Clinical trial NCT02647619: Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF
Official title: A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dupuytren Contracture
Keywords: Primary Dd disase
MCP joint
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Total Passive Extension Deficit
timeFrame: 5 years
Secondary outcomes:
measure: Quick Dash (Disabilities of the shoulder and Hand)
timeFrame: 5 years
measure: EQ5D (Euroqol 5 Dimensions)
timeFrame: 5 years
measure: Brief MHQ (Michigan Hand Questionare)
timeFrame: 5 years
measure: URAM (Unité Rhumatologique des Affections de la Main)
timeFrame: 5 years
measure: Jamar grip strength
timeFrame: 1,4,26 weeks and one year.
measure: VAS (Visual analogue scale) pain
timeFrame: 1,4,26 weeks and one year
measure: VAS (Visual analogue sale) satisfaction
timeFrame: 1,4,26 weeks. 1,2 and 5 years
measure: Complications
timeFrame: 1,4,weeks One year
measure: Recurrence
timeFrame: 1,4,26 weeks. 1,2 and 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Per-Henrik Randsborg, PhD
role: STUDY_DIRECTOR
References: