Osteoporotic Vertebral Compression FractureUNI-BI PVPNCT07198776
Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia
A study testing Percutaneous Vertebroplasty in people with Osteoporotic Vertebral Compression Fracture, run by Igor Movrin at 1 site in Slovenia.
Trial summary
Osteoporotic vertebral compression fractures are a common cause of severe back pain and disability in elderly patients. Percutaneous vertebroplasty (PVP) with polymethylmethacrylate (PMMA) cement is widely used to relieve pain and stabilize the fractured vertebra. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoporotic Vertebral Compression Fracture
- What is being tested?
- Percutaneous Vertebroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2022to 30 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- Active infection
- Coagulopathy
- Burst fracture with retropulsion
- Neurological deficit
- Malignancy-related fracture
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Center Maribor, Department of Traumatology
Maribor, 2000
About this study
Official title: Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia: A Prospective Randomised Comparative Study With 6-Month Follow-Up
Osteoporotic vertebral compression fractures are a common cause of severe back pain and disability in elderly patients. Percutaneous vertebroplasty (PVP) with polymethylmethacrylate (PMMA) cement is widely used to relieve pain and stabilize the fractured vertebra. However, there is ongoing debate whether unilateral or bilateral vertebroplasty provides better clinical and radiological outcomes. This prospective randomized controlled trial was conducted at the University Medical Center Maribor to compare unilateral versus bilateral PVP performed under local anaesthesia. A total of 196 patients with acute osteoporotic vertebral compression fractures were enrolled and randomly assigned to one of the two groups. The primary outcome measure was pain reduction assessed by Visual Analogue Scale (VAS). Secondary outcomes included functional improvement measured by the Oswestry Disability Index (ODI), procedure duration, fluoroscopy time, injected cement volume, radiological changes (vertebral height, kyphotic angle), and perioperative complications. The results are expected to provide evidence to guide optimal surgical management of osteoporotic vertebral fractures.
- Being tested
- Percutaneous Vertebroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous VertebroplastyProcedure or surgery
Injection of PMMA cement into fractured vertebra under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Vertebroplasty | Experimental | Patients undergo percutaneous unilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia. Receives: Procedure: Percutaneous Vertebroplasty |
| Bilateral Vertebroplasty | Active comparator | Patients undergo percutaneous bilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia. Receives: Procedure: Percutaneous Vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (VAS score)
Pain intensity measured on a Visual Analogue Scale (0-10; higher scores = worse pain).
Measured: From baseline (preoperative) to 6 months post-procedure
Oswestry Disability Index (ODI)
Oswestry Disability Index score, range 0-100%, higher scores = greater disability.
Measured: From baseline to 6 months post-procedure
Secondary outcomes (6)
Operative time
Duration of vertebroplasty procedure measured in minutes.
Measured: During procedure
Fluoroscopy time
Duration of fluoroscopic exposure during vertebroplasty, measured in seconds.
Measured: During procedure
Injected cement volume
Total volume of polymethylmethacrylate (PMMA) cement injected into the fractured vertebra, measured in milliliters.
Measured: During procedure
Vertebral height restoration
Percentage restoration of anterior vertebral body height on lateral radiographs.
Measured: From baseline (preoperative) to hospital discharge (postoperative day 1)
Kyphotic angle correction
Change in local kyphotic angle (°) on lateral radiographs.
Measured: From baseline (preoperative) to hospital discharge (postoperative day 1)
Complications
Incidence of perioperative and follow-up complications, including cement leakage, adjacent fractures, infection, or neurological events.
Measured: Intraoperative and 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Jan 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral Compression FractureStudies 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
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igor Movrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Igor Movrin, University Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198776
- Sponsor's protocol ID
- National Medical Ethics Commit
- Acronym
- UNI-BI PVP
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia: A Prospective Randomised Comparative Study With 6-Month Follow-Up
- ClinicalTrials.gov ID
- NCT07198776
- Acronym / sponsor ID
- UNI-BI PVP / National Medical Ethics Commit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Igor MovrinUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Sep 2025 (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.
Osteoporotic vertebral compression fractures are a common cause of severe back pain and disability in elderly patients. Percutaneous vertebroplasty (PVP) with polymethylmethacrylate (PMMA) cement is widely used to relieve pain and stabilize the fractured vertebra. However, there is ongoing debate whether unilateral or bilateral vertebroplasty provides better clinical and radiological outcomes. This prospective randomized controlled trial was conducted at the University Medical Center Maribor to compare unilateral versus bilateral PVP performed under local anaesthesia. A total of 196 patients with acute osteoporotic vertebral compression fractures were enrolled and randomly assigned to one of the two groups. The primary outcome measure was pain reduction assessed by Visual Analogue Scale (VAS). Secondary outcomes included functional improvement measured by the Oswestry Disability Index (ODI), procedure duration, fluoroscopy time, injected cement volume, radiological changes (vertebral height, kyphotic angle), and perioperative complications. The results are expected to provide evidence to guide optimal surgical management of osteoporotic vertebral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Vertebroplasty | Experimental | Procedure: Percutaneous VertebroplastyPatients undergo percutaneous unilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia. |
| Bilateral Vertebroplasty | Active comparator | Procedure: Percutaneous VertebroplastyPatients undergo percutaneous bilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Active infection
- Coagulopathy
- Burst fracture with retropulsion
- Neurological deficit
- Malignancy-related fracture
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 VertebroplastyInjection of PMMA cement into fractured vertebra under fluoroscopic guidance. | Procedure or surgery | Bilateral Vertebroplasty, Unilateral Vertebroplasty |
Primary outcome
Change in pain intensity (VAS score)
Time frame: From baseline (preoperative) to 6 months post-procedure
Pain intensity measured on a Visual Analogue Scale (0-10; higher scores = worse pain).
Oswestry Disability Index (ODI)
Time frame: From baseline to 6 months post-procedure
Oswestry Disability Index score, range 0-100%, higher scores = greater disability.
6 secondary outcomes
Operative time
Time frame: During procedure
Fluoroscopy time
Time frame: During procedure
Injected cement volume
Time frame: During procedure
Vertebral height restoration
Time frame: From baseline (preoperative) to hospital discharge (postoperative day 1)
Kyphotic angle correction
Time frame: From baseline (preoperative) to hospital discharge (postoperative day 1)
Complications
Time frame: Intraoperative and 6 months post-procedure
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 30 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Osteoporotic Vertebral Compression Fracture, run by Igor Movrin at 1 site in Slovenia.
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 0 inclusion and 5 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 30 Sep 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 Slovenia. 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?
Change in pain intensity (VAS score) (time frame: From baseline (preoperative) to 6 months post-procedure). The study lists 2 primary outcomes in all. 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 30 Sep 2025.