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Recurrence of DD in the thumb


- candidate number22973
- NTR NumberNTR5550
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2015
- Secondary IDs54805.042.15 
- Public TitleRecurrence of DD in the thumb
- Scientific TitleRecurrence of Dupuytren's Disease after treatment with Collagenase Clostridium Histolyticum (CCH) in the thumb
- ACRONYM
- hypothesisDupuytren's disease is a progressive disease and often recurs. We will measure increase in degrees of extension deficit 3 and 6 years after treatment with CCH.
- Healt Condition(s) or Problem(s) studiedDupuytren's Disease
- Inclusion criteria12 subjects who had CCH treatment in 14 thumbs during previous study
- Exclusion criteriaSubjects who had new treatment of the thumb since their treatment with CCH
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2015
- planned closingdate15-jun-2020
- Target number of participants12
- InterventionsSubjects will be measured with a non invasive goniometer
- Primary outcomeIncrease in degrees extension deficit in thumb or first webspace
- Secondary outcomeNot applicable
- Timepointsaround 3 and 6 years post treatment with CCH
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Dreise
- CONTACT for SCIENTIFIC QUERIES P.M.N. Werker
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryTo be able to give our patients with DD in the thumb the best treatment options it is not only important to know that the treatment works, but also how long the effect will last. Especially in DD, which is a progressive disease and often recurs after the different treatment options, it is important to know how often, over what time period and in which degree it recurs.
- Main changes (audit trail)
- RECORD14-okt-2015 - 4-feb-2016


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