participants centres. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in INC.
Key inclusion criteria (2 listed)
- Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropatheis Consortium (INC)
- Willing to complete survey
Key exclusion criteria (2 listed)
- Does not read or speak English
- Inability to provide informed consent
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 |
|---|---|---|
| Survey | Other | Orthopaedic surgeons |
Primary outcome
Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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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. This study is not recruiting at the moment.
Prof Mary Reilly study chair
National Hospital for Neurology and Neurosurgery
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 Charcot-Marie-Tooth Disease, run by University College London Hospitals 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jan 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients (time frame: 1 day). 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 30 Jan 2015.