Survey of Current Management of Orthopaedic Complications in CMT Patients

Charcot-Marie-Tooth Disease Clinical Trial

Official title:

Survey of Current Management of Orthopaedic Complications in Charcot Marie Tooth Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001038
• Other study ID #: INC 6608
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: January 29, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board (NIH)
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Tooth Diseases

Intervention

Other:
• Survey

Locations

Country	Name	City	State
United Kingdom	National Hospital for Neurology and Neurosurgery	London

Sponsors (16)

Lead Sponsor

Collaborator

University College London Hospitals

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients		1 day	No