ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001240235

Ethics application status

Approved

Date submitted

25/06/2015

Date registered

23/07/2018

Date last updated

4/12/2019

Date data sharing statement initially provided

11/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A prospective randomised pilot study comparing patient outcomes and cost-effectiveness of injectable collagenase fasciotomy with percutaneous needle fasciotomy for the treatment of Dupuytren’s disease of the hand

Scientific title

For people with Dupuytren's disease of the hand, is treatment with percutaneous fasciotomy as effective as injectable collagenase in improving functionality and fixed flexure angles.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Dupuytrens disease

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Percutaneous Needle Fasciotomy is a minimally invasive procedure and involves the division and release of the flexion contracture using a needle. Local anesthetic is injected into palm of hand at the site of the Dupuytren bands. This serves two purposes, to numb the hand and to separate the band from surrounding tissue. A fine needle is then used to repeatedly puncture the band so it weakens and breaks. Each Dupuytren effected band is broken in 2 places. It is done as a single procedure, and multiple bands can be treated at the same time. The length of the procedure depends on the number of bands that are treated, approximately 5 minutes per band, after allowing 5-10 minutes for the anaesthetic to take effect. The intervention will be adminsitered by one of two Plastic Surgeons who are part of the research team.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Injectable collagenase method is a short procedure where the CollA (Ziaflex) is injected at one consultation and released at a second at least a day later, having given the enzyme time to work. Ziaflex comes in 0.9ml ampoules. 0.4-0.6 ml is used for each cord. Up to 2 cords can be treated at one time. The procedure is performed by a Plastic Surgeon, and will take approximately 5-10 minutes per cord.

Control group

Active

Outcomes

Primary outcome [1]

Change in angle of flexion in the primary randomised joint. Measured by a blinded hand therapist using a goniometer.

Timepoint [1]

One month

Primary outcome [2]

Proportion of successful procedures as measured by the degree of contracture <5 degrees. This will be measured using a goniometer.

Timepoint [2]

One month

Secondary outcome [1]

The Unite Rhumatologique des Affections de la Main (URAM) scale

Timepoint [1]

4 weeks, 3 months and 2 years

Secondary outcome [2]

Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire

Timepoint [2]

4 weeks, 3 months and 2 years

Secondary outcome [3]

Requires further surgical management of the treated cords (Yes/No)

Timepoint [3]

2 years post intervention

Eligibility

Key inclusion criteria

Dupuytren’s disease with contracture (20-100 degrees Metacarpo-phalyngeal (MCP) joint or 20-80 at the proximal interphalyngeal (PIP) joint.)
Consulting clinician deems it appropriate management for the patient to have one or other of the fasciotomy procedures
No previous treatment within 90 days
Able to provide informed consent; age 18 years and older

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Bleeding disorder, blood thinning treatment (except aspirin 150mg/day)
Allergy to collagenase ; pregnancy, breast feeding; neuromuscular disorders
Administration of tetracyclines, antracyclines or anthraquinones in the past 14 days (these meds inhibit matrix metalloproteinase-mediate collagen degradation at suprapharmacological concentrations in vitro).

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Once generated, allocations will be contained in sealed opaque envelopes at the research centre. The surgeon will open consecutive allocation envelopes immediately prior to intervention.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random number tables will be generated to allocate treatment.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Outcome assessors will be masked to the treatment allocation group. Disease across a single joint (proximal interphalangeal or metacarpophalangeal) will be identified for randomisation. Other joints may be treated, but not randomised. Information about other joints which have been treated will also be collected as a nested observational study.

Phase

Phase 3 / Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

The adequacy of randomisation will be tested by comparing the distribution of potential confounding variables between the intervention groups: age, gender, proxy SEIFA, severity of disease, baseline function scales etc. This will be performed using general linear modelling, ordered logistic regression and logistic regression for continuous, ranked and binary data respectively. Any deviations from even distributions will result in those variables being assessed for inclusion of those variables in the multivariate primary outcome analysis. Variables to be included in the subsequent analyses will be selected by stepwise multivariate regression of the types specified below.
The primary outcome is measured as the change in the angle of flexion at the different MP and IP joints from before the operation to after the follow-up period. The analysis will involve mixed effects linear regression corrected for repeated measures to test the difference in change over time. In addition, the difference in proportions of success of treatment as measured by achievement of <5 degree flexion between the two groups will be estimated using repeated measures Poisson regression. The DASH, URAM and VAS satisfaction scores are rank-ordered in nature, and the changes in these scales will be estimated using mixed effects ordered logistic regression corrected for repeated measures.
At the 2 year follow-up the need for further treatment will be determined and this data will be used as input data for a relative cost effectiveness analysis of the two procedures, factoring in the costs of initial treatment, cost of further treatment and functional effectiveness of treatment.

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

The distribution of Xiaflex has been discontinued in Australia. This appears to be a business decision by the manufacturer not due to safety or efficacy concerns. Therefore this study cannot commence. The news of discontinuation came to us prior to commencing recruitment.

Date of first participant enrolment

Anticipated

1/10/2019

Actual

Date of last participant enrolment

Anticipated

1/10/2020

Actual

Date of last data collection

Anticipated

1/10/2022

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment hospital [1]

Launceston General Hospital - Launceston

Recruitment postcode(s) [1]

7250 - Launceston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Research Trust

Address [1]

Level 5
Launceston General Hospital
Charles Street
Launceston Tasmania 7250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

274-280 Charles Street
Launceston Tasmania 7250

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Tasmania

Address [1]

Launceston Clinical School
Level 2
Northern Integrated Care Service
Frankland Street
Launceston Tasmania 7277

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania Health & Medical Human Research Ethics Committee [EC00337]

Ethics committee address [1]

University of Tasmania
301 Sandy Bay Road
Sandy Bay, Tasmania, 7005

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/11/2017

Approval date [1]

13/07/2018

Ethics approval number [1]

H0016972

Summary

Brief summary

This study aims to compare two treatments for the management of Dupuytren's disease of the hand.  The two treatments can both be performed in the surgeons rooms without requiring a major surgical procedure.  The two treatments are 1) the use of a needle to divide the tissue causing the contracture, and 2) the use of a chemical substance to break down the tissue causing the contracture.  The hypothesis of this study is that the use of needle is as effective as the  use of a chemical substance, and less expensive.

Trial website

N/A

Trial related presentations / publications

None to date

Public notes

The distribution of Xiaflex has been discontinued in Australia. This appears to be a business decision by the manufacturer not due to safety or efficacy concerns. Therefore this study cannot commence. The news of discontinuation came to us prior to commencing recruitment.

Contacts

Principal investigator

Name

Dr Michael Thomson

Address

Dept of Surgery
Launceston General Hospital
274-280 Charles Street
Launceston, Tasmania, 7250

Country

Australia

Phone

+61 3 6777 6777

Fax

michaelthomson@yahoo.com

Contact person for public queries

Name

Kathryn Ogden

Address

Launceston Clinical School
University of Tasmania
Level 2, Northern Integrated Care Service
41 Frankland Street
Launceston, Tasmania, 7250

Country

Australia

Phone

+ 61 3 6777 8790

Fax

kathryn.ogden@utas.edu.au

Contact person for scientific queries

Name

Kathryn Ogden

Address

Launceston Clinical School
University of Tasmania
Level 2, Northern Integrated Care Service
41 Frankland Street
Launceston, Tasmania, 7250

Country

Australia

Phone

+ 61 3 6777 8790

Fax

kathryn.ogden@utas.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data that underlie the results reported in any publications after deidentification

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years after publication

Available to whom?

Researchers who provide a methodologically sound proposal

Available for what types of analyses?

To acheive the aims of the approved proposal

How or where can data be obtained?

Proposals should be directed to kathryn.ogden@utas.edu.au . To gain access data requestors will need to sign a data access agreement. Data will be available for 5 years on a third party website (to be determined)

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
2767	Study protocol	kathryn.ogden@utas.edu.au
2768	Statistical analysis plan	kathryn.ogden@utas.edu.au
2769	Informed consent form	kathryn.ogden@utas.edu.au
2770	Ethical approval	kathryn.ogden@utas.edu.au	368822-(Uploaded-03-07-2019-09-20-04)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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