Survey of Current Management of Orthopaedic Complications in CMT Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University College London Hospitals
Sponsor:
Collaborators:
National Hospital for Neurology and Neurosurgery, London
University of Iowa Health Care
Children's Hospital of Philadelphia
University of Pennsylvania
University of Rochester
Dubowitz Neuromuscular Centre
The Children's Hospital at westmead, The University of Sydney
Carlo Besta Neurological Institute
Johns Hopkins University
Vanderbilt University
University of Washington
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
Information provided by (Responsible Party):
Prof Mary Reilly, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT02001038
First received: November 27, 2013
Last updated: December 3, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Charcot-Marie-Tooth Disease
Other: Survey

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Survey of Current Management of Orthopaedic Complications in Charcot Marie Tooth Disease Patients

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: February 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Orthopaedic surgeons
Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients at participants centres.
Other: Survey

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001038

Contacts
Contact: Matilde Laura, MD, PhD +44(0)2034488024 m.laura@ulc.ac.uk

Locations
United Kingdom
National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College London Hospitals
National Hospital for Neurology and Neurosurgery, London
University of Iowa Health Care
Children's Hospital of Philadelphia
University of Pennsylvania
University of Rochester
Dubowitz Neuromuscular Centre
The Children's Hospital at westmead, The University of Sydney
Carlo Besta Neurological Institute
Johns Hopkins University
Vanderbilt University
University of Washington
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
Investigators
Study Chair: Prof Mary Reilly National Hospital for Neurology and Neurosurgery
  More Information

No publications provided

Responsible Party: Prof Mary Reilly, Professor of Clinical Neurology and Consultant Neurologist, University College London Hospitals
ClinicalTrials.gov Identifier: NCT02001038     History of Changes
Other Study ID Numbers: INC 6608
Study First Received: November 27, 2013
Last Updated: December 3, 2013
Health Authority: United States: Data and Safety Monitoring Board (NIH)

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Tooth Diseases
Stomatognathic Diseases
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014