Trial Review

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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] 286971 0
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 295432 0
Condition category
Condition code
Other 295685 295685 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Human Genetics and Inherited Disorders 307744 307744 0 0
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] 292177 0
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] 295391 0
Change in angle of flexion in the primary randomised joint. Measured by a blinded hand therapist using a goniometer.
Timepoint [1] 295391 0
One month
Primary outcome [2] 306730 0
Proportion of successful procedures as measured by the degree of contracture <5 degrees. This will be measured using a goniometer.
Timepoint [2] 306730 0
One month
Secondary outcome [1] 315499 0
The Unite Rhumatologique des Affections de la Main (URAM) scale
Timepoint [1] 315499 0
4 weeks, 3 months and 2 years
Secondary outcome [2] 315500 0
Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire
Timepoint [2] 315500 0
4 weeks, 3 months and 2 years
Secondary outcome [3] 315501 0
Requires further surgical management of the treated cords (Yes/No)
Timepoint [3] 315501 0
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?
No
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] 3967 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 23446 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 291528 0
Charities/Societies/Foundations
Name [1] 291528 0
Clifford Craig Medical Research Trust
Country [1] 291528 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
274-280 Charles Street
Launceston Tasmania 7250
Country
Australia
Secondary sponsor category [1] 290209 0
University
Name [1] 290209 0
University of Tasmania
Address [1] 290209 0
Launceston Clinical School
Level 2
Northern Integrated Care Service
Frankland Street
Launceston Tasmania 7277
Country [1] 290209 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293069 0
Tasmania Health & Medical Human Research Ethics Committee [EC00337]
Ethics committee address [1] 293069 0
University of Tasmania
301 Sandy Bay Road
Sandy Bay, Tasmania, 7005
Ethics committee country [1] 293069 0
Australia
Date submitted for ethics approval [1] 293069 0
13/11/2017
Approval date [1] 293069 0
13/07/2018
Ethics approval number [1] 293069 0
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 58346 0
Dr Michael Thomson
Address 58346 0
Dept of Surgery
Launceston General Hospital
274-280 Charles Street
Launceston, Tasmania, 7250
Country 58346 0
Australia
Phone 58346 0
+61 3 6777 6777
Fax 58346 0
Email 58346 0
[email protected]
Contact person for public queries
Name 58347 0
Dr Kathryn Ogden
Address 58347 0
Launceston Clinical School
University of Tasmania
Level 2, Northern Integrated Care Service
41 Frankland Street
Launceston, Tasmania, 7250
Country 58347 0
Australia
Phone 58347 0
+ 61 3 6777 8790
Fax 58347 0
Email 58347 0
[email protected]
Contact person for scientific queries
Name 58348 0
Dr Kathryn Ogden
Address 58348 0
Launceston Clinical School
University of Tasmania
Level 2, Northern Integrated Care Service
41 Frankland Street
Launceston, Tasmania, 7250
Country 58348 0
Australia
Phone 58348 0
+ 61 3 6777 8790
Fax 58348 0
Email 58348 0
[email protected]

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 [email protected] . 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.TypeCitationLinkEmailOther DetailsAttachment
2767Study protocol  [email protected]
2768Statistical analysis plan  [email protected]
2769Informed consent form  [email protected]
2770Ethical approval  [email protected] 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.