Dupuytrens ContracturePhase 4PNFvsxiapexNCT02476461
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
A Phase 4 study testing xiapex and percutaneous needle fasciotomy in people with Dupuytrens Contracture, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytrens Contracture
- What is being tested?
- xiapex and percutaneous needle fasciotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees
Who cannot join
- previous treated dupuytrens contracture same hand
- more than tree fingers involvement
- we will not include thumbs
- other things affecting hand function
- ASA>3
- expected to live under five years
Show all 11Show fewer
- Tetracycline treatment within two weeks
- pregnancy
- nursing
- allergy to clostridium histolyticum
- participant in other trial
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo Universitetssykehus
Oslo, Oslo, 0424
hallgeir bratberg, MD, +4790578848, hbratbe@ous-hf.no
About this study
Official title: Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.
Read the detailed description
Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.
A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.
The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.
The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.
The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.
Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.
Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.
Exclution criteria:
Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial
- Conditions
- Dupuytrens Contracture
- Being tested
- xiapex, percutaneous needle fasciotomy
- Keywords
- percutanepus needle fasciotomy, xiapex, clostridium histolyticum
- 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 clostridium histolyticum
percutaneous needle fasciotomyProcedure or surgery
Also called PNF
| Study group | Role | What they receive |
|---|---|---|
| xiapex | Active comparator | 1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual Receives: Drug: xiapex |
| PNF | Experimental | percutaneous needle fasciotomi is performed at affected cords Receives: Procedure: percutaneous needle fasciotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
contracture size (degrees)
Measured: five years
Secondary outcomes (1)
contracture size
Contracture size mesured in degrees in each finger joint
Measured: post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytrens ContractureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hallgeir bratberg, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476461
- Sponsor's protocol ID
- 1234
- Acronym
- PNFvsxiapex
- Status last verified
- Apr 2015
- First submitted
- 5 Jun 2015
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
- ClinicalTrials.gov ID
- NCT02476461
- Acronym / sponsor ID
- PNFvsxiapex / 1234
- Conditions
- Dupuytrens Contracture
- Keywords
- percutanepus needle fasciotomy, xiapex, clostridium histolyticum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 19 Jun 2015 (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.
The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.
Detailed description
Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.
A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.
The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.
The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.
The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.
Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.
Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.
Exclution criteria:
Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xiapex | Active comparator | Drug: xiapex1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual |
| PNF | Experimental | Procedure: percutaneous needle fasciotomypercutaneous needle fasciotomi is performed at affected cords |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees
Key exclusion criteria (11 listed)
- previous treated dupuytrens contracture same hand
- more than tree fingers involvement
- we will not include thumbs
- other things affecting hand function
- ASA>3
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: clostridium histolyticum | Drug | xiapex |
| percutaneous needle fasciotomyAlso: PNF | Procedure or surgery | PNF |
Primary outcome
contracture size (degrees)
Time frame: five years
1 secondary outcome
contracture size
Time frame: post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
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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.
hallgeir bratberg, MD principal investigator
Oslo University Hospital
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 percutaneous needle fasciotomy in people with Dupuytrens Contracture, run by Oslo University Hospital 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hallgeir bratberg, MD (+4790578848, hbratber@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contracture size (degrees) (time frame: five 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 19 Jun 2015.