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Health-Related Quality of Life in Patients With Dupuytren's Disease

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00468949
First received: May 2, 2007
Last updated: July 27, 2011
Last verified: July 2011

May 2, 2007
July 27, 2011
May 2007
July 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00468949 on ClinicalTrials.gov Archive Site
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Health-Related Quality of Life in Patients With Dupuytren's Disease
Health-Related Quality of Life in Patients With Dupuytren's Disease: A Prospective Cohort Study.

Main Research Questions:

We want to measure the change in quality of life in Dupuytren's disease patients who do and do not undergo surgery. Also, we want to test the validity of health related quality of life measurements in patients with Dupuytren's disease.

Why is this research important? Some patients with Dupuytren's contracture require excision surgery or palmar fasciectomy. Other patient's with Dupuytren's contracture do not require surgery; however, these patients may need surgery in the future. No studies have reported the health-related quality of life of patients with Dupuytren's disease whether related to surgical intervention or not.

What is being studied? We are studying the difference and change in health-related quality of life in patients suffering from Dupuytren's disease who require excision surgery and do not require surgery.

Previous research on Dupuytren's disease has not reported the health-related quality of life (HRQL) of patients' whether related to surgical intervention or not. The primary objective of this study is to measure the change in HRQL in Dupuytren's contracture patients who do and do not undergo palmar fasciectomy. Health related quality of life will be measured using the 1) Health Utilities Index Mark III (HUI3); 2) Short Form-36 (SF-36); and the 3) Michigan Hand Outcomes Questionnaire (MHQ). The secondary objective is to look at the measurement properties, including the reliability and responsiveness, of each of the three HRQL instruments when they are used in patients with Dupuytren's contracture. We will also assess the concurrent validity of each of the HRQL instruments.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with dupuytren's contracture

Dupuytren's Contracture
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  • 1
    Patients undergoing excision surgery for their dupuytren's contracture
  • 2
    Patients not undergoing surgery for their excision surgery
Thoma A, Kaur MN, Ignacy TA, Levis C, Martin S, Duku E, Haines T. Health-related quality of life in patients undergoing palmar fasciectomy for Dupuytren's disease. Plast Reconstr Surg. 2014 Jun;133(6):1411-9. doi: 10.1097/PRS.0000000000000177.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who have the diagnosis of Dupuytren's disease
  • able to comprehend English to complete the self-reported questionnaires
  • willing to provide informed consent.

Exclusion Criteria:

  • patients who have had previous Dupuytren's contracture surgery on the same hand
  • patients who have carpal tunnel syndrome, rheumatoid arthritis, connective tissue disorder, tenosynovitis, or another condition that could affect quality of life
  • patients who are under the age of 18 years.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00468949
06-2713
No
Dr. Achilleas Thoma, McMaster University
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: Achilleas Thoma, MD MSC St. Josephs Hamilton Health Care / McMaster University
McMaster University
July 2011

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