Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.

Conditions
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Dupuytren Contracture

Intervention / Treatment
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* Drug: Xiapex
* Procedure: Needle aponeurotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Dd disease (no earlier treatment for this condition of the hand involved) Single digit involvement, one of the three ulnar digits Average norwegian language skills. MCPJ contracture of 30 degrees or more and less than 20 degree involvement of the adjacent PIPJ Minimum 18 y.o. Exclusion Criteria: Involvement of 2 fingers/joints Earlier treatment for Dd disease of the same hand, affection of addjecent PIPJ of 20 degrees or mor Pregnancy Ongoing treatment with platelet inhibitors Treatment with tetracycline 2 weeks prior to treatment date Poor norwegian language skills Participation in other studies 4 weeks prior or after treatment date Need to treat of both hands

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Needle aponeurotomy<br>percutaneous transection or pretendinous palmar dupytren cord | Procedure: Needle aponeurotomy<br>* 26 G needle multiple perforation tecqnique with local anesthetic<br>* Other names: Percutaneous needle fasiotomy;|
| Active Comparator: Xiapex<br>Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord | Drug: Xiapex<br>* Injection of collagenase of primary dupytren cord<br>* Other names: Xiaflex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Total Passive Extension Deficit |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Dash (Disabilities of the shoulder and Hand) |  | 5 years | 
| EQ5D (Euroqol 5 Dimensions) |  | 5 years | 
| Brief MHQ (Michigan Hand Questionare) |  | 5 years | 
| URAM (Unité Rhumatologique des Affections de la Main) |  | 5 years | 
| Jamar grip strength |  | 1,4,26 weeks and one year. | 
| VAS (Visual analogue scale) pain | 0 is no pain, 10 maximum pain | 1,4,26 weeks and one year | 
| VAS (Visual analogue sale) satisfaction | 0 is not satisfied, 10 maximum satisfied | 1,4,26 weeks. 1,2 and 5 years | 
| Complications | AE,SAE,SUSAR | 1,4,weeks One year | 
| Recurrence | def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ | 1,4,26 weeks. 1,2 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Dd disase, MCP joint