Osteoporotic FracturesVOPENCT01537770
Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures
A study testing Percutaneous vertebroplasty and Lidocaine injection in people with Osteoporotic Fractures, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
The main purpose of this study: to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Fractures
- What is being tested?
- Percutaneous vertebroplasty and Lidocaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Apr 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VCF on X-ray of the spine (minimal 15% loss of height) level of VCF Th6 or lower
- back pain ≤ 8 weeks at time of surgery
- ≥ 50 years of age
- bone edema on MRI of the fractured vertebral body
- focal tenderness on VCF level
Who cannot join
- severe cardio-pulmonary condition
- untreatable coagulopathy
- systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
- suspected alternative underlying disease (malignancy)
- radicular and/or cauda compression syndrome
- contra-indication for MRI
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Middelfart Spinesurgery research department
Middelfart, Region Syddanmark, 5500
About this study
Official title: Percutaneous Vertebroplasty Opposite - Infiltration of the Periost and Vertebral Body With Lidocaine - as Pain Palliative Treatment of Osteoporotic Vertebral Fractures of the Thoracic and Lumbar Spine
The main purpose of this study:
- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine.
Secondary purposes:
- To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine.
- measure if there are differences in change of lung capacity between the two methods
Read the detailed description
The objective of this study is to evaluate the efficacy of bone cement injection (PVP) for patients with acute painful osteoporotic compression fractures, as compared with a simulated procedure with injection of Lidocaine. Our hypothesis is, that patients who had undergone PVP would report less pain during the first 1-12 weeks and at 12 months (primary outcomes) than those in the sham control group.
The study design of VOPE is a single center double blinded RCT concerning the treatment of patients with a painful osteoporotic VCF. Patients are referred to the principal investigator at Middelfart hospital from the emergency rooms, orthopedics departments, GP's and chiropractors from the Region of Southern Denmark. Prior to enrolling patients randomization-envelopes are constructed in blocks of 20. Upon obtaining informed consent, a study-number is assigned to each patient. The final randomization for each patient, takes place in the operation room upon opening the sealed envelope deciding which of the two operations are to be performed. A total of 80 patients will be enrolled, 40 in each group. This is based on the assumption of a 2.0 point difference in pain relief (VAS Score) and a maximum of 35% withdrawal rate (α=0.05 and β=0.20). The enrolment of patients will take place in a single center, the spine surgery department of Middelfart hospital in Denmark. Randomization will start February 2012 with an expected completion of enrolment by May 2013. There is a one-year follow-up, with the possibility of an extended follow-up at two years.
The overall Institutional Review Board approval is obtained at Middelfart Hospital.
Osteoporosis- and pain medication:
All patients are, in cooperation with the osteoporosis clinic at Odense University Hospital (OUH), DXA-scanned 3 times during the follow-up period, and receives, regarding these results, the correct antiosteoporotic treatment determined by a endocrinology senior consultant. Analgesics are classified following the WHO classification: (1) Paracetamol (acetaminophen), (2) Tramadol, (3) Tramadol and Paracetamol, (4) Morphine.
Clinical follow-up:
An experienced nurse-practitioner and research consultant requests patients to fill out a standard questionnaire before and at 1 day, 1-11 weeks, and 3 and 12 months after the procedure. The patients will receive a folder including questionnaires for each of the first 11 weeks and will be contacted by telephone once every week and asked to fill out the questionnaires. The questionnaire consist of the VAS and NRS score and questions about use of pain medication. The VAS score is a 10 cm line pain score ranging from "no pain" to "worst pain ever", the NRS is a similar tool where patients are asked in 3 different ways to describe their pain between 0 and 10 where 10 is the worst pain ever. Other medical treatment is registered at 0, 3 and 12 months.
Secondary outcomes are back pain related disability and QOL as measured with the SF-36 Questionnaire and the EuroQol 5D Questionnaire. The EQ5D score ranges from 0 (worst quality of life) to 1 (best quality of life). This questionnaire will be completed at three measurement moments (before and at 3, and 12 months after the procedure). SF-36 scores from 0-100, (100 as the best outcome), 4 domains describing tghe physical function and 4 describing mental health. The lung capacity will be measured by the principal investigator with a spirometer at before and at 3 and 12 months.
Statistical analysis:
The data will be analysed according to the intention-to-treat principle. Standard statistical techniques will be used to describe characteristics of patients in both groups using the STATA programme. If incomparability appears at baseline, we will in secondary analysis adjust for differences. The primary outcome, significant pain relief will be compared with the analysis of variance for repeated measures. If adjustment for possible baseline incomparability is needed, analysis of covariance will be done.
- Conditions
- Osteoporotic Fractures
- Being tested
- Percutaneous vertebroplasty, Lidocaine injection
- Keywords
- Vertebroplasty, Low energy osteoporotic vertebral fractures, of the thoracic and/or lumbar spine
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous vertebroplastyProcedure or surgery
Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.
Lidocaine injectionProcedure or surgery
Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure.
| Study group | Role | What they receive |
|---|---|---|
| Vertebroplasty | Active comparator | Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the cement reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein. Receives: Procedure: Percutaneous vertebroplasty |
| lidocaine injection | Sham comparator | Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure. Receives: Procedure: Lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Primary outcome will be pain relief at 1 day, 1-12 weeks, and 12 months. The questionnaire consist of the Visuel Analog Score ( VAS score), on a 0-100 scale, where 0 is no pain and 100 is so much pain you can immagine and questions about use, ammount and type of pain medication. Patients are asked to fill out the VAS and Numeric Rating Scale (NRS score), a scale from 0 to 10, where 0 is no pain and 10 is is so much pain you can immagine , and use of analgesics is recorded once every week during the first 3 months after randomization.
Measured: 12 Months
Secondary outcomes (4)
European Quality of life 5 Dimensions EQ5D
Quality of life as meassured with the European Quality of life 5 dimensions ( EuroQol 5D) questionnaire at 3 and 12 months. It consists of 5 different questions.
EQ5D ranges from -0.624 to 1.0 where a low value indicates a quality of life worse than death and 1 indicates the highest quality of life
Measured: 12 months
Physical function, disability etc.
The patients fill out the SF-36 questionnaire at baseline and at 3 and 12 months. It consists of 36 questions containing 8 domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning,emotional role functioning, social role functioning, mental health.
Measured: 12 months
Lung capacity
Lungcapacity as examined with a spirometer at 3 and 12 months. The patients history of lungdiseases and use of medicin affecting the lungcapacity is registered at baseline and at 3 and 12 months.
Measured: 12 months
Subsidence of the affected vertebral bodies and local kyphosis
X-ray images of the entire spine, lateral view at 3 and 12 months.
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Emil Jesper Hansen, Spine Centre of Southern Denmark
- Investigators
- Mikkel Ø Andersen, MD, associate Professor, Study chair, Sygehus LillebaeltEmil J Hansen, MD, PhD student, Principal investigator, Sygehus LillebaeltRikke Rousing, PhD, Study director, Sygehus LillebaeltHans Tropp, MD, Professor, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537770
- Sponsor's protocol ID
- 2010-024050-10
- Acronym
- VOPE
- Status last verified
- May 2025
- First submitted
- 17 Feb 2012
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebroplasty Opposite - Infiltration of the Periost and Vertebral Body With Lidocaine - as Pain Palliative Treatment of Osteoporotic Vertebral Fractures of the Thoracic and Lumbar Spine
- ClinicalTrials.gov ID
- NCT01537770
- Acronym / sponsor ID
- VOPE / 2010-024050-10
- Conditions
- Osteoporotic Fractures
- Keywords
- Vertebroplasty, Low energy osteoporotic vertebral fractures, of the thoracic and/or lumbar spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Feb 2012 (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 main purpose of this study:
- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine.
Secondary purposes:
- To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine.
- measure if there are differences in change of lung capacity between the two methods
Detailed description
The objective of this study is to evaluate the efficacy of bone cement injection (PVP) for patients with acute painful osteoporotic compression fractures, as compared with a simulated procedure with injection of Lidocaine. Our hypothesis is, that patients who had undergone PVP would report less pain during the first 1-12 weeks and at 12 months (primary outcomes) than those in the sham control group.
The study design of VOPE is a single center double blinded RCT concerning the treatment of patients with a painful osteoporotic VCF. Patients are referred to the principal investigator at Middelfart hospital from the emergency rooms, orthopedics departments, GP's and chiropractors from the Region of Southern Denmark. Prior to enrolling patients randomization-envelopes are constructed in blocks of 20. Upon obtaining informed consent, a study-number is assigned to each patient. The final randomization for each patient, takes place in the operation room upon opening the sealed envelope deciding which of the two operations are to be performed. A total of 80 patients will be enrolled, 40 in each group. This is based on the assumption of a 2.0 point difference in pain relief (VAS Score) and a maximum of 35% withdrawal rate (α=0.05 and β=0.20). The enrolment of patients will take place in a single center, the spine surgery department of Middelfart hospital in Denmark. Randomization will start February 2012 with an expected completion of enrolment by May 2013. There is a one-year follow-up, with the possibility of an extended follow-up at two years.
The overall Institutional Review Board approval is obtained at Middelfart Hospital.
Osteoporosis- and pain medication:
All patients are, in cooperation with the osteoporosis clinic at Odense University Hospital (OUH), DXA-scanned 3 times during the follow-up period, and receives, regarding these results, the correct antiosteoporotic treatment determined by a endocrinology senior consultant. Analgesics are classified following the WHO classification: (1) Paracetamol (acetaminophen), (2) Tramadol, (3) Tramadol and Paracetamol, (4) Morphine.
Clinical follow-up:
An experienced nurse-practitioner and research consultant requests patients to fill out a standard questionnaire before and at 1 day, 1-11 weeks, and 3 and 12 months after the procedure. The patients will receive a folder including questionnaires for each of the first 11 weeks and will be contacted by telephone once every week and asked to fill out the questionnaires. The questionnaire consist of the VAS and NRS score and questions about use of pain medication. The VAS score is a 10 cm line pain score ranging from "no pain" to "worst pain ever", the NRS is a similar tool where patients are asked in 3 different ways to describe their pain between 0 and 10 where 10 is the worst pain ever. Other medical treatment is registered at 0, 3 and 12 months.
Secondary outcomes are back pain related disability and QOL as measured with the SF-36 Questionnaire and the EuroQol 5D Questionnaire. The EQ5D score ranges from 0 (worst quality of life) to 1 (best quality of life). This questionnaire will be completed at three measurement moments (before and at 3, and 12 months after the procedure). SF-36 scores from 0-100, (100 as the best outcome), 4 domains describing tghe physical function and 4 describing mental health. The lung capacity will be measured by the principal investigator with a spirometer at before and at 3 and 12 months.
Statistical analysis:
The data will be analysed according to the intention-to-treat principle. Standard statistical techniques will be used to describe characteristics of patients in both groups using the STATA programme. If incomparability appears at baseline, we will in secondary analysis adjust for differences. The primary outcome, significant pain relief will be compared with the analysis of variance for repeated measures. If adjustment for possible baseline incomparability is needed, analysis of covariance will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebroplasty | Active comparator | Procedure: Percutaneous vertebroplastyUsing fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the cement reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein. |
| lidocaine injection | Sham comparator | Procedure: Lidocaine injectionUsing fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- VCF on X-ray of the spine (minimal 15% loss of height) level of VCF Th6 or lower
- back pain ≤ 8 weeks at time of surgery
- ≥ 50 years of age
- bone edema on MRI of the fractured vertebral body
- focal tenderness on VCF level
Key exclusion criteria (6 listed)
- severe cardio-pulmonary condition
- untreatable coagulopathy
- systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
- suspected alternative underlying disease (malignancy)
- radicular and/or cauda compression syndrome
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 |
|---|---|---|
| Percutaneous vertebroplastyUsing fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein. | Procedure or surgery | Vertebroplasty |
| Lidocaine injectionUsing fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure. | Procedure or surgery | lidocaine injection |
Primary outcome
Pain relief
Time frame: 12 Months
Primary outcome will be pain relief at 1 day, 1-12 weeks, and 12 months. The questionnaire consist of the Visuel Analog Score ( VAS score), on a 0-100 scale, where 0 is no pain and 100 is so much pain you can immagine and questions about use, ammount and type of pain medication. Patients are asked to fill out the VAS and Numeric Rating Scale (NRS score), a scale from 0 to 10, where 0 is no pain and 10 is is so much pain you can immagine , and use of analgesics is recorded once every week during the first 3 months after randomization.
4 secondary outcomes
European Quality of life 5 Dimensions EQ5D
Time frame: 12 months
Physical function, disability etc.
Time frame: 12 months
Lung capacity
Time frame: 12 months
Subsidence of the affected vertebral bodies and local kyphosis
Time frame: 12
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 2 Jun 2026.
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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.
Mikkel Ø Andersen, MD, associate Professor study chair
Sygehus Lillebaelt
Emil J Hansen, MD, PhD student principal investigator
Sygehus Lillebaelt
Rikke Rousing, PhD study director
Sygehus Lillebaelt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous vertebroplasty and Lidocaine injection in people with Osteoporotic Fractures, run by Spine Centre of Southern Denmark 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 5 inclusion and 6 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 2 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
Pain relief (time frame: 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 2 Jun 2026.