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
  Purpose

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.


Condition
Dupuytren's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Comparison of Dynamic Versus Static Splinting After Dupuytren's Contracture Release

Further study details as provided by Massachusetts General Hospital:

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

Estimated Enrollment: 60
Study Start Date: June 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Static Splint
2
Dynamic Splint

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Orthopaedic Hand Clinic

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575458

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David C. Ring, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David Ring, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00575458     History of Changes
Other Study ID Numbers: 2005p002466
Study First Received: December 14, 2007
Last Updated: November 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 14, 2014