Akershus University Hospital
Oslo, Akershus, 1478, Norway
NCT Number: NCT02647619
Aim:
Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy.
Materials and methods:
30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°.
1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Oslo, Akershus, 1478, Norway
Open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for Dupytren´s disease (Dd) despite considerable risk of complications.
There is an increasing interest in Scandinavia in the treatment of Dd with Clostridium Histolyticum (Xiapex ®, Auxillium). However the enzyme is expensive and long-term effects are not well documented. More studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis.
The treatment arm of Xiapex in this study follows the recommendation as by the producer.
The other treatment of Dd contracture in this study is needle fasiotomy/aponeurotomy. We use multiple perforation technigue with 26 G needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended.
The two procedures leave little scar tissue lessening the challenges posed by the reoperations.
Recurrence rate of contracture following different treatments of Dupuytren's disease differs widely in the literature, and the rate is influenced by multiple factors.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of collagenase of primary dupytren cord
Other names: Xiaflex
26 G needle multiple perforation tecqnique with local anesthetic
Other names: Percutaneous needle fasiotomy
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 1,4,26 weeks and one year.
Time frame: 1,4,26 weeks and one year
0 is no pain, 10 maximum pain
Time frame: 1,4,26 weeks. 1,2 and 5 years
0 is not satisfied, 10 maximum satisfied
Time frame: 1,4,weeks One year
AE,SAE,SUSAR
Time frame: 1,4,26 weeks. 1,2 and 5 years
def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ
University Hospital, Akershus
Other
A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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