Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF
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|ClinicalTrials.gov Identifier: NCT02647619|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2016
Last Update Posted : January 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dupuytren Contracture||Drug: Xiapex Procedure: Needle aponeurotomy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Active Comparator: Needle aponeurotomy
percutaneous transection or pretendinous palmar dupytren cord
Procedure: Needle aponeurotomy
26 G needle multiple perforation tecqnique with local anesthetic
Other Name: Percutaneous needle fasiotomy
Active Comparator: Xiapex
Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord
Injection of collagenase of primary dupytren cord
Other Name: Xiaflex
- Reduction in Total Passive Extension Deficit [ Time Frame: 5 years ]
- Quick Dash (Disabilities of the shoulder and Hand) [ Time Frame: 5 years ]
- EQ5D (Euroqol 5 Dimensions) [ Time Frame: 5 years ]
- Brief MHQ (Michigan Hand Questionare) [ Time Frame: 5 years ]
- URAM (Unité Rhumatologique des Affections de la Main) [ Time Frame: 5 years ]
- Jamar grip strength [ Time Frame: 1,4,26 weeks and one year. ]
- VAS (Visual analogue scale) pain [ Time Frame: 1,4,26 weeks and one year ]0 is no pain, 10 maximum pain
- VAS (Visual analogue sale) satisfaction [ Time Frame: 1,4,26 weeks. 1,2 and 5 years ]0 is not satisfied, 10 maximum satisfied
- Complications [ Time Frame: 1,4,weeks One year ]AE,SAE,SUSAR
- Recurrence [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647619
|Akershus University Hospital|
|Oslo, Akershus, Norway, 1478|
|Study Director:||Per-Henrik Randsborg, PhD||University Hospital, Akershus|