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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Osteoporotic Fractures, Vertebral Fracture

In brief

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.

Key facts

Study ID

NCT06141187

Run by

Spine Centre of Southern Denmark

People needed

240

Starts

2024-01-01

Expected to finish

2030-12-31

Last updated by the study team

2025-01-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• - 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.

Where it is running

• Rygcenter Syddanmark — Middelfart, Fyn, Denmark (enrolling)

Full record on ClinicalTrials.gov

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