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

Launched by SPINE CENTRE OF SOUTHERN DENMARK · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called percutaneous vertebroplasty (PVP) to see if it effectively reduces severe pain in people who have certain types of painful spinal fractures due to osteoporosis. The trial will compare the effects of PVP to a sham procedure, which means some participants will receive a fake treatment that doesn’t actually involve the PVP procedure. Researchers want to find out not only if PVP helps with pain relief but also how it affects patients’ quality of life and any related costs.

To participate in this trial, individuals must be 50 years or older and diagnosed with specific types of painful spinal compression fractures that can be seen on an MRI. Participants should have a significant level of back pain and must be able to understand Danish. Those with serious health issues or certain conditions that prevent them from safely undergoing the procedure will not be eligible. If chosen to participate, individuals can expect to be monitored for 12 weeks to assess how their pain and daily life improve after treatment. Overall, this trial aims to provide valuable information about the benefits and costs of treating osteoporotic spinal fractures.

Gender

ALL

Eligibility criteria

• 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.