Survey of Current Management of Orthopaedic Complications in CMT Patients

January 29, 2015 updated by: Prof Mary Reilly, University College London Hospitals

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • National Hospital For Neurology and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in INC.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Does not read or speak English
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthopaedic surgeons
Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients at participants centres.
Other: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Collaborators

Johns Hopkins University
Children's Hospital of Philadelphia
University of Pennsylvania
University of Iowa
National Institutes of Health (NIH)
University of Washington
Vanderbilt University
Stanford University
University of Rochester
Sydney Children's Hospitals Network
Dubowitz Neuromuscular Centre
Carlo Besta Neurological Institute
National Hospital for Neurology and Neurosurgery, London
Data Management and Coordinating Center (DMCC)
Federal, State foundation and industry support: National Institute of Health (NIH), Muscular Dystrophy Association, Charcot Marie Tooth Association

Investigators

  • Study Chair: Prof Mary Reilly, National Hospital For Neurology and Neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INC 6608

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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