Skip to content

Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02476461
Acronym
PNFvsxiapex
Enrollment
50
Registered
2015-06-19
Start date
2015-04-30
Completion date
2021-01-31
Last updated
2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytrens Contracture

Keywords

percutanepus needle fasciotomy, xiapex, clostridium histolyticum

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

Interventions

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * ASA\>3 * expected to live under five years * Tetracycline treatment within two weeks * pregnancy * nursing * allergy to clostridium histolyticum * participant in other trial

Design outcomes

Primary

MeasureTime frame
contracture size (degrees)five years

Secondary

MeasureTime frameDescription
contracture sizepost treatmentContracture size mesured in degrees in each finger joint

Other

MeasureTime frameDescription
contracture size (degrees)one yearcontracture size mesured in degrees in each finger joint
quick-Dashone, three and five yearsQuick-DASH functional score measured in points.
Painone, three, five yearsVisual Analogue score
Hand disabilityoen, three, five yearsVisual Analogue score

Countries

Norway

Contacts

Primary Contacthallgeir bratberg, MD
hbratber@ous-hf.no+4790578848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026