- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876498
Registry of Patient With M. Dupuytren and Validation of the Brief MHQ
August 19, 2016 updated by: Daniel Herren, Schulthess Klinik
Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire
The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8008
- Schulthess Klinik
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with M.Dupuytren with Xiapex injection or surgery
Description
Inclusion Criteria:
- M.Dupuytren, over 18y, able to speak and understand german
Exclusion Criteria:
- recurrence, pregnancy, incapable of contracting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient with M. Dupuytren
Xiaflex Surgery
|
Xiaflex surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Michigan Hand Questionnaire
Time Frame: 6 weeks
|
Patient reported outcome measurement by hand disorders
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint mobility
Time Frame: 3 years
|
Measuring the joint mobility of the fingers with the goniometer
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 3 years
|
Measuring pain with the Numeric rating scale
|
3 years
|
|
Grip Strength
Time Frame: 3 years
|
Measuring grip strength with the dynamometer
|
3 years
|
|
Quick DASH
Time Frame: 3 year
|
Patient reported outcome measurement by arm, shoulder and hand disorders
|
3 year
|
|
Euroqol 5l5d
Time Frame: 3 years
|
analysis of the costs and utilities
|
3 years
|
|
Michigan Hand Questionnaire
Time Frame: 3 years
|
Patient reported outcome measurement by hand disorders
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Daniel Herren, Dr. med., Schulthess Klinik
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
June 10, 2013
First Posted (ESTIMATE)
June 12, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 22, 2016
Last Update Submitted That Met QC Criteria
August 19, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Brief MHQ1
- Dupuytren 1 (REGISTRY: Dupuytren 1)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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