RecruitingNot Applicable

Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

Denmark240 participantsStarted 2024-01-01

Plain-language 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 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * \- 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. * 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.

What they're measuring

Pain intensity using the 100-point VAS

Timeframe: 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

Trial details

NCT IDNCT06141187

SponsorSpine Centre of Southern Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Mikkel Ø Andersen, MD

+45 2320 9173 mikkel.andersen2@rsyd.dk