A Phase 4 interventional study of xiapex and percutaneous needle fasciotomy in Dupuytrens Contracture, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-19.
Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment
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.
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.
Exclution criteria:
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
81 studies on the registry are indexed under Dupuytren Contracture; 17 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 60 interventional studies indexed under Dupuytren Contracture.
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Exclusion Criteria:
1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
Drug: xiapex
percutaneous needle fasciotomi is performed at affected cords
Procedure: percutaneous needle fasciotomy
Also known as: clostridium histolyticum
Also known as: PNF
contracture size (degrees)
Time frame: five years
contracture size
Contracture size mesured in degrees in each finger joint
Time frame: post treatment
contracture size (degrees)
contracture size mesured in degrees in each finger joint
Time frame: one year
contracture size (degrees)
contracture size mesured in degrees in each finger joint
Time frame: three years
quick-Dash
Quick-DASH functional score measured in points.
Time frame: one, three and five years
Pain
Visual Analogue score
Time frame: one, three, five years
Hand disability
Visual Analogue score
Time frame: oen, three, five years
The record gives a start of Apr 2015, a primary completion of Apr 2016 and a completion of Jan 2021. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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