[Minimally invasive cement augmentation of osteoporotic vertebral compression fractures with the new radiofrequency kyphoplasty].

OBJECTIVE: Minimally invasive cement augmentation of painful osteoporotic vertebral compression fractures in elderly patients. INDICATIONS: Painful osteoporotic vertebral compression fractures in elderly patients (> 65 years of age) after conservative therapy failure. Painful aggressive primary tumors of the spine or osteolytic metastases to the spine with high risk of vertebral fracture in the palliative care setting. CONTRAINDICATIONS: General contraindications for surgical interventions. Local soft-tissue infection. Osteomyelitis, discitis or systemic infection. Coagulopathy refractory to treatment or bleeding diathesis. Asymptomatic vertebral compression fractures. Burst of the posterior vertebral column with high degree of spinal canal stenosis. Primary or metastatic spinal tumors with epidural growth. SURGICAL TECHNIQUE: Prone position on a radiolucent operating table. Fluoroscopic localization of the fractured vertebra using two conventional C-arm devices (anteroposterior and lateral views). Fluoroscopic localization of the fractured vertebra using two conventional C-arm devices (anteroposterior and lateral views). An introducer is inserted through a small skin incision into the pedicle under fluoroscopic guidance. To create a site- and size-specific three-dimensional cavity in the center of the fractured vertebra, the navigational VertecoR™ MidLine Osteotome was inserted through the correctly sited introducer and guided fluoroscopically. As the MidLine Osteotome allows angulation of the tip up to 90° by rotating the handle, a cavity over the midline of the vertebral body can mainly be created through one pedicle. The radiofrequency activated cohesive ultrahigh viscosity PMMA cement (ER(2) bone cement) is injected stepwise on demand by remote control under continuous pressure from the hydraulic assembly into the vertebral body. POSTOPERATIVE MANAGEMENT: Bed rest for 6 h postoperatively in supine position. Early mobilization without a corset on the day of surgery. Specific back and abdominal exercises that strengthen the back and abdominal muscles. Pain dependent increase of weight bearing. Continue osteoporosis therapy and start specific drug therapy according to the local guidlines if necessary.
RESULTS: In all, 44 patients (29 women, 15 men) with a mean age of 73.5 years with a total of 62 painful osteoporotic vertebral fractures were treated with RF kyphoplasty from May 2009 until July 2010, and followed over a period of 12 months. The mean operating time per patient was 36.2 min, the operating time per vertebra was 25.7 min. All the patients studied experienced an early and persistent significant pain relief even 12 months after therapy (8 ± 1.4 vs. 2.7 ± 1.9) according to the visual analogue pain scale. According to the Oswestry Disability Index (ODI) as a disease-specific disability measure all the patients improved significantly (p < 0.001) in the level of disability after operative treatment (56.2 ± 18.8 vs. 34.5 ± 16.6). Cement leakage was detected in 17 out of 62 (27.4 %) augmented vertebrae, whereas all the patients with cement leakage remained asymptomatic. One patient had subsequent vertebral fractures after a period of 6 months.