Osteoporotic FracturesVOPE2NCT06141187
Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.
A study testing Vertebroplasty in people with Osteoporotic Fractures and Vertebral Fracture, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Fractures, Vertebral Fracture
- What is being tested?
- Vertebroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
- Focal tenderness on the level of the vertebral fracture.
- Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence
- Osteoporotic Fractures type 1-4.
- Fracture involves no more than 4 vertebral body levels.
- PVP can be done in one session.
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- Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.
- Able to understand and read Danish.
- Written informed consent.
- Relevant pain started ≤ 3 months prior to enrollment.
Who cannot join
- - Contra-indications for spine surgery.
- Platelets < 30 mia/l.
- Osteoporotic Fractures type 5 and Pincer-type.
- Complete collapse of the vertebral body precluding insertion of needle.
- Presence of neurologic deficit.
- Contraindications for MRI scanning.
Show all 11Show fewer
- Psychological or psychiatric disorder that is expected to interfere with compliance.
- Active malignancy.
- Mini Mental State Examination (MMSE) test score below 24.
- History of chronic back pain requiring ongoing opiate use.
- Systemic or local infection of the spine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rygcenter Syddanmark
Middelfart, Fyn, 5500
Mikkel Ø Andersen, MD, Mikkel.andersen2@rsyd.dk
Andreas K Andresen, MD, Andreas.Andresen@rsyd.dk
About this study
Official title: Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial
The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty.
The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.
Read the detailed description
The study design is a prospective, double-blind, randomized, sham-controlled clinical trial where patients are stratified into either involvement of 1-2 vertebral levels or 3-4 levels and randomized to either vertebroplasty or a sham operation. The trial is designed in accordance with the SPIRIT guidelines.
Patients will be examined in the outpatient clinic at the Center for Spine Surgery and Research, Lillebaelt Hospital, Kolding, Denmark. MRI scans and X-ray images will be performed at the radiology department at the hospital. Experienced neuro-radiologists carry out image analyses.
Spine surgeons who are experienced in PVP will perform the surgical procedures. Anaesthesiologists and spine surgeons are present at the facility in case of complications, following recommendations by the National Health Authority and have the capacity/capability to decompress the spinal canal in case of cement leakage.
Study subjects will be recruited from patients diagnosed with painful x-ray verified vertebral compression fractures in the Region of southern Denmark. The patients will be identified and referred to the trial site by the patients' general practitioner, chiropractor, physiotherapist, or from hospital inpatient and emergency departments in the region of Southern Denmark.
Subjects will initially be stratified into two groups based on the number of OVCFs into 1-2 levels or 3-4 levels. Within each of these two groups, randomization sheets in varying blocks of 8 with an equal number of PVP and sham patients in each block will be generated using software (www.randomizer.org) and will be placed in numbered, opaque, sealed envelopes. Treatment group assignment will be performed by a scrub nurse in the surgical theatre after the patient is draped but prior to skin incision. Throughout the trial, only the surgeon and the OR-nurse will have knowledge of the treatment assignment. The patient and all assessors remain blinded to the treatment group throughout the study.
During hospitalization, perioperative data on operation time, theater time and complications will be collected from the operating room staff during surgery. Upon discharge, length of stay will be recorded for each patient. After discharge, all visits to the outpatient clinic, either to the surgeon, nurse or physiotherapist as well as phone calls with questions regarding their procedure to the surgical nurse and time spent will be recorded.
Patients will be seen in the clinic for evaluation at 4, 12, and 52 weeks after treatment. MRI and full-standing anteroposterior and lateral radiographs will be taken at the 12-week follow-up time point. This will allow for identification of any healing at the index level as well as any new-onset OVCFs.
Treatment effectiveness analyses of the randomized trial data will performed on an intent-to-treat basis. Enrolled patients and outcome assessors will remain blinded for the duration of the trial. The 12-week follow-up will be the primary endpoint.
- Conditions
- Osteoporotic Fractures, Vertebral Fracture
- Being tested
- Vertebroplasty, Sham Vertebroplasty
- Keywords
- vertebroplasty, Pain
- Medical subject headings
- Osteoporotic Fractures, Spinal Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
PVP
Sham VertebroplastyProcedure or surgery
Sham PVP
| Study group | Role | What they receive |
|---|---|---|
| Vertebroplasty | Active comparator | Polymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy Receives: Procedure: Vertebroplasty |
| Sham vertebroplasty | Sham comparator | A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body. Receives: Procedure: Sham Vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using the 100-point VAS
Self-reported average pain intensity over the previous 24 hours, using the 100-point VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
Measured: VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
Secondary outcomes (5)
Patient-reported disability.
The patients rate their disability at the time of enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization using the Oswestry Disability Index (ODI) questionnaire
Measured: Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization
Health-related quality of life.
HRQL on the EuroQol 5-dimension 5-level (EQ-5D-5L)
Measured: Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization
Global Perceived Effect scale
Global perceived effect of the treatment will be assessed using single question with seven-point descriptive scaling with the answers
Measured: Recorded at 4 and 12 weeks, 12 and 24 months post-randomization
Sagittal balance
Full-length 36" lateral scoliosis radiographs taken with hands placed on the clavicles will be obtained to measure Pelvic Incidence, Pelvic Tilt, Sacral Slope, C7-Plumb Line and Lumbar Lordosis/Thoracic Kyphosis both preoperatively and after 12 months
Measured: Recorded at enrolment and 12 months post-randomization
Societal costs of treatment
The intervention costs will be obtained using data from hospital registries about outpatient contacts, inpatient admissions and length of stay, staff time for surgical procedure, recovery and rehabilitation.
Measured: Recorded 1 day at discharge and 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikkel Ø Andersen, MD, Principal investigator, Sygehus Lillebælt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141187
- Sponsor's protocol ID
- MS/KIR 012/2023
- Acronym
- VOPE2
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the project is terminated, data from the project database will be archived at the Danish National Archives, and the research group will save an anonymized version of patient information from the database. After the project results are published, interested researchers will have two options for re-use of the data: upon receiving required permits they may apply for data extracts from DaneSpine and from the Danish National Archives - or they may receive anonymized raw data from DaneSpine and the project data base from us
Publications
Andersen MO, Andresen AK, Hartvigsen J, Hermann AP, Sorensen J, Carreon LY. Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2. J Orthop Surg Res. 2024 Nov 30;19(1):813. doi: 10.1186/s13018-024-05301-x.
PubMed 39614265
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06141187
- Acronym / sponsor ID
- VOPE2 / MS/KIR 012/2023
- Conditions
- Osteoporotic Fractures, Vertebral Fracture
- Keywords
- vertebroplasty, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Nov 2023 (actual)
- 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 randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty.
The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.
Detailed description
The study design is a prospective, double-blind, randomized, sham-controlled clinical trial where patients are stratified into either involvement of 1-2 vertebral levels or 3-4 levels and randomized to either vertebroplasty or a sham operation. The trial is designed in accordance with the SPIRIT guidelines.
Patients will be examined in the outpatient clinic at the Center for Spine Surgery and Research, Lillebaelt Hospital, Kolding, Denmark. MRI scans and X-ray images will be performed at the radiology department at the hospital. Experienced neuro-radiologists carry out image analyses.
Spine surgeons who are experienced in PVP will perform the surgical procedures. Anaesthesiologists and spine surgeons are present at the facility in case of complications, following recommendations by the National Health Authority and have the capacity/capability to decompress the spinal canal in case of cement leakage.
Study subjects will be recruited from patients diagnosed with painful x-ray verified vertebral compression fractures in the Region of southern Denmark. The patients will be identified and referred to the trial site by the patients' general practitioner, chiropractor, physiotherapist, or from hospital inpatient and emergency departments in the region of Southern Denmark.
Subjects will initially be stratified into two groups based on the number of OVCFs into 1-2 levels or 3-4 levels. Within each of these two groups, randomization sheets in varying blocks of 8 with an equal number of PVP and sham patients in each block will be generated using software (www.randomizer.org) and will be placed in numbered, opaque, sealed envelopes. Treatment group assignment will be performed by a scrub nurse in the surgical theatre after the patient is draped but prior to skin incision. Throughout the trial, only the surgeon and the OR-nurse will have knowledge of the treatment assignment. The patient and all assessors remain blinded to the treatment group throughout the study.
During hospitalization, perioperative data on operation time, theater time and complications will be collected from the operating room staff during surgery. Upon discharge, length of stay will be recorded for each patient. After discharge, all visits to the outpatient clinic, either to the surgeon, nurse or physiotherapist as well as phone calls with questions regarding their procedure to the surgical nurse and time spent will be recorded.
Patients will be seen in the clinic for evaluation at 4, 12, and 52 weeks after treatment. MRI and full-standing anteroposterior and lateral radiographs will be taken at the 12-week follow-up time point. This will allow for identification of any healing at the index level as well as any new-onset OVCFs.
Treatment effectiveness analyses of the randomized trial data will performed on an intent-to-treat basis. Enrolled patients and outcome assessors will remain blinded for the duration of the trial. The 12-week follow-up will be the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebroplasty | Active comparator | Procedure: VertebroplastyPolymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy |
| Sham vertebroplasty | Sham comparator | Procedure: Sham VertebroplastyA short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
- Focal tenderness on the level of the vertebral fracture.
- Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence
- Osteoporotic Fractures type 1-4.
- Fracture involves no more than 4 vertebral body levels.
Key exclusion criteria (11 listed)
- - Contra-indications for spine surgery.
- Platelets < 30 mia/l.
- Osteoporotic Fractures type 5 and Pincer-type.
- Complete collapse of the vertebral body precluding insertion of needle.
- Presence of neurologic deficit.
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 |
|---|---|---|
| VertebroplastyPVP | Procedure or surgery | Vertebroplasty |
| Sham VertebroplastySham PVP | Procedure or surgery | Sham vertebroplasty |
Primary outcome
Pain intensity using the 100-point VAS
Time frame: VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
Self-reported average pain intensity over the previous 24 hours, using the 100-point VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
5 secondary outcomes
Patient-reported disability.
Time frame: Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization
Health-related quality of life.
Time frame: Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization
Global Perceived Effect scale
Time frame: Recorded at 4 and 12 weeks, 12 and 24 months post-randomization
Sagittal balance
Time frame: Recorded at enrolment and 12 months post-randomization
Societal costs of treatment
Time frame: Recorded 1 day at discharge and 12 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 39614265Andersen MO, Andresen AK, Hartvigsen J, Hermann AP, Sorensen J, Carreon LY. Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2. J Orthop Surg Res. 2024 Nov 30;19(1):813. doi: 10.1186/s13018-024-05301-x.
- Individual participant dataSharing planned: No. When the project is terminated, data from the project database will be archived at the Danish National Archives, and the research group will save an anonymized version of patient information from the database. After the project results are published, interested researchers will have two options for re-use of the data: upon receiving required permits they may apply for data extracts from DaneSpine and from the Danish National Archives - or they may receive anonymized raw data from DaneSpine and the project data base from us
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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.
Mikkel Ø Andersen, MD principal investigator
Sygehus Lillebælt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebroplasty in people with Osteoporotic Fractures and Vertebral Fracture, 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 10 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikkel Ø Andersen, MD (+45 2320 9173, mikkel.andersen2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity using the 100-point VAS (time frame: VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141187, which also lists 1 linked publication.
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 6 Jan 2025.