BACKGROUND: We evaluated the fusion efficacy and clinical outcomes of a cage containing a biphasic calcium phosphate ceramic (Triosite) in treating cervical spondylosis. METHODS: We randomly divided 100 patients with cervical spondylosis undergoinganterior discectomy with interbody polyetheretherketone (PEEK) fusion into 2 groups in the past 2 years: group A (n = 50), PEEK cage containing a biphasic calcium phosphate ceramic (Triosite), and group B (n = 50), PEEK cage containing an autogenous iliac bone graft. We compared the fusion rate, fusion time, spinal curvature, and neuroforamen size between the 2 groups. We also compared excess operation time, excess blood loss, hospital stay, complications, and neurological recovery status between the groups. RESULTS: The fusion rates were 57%, 67%, 77%, 82%, 92%, and 100% in group A and 81%, 86%, 95%, 95% 100%, and 100% in group B in the first 6 postoperative months. The fusion rate in group A was significantly lower than that in group B in the first 5 months after the procedure (P < .05 and P < .01, respectively), but the fusion rate reached 100% in both groups by the sixth month. Within the first 6 months, as the fusion level increased, the fusion rates reduced and time to fusion was delayed in both groups. There were no donor site complications in group A. However, 3 patients (6%) from group B experienced complications (1, wound infection; 1, numbness of thigh; and 1, subcutaneous hematoma) (P < .001). The hospital stay was shorter in group A (4.43 +/- 2.36 days) than in group B (7.00 +/- 3.77 days) (P = .001). The mean excessive blood loss and excessive operative time for an iliac bone graft in group B were 15 +/- 5 mL and 10 +/- 6 minutes. There was no statistical significance in spinal curve correction, neuroforamen enlargement, and neurological recovery. CONCLUSIONS: A cage containing a biphasic calcium phosphate ceramic resulted in complete fusion by the sixth postoperative month, although the fusion rate was lower than that in a cage containing an autograft during the first 5 months after the operation and the time to fusion was delayed. Using a cage containing a biphasic calcium phosphate ceramic leads to a shorter hospital stay, less blood loss, shorter operative time, and no donor site complications. It seemed to be a good substitute for cervical spondylotic fusion.
RCT Entities:
BACKGROUND: We evaluated the fusion efficacy and clinical outcomes of a cage containing a biphasic calcium phosphate ceramic (Triosite) in treating cervical spondylosis. METHODS: We randomly divided 100 patients with cervical spondylosis undergoing anterior discectomy with interbody polyetheretherketone (PEEK) fusion into 2 groups in the past 2 years: group A (n = 50), PEEK cage containing a biphasic calcium phosphate ceramic (Triosite), and group B (n = 50), PEEK cage containing an autogenous iliac bone graft. We compared the fusion rate, fusion time, spinal curvature, and neuroforamen size between the 2 groups. We also compared excess operation time, excess blood loss, hospital stay, complications, and neurological recovery status between the groups. RESULTS: The fusion rates were 57%, 67%, 77%, 82%, 92%, and 100% in group A and 81%, 86%, 95%, 95% 100%, and 100% in group B in the first 6 postoperative months. The fusion rate in group A was significantly lower than that in group B in the first 5 months after the procedure (P < .05 and P < .01, respectively), but the fusion rate reached 100% in both groups by the sixth month. Within the first 6 months, as the fusion level increased, the fusion rates reduced and time to fusion was delayed in both groups. There were no donor site complications in group A. However, 3 patients (6%) from group B experienced complications (1, wound infection; 1, numbness of thigh; and 1, subcutaneous hematoma) (P < .001). The hospital stay was shorter in group A (4.43 +/- 2.36 days) than in group B (7.00 +/- 3.77 days) (P = .001). The mean excessive blood loss and excessive operative time for an iliac bone graft in group B were 15 +/- 5 mL and 10 +/- 6 minutes. There was no statistical significance in spinal curve correction, neuroforamen enlargement, and neurological recovery. CONCLUSIONS: A cage containing a biphasic calcium phosphate ceramic resulted in complete fusion by the sixth postoperative month, although the fusion rate was lower than that in a cage containing an autograft during the first 5 months after the operation and the time to fusion was delayed. Using a cage containing a biphasic calcium phosphate ceramic leads to a shorter hospital stay, less blood loss, shorter operative time, and no donor site complications. It seemed to be a good substitute for cervical spondylotic fusion.