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Registry of Patient With M. Dupuytren and Validation of the Brief MHQ

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01876498
First Posted: June 12, 2013
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Herren, Schulthess Klinik
  Purpose
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.

Condition Intervention
Dupuytren Contracture Collagen Shrinkage CRF Procedure: Xiaflex surgery

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire

Resource links provided by NLM:


Further study details as provided by Daniel Herren, Schulthess Klinik:

Primary Outcome Measures:
  • Brief Michigan Hand Questionnaire [ Time Frame: 6 weeks ]
    Patient reported outcome measurement by hand disorders


Secondary Outcome Measures:
  • Joint mobility [ Time Frame: 3 years ]
    Measuring the joint mobility of the fingers with the goniometer


Other Outcome Measures:
  • Pain [ Time Frame: 3 years ]
    Measuring pain with the Numeric rating scale

  • Grip Strength [ Time Frame: 3 years ]
    Measuring grip strength with the dynamometer

  • Quick DASH [ Time Frame: 3 year ]
    Patient reported outcome measurement by arm, shoulder and hand disorders

  • Euroqol 5l5d [ Time Frame: 3 years ]
    analysis of the costs and utilities

  • Michigan Hand Questionnaire [ Time Frame: 3 years ]
    Patient reported outcome measurement by hand disorders


Enrollment: 60
Study Start Date: August 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient with M. Dupuytren
Xiaflex Surgery
Procedure: Xiaflex surgery
Xiaflex surgery

Detailed Description:
examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with M.Dupuytren with Xiapex injection or surgery
Criteria

Inclusion Criteria:

  • M.Dupuytren, over 18y, able to speak and understand german

Exclusion Criteria:

  • recurrence, pregnancy, incapable of contracting
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876498


Locations
Switzerland
Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Investigators
Study Chair: Daniel Herren, Dr. med. Schulthess Klinik
  More Information

Responsible Party: Daniel Herren, Dr. med. Daniel Herren, Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01876498     History of Changes
Other Study ID Numbers: Brief MHQ1
Dupuytren 1 ( Registry Identifier: Dupuytren 1 )
First Submitted: June 10, 2013
First Posted: June 12, 2013
Last Update Posted: August 22, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases