Dupuytren's ContractureNCT00468949
Health-Related Quality of Life in Patients With Dupuytren's Disease
An observational study of Dupuytren's Contracture, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dupuytren's Contracture
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with dupuytren's contracture
Who may be able to join
- patients who have the diagnosis of Dupuytren's disease
- able to comprehend English to complete the self-reported questionnaires
- willing to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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
- Dupuytren's Contracture
- Keywords
- Health-Related Quality of Life, Dupuytren's Disease, Health Utilities Index, Short Form-36;, Michigan Hand Outcomes Questionnaire
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing excision surgery for their dupuytren's contracture | |
| 2 | Patients not undergoing surgery for their excision surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren's ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Investigators
- Achilleas Thoma, MD MSC, Principal investigator, St. Josephs Hamilton Health Care / McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468949
- Sponsor's protocol ID
- 06-2713
- Status last verified
- Jul 2011
- First submitted
- 2 May 2007
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24569424
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in Patients With Dupuytren's Disease: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT00468949
- Acronym / sponsor ID
- 06-2713
- Conditions
- Dupuytren's Contracture
- Keywords
- Health-Related Quality of Life, Dupuytren's Disease, Health Utilities Index, Short Form-36;, Michigan Hand Outcomes Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- May 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients undergoing excision surgery for their dupuytren's contracture |
| 2 | – | –Patients not undergoing surgery for their excision surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dupuytren's contracture
Key inclusion criteria (3 listed)
- patients who have the diagnosis of Dupuytren's disease
- able to comprehend English to complete the self-reported questionnaires
- willing to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Derived from this study: PubMed 24569424Thoma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achilleas Thoma, MD MSC principal investigator
St. Josephs Hamilton Health Care / McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Contracture, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.