Registry of Patient With M. Dupuytren and Validation of t... | NCT01876498

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

NCT01876498

Sponsor

Schulthess Klinik

Status

Completed

Last Update Posted

Aug 22, 2016Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Dupuytren Contracture
Collagen Shrinkage
CRF

Interventions

Xiaflex surgery

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Dupuytren 1	Registry Identifier	Dupuytren 1

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 10, 2013

First Posted Date

Jun 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2016

Last Update Posted Date

Aug 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with M. Dupuytren		Xiaflex Surgery	Procedure: Xiaflex surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xiaflex surgery	Procedure	Xiaflex surgery	Patient with M. Dupuytren

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brief Michigan Hand Questionnaire	Patient reported outcome measurement by hand disorders	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Joint mobility	Measuring the joint mobility of the fingers with the goniometer	3 years

Other Outcomes

Measure	Description	Time Frame
Pain	Measuring pain with the Numeric rating scale	3 years
Grip Strength	Measuring grip strength with the dynamometer	3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

recurrence, pregnancy, incapable of contracting

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with M.Dupuytren with Xiapex injection or surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Herren, Dr. med.	Schulthess Klinik	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schulthess Klinik		Zurich	Canton of Zurich	8008	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D004387	Dupuytren Contracture

Ancestor Terms

ID	Term
D005350	Fibroma
D018218	Neoplasms, Fibrous Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue

Browse Leaves

Not provided

Browse Branches

Not provided