Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

Launched by PROF NICOLAS THEUMANN · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called vertebroplasty, which is used for patients with vertebral compression fractures caused by osteoporosis or tumors. The main goal of the study is to see how a person's spine alignment (sagittal balance) affects their recovery and overall outcomes after the procedure. Researchers will collect information on patients' back pain, how their daily activities are impacted, and any complications that may arise after treatment.

If you are over 18 years old and have a painful vertebral compression fracture confirmed by an MRI, you may be eligible to participate. However, certain conditions may exclude you from the trial, such as severe spinal issues or infections. Participants can expect to receive standard care and follow-up visits as part of the study. Your involvement could help improve understanding of how to better treat and manage vertebral compression fractures in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients \>18 years.
• • Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.
• • Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.
• • Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor
• • Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included.
• • Study Specific Inclusion Criterion • Signed informed consent
• Exclusion Criteria:
• • Infection
• • Vertebral body collapse to less than 1/3 (33%) of original height
• • Vertebral plana (\>90% vertebral body collapse)
• • Spinal stenosis (retro pulsed fragments).
• • Unstable spine warranting surgical stabilization
• • Prophylactic treatment of any vertebrae with vertebroplasty
• • Irreversible life threating bleeding disorders
• • End stage kidney disease
• • Drug dependence (IVDU)
• • Pregnancy
• Study Specific Exclusion Criterion:
• • • Unable or unwilling to follow the standard of care prescribed follow-up visits