STUDY DESIGN/ SETTING: Class 2 level of evidence: This is a prospective, consecutive series of 229 prosthetic implantations that were concurrently enrolled between single-level versus multilevel cervical arthroplasty comprising an FDA Pilot Study. OBJECTIVE: This study investigated multilevel cervical disc replacement in relation to single-level cervical arthroplasty to find if the same reduction in clinical success would occur with this alternative treatment. SUMMARY OF BACKGROUND DATA: Usually, the clinical outcomes of instrumented cervical fusions deteriorate as the number of vertebral levels of involvement increases. METHODS: A total of 229 patients presented with cervical herniated nucleus pulposus, cervical spondylosis, and/or adjacent segment disease with cervical radiculopathy or myelopathy. Following anterior cervical neurologic decompression seventy-one patients required porous coated motion (PCM) cervical arthroplasties from C3-C4 to C7-T1 (Group S, single level). Sixty-nine patients underwent 158 multilevel PCM cervical arthroplasties (Group M, multilevel) during the same time interval, for the same indications, performed by the same surgeons under the same clinical protocol: double level, 53 cases; three levels, 12 cases: and 4 levels, 4 cases. RESULTS: The self-assessment outcomes instruments showed significantly more improvement for the multilevel cases. The mean improvement in the NDI for the single cases was 37.6% versus the multilevel cases mean improvement in NDI was 52.6% (P = 0.021). The difference between the two was statistically significant. The mean improvement in the VAS showed the same association: single-level mean improvement 58.4% versus the multilevel cases mean VAS improvement was 65.9%. The Odom's were also more improved for the multilevel versus the single-level group: 93.9% versus 90.5% in the excellent, good, and fair categories. The reoperation rates and serious adverse events were similar between the single-level (S = 3) to the multilevel arthroplasty (M = 2) groups. Kaplan-Meier implant survivorship analysis at 3 years for the cohort of 229 prostheses was 94.5% (confidence interval, 1.00-0.820). CONCLUSIONS: This prospective study of cervical arthroplasty is the first report to date showing significantly improved clinical outcomes for multilevel cervical arthroplasty compared with single-level cervical disc replacement using an FDA validated outcome instrument.
STUDY DESIGN/ SETTING: Class 2 level of evidence: This is a prospective, consecutive series of 229 prosthetic implantations that were concurrently enrolled between single-level versus multilevel cervical arthroplasty comprising an FDA Pilot Study. OBJECTIVE: This study investigated multilevel cervical disc replacement in relation to single-level cervical arthroplasty to find if the same reduction in clinical success would occur with this alternative treatment. SUMMARY OF BACKGROUND DATA: Usually, the clinical outcomes of instrumented cervical fusions deteriorate as the number of vertebral levels of involvement increases. METHODS: A total of 229 patients presented with cervical herniated nucleus pulposus, cervical spondylosis, and/or adjacent segment disease with cervical radiculopathy or myelopathy. Following anterior cervical neurologic decompression seventy-one patients required porous coated motion (PCM) cervical arthroplasties from C3-C4 to C7-T1 (Group S, single level). Sixty-nine patients underwent 158 multilevel PCM cervical arthroplasties (Group M, multilevel) during the same time interval, for the same indications, performed by the same surgeons under the same clinical protocol: double level, 53 cases; three levels, 12 cases: and 4 levels, 4 cases. RESULTS: The self-assessment outcomes instruments showed significantly more improvement for the multilevel cases. The mean improvement in the NDI for the single cases was 37.6% versus the multilevel cases mean improvement in NDI was 52.6% (P = 0.021). The difference between the two was statistically significant. The mean improvement in the VAS showed the same association: single-level mean improvement 58.4% versus the multilevel cases mean VAS improvement was 65.9%. The Odom's were also more improved for the multilevel versus the single-level group: 93.9% versus 90.5% in the excellent, good, and fair categories. The reoperation rates and serious adverse events were similar between the single-level (S = 3) to the multilevel arthroplasty (M = 2) groups. Kaplan-Meier implant survivorship analysis at 3 years for the cohort of 229 prostheses was 94.5% (confidence interval, 1.00-0.820). CONCLUSIONS: This prospective study of cervical arthroplasty is the first report to date showing significantly improved clinical outcomes for multilevel cervical arthroplasty compared with single-level cervical disc replacement using an FDA validated outcome instrument.
Authors: Ioannis D Gelalis; Dimitrios V Papadopoulos; Dionysios K Giannoulis; Andreas G Tsantes; Anastasios V Korompilias Journal: Eur J Orthop Surg Traumatol Date: 2017-10-06