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

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

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.

Study Overview

• Status: Completed
• Conditions: Dupuytren Contracture
• Intervention / Treatment: Procedure: Needle aponeurotomy; Drug: Xiapex

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Oslo, Akershus, Norway, 1478
      • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Study Director: Per-Henrik Randsborg, PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: MCP joint; Primary Dd disase
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: 2639063; 2013-001221-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No