Dupuytren's interventions surgery vs collagenase | Recruiting
Dupuytren's interventions surgery v... | Recruiting
Dupuytren's interventions surgery vs collagenase
DISC

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Medical Conditions
  • Dupuytren's contracture
Primary Contact Details
Ms Catherine Arundel
+44 1904 321 116
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN18254597
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Background and study aims
Dupuytren’s contracture is a common problem affecting the hand. The condition is caused by fibrous tissue which forces the finger to bend down into the palm meaning patients cannot straighten their finger. The common treatment is surgery to remove the tissue and straighten the bent finger. A new treatment is a Collagenase injection, which softens the fibrous tissue. This is given in clinic, and is followed up in clinic a few days later where the finger is moved to help to straighten it. Both treatments are offered on the NHS in England and are used in the USA and Europe, but it is not known if the injection is as good as surgery at correcting the bent finger, if the correction continues in the long term and if the complication rates are similar. The aim of this study is to find out whether collagenase injections are as good and as safe as surgery for treating this condition and to find out the cost of both treatments to see which is the best value for money. Participants are also asked what they think about the different treatments, to see if they prefer one treatment more than the other.

Who can participate?
Patients aged 18 and over who have Dupytren’s contracture

What does the study involve?
The participant’s hand is assessed and a photograph is taken, and the participant is asked some questions about their condition and their general health. Participants are then randomly allocated to receive either the injection or surgery. Before they receive their treatment, the hand is re-assessed and the participant completes a short questionnaire about their hand health. During the study participants come to the hospital for another 4 visits where their hand is assessed, they are asked some questions about their hand function and general health, and a photograph of their hand is taken.

What are the possible benefits and risks of participating?
The information from this study may help doctors to treat people with Dupuytren’s contracture more effectively in the future. However, as with any treatment, there are always potential risks. Common side effects of Collagenase include injection site swelling, bruising and pain. These often subside within 1 – 2 weeks of the injection. The injection may also cause dizziness, headaches, a tingling sensation or a reduced sense of touch. Very rarely, allergic reactions and tendon rupture may occur. Common side effects of surgery may be experienced such as pain, bruising, swelling or infection, in addition to anaesthetic side effects such as dizziness, headaches and numbness.

Where is the study run from?
University of York (UK)

When is the study starting and how long is it expected to run for?
May 2017 to October 2021

Who is funding the study?
National Institute for Health Research Health Technology Assessment Programme (UK)

Who is the main contact?
1. Catherine Arundel (scientific)
catherine.arundel@york.ac.uk
2. Michelle Watson (public)
michelle.watson@york.ac.uk
Research Details
  • Collagenase injection is not inferior to limited fasciectomy in the correction of Dupuytren’s contracture of the hand.

    More information can be found at:
    https://ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialNumber=ISRCTN18254597
Phase
Phase IV
Study Design
Multi-centre randomised controlled non-inferiority pragmatic trial
Study Type
Interventional
Intervention

The participant's hand is assessed, a photograph is taken and they are asked some questions about their condition and their general health. Participants are randomised to either the intervention or the control group. Before they receive their treatment, their hand is re-assessed and they are asked to complete a short questionnaire about their hand health.

1. Intervention: Collagenase Clostridium histolyticum injections
Depending on the cord affected 0.25ml or 0.20ml of reconstituted solution (0.58mg Collagenase Clostridium histolyticum) is injected as three aliquots: 0.25ml for cord in a metacarpophalangeal (MCP) joint, 0.20ml for cord in a proximal interphalangeal (PIP) joint. The three aliquots are distributed via injection into an affected cord at set anatomical points through a single needle puncture at a single time point. Patients will be scheduled for Collagenase injection within 18 weeks following randomisation (as per referral to treatment time RTT), however where possible sites should complete this procedure within 12 weeks post randomisation. After an interval of one to seven days, the patient then returns to clinic and, under local anaesthetic, the cord is snapped using a four-step process. Two additional visits by the patient may therefore be required for the intervention to be delivered; one for injection and one for manipulation. Separate cords may be injected at the same treatment, in line with the SmPC, following the injection procedure and using separate vials for each cord. If multiple cords are injected, only the reference cord injection will be deemed to be part of the trial treatment. Given the pragmatic nature of DISC, follow-up Collagenase injections will be at clinician discretion this includes the timing of manipulation and of further injections to the same cord.

2. Control: limited fasciectomy surgery
Limited fasciectomy involves the removal, under anaesthesia and tourniquet control, of the diseased fascia, nodule and cord, or a part of it, to correct the contracture of the joint. As deemed clinically appropriate, the skin may then be left to heal by secondary intention, closed directly, or closed with a Z plasty or closed using a full thickness skin graft. Patients will be scheduled for the limited fasciectomy surgery to be completed within 18 weeks following randomisation (as per referral to treatment time-RTT), however where possible sites should complete this procedure within 12 weeks post randomisation.

During the study participants need to come to the hospital for another 4 visits where their hand is assessed, they are asked some questions about their hand function and general health, and a photograph is taken of their hand.

Intervention Type
Drug
Primary Outcome Measures
    Hand health and overall hand assessment, measured using the Patient Evaluation Measure at baseline, pre treatment, 3 months, 6 months, 1 year and 2 years post treatment
Secondary Outcome Measures
    1. Disability, measured using the Unité Rhumatologique des Affections de la Main (URAM) Patient Rated Outcome Measure at baseline, 3 months, 6 months, 1 year and 2 years post treatment
    2. Hand function, daily activities, work performance, pain, aesthetics and patient satisfaction, measured using the Michigan Hand Questionnaire (MHQ) Measured at baseline, 1 year and 2 years post treatment
    3. Extension deficit and total active movement (for stiffness), measured using goniometry and photograph data at baseline, pre/post treatment and 3 months, 6 months, 1 year and 2 years post treatment
    4. Recurrence, measured using goniometry at 3 months, 6 months, 1 year and 2 years post treatment
    5. Further procedures, recorded by clinicians at 3 months, 6 months, 1 year and 2 years post treatment
    6. Complications, recorded by clinicians at 3 months, 6 months, 1 year and 2 years post treatment
    7. Generic health status, measured using the EQ-5D-5L at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years post treatment
    8. Resource use, measured using trial specific resource use questionnaire to collect NHS resource use, return to work and out of pocket expenses at 3 months, 6 months, 1 year and 2 years post treatment
    9. Time to recovery of function, measured using Single Assessment Numeric Evaluation (SANE) via remote data collection at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years post treatment
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
710
Participant Inclusion Criteria
    1. Male or female and aged 18 years or over
    2. Presence of discrete, palpable, contracted cord involving the metacarpophalangeal joint and/or proximal interphalangeal joint of a finger
    3. Degree of contracture ≥30 degrees in either joint i.e. patient cannot put the palm of the hand flat on a table (Hueston’s Table top test)
    4. Able to identify a predominant cord for treatment which would not require more than one Collagenase injection as treatment
    5. Appropriate for limited fasciectomy surgery and Collagenase injection for Dupuytren’s contracture (i.e. cords suitable for CCH and limited fasciectomy and not requiring skin grafting or PNF (e.g. discrete MCP cords in elderly))
    6. Patient is willing and able to give informed consent for participation in the study
Participant Exclusion Criteria
    1. Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4)
    2. History of previous intervention for Dupuytren’s contracture (e.g. surgery, Collagenase injection or needle fasciectomy) on the same hand
    3. History of any other pre-existing disorder of the hand causing significant restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis
    4. Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages
    5. Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible
    6. Contraindicated for use of Collagenase including hypersensitivity to: Collagenase, Sucrose, Ketorolac Trometamol, hydrochloric acid, calcium chloride dehydrate, sodium chloride
    7. Diagnosis of a coagulation disorder
    8. Any other significant disease or disorder (including autoimmune disorders) which, in the opinion of the Investigator, may put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
    9. Participation in another research study involving an investigational product in the past 12 weeks
    10. Female participants who report to be pregnant or breastfeeding
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Liverpool
L7 8XP
Southampton
SO16 6YD
Newcastle upon Tyne
NE7 7DN
Leicester
LE5 4QF
Derby
DE22 3NE
Birmingham
B31 2AP
Trial Contact(s)
Primary Trial Contact
Ms Catherine Arundel
+44 1904 321 116
Other Trial Contacts
Dr Puvan Tharmanathan
+44 1904 321 844
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuytren’s contracture in adult patients
EudraCT Number
2016-004251-76
Funder(s)
  • Health Technology Assessment Programme
Other Study ID Numbers
Sponsor ID: 2087230; HTA 15/102/04
Sponsor(s)
University Hospitals of Leicester NHS Trust
Key Dates

Recruitment Start Date

01 May 2017

Recruitment End Date

31 Oct 2019

Trial Start Date

01 May 2017

Trial End Date

31 Oct 2021

Date added to source

11 Apr 2017

Date updated in source

19 Sep 2017