PainNCT00203554
Percutaneous Vertebroplasty Versus Conservative Treatment of Pain
A study testing Poly methylmetacrylate, PMMA in people with Pain and Osteoporosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Osteoporosis, Fracture
- What is being tested?
- Poly methylmetacrylate, PMMA
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2004to Jan 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- new pain in spine (within 6 months)
- x-ray verified low energy spinal fracture(s)
Who cannot join
- less than 20% or more than 90% reduction of the vertebral height
- lack of pain at fracture level
- no need for continuous analgesic treatment
- patient no able to communicate
- general anaesthesia contraindicated
- MRI not possible
Show all 10Show fewer
- coagulopathy (not adjustable)
- spondylitis
- discitis
- spinal metastasis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep of Neuroradiology, Aarhus University Hospital
Aarhus, DK 8000
About this study
Official title: Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine
The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.
Read the detailed description
In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.
The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.
Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.
- Conditions
- Pain, Osteoporosis, Fracture
- Being tested
- Poly methylmetacrylate, PMMA
- Keywords
- osteoporosis, vertebra, fracture, pain, percutaneous, vertebroplasty, polymethylmetacrylate
- Medical subject headings
- Pain, Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly methylmetacrylate, PMMAGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain
Measured: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
Secondary outcomes (1)
Needs for analgetics, number of days at hospital, level of ADL
Measured: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Leif Sorensen, Consultant, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203554
- Sponsor's protocol ID
- 20020306
- Status last verified
- Mar 2008
- First submitted
- 16 Sep 2005
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine
- ClinicalTrials.gov ID
- NCT00203554
- Acronym / sponsor ID
- 20020306
- Conditions
- Pain, Osteoporosis, Fracture
- Keywords
- osteoporosis, vertebra, fracture, pain, percutaneous, vertebroplasty, polymethylmetacrylate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Sep 2005 (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 compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.
Detailed description
In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.
The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.
Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- new pain in spine (within 6 months)
- x-ray verified low energy spinal fracture(s)
Key exclusion criteria (10 listed)
- less than 20% or more than 90% reduction of the vertebral height
- lack of pain at fracture level
- no need for continuous analgesic treatment
- patient no able to communicate
- general anaesthesia contraindicated
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 |
|---|---|---|
| Poly methylmetacrylate, PMMA | Genetic | – |
Primary outcome
Level of pain
Time frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
1 secondary outcome
Needs for analgetics, number of days at hospital, level of ADL
Time frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
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 27 Mar 2008.
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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.
Leif Sorensen, Consultant principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly methylmetacrylate, PMMA in people with Pain and Osteoporosis, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 10 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 27 Mar 2008. 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 Denmark. 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.
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?
Level of pain (time frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.). 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 27 Mar 2008.