CLINICAL EVIDENCE: VCF MULTISPECIALTY STUDY VERTEBRAL COMPRESSION FRACTURES

MANAGEMENT OF VERTEBRAL COMPRESSION FRACTURES

A Clinical Care Pathway Developed by a Multispecialty Panel Using the RAND/UCLA Appropriateness Method¹

The RAND™/UCLA Appropriateness Method (RAM), developed by a multispecialty expert panel, helped establish a clinical care pathway for patients with vertebral compression fractures (VCF), including:

• Key signs and symptoms of suspected VCF
• Diagnostic evaluation of patients with suspected VCF
• Appropriateness criteria for vertebral augmentation (VA) or nonsurgical management (NSM)
• Contraindications for VA
• Follow-up after treatment

METHODOLOGY

RAM provides a highly structured approach to produce patient-specific recommendations by combining best available scientific evidence with the collective judgment of a panel of experts. Two parts:

Literature review: The final document included the results of 83 studies (systematic reviews, randomized controlled trials, and observational studies), each including at least 200 patients.

Panel process: Twelve-member expert panel chosen by steering committee based on scientific and clinical expertise in diagnosing and treating patients with VCF (Neurosurgery, Interventional Neuro Radiology, Pain Medicine, Orthopedic Surgery).

ASSUMPTIONS

Included:

• Patient presented to ER or outpatient clinic
• Moderate-to-severe back pain (VAS ≥ 5) as the primary or secondary complaint

Excluded:

• High-velocity trauma
• Suspected malignant non-fragility fracture
• Younger than 18 years

This project was supported by a grant from Medtronic. However, Medtronic was not involved in the design or execution of the project, nor the preparation and review of this manuscript. Names of panel members were not disclosed to the sponsor, and panel members were not informed about the identity of the sponsor before submission of the manuscript.

Limitation: Double-blinded doesn’t mitigate that the panel process was subjective input. It included strict adherence by the multidisciplinary experts to adopt the RAND methodology process, based on published clinical evidence and expertise.

View the clinical care pathway recommendations for patients presenting with moderate to severe back pain.

About Balloon Kyphoplasty (BKP)

BKP is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. The complication rate with BKP has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal.

Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as: cardiac arrest, cerebrovascular accident, myocardial infarction, pulmonary embolism, or cardiac embolism.

For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.

Learn more about balloon kyphoplasty.