NCT00468949

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

4.2 years

First QC Date

May 2, 2007

Last Update Submit

July 27, 2011

Conditions

Keywords

Health-Related Quality of LifeDupuytren's DiseaseHealth Utilities IndexShort Form-36;Michigan Hand Outcomes Questionnaire

Study Arms (2)

1

Patients undergoing excision surgery for their dupuytren's contracture

2

Patients not undergoing surgery for their excision surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dupuytren's contracture

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Achilleas Thoma, MD MSC

    St. Josephs Hamilton Health Care / McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Study Start

May 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations