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

NCT ID: NCT00468949

Last Updated: 2011-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dupuytren's Contracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients undergoing excision surgery for their dupuytren's contracture

No interventions assigned to this group

2

Patients not undergoing surgery for their excision surgery

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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McMaster University

Principal Investigators

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Achilleas Thoma, MD MSC

Role: PRINCIPAL_INVESTIGATOR

St. Josephs Hamilton Health Care / McMaster University

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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):1411-1419. doi: 10.1097/PRS.0000000000000177.

Reference Type DERIVED
PMID: 24569424 (View on PubMed)

Other Identifiers

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06-2713

Identifier Type: -

Identifier Source: org_study_id

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