Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire
Registry of Patient With M. Dupuytren and Validation of the Brief MHQ
Sponsors
Source
Schulthess Klinik
Oversight Info
Has Dmc
No
Brief Summary
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.
Detailed Description
examination of the characteristics of Patient with Morbus Dupuytren and the psychometric
properties of the Brief Michigan Hand Questionnaire by this patients
Overall Status
Completed
Start Date
2013-08-01
Completion Date
2015-07-01
Primary Completion Date
2015-07-01
Study Type
Observational [Patient Registry]
Primary Outcome
Measure |
Time Frame |
|
Brief Michigan Hand Questionnaire |
6 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Joint mobility |
3 years |
Number Of Groups
1
Enrollment
60
Conditions
Intervention
Intervention Type
Procedure
Intervention Name
Description
Xiaflex surgery
Arm Group Label
Patient with M. Dupuytren
Eligibility
Study Pop
patients with M.Dupuytren with Xiapex injection or surgery
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- M.Dupuytren, over 18y, able to speak and understand german
Exclusion Criteria:
- recurrence, pregnancy, incapable of contracting
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Daniel Herren, Dr. med. |
Study Chair |
Schulthess Klinik |
Location
Facility |
|
Schulthess Klinik Zurich 8008 Switzerland |
Location Countries
Country
Switzerland
Verification Date
2016-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Schulthess Klinik
Investigator Full Name
Daniel Herren
Investigator Title
Dr. med. Daniel Herren
Has Expanded Access
No
Condition Browse
Secondary Id
Dupuytren 1
Arm Group
Arm Group Label
Patient with M. Dupuytren
Description
Xiaflex Surgery
Firstreceived Results Date
N/A
Other Outcome
Measure
Pain
Time Frame
3 years
Description
Measuring pain with the Numeric rating scale
Measure
Grip Strength
Time Frame
3 years
Description
Measuring grip strength with the dynamometer
Measure
Quick DASH
Time Frame
3 year
Description
Patient reported outcome measurement by arm, shoulder and hand disorders
Measure
Euroqol 5l5d
Time Frame
3 years
Description
analysis of the costs and utilities
Measure
Michigan Hand Questionnaire
Time Frame
3 years
Description
Patient reported outcome measurement by hand disorders
Target Duration
1 Year
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
June 10, 2013
Study First Submitted Qc
June 10, 2013
Study First Posted
June 12, 2013
Last Update Submitted
August 19, 2016
Last Update Submitted Qc
August 19, 2016
Last Update Posted
August 22, 2016
ClinicalTrials.gov processed this data on August 24, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.