Stephen I Ryu1, Michelle Mitchell, Daniel H Kim. 1. Department of Neurosurgery, Stanford University, 300 Pasteur Drive, R-297, Stanford, CA 94305, USA. seoulman@stanford.edu
Abstract
INTRODUCTION:Intervertebral carbon fiber cages may reduce graft collapse and promote bony fusion. Their safety and efficacy in the cervical spine have been investigated; however, no study has compared the outcomes of anterior cervical decompression and placement of a carbon fiber cage with placement of allograft and plate. METHODS:Forty consecutive patients who met inclusion criteria were enrolled and randomized to anterior cervical discectomy with carbon fiber cage alone (n=20) or with allograft with plating (n=20). Clinical and radiographic evaluations were performed at baseline and at 6 weeks, 3, 6, 12 and 24 months. Neck and arm pain as well as neck disability index (NDI) were assessed at every visit. The Short Form (SF)-36 was completed prior to operation and at 12-month intervals. Cervical radiographs were evaluated pre-op and at every follow-up for evidence of fusion and instability. RESULTS: No significant difference was found between the two randomized groups with respect to pre-operative age (mean 50 years), sex, employment status, duration of pain or cervical levels affected. The mean follow-up period was 14 months (range, 6-26 months). The clinical pain and disability improvements were similar for both treatments. Post-operative donor site pain was only present in the cage group, but not of significant long-term disability. At up to 24 months, NDI scores were significantly improved in both groups when compared with baseline. At 12 and 24 months, all SF-36 questionnaire responses were also improved in both the treatment groups. However, there was no statistically significant difference in outcomes between the two groups at any time. The fusion rate was 100% in both groups by 12 and 24 months, without evidence of instability. There were no differences in complications between both groups. CONCLUSIONS: The outcomes after cervical decompression and placement of a carbon fiber cage appear to be similar to cervical decompression with allograft and plating by the Smith-Robinson technique.
RCT Entities:
INTRODUCTION: Intervertebral carbon fiber cages may reduce graft collapse and promote bony fusion. Their safety and efficacy in the cervical spine have been investigated; however, no study has compared the outcomes of anterior cervical decompression and placement of a carbon fiber cage with placement of allograft and plate. METHODS: Forty consecutive patients who met inclusion criteria were enrolled and randomized to anterior cervical discectomy with carbon fiber cage alone (n=20) or with allograft with plating (n=20). Clinical and radiographic evaluations were performed at baseline and at 6 weeks, 3, 6, 12 and 24 months. Neck and arm pain as well as neck disability index (NDI) were assessed at every visit. The Short Form (SF)-36 was completed prior to operation and at 12-month intervals. Cervical radiographs were evaluated pre-op and at every follow-up for evidence of fusion and instability. RESULTS: No significant difference was found between the two randomized groups with respect to pre-operative age (mean 50 years), sex, employment status, duration of pain or cervical levels affected. The mean follow-up period was 14 months (range, 6-26 months). The clinical pain and disability improvements were similar for both treatments. Post-operative donor site pain was only present in the cage group, but not of significant long-term disability. At up to 24 months, NDI scores were significantly improved in both groups when compared with baseline. At 12 and 24 months, all SF-36 questionnaire responses were also improved in both the treatment groups. However, there was no statistically significant difference in outcomes between the two groups at any time. The fusion rate was 100% in both groups by 12 and 24 months, without evidence of instability. There were no differences in complications between both groups. CONCLUSIONS: The outcomes after cervical decompression and placement of a carbon fiber cage appear to be similar to cervical decompression with allograft and plating by the Smith-Robinson technique.
Authors: F Kandziora; R Pflugmacher; J Schäfer; C Born; G Duda; N P Haas; T Mittlmeier Journal: Spine (Phila Pa 1976) Date: 2001-09-01 Impact factor: 3.468