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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014