The bone cement leakage is the most bothersome problem occurring during these procedures. Although most bone cement leakage did not cause clinical symptoms, some articles have reported serious complications such as symptomatic pulmonary embolism and intra-cardiac foreign body (Abdul-Jalil et al., 2007; Kim et al., 2013; Sifuentes Giraldo et al., 2013).
The combination of low-viscosity cement and high injection pressure leads to more frequent cement leakage through fractures and blood vessels (Nieuwenhuijse et al., 2011; Ma et al., 2012). More compression of the vertebral body and greater cortical disruption are also risk factors of bone cement leakage (Nieuwenhuijse et al., 2011). The presence of an
intravertebral cleft is also related to greater bone cement leakage (Ha et al., 2006;
Nieuwenhuijse et al., 2011).
When compared with kyphoplasty, the vertebroplasty itself is a risk factor because of the use of lower viscosity cement and a smaller diameter needle. Leakage rates ranging from 11%
to 73% have been reported in previous studies (Garfin et al., 2001; Watts et al., 2001;
Shapiro et al., 2003). The different diagnostic criteria used for leakage detection by X-ray were assumed to be a cause of this wide range of leakage rates. As shown in the CT study, if stricter criteria were applied, the leakage rate determined by X-ray would significantly increase (Schmidt et al., 2005).
Meta-analysis of the bone cement leakage rate revealed a value of 21.6% for
vertebroplasty and 13.1% for kyphoplasty, and the difference was statistically significant (Ma et al., 2012). The lower leakage rate is a practical reason for the preference for
kyphoplasty. The leakage rate in the present study was 51.4% for vertebroplasty and 43.8%
for kyphoplasty, and these values were not statistically different (Table 2). The high rate of bone cement leakage of the conventional vertebroplasty could be adequately reduced by the use of the bone filler device.
- 20 - F. Leakage risk factors due to preoperative conditions
Logistic regression analysis of the preoperative conditions showed BMD and diagnosis to operation interval to be the significant risk factors. The bone cement leakage decreased 48.2% when BMD decreased by one unit. The leakage decreased 3.4% when diagnosis to operation interval decreased by one day (Table 5). In turn, an osteoporotic vertebra with low BMD had a low risk of bone cement leakage. Early operation after diagnosis also decreased the leakage rate. The operation type was not a statistically significant risk factor; the choice of the vertebroplasty with the bone filler device was not a risk factor of bone cement leakage.
Although the intravertebral cleft was generally considered to be a risk factor for bone cement leakage, a recent study reported that it was not (Tanigawa et al., 2009). The present study also supported this conclusion as the logistic regression analysis also indicated that the intravertebral cleft was not a risk factor.
G. Limitations
The present study had several limitations. It was non-randomized and observational study.
A control group that underwent conservative management was not included. The bone cement injection pressure and velocity were controlled manually. Operative results were one surgeon’s results. Multicenter research and would increase reliability. Randomized case control trials should be evaluated.
- 21 -
V. CONCLUSION
Kyphoplasty is regarded as the next step in conventional vertebroplasty. However, this procedure has a few drawbacks such as destruction of the vertebral trabecular structure, a lumped shape bone cement distribution, and higher medical costs. Vertebroplasty with a bone filler device is a simple and familiar procedure. It showed an equivalent compression ratio reduction to that achieved with kyphoplasty. The bone cement distribution was more physiological and lumped distribution was avoided. Sufficient bone cement injection was possible without increasing the rate of bone cement leakage. Therefore, vertebroplasty with a bone filler device can be considered as a compatible option for the osteoporotic compression fracture, and has the advantages of both conventional vertebroplasty and kyphoplasty.
- 22 -
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- 27 -
- 국문 요약 -
피스톤 방식 주입기를 이용한 척추체 성형술의 효과
아주대학교 대학원 의학과 양 동 훈
(지도교수: 조 기 홍)
배경: 척추체 성형술과 풍선 척추체 성형술은 골다공증성 척추 압박골절에 널리 쓰이는 치료법이다. 풍선 척추체 성형술이 더 나은 효과를 보인다고 알려져 있으 나 척추체의 골소주를 파괴하고 비용이 더 높다는 단점이 있다.
목적: 피스톤 방식 뼈시멘트 주입기를 이용한 척추체 성형술과 풍선 척추체 성형 술의 결과를 비교한다.
연구 디자인: 두 가지 수술 그룹의 비교를 통한 단면 연구.
연구 대상: 2008년 1월부터 2012년 10월까지 수술을 시행한 222명.
결과 측정: 수술 전 후의 척추체 높이, 척추체 압박율, 및 Cobb 각도를 측정하고 비교하였다.
방법: 222명 중 27명을 제외한 195명의 환자가 포함되었으며, 1분절의 골절은 169 명 이었고 (86.7%), 두 분절의 골절은 26명 이었다 (13.3%). 총 221개의 척추 분 절에 대해 두 그룹간의 차이를 알기 위해 통계학적 분석을 시행하였다.
결과: 척추체 높이와 압박율은 Cobb각도와 비교 시 더 높은 상관관계를 보였으 며. 세 변수 중 척추체 압박율이 가장 영향력 있는 변수였다. 일반선형모델로 보
- 28 -
정한 수술 후 척추체 높이와 Cobb 각도는 두 수술 그룹 간 유의한 차이를 보인 반면, 보정한 수술 후 압박율은 유의한 차이를 보이지 않았다 (p < 0.05). 뼈시멘 트 분포는 척추체 성형술 군에서는 대부분이 spongy형태를 보였으나 (94.5%), 풍 선 척추체 성형술 군에서는 42%로 낮았다. 높은 골밀도 (BMD) 수치와 진단 후 수술까지의 긴 기간은 뼈시멘트 누출을 증가시키는 위험 인자였다.
결론: 피스톤 방식 뼈시멘트 주입기를 이용한 척추체 성형술은 풍선 척추체 성형 술과 대등한 압박율 복원 및 뼈시멘트 누출율을 보일 뿐 아니라, 대부분이 spongy 형태의 뼈시멘트 분포를 보여. 척추체 성형술과 풍선 척추체 성형술의 이 점을 함께 보여주는 효과적인 치료 방법으로 생각된다.
핵심어: 척추체 성형술, 풍선 척추체 성형술, bone filler, 척추체 압박 골절, 뼈시멘 트