Dupuytrens Contracture Clinical Trial
Official title:
Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01538017 -
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
|
N/A |