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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT02476461 |
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Date of registration:
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05/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
PNFvsxiapex |
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Scientific title:
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Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02476461 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Norway
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Contacts
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Name:
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hallgeir bratberg, MD |
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Address:
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Telephone:
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+4790578848 |
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Email:
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hbratber@ous-hf.no |
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Affiliation:
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Name:
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hallgeir bratberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Name:
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hallgeir bratberg, MD |
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Address:
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Telephone:
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+4790578848 |
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Email:
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hbratbe@ous-hf.no |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- symptomatic Dupuytrens contracture with palpable cord, involving MCP, total
contracture size over 30 degrees
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dupuytrens Contracture
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Intervention(s)
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Drug: xiapex
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Procedure: percutaneous needle fasciotomy
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Primary Outcome(s)
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contracture size (degrees)
[Time Frame: five years]
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Secondary Outcome(s)
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contracture size
[Time Frame: post treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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