Jae Hyup Lee1, Chang-Bae Kong2, Jae Jun Yang3, Hee-Jong Shim4, Ki-Hyoung Koo3, Jeehyoung Kim5, Choon-Ki Lee6, Bong-Soon Chang7. 1. Department of Orthopedic Surgery, College of Medicine, Seoul National University, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Korea; Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-Gu, Seoul, 07061, Korea. 2. Department of Orthopedic Surgery, Korea Cancer Center Hospital, 75, Nowon-ro, Nowon-gu, Seoul, Korea. 3. Department of Orthopedic Surgery, Dongguk University Ilsan Hospital, 27, Dongguk-ro, Ilsan Dong-gu, Goyang-si, 10326, Korea. 4. Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-Gu, Seoul, 07061, Korea. 5. Department of Orthopedic Surgery, Seoul Sungsim General Hospital, 259, Wangsan-ro, Dongdaemun-gu, Seoul, 02488, Korea. 6. Department of Orthopedic Surgery, College of Medicine, Seoul National University, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Korea; Department of Orthopedic Surgery, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Korea. 7. Department of Orthopedic Surgery, College of Medicine, Seoul National University, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Korea; Department of Orthopedic Surgery, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Korea. Electronic address: bschang@snu.ac.kr.
Abstract
BACKGROUND CONTEXT: The CaO-SiO2-P2O5-B2O3 glass ceramics spacer generates chemical bonding to adjacent bones with high mechanical stability to produce a union with the end plate, and ultimately stability. PURPOSE: The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with a titanium cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field. STUDY DESIGN/ SETTING: This is a prospective, stratified randomized, multicenter, single-blinded, comparator-controlled non-inferiority trial. PATIENT SAMPLE: The present study was conducted in four hospitals and enrolled a total of 86 patients between 30 and 80 years of age who required one-level PLIF due to severe spinal stenosis, spondylolisthesis, or huge disc herniation. OUTCOME MEASURES: The Oswestry Disability Index (ODI), Short Form-36 Health Survey (SF-36), and pain visual analog scale (VAS) were assessed before surgery and at 3, 6, and 12 months after surgery. The spinal fusion rate was assessed at 6 and 12 months after surgery. METHODS: The spinal fusion rate and the area of fusion, subsidence of each CaO-SiO2-P2O5-B2O3 glass ceramics and titanium cage, and the extent of osteolysis were evaluated using a dynamic plain radiography and a three-dimensional computed tomography at 12 months after surgery. The present study was supported by BioAlpha, and some authors (JHL, C-KL, and B-SC) have stock ownership (<10,000 US dollars). RESULTS: From the plain radiography results, the 6-month fusion rates for the bioactive glass ceramics group and the titanium group were 89.7% and 91.4%, respectively. In addition, the 12-month fusion rates based on CT scan were 89.7% and 91.2%, respectively, showing no significant difference. However, the bone fusion area directly attached to the end plate of either bioactive glass ceramics or the titanium cage was significantly higher in the bioactive glass ceramics group than in the titanium group. The ODI, SF-36, back pain, and lower limb pain in both groups significantly improved after surgery, with no significant differences between the groups. No significant differences between the two groups were observed in the extent of subsidence and osteolysis. CONCLUSIONS: In lumbar posterior interbody fusion surgery, CaO-SiO2-P2O5-B2O3 glass ceramics spacer showed a similar fusion rates and clinical outcomes compared with titanium cage.
RCT Entities:
BACKGROUND CONTEXT: The CaO-SiO2-P2O5-B2O3 glass ceramics spacer generates chemical bonding to adjacent bones with high mechanical stability to produce a union with the end plate, and ultimately stability. PURPOSE: The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with a titanium cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field. STUDY DESIGN/ SETTING: This is a prospective, stratified randomized, multicenter, single-blinded, comparator-controlled non-inferiority trial. PATIENT SAMPLE: The present study was conducted in four hospitals and enrolled a total of 86 patients between 30 and 80 years of age who required one-level PLIF due to severe spinal stenosis, spondylolisthesis, or huge disc herniation. OUTCOME MEASURES: The Oswestry Disability Index (ODI), Short Form-36 Health Survey (SF-36), and pain visual analog scale (VAS) were assessed before surgery and at 3, 6, and 12 months after surgery. The spinal fusion rate was assessed at 6 and 12 months after surgery. METHODS: The spinal fusion rate and the area of fusion, subsidence of each CaO-SiO2-P2O5-B2O3 glass ceramics and titanium cage, and the extent of osteolysis were evaluated using a dynamic plain radiography and a three-dimensional computed tomography at 12 months after surgery. The present study was supported by BioAlpha, and some authors (JHL, C-KL, and B-SC) have stock ownership (<10,000 US dollars). RESULTS: From the plain radiography results, the 6-month fusion rates for the bioactive glass ceramics group and the titanium group were 89.7% and 91.4%, respectively. In addition, the 12-month fusion rates based on CT scan were 89.7% and 91.2%, respectively, showing no significant difference. However, the bone fusion area directly attached to the end plate of either bioactive glass ceramics or the titanium cage was significantly higher in the bioactive glass ceramics group than in the titanium group. The ODI, SF-36, back pain, and lower limb pain in both groups significantly improved after surgery, with no significant differences between the groups. No significant differences between the two groups were observed in the extent of subsidence and osteolysis. CONCLUSIONS: In lumbar posterior interbody fusion surgery, CaO-SiO2-P2O5-B2O3 glass ceramics spacer showed a similar fusion rates and clinical outcomes compared with titanium cage.