Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
PNFvsxiapex
Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJune 19, 2015
April 1, 2015
1 year
June 5, 2015
June 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
contracture size (degrees)
five years
Secondary Outcomes (1)
contracture size
post treatment
Other Outcomes (5)
contracture size (degrees)
one year
contracture size (degrees)
three years
quick-Dash
one, three and five years
- +2 more other outcomes
Study Arms (2)
xiapex
ACTIVE COMPARATOR1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
PNF
EXPERIMENTALpercutaneous needle fasciotomi is performed at affected cords
Interventions
Eligibility Criteria
You may qualify if:
- symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees
You may not qualify if:
- previous treated dupuytrens contracture same hand
- more than tree fingers involvement
- we will not include thumbs
- other things affecting hand function
- ASA\>3
- expected to live under five years
- Tetracycline treatment within two weeks
- pregnancy
- nursing
- allergy to clostridium histolyticum
- participant in other trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo Universitetssykehus
Oslo, Oslo County, 0424, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
hallgeir bratberg, MD
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 19, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2016
Study Completion
January 1, 2021
Last Updated
June 19, 2015
Record last verified: 2015-04