Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

Conditions
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Dupuytrens Contracture

Intervention / Treatment
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* Drug: xiapex
* Procedure: percutaneous needle fasciotomy


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: xiapex<br>1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual | Drug: xiapex<br> <br> * Other names: clostridium histolyticum;|
| Experimental: PNF<br>percutaneous needle fasciotomi is performed at affected cords | Procedure: percutaneous needle fasciotomy<br> <br> * Other names: PNF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contracture size (degrees) |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contracture size | Contracture size mesured in degrees in each finger joint | post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutanepus needle fasciotomy, xiapex, clostridium histolyticum