Dupuytren ContracturePhase 4NCT02647619
Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF
A Phase 4 study testing Xiapex and Needle aponeurotomy in people with Dupuytren Contracture, run by University Hospital, Akershus at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Xiapex and Needle aponeurotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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°.
- 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.
Read the 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.
- Conditions
- Dupuytren Contracture
- Being tested
- Xiapex, Needle aponeurotomy
- Keywords
- Primary Dd disase, MCP joint
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XiapexDrug
Also called Xiaflex
Injection of collagenase of primary dupytren cord
Needle aponeurotomyProcedure or surgery
Also called Percutaneous needle fasiotomy
26 G needle multiple perforation tecqnique with local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Needle aponeurotomy | Active comparator | percutaneous transection or pretendinous palmar dupytren cord Receives: Procedure: Needle aponeurotomy |
| Xiapex | Active comparator | Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord Receives: Drug: Xiapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Total Passive Extension Deficit
Measured: 5 years
Secondary outcomes (9)
Quick Dash (Disabilities of the shoulder and Hand)
Measured: 5 years
EQ5D (Euroqol 5 Dimensions)
Measured: 5 years
Brief MHQ (Michigan Hand Questionare)
Measured: 5 years
URAM (Unité Rhumatologique des Affections de la Main)
Measured: 5 years
Jamar grip strength
Measured: 1,4,26 weeks and one year.
VAS (Visual analogue scale) pain
0 is no pain, 10 maximum pain
Measured: 1,4,26 weeks and one year
VAS (Visual analogue sale) satisfaction
0 is not satisfied, 10 maximum satisfied
Measured: 1,4,26 weeks. 1,2 and 5 years
Complications
AE,SAE,SUSAR
Measured: 1,4,weeks One year
Recurrence
def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ
Measured: 1,4,26 weeks. 1,2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startOct 2013
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingi Thor Hauksson, University Hospital, Akershus
- Investigators
- Per-Henrik Randsborg, PhD, Study director, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647619
- Sponsor's protocol ID
- 2639063
- Other IDs
- 2013-001221-13
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2015
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.
- ClinicalTrials.gov ID
- NCT02647619
- Acronym / sponsor ID
- 2639063
- Conditions
- Dupuytren Contracture
- Keywords
- Primary Dd disase, MCP joint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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°.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle aponeurotomy | Active comparator | Procedure: Needle aponeurotomypercutaneous transection or pretendinous palmar dupytren cord |
| Xiapex | Active comparator | Drug: XiapexInjection of 0.58 mg collagenase into pretendinous palmar dupytren cord |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XiapexAlso: XiaflexInjection of collagenase of primary dupytren cord | Drug | Xiapex |
| Needle aponeurotomyAlso: Percutaneous needle fasiotomy26 G needle multiple perforation tecqnique with local anesthetic | Procedure or surgery | Needle aponeurotomy |
Primary outcome
Reduction in Total Passive Extension Deficit
Time frame: 5 years
9 secondary outcomes
Quick Dash (Disabilities of the shoulder and Hand)
Time frame: 5 years
EQ5D (Euroqol 5 Dimensions)
Time frame: 5 years
Brief MHQ (Michigan Hand Questionare)
Time frame: 5 years
URAM (Unité Rhumatologique des Affections de la Main)
Time frame: 5 years
Jamar grip strength
Time frame: 1,4,26 weeks and one year.
VAS (Visual analogue scale) pain
Time frame: 1,4,26 weeks and one year
VAS (Visual analogue sale) satisfaction
Time frame: 1,4,26 weeks. 1,2 and 5 years
Complications
Time frame: 1,4,weeks One year
Recurrence
Time frame: 1,4,26 weeks. 1,2 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per-Henrik Randsborg, PhD study director
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiapex and Needle aponeurotomy in people with Dupuytren Contracture, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Total Passive Extension Deficit (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.