The Clinical Study Of "Internal Retractor" BacFuse For Lumbar Disc Herniation

Objective:To study the short-medium term clinical effect of the BacFuse for the lumbar disc herniation(LDH), to discuss the affect on symptom of patients and structure of spine and to analysis the condition of clinical use.Methods:The study analysis the patients suffered from LDH retrospectively who have been implanted the BacFuse in Beijing Friendship Hospital. There were 25 patients and 29 surgical levels included in the study. The researchers have collected the information of demography and operation. The clinical and X-ray assessment have been done on preoperation, postoperation,3-month,6-month and 12-month, and the CT data was assess on preoperation and postoperation. Clinical index such as VAS, ODI and JOA assessed clinical symptom and physical function. The intervertebral angle, posterior disk height and foraminal height were measured in X-ray. The patients were taken CT at preoperation and postoperation. The area and distance of herniated disc were measured in CT.Results:After implantation, the VAS decreased from (6.61±1.29) on preoperation to (2.78±1.00) on the last follow up, the ODI decreased from (31.9±8.3) to (15.9±6.4), the JOA increased from (9.6±3.0) to (18.8±3.2). The clinical effective rate is 84.0%. In the X-ray, the intervertebral angle decreased from (10.1±5.4)° on preoperation to (8.4±4.9)° on the last follow up, the anterior disk height decreased from (1.60±0.57)cm to (1.48±0.58)cm, the posterior disk height increased from (0.65±0.29)cm to (0.78±0.27)cm, the foraminal height increased from (2.01±0.35)cm on preoperation to (2.16±0.37)cm, however, the foraminal width was not changed. Compared to the data of preoperation, the posterior disk height increased 32.3% and foraminal height increased 10.4% at postoperation, while these have lost 9.3% and 2.7% on the last follow-up. The CT showed that area of herniated disc decreased from (96.4±37.8)mm2 to (83.8±31.1)mm2 (7.4%) and foraminal area increased from (94.7±36.0)mm2 to (106.0±36.3)mm2 (11.8%).Conclusion:The BacFuse can relieve symptom and affect the biomechanics of the spine, which make the herniated disc retract partially, playing a "Internal Retractor" role in spine. BacFuse implantation is a new effective therapy for LDH.