18S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S-205S

PATIENT SAMPLE: 23 patients without osteoporotic background and

whose CT scan showed evidence for thoracolumbar compression fracture

(A1, A2, A3.1) were prospectively included after a spinal traumatic event.

All patients underwent a percutaneous procedure using a VCCEI within 10

days post trauma (20 single level, 3 double level).

OUTCOME MEASURES: CT scans were performed prior to surgery, at

discharge and at 6 months follow-up. Clinical data such as VAS score, pain

medication, and time to discharge were also collected before and after

surgery.

METHODS: All data were collected and analyzed by an external statisti-

cal unit. Height restoration was calculated using the 9 points method based

on measurement of specific anatomical points. A new method using pre-

and post-op CT Scans has been developed by the LBM-ENSAM (PARIS)

allowing vertebral 3D mapping and assessment of height restoration after

surgery.

RESULTS: No complication has been observed for any of the patients. VAS

score showed a pain reduction from 7.1 to 2.1 on average after surgery asso-

ciated with pain medication reduction. Mean time to discharge without brace

was 3.2 days. Mean height restoration at anterior part of vertebra was 2.3 mm

(min:0,1 mm/max:7.2 mm) and 2.4 mm (min:0.1 mm/max:6.9 mm) at the

mid-portion. The 3D mapping showed an improvement of height greater than

those calculated by the 9 points method.

CONCLUSIONS: The use of this permanent VCCEI in burst fractures

allows quick discharge of patient and provides a good height restoration

specifically for patients treated within one week after the traumatic event.

These preliminary results are encouraging and must lead to a further study

enrolling a larger number of patients comparing this VCCEI with orthopedic

treatments. Moreover, the 3D mapping of the pre- and post-treated vertebrae

might be a useful tool in the future to avoid measurements bias met with the 9

points method which does not show the complete vertebral body height

restoration.

FDA DEVICE/DRUG STATUS: SpineJack: Investigational/Not approved.

doi: 10.1016/j.spinee.2009.08.041

33. Therapeutic Efficacy of Injectable Calcium Phosphate Cement in

Osteoporotic Vertebral Body Compression Fracture: Prospective

Non-Randomized Controlled Study

Park Chun-Kun, MD; The Catholic University of Korea, Seoul, South

Korea

BACKGROUND CONTEXT: Vertebral augmentation with polymethyl-

methacrylate (PMMA) cement has become a major treatment modality

of osteoporotic vertebral compression fractures (VCF). However, PMMA

has several disadvantages such as inorganic material, potential thermal

necrosis and monomer toxicity.

PURPOSE: To elucidate clinical efficacy of an injectable calcium phos-

phate cement (CPC) for kyphoplasty in VCF, which is nontoxic, osteocon-

ductive and bioabsorbable, and potentiality to replace PMMA.

STUDY DESIGN/SETTING: Prospective non-randomized controlled

study with the full approval of IRB.

PATIENT SAMPLE: Consecutive cases of osteoporotic vertebral body

compression fractures between April 2006 and January 2007.

OUTCOME MEASURES: Assessment of the clinical outcome was done

using VAS and ODI.

METHODS: According to the predesigned protocol, the evaluation was

done 1 day before, 2 days after and then again at 3 months and 6 months

after the operation. All patients underwent far lateral extrapedicular single

balloon kyphoplasty with CPC under an informed consent. Assessment of

the clinical outcome was done using VAS and ODI. The degrees of verte-

bral height loss and kyphotic angle were measured by observing plain X-

ray. Blood test for variation of postoperative serum calcium levels was

done in all cases.

RESULTS: Total 26 patients were composed of 4 males and 22 females. The

age was ranged from 57 to 87 years (mean age: 72.23 6 8.96). Twenty-one

patients received the operation in single vertebra and five patients in two ver-

tebrae, so total 31 vertebrae were treated. Mean maximal volume of balloon

inflation was 4.3560.71 cc (ranged from 3 to 6 cc). The average amount of

CPC in a single vertebra was 3.6860.87 cc (ranged from 2 to 5 cc). At six

month after operation, the VAS and ODI was decreased from 7.5361.07

to 2.2361.42 (P50.000) and from 31.6561.57 to 16.9261.71 (P50.000),

respectively. The degree of preoperative vertebral height loss (mean;

26.71613.22%) was not changed at 1 month after operation (mean;

26.67611.98%) (p50.987). However, at 6 months after operation, the pro-

gression of vertebral height loss was observed (mean; 37.35614.59%,

p50.000). The preoperative kyphotic angle (mean; 8.4367.10) was not

changed at 1 month after operation (mean; 7.5468.09) (p50.313). The angle

was getting increased until 6 months after operation, but statistically not

significant (mean; 9.5067.26, p50.080). Postoperative serum calcium level

was within normal ranges, and there was no systemic complication related to

CPC. Postoperatively, small amount of CPC leakage to spinal canal was

observed in 15 cases, among which no patient presented clinical symptoms

but one patient of transient intercostal neuralgia.

CONCLUSIONS: Our results demonstrate that the injectable CPC has

therapeutic efficacy without serious complications or violation of serum

calcium level. However, several disadvantages of CPC were observed in

the present study: Poor injectability of CPC, which caused insufficient

filling of the cave made by balloon inflation; progressive loss of augmen-

tation properties during follow-up. High occurrence rate of epidural leak-

age of CPC also could be a potential shortcoming.

FDA DEVICE/DRUG STATUS: Balloon Kyphoplasty: Approved for this

indication; Injectable Calcium Phophate: Investigational/Not approved.

doi: 10.1016/j.spinee.2009.08.042

34. Balloon Kyphoplasty Improves Roland-Morris Disability Scores

and Bone Pain Among Cancer Patients with Vertebral Compression

Fractures: Interim Analysis from a Phase IV Randomized Trial

Frank Vrionis, MD, PhD1, John Tillman2, Mohamad Hussein, MD3,

Robert Pflugmacher, MD4, Peter Jarzem, MD5, Zonder Jeffrey6,

James Berenson7; 1Tampa, FL, USA; 2Sunnyvale, CA, USA; 3Moffitt

Research & Cancer Center, Tampa, FL, USA; 4Charite Hospital University

Berlin, Berlin, Germany, Germany; 5Santa Cabrini Hospital, Montreal,

QC, Canada; 6Wayne State University, Detroit, MI, USA; 7University of

California, Los Angeles, Los Angeles, CA, USA

BACKGROUND CONTEXT: Destructive vertebral lesions are a common

source of morbidity among patients with cancer. Kyphoplasty is a mini-

mally invasive surgical procedure performed for patients with painful ver-

tebral compression fractures (VCFs) with the goal of reducing pain and

disability and improving quality of life.

PURPOSE: The Cancer Fracture Evaluation (CAFE) trial was initiated to com-

pare effectiveness and safety of balloon kyphoplasty to nonsurgical care for

treating acute, painful vertebral compression fractures among cancer patients.

STUDY DESIGN/SETTING: This is an international, multicenter,

randomized, controlled clinical study.

PATIENT SAMPLE: Adult patients diagnosed with a variety of cancers

and 3 painful VCFs (VAS 4) were randomly assigned to kyphoplasty

(N570) or nonsurgical supportive care (N564). Patients with primary

bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture

site were excluded as well as patients with spinal cord compression.

OUTCOME MEASURES: The primary objective was to determine the

change in the Roland-Morris Disability questionnaire at one month. Back

pain and adverse events were also assessed.

METHODS: 21 sites enrolled 134 patients after consent and ethical

review board approval. Kyphoplasty subjects were treated using a percuta-

neous, bilateral approach; control patients received conservative treatment

according to the standard practices of participating hospitals. We describe

1-month follow-up results from a preplanned interim analysis. For pain and

function, patients with complete data are included whereas all enrolled

patients were analyzed for safety.