Survey of Current Management of Orthopaedic Complications... | NCT02001038

Studies
Survey of Current Management of Orthopaedic Complications in CMT Patients

NCT02001038

Sponsor

University College London Hospitals

Status

Completed

Last Update Posted

Jan 30, 2015Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Charcot-Marie-Tooth Disease

Interventions

Survey

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Nov 27, 2013

First Submission Date that Met QC Criteria

Dec 3, 2013

First Posted Date

Dec 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2015

Last Update Posted Date

Jan 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Mary Reilly, Professor of Clinical Neurology and Consultant Neurologist, University College London HospitalsPrincipal Investigator

Lead Sponsor

University College London HospitalsOTHER

Collaborators

Name	Class
National Hospital for Neurology and Neurosurgery, London	UNKNOWN
University of Iowa	OTHER
Children's Hospital of Philadelphia	OTHER
University of Pennsylvania

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orthopaedic surgeons		Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients at participants centres.	Other: Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other		Orthopaedic surgeons

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof Mary Reilly	National Hospital for Neurology and Neurosurgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Hospital for Neurology and Neurosurgery		London		WC1N 3BG	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D002607	Charcot-Marie-Tooth Disease

Ancestor Terms

ID	Term
D015417	Hereditary Sensory and Motor Neuropathy
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D020271	Heredodegenerative Disorders, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided