An interventional study of Vertebroplasty and Sham Vertebroplasty in Osteoporotic Fractures and Vertebral Fracture, sponsored by Spine Centre of Southern Denmark. Recruiting at 1 site in Denmark. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Spine Centre of Southern Denmark · Not applicable, Interventional, and Treatment
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.
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.
87 studies on the registry are indexed under Osteoporotic Fractures; 22 are open to participants now.
This study's planned enrollment of 240 is above the median of 120 across 49 interventional studies indexed under Osteoporotic Fractures.
Browse Osteoporotic Fractures studies →Spine Centre of Southern Denmark is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Polymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy
Procedure: Vertebroplasty
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.
Procedure: Sham Vertebroplasty
PVP
Sham PVP
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
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
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Recorded 1 day at discharge and 12 months post-randomization
Plan to share: 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
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2028, 59 months after the start.
Of 22 interventional studies with no phase under Osteoporotic Fractures, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's planned 59 months is above that.
How these figures are worked out, and which studies are left out of them.
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Spine Centre of Southern Denmark