- 作者：Matthew Songer ; David Baskin ; Mark Kabins ; Arden Reynolds ; Paul Zak
- 刊名：The Spine Journal
- 出版年：2002
- 出版时间：September - October 2002
- 年：2002
- 卷：2
- 期：5, Supplement 1
- 页码：64
- 全文大小：46 K
Purpose: The purpose is to determine if coralline hydroxyapatite is equivalent to autograft in fusion rates and clinical outcome at 36 months in anterior cervical fusions.
Methods used: Fifty-eight patients requiring a one- or two-level anterior cervical fusion for degenerative conditions or herniated disc were enrolled in this prospective, randomized, controlled, multicenter investigational study. They were randomly assigned to receive either ProOsteon 200 coralline hydroxyapatite or iliac crest autograft. An anterior cervical plate was used with either bone graft material. Patients were followed with sequential X-rays for a minimum of 2 years to evaluate graft incorporation. Independent assessment of fusion was based on radiographic evidence of trabecular bridging. Clinical outcomes entailed pre- and posttreatment assessments of patient-reported pain, medication usage, functional capacity, work status and neurological status. Complication rates were compared for both groups.
of findings:Of the 58 subjects, 20 were male and 38 were female. Twenty-eight patients received iliac crest autograft, and 30 received coralline hydroxyapatite. The mean follow-up was 38 and 36 months for the coralline hydroxyapatite and autogenous groups, respectively. There was no significant difference in the demographics between the two groups except with respect to smoking habits and number of levels fused. The coralline hydroxyapatite group had a higher percentage of smokers (43 % vs. 32 % autograft) and had more levels fused (47 % single vs. 71 % in autograft). There was no significant difference between the groups in fusion rates (96 % for autograft and 83 % in the coralline hydroxyapatite group, P=.195) and percent of collapse (17 % for coralline hydroxyapatite group and 7 % for autograft group, P=.425).
The clinical outcome scores all improved comparably in both groups. At 2 years after surgery, there was no difference in the pain, medication, work and functional scores. There were six complications in the coralline hydroxyapatite group and five in the autograft group. Eight of the 11 complications occurred in smokers. There were five nonunions in the coralline hydroxyapatite group; three were smokers, and one was elderly (79 years) with multiple medical problems. There were no harvest site complications in the coralline hydroxyapatite group, whereas there were 14 % harvest-related events in the autograft group (p=.106). In the autograft group there was one nonunion (smoker) and four graft site complications (two infections and two prolonged pain [longer than 3 months]).
Relationship between findings and existing knowledge: There was no significant difference in the fusions rates or degree of subsidence of these two graft materials. The most significant difference was the lack of donor site morbidity, which resulted in a shorter hospital stay and quicker return to work. The failures of the coralline hydroxyapatite occurred in patients with high risk of nonunion (smokers and one elderly man with multiple medical problems).
Overall significance of findings: Coralline hydroxyapatite bone graft substitute in anterior cervical interbody fusions has a fusion rate equivalent to autograft without the donor graft morbidity in patients without high risk factors for nonunion. This is an acceptable and lower-cost alternative to allograft, and the return to normal function is quicker compared with an autograft.
Disclosures: Device or drug: ProOsteon 200 coralline hydroxyapatite. Status: investigational, synthesis cervical plate: approved.
Conflict of interest: Matthew Songer, received financial support from Pro Osteon.