Splinting for Dupuytren's Contracture Release | NCT00575458

Studies
Splinting for Dupuytren's Contracture Release

NCT00575458

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Nov 16, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Dupuytren's Disease

Interventions

Not provided

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

Nov 2010

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

Jun 2005

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 14, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 18, 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

Nov 15, 2010

Last Update Posted Date

Nov 16, 2010Estimated

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

This study is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Static Splint
2		Dynamic Splint

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
males and females with Dupuytren's contracture
patients with contracture of less than 30 degrees of MCP contractions and no contractions of the IP joints

Exclusion Criteria:

previous surgical treatment for Dupuytren's
contracture of MCP greater than 30 degrees
contraindications for dynamic splinting (upper limb amputees, paresis, ect.)

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

Orthopaedic Hand Clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David C. Ring, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D004387	Dupuytren Contracture

Ancestor Terms

ID	Term
D005350	Fibroma
D018218	Neoplasms, Fibrous Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue

Browse Leaves

Not provided

Browse Branches

Not provided