Splinting for Dupuytren's Contracture Release

This study has been completed.

Sponsor:

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00575458

First received: December 14, 2007

Last updated: November 15, 2010

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2007

Last Updated Date

November 15, 2010

Start Date ^ICMJE

June 2005

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00575458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Splinting for Dupuytren's Contracture Release

Official Title ^ICMJE

Prospective Randomized Comparison of Dynamic Versus Static Splinting After Dupuytren's Contracture Release

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Orthopaedic Hand Clinic

Condition ^ICMJE

Dupuytren's Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

1
Static Splint
2
Dynamic Splint

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00575458

Other Study ID Numbers ^ICMJE

2005p002466

Has Data Monitoring Committee

Responsible Party

David Ring, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David C. Ring, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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