Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients

BMC Musculoskeletal Disorders

Jon E Block²  Larry E Miller²  Thomas Repantis¹  Panagiotis Korovessis¹ 

[1] Orthopaedic Department, General Hospital "Agios Andreas", 1 Tsertidou str, 26224 Patras, Greece;Jon E. Block, PhD, Inc., 2210 Jackson Street, Suite 401, San Francisco, CA 94115 USA

关键词: Vertebral augmentation;    Osteoporosis;    Minimally invasive;    Fracture;   

Others  :  1152272
DOI  :  10.1186/1471-2474-12-206

 received in 2011-02-11, accepted in 2011-09-22,  发布年份 2011

【 摘 要 】

Background

Minimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation.

Methods

Forty-two vertebral fractures were identified in 26 consecutive patients (mean age 74 ± 9 years). All patients were treated with a novel percutaneous vertebral augmentation device (Kiva^® VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA). Indications for surgery included recent (≤ 3 months) symptomatic osteoporotic vertebral fracture (n = 34) and pathologic vertebral fractures (e.g. metabolic bone disease, myeloma, metastasis) (n = 8) located between T10 and S1. Patient outcomes were evaluated pre-treatment and at 2- and 6-month follow-up visits. Postoperative cement extravasation was assessed with computed tomography. Patient-reported back pain was quantified using an 11-point numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index on a 0 to 100% scale.

Results

No cases of intraoperative hypotension, respiratory disturbance, neurological deterioration, infection, or death were observed. There were 2 (4.8%) levels where anterior cement leakage was visible radiographically in patients with osteolyses. No intracanal leakage was observed. Back pain scores improved 71% (p < 0.001) from pre-treatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001).

Conclusions

The initial clinical experience with the Kiva^® System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.

【 授权许可】

   
2011 Korovessis et al; licensee BioMed Central Ltd.

【 图 表 】

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