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Clinical Trials/NCT02476461
NCT02476461
Unknown
Phase 4

Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

Oslo University Hospital1 site in 1 country50 target enrollmentApril 2015

Overview

Phase
Phase 4
Intervention
xiapex
Conditions
Dupuytrens Contracture
Sponsor
Oslo University Hospital
Enrollment
50
Locations
1
Primary Endpoint
contracture size (degrees)
Last Updated
10 years ago

Overview

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
January 2021
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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
  • expected to live under five years
  • Tetracycline treatment within two weeks
  • pregnancy
  • allergy to clostridium histolyticum
  • participant in other trial

Arms & Interventions

xiapex

1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual

Intervention: xiapex

PNF

percutaneous needle fasciotomi is performed at affected cords

Intervention: percutaneous needle fasciotomy

Outcomes

Primary Outcomes

contracture size (degrees)

Time Frame: five years

Secondary Outcomes

  • contracture size(post treatment)

Study Sites (1)

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