The Effect of Surgical Incision Size on Carpal Tunnel Sur... | NCT00435071

Studies
The Effect of Surgical Incision Size on Carpal Tunnel Surgery

NCT00435071

Sponsor

Vanderbilt University

Status

Terminated

Last Update Posted

Feb 18, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Carpal Tunnel Syndrome

Interventions

Carpal Tunnel Release Surgery
Carpal tunnel release surgery

Countries

United States

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

Feb 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator initiated suspension to focus on other studies.

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Feb 12, 2007

First Submission Date that Met QC Criteria

Feb 12, 2007

First Posted Date

Feb 14, 2007Estimated

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

Feb 17, 2011

Last Update Posted Date

Feb 18, 2011Estimated

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: Carpal Tunnel Release Surgery
2	Active Comparator		Procedure: Carpal tunnel release surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carpal Tunnel Release Surgery	Procedure	Patient will have large incision size during carpal tunnel release surgery.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.		6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing open carpal tunnel release will be included in this study.
Patients must have clinical evidence of Carpal Tunnel Syndrome
Patients must have positive EMG results

Patient selection factors include:

Ability and willingness to follow instructions
Patients who are able and willing to return for follow-up evaluations.
Patients of all races and genders.
Patients who are able to follow care instructions.

Exclusion Criteria:

Patients less than 18 years old
Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Daniels	VUMC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt Orthopaedic Institute		Nashville	Tennessee	37232-8828	United States

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided