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

This study is currently recruiting participants.
Verified February 2014 by Schulthess Klinik
Sponsor:
Information provided by (Responsible Party):
Daniel Herren, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01876498
First received: June 10, 2013
Last updated: February 26, 2014
Last verified: February 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: June 2017
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01876498

Locations
Switzerland
Schulthess Klinik Recruiting
Zurich, Switzerland, 8008
Contact: Daniel Herren, Dr.med.    +41(0)443857481    daniel.herren@kws.ch   
Principal Investigator: Daniel Herren, Dr. med.         
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: February 26, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on April 22, 2014