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

Dupuytren Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647619
• Other study ID #: 2639063
• Secondary ID: 2013-001221-13
• Status: Completed
• Phase: Phase 4
• Start date: October 2013
• Est. completion date: April 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture

Intervention

Drug:
• Xiapex
Injection of collagenase of primary dupytren cord

Procedure:
• Needle aponeurotomy
26 G needle multiple perforation tecqnique with local anesthetic

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Oslo	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Total Passive Extension Deficit		5 years
Secondary	Quick Dash (Disabilities of the shoulder and Hand)		5 years
Secondary	EQ5D (Euroqol 5 Dimensions)		5 years
Secondary	Brief MHQ (Michigan Hand Questionare)		5 years
Secondary	URAM (Unité Rhumatologique des Affections de la Main)		5 years
Secondary	Jamar grip strength		1,4,26 weeks and one year.
Secondary	VAS (Visual analogue scale) pain	0 is no pain, 10 maximum pain	1,4,26 weeks and one year
Secondary	VAS (Visual analogue sale) satisfaction	0 is not satisfied, 10 maximum satisfied	1,4,26 weeks. 1,2 and 5 years
Secondary	Complications	AE,SAE,SUSAR	1,4,weeks One year
Secondary	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