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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniel Herren, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01876498
First received: June 10, 2013
Last updated: October 13, 2014
Last verified: October 2014
  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: 3 Years
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 Schulthess Klinik:

Primary Outcome Measures:
  • Brief Michigan Hand Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patient reported outcome measurement by hand disorders


Secondary Outcome Measures:
  • Joint mobility [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measuring the joint mobility of the fingers with the goniometer


Other Outcome Measures:
  • Pain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measuring pain with the Numeric rating scale

  • Grip Strength [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measuring grip strength with the dynamometer

  • Quick DASH [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    Patient reported outcome measurement by arm, shoulder and hand disorders

  • Euroqol 5l5d [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    analysis of the costs and utilities

  • Michigan Hand Questionnaire [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Patient reported outcome measurement by hand disorders


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: September 2017
Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876498

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

No publications provided

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
Study First Received: June 10, 2013
Last Updated: October 13, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Connective Tissue Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014