Kyphoplasty with single balloon inflation followed by cement filling for osteoporotic vertebral compression fractures

Gang SUN; Peng JIN; Xunwei LIU; Zhiyong XIE; Fandong LI; Yuhai YI; Xuping ZHANG; Runsong HAO

ABSTRACT

BACKGROUND:

In kyphoplasty procedure, two balloons are inserted into the vertebral body and inflated simultaneously for height symmetric restoration of the vertebral body. However, the expensive cost of balloon of kyphoplasty limits the extensive development of this procedure in developing countries. In this study, we try to inflate single balloon with bilateral transpedicular routes alternatively to achieve vertebral body height balanced restoration and reduce operation expenditure. But biocompatibility of bone cement and effect of kyphoplasty still need further observation.

OBJECTIVE:

To investigate the biocompatibility of bone cement and the clinical efficacy of bipedicular kyphoplasty for osteoporotic vertebral compression fractures by inserting single inflatable balloon into injured vertebral body and filling bone cement in the cavity caused by inflating balloon via bipedicular approach.

DESIGN:

Controlled observation.

SETTING:

Department of Medical Imaging, General Hospital of Jinan Military Area Command of Chinese PLA.

PARTICIPANTS:

Twenty-two patients (31 vertebral bodies) undergoing kyphoplasty with single balloon in Department of Medical Imaging, General Hospital of Ji'nan Military Area Command of Chinese PLA from May 2004 to May 2005 were selected, including 5 males and 17 females aged 68-85 years. Patients with painful compression fractures caused by osteoporosis were enrolled, and confirmed by CT and MRI with complete vertebral posterior wall but no spine deformity. The informed consent was obtained from all subjects, and the experiment and treatment were approved by Ethics Committee.

METHODS:

The especial instrument for kyphoplasty including puncturing device and balloon were provided by Shandong Guanlong Medical Utensils Co., Ltd. [LDAI (T) 2004 No. 2150017]; bone cement (Polymethymethacrylate) was made in China [MAIT 2005(T) No. 3650267]. Under X-ray fluoroscopy monitoring, single inflatable balloon was inserted into fractured vertebral body by puncturing needle and inflated via bipedicular approach to restore vertebral height. MAIN OUTCOME

MEASURES:

①Bone cement biocompatibility during and after surgery; ②pain relief within 72 hours after surgery, restoration of vertebral height and correction of kyphotic deformity.

RESULTS:

①Bone cement biocompatibility Little cement leakage was observed at one intervertebral space of one patient by X-ray film, but no clinical symptoms, inflammatory reaction or rejection were found. ②Obvious pain relief was found in 22 cases with within 72 hours after kyphoplasty. ③The height loss of the anterior and middle vertebral body reduced from (14.70±4.21) mm and (10.62±4.11) mm preoperatively to (10.38±4.23) mm and (6.45±4.04) mm postoperatively after single balloon inflation and cement filling. Cobb angle was corrected averagely from (21.15±6.33)° preoperatively to (11.64±4.33)° postoperatively.

CONCLUSION:

Biocompatibility of bone cement is good, and no specific adverse effects are found in despite of cement leakage. Bipedicular kyphoplasty with single balloon for painful osteoporotic vertebral compression fractures effectively restores vertebral heights and relieves pain.