Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- contracture size (degrees)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
PNF
percutaneous needle fasciotomi is performed at affected cords
Intervention: percutaneous needle fasciotomy (Procedure)
Outcomes
Primary Outcomes
contracture size (degrees)
Time Frame: five years
Secondary Outcomes
- contracture size(post treatment)