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Efficacy and Safety of Balloon
Kyphoplasty Compared with
Non-Surgical Care for
Vertebral Compression
Fracture (FREE):
A Randomised
Controlled Trial





Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S for the Fracture REduction Evaluation (FREE) Study Investigators. The Lancet. March 2009; Vol 373:1016-24.

24-month Data FREE Study Outcomes12-month Data FREE Study Outcomes

Balloon Kyphoplasty versus
Non-surgical Fracture Management for Treatment of Painful Vertebral Body Compression Fractures in Patients with Cancer: A Multicentre, Randomised Controlled Trial


Berenson J, Pflugmacher R, Jarzem P,
Zonder J, Schechtmann K, Tillman JB,
Bastian L, Ashraf T, Vrionis F, for the
Cancer Patient Fracture Evaluation
(CAFE) Investigators.

The Lancet Oncology
Published Online February 17, 2011

CAFE Study Outcomes
Relief.
Mobility.
Quality of Life.

Kyphon® Balloon Kyphoplasty

Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures (VCFs) by reducing and stabilizing the fractures. It has been clinically shown to reduce the fracture, relieve back pain, and improve quality of life.

Unlike other treatments, balloon kyphoplasty utilizes orthopedic balloons to restore vertebral body height and correct angular deformity. Through a bilateral approach, balloons are guided through working cannulae into the vertebra and carefully inflated to reduce the fracture.

After reduction, the balloons are deflated and removed. The resulting cavity (void) allows for a controlled deposition of Kyphon® bone cement, forming an internal cast and stabilizing the fracture.