NCT01876498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

June 10, 2013

Last Update Submit

August 19, 2016

Conditions

Dupuytren ContractureCollagen ShrinkageCRF

Outcome Measures

Primary Outcomes (1)

  • Brief Michigan Hand Questionnaire

    Patient reported outcome measurement by hand disorders

    6 weeks

Secondary Outcomes (1)

  • Joint mobility

    3 years

Other Outcomes (5)

  • Pain

    3 years

  • Grip Strength

    3 years

  • Quick DASH

    3 year

  • +2 more other outcomes

Study Arms (1)

Patient with M. Dupuytren

Xiaflex Surgery

Procedure: Xiaflex surgery

Interventions

Xiaflex surgeryPROCEDURE

Xiaflex surgery

Patient with M. Dupuytren

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with M.Dupuytren with Xiapex injection or surgery

You may qualify if:

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

You may not qualify if:

  • recurrence, pregnancy, incapable of contracting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Daniel Herren, Dr. med.

    Schulthess Klinik

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Daniel Herren

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

CH(1)