Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture (PNFvsxiapex)
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|ClinicalTrials.gov Identifier: NCT02476461|
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dupuytrens Contracture||Drug: xiapex Procedure: percutaneous needle fasciotomy||Phase 4|
Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.
A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.
The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.
The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.
The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.
Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.
Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.
Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||January 2021|
Active Comparator: xiapex
1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
Other Name: clostridium histolyticum
percutaneous needle fasciotomi is performed at affected cords
Procedure: percutaneous needle fasciotomy
Other Name: PNF
- contracture size (degrees) [ Time Frame: five years ]
- contracture size [ Time Frame: post treatment ]Contracture size mesured in degrees in each finger joint
- contracture size (degrees) [ Time Frame: one year ]contracture size mesured in degrees in each finger joint
- contracture size (degrees) [ Time Frame: three years ]contracture size mesured in degrees in each finger joint
- quick-Dash [ Time Frame: one, three and five years ]Quick-DASH functional score measured in points.
- Pain [ Time Frame: one, three, five years ]Visual Analogue score
- Hand disability [ Time Frame: oen, three, five years ]Visual Analogue score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476461
|Contact: hallgeir bratberg, MDfirstname.lastname@example.org|
|Oslo, Norway, 0424|
|Contact: hallgeir bratberg, MD +4790578848 email@example.com|
|Principal Investigator:||hallgeir bratberg, MD||Oslo University Hospital|