Clinical and Radiographic Outcome of Patients with Cervical Spondylotic Myelopathy Undergoing Total Disc Replacement.

Abstract

MINI: Cervical total disc replacement (with ProDisc Vivio) in patients with CSM yielded good clinical (NDI, VAS, JOA scores, Nurick grades) and radiographic outcomes and was found a reliable, safe and motion preserving surgical treatment option, although its indication is very limited due to numerous exclusion criterias.\n\n\nSTUDY DESIGN\nNon-randomized prospective and single center clinical trial.\n\n\nOBJECTIVE\nInvestigate the clinical and radiographic efficacy of ProDisc Vivo cervical total disc replacement (cTDR) in patients with clinical and radiographic documented cervical spondylotic myelopathy (CSM), due to degenerative changes at the index level.\n\n\nSUMMARY OF BACKGROUND DATA\nDecompression and fusion is still the gold standard in patients with cervical myelopathy. Very limited data are available regarding the application of cTDR in patients with clinical and radiological documented CSM in context of clinical and radiographic outcomes.\n\n\nMETHODS\nClinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires as well as the Nurick grade and the JOA score. The radiological outcome included the range of motion (ROM), the segmental and global (C2-C7) lordosis and the occurrence of heterotopic ossifications.\n\n\nRESULTS\n18 consecutive patients (10 males, 8 females) with documented clinical and radiological signs of myelopathy were included in this investigation. The study population had a mean age of 52.4 years and a follow up period of 20.3 months in average (range 3-48 month). The mean range ROM of the index level stayed consistent with 6.8° preoperatively and 7.2° (p\u200a=\u200a0.578) at the last follow up, the global lordosis in neutral position changed from 3.5° to 14.2° significantly (p\u200a=\u200a0.005) in mean. The JOA score improved from 11.3 to 16.6 (p\u200a<\u200a0.001) as well as the NDI 36.7 to 10.3 (p\u200a<\u200a0.001) and the VAS score from 5.7/6.1\u200a(arm/neck) to 1.3/2.0 (p\u200a<\u200a0.001/p\u200a<\u200a0.001). The mean Nurick grade was 1.33 preoperativley and droped down in all cases to Nurick grade of 0 (p\u200a<\u200a0.001).\n\n\nCONCLUSION\ncTDR (with ProDisc Vivio) in patients with CSM yielded good clinical and radiographic outcomes and was found a reliable, safe and motion preserving surgical treatment option, although its indication is very limited due to numerous exclusion criterias.\n\n\nLEVEL OF EVIDENCE\n4.