Fleck Steffen, Lang Anna, Lehmberg Jens, Landscheidt Julia Fee, Gerlach Ruediger, Rathert Julian, Ulrich Christian, Schär Ralph T, Hartmann Sebastian, Mueller Jan-Uwe, Thome Claudius
Department of Neurosurgery, University Medicine Greifswald, Greifswald, Germany.
Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria.
Global Spine J. 2024 Mar;14(2):429-437. doi: 10.1177/21925682221109563. Epub 2022 Aug 5.
Clinical observational study.
The ROTAIO® cervical disc prosthesis is a novel unconstrained implant with a variable center of rotation aiming at physiological motion. The objective of this multicenter prospective trial was to evaluate clinical outcome and complications within 2 years.
120 patients (72 females and 48 males with median age of 43.0 years [23-60 yrs] underwent ACDA (ROTAIO®, SIGNUS Medical, Alzenau, Germany) and were prospectively followed for 24 months. Preoperative complaints were mainly associated with radiculopathy (n = 104) or myelopathy (n=16). There were 108 monosegmental and 12 bisegmental procedures including 6 hybrid constructs. Clinical outcome was evaluated at 3, 12 and 24 months in 100%, 96% and 77% of the cohort by VAS, NDI, WL-26, Patients Satisfaction Index (PSI), SF-36, Nurick Score, mJOA, Composite Success Rate, complications, patients overall satisfaction and analgesics use.
Highly significant clinical improvements were observed according to NDI and VAS (P < .0001 (arm); P < .001 (neck); P = .002 (head)) at all time points. Analgetic use could be reduced in 87.1 to 95.2%. Doctors visits have been reduced in 93.8% after 24 months. Patients overall satisfaction was high with 78.4 to 83.5% of patients. The composite success rate was 77.5% after 12 months and 76.9% after 24 months. There were no major complications in this series. Slight subsidence of the prosthesis was observed in 2 patients and 3 patients demonstrated fusion after 24 months. 2 patients developed symptomatic foraminal stenosis, so that implant removal and fusion was performed resulting in a revision rate of 1.7% in 2 years.
The ROTAIO® cervical disc prosthesis is a safe and efficient treatment option for symptomatic degenerative disc disease demonstrating highly significant clinical improvement and high patient`s overall satisfaction with very low revision rates at 2 years.
临床观察性研究。
ROTAIO®颈椎间盘假体是一种新型无约束植入物，其旋转中心可变，旨在实现生理运动。这项多中心前瞻性试验的目的是评估2年内的临床结果和并发症。
120例患者（72例女性，48例男性，中位年龄43.0岁[23 - 60岁]）接受了ACDA（ROTAIO®，SIGNUS Medical，德国阿尔策瑙）手术，并进行了为期24个月的前瞻性随访。术前主诉主要与神经根病（n = 104）或脊髓病（n = 16）相关。有108例单节段手术和12例双节段手术，包括6例混合结构手术。分别在术后3个月、12个月和24个月对队列中100%、96%和77%的患者通过视觉模拟评分法（VAS）、颈部功能障碍指数（NDI）、WL - 26、患者满意度指数（PSI）、简明健康状况调查量表（SF -
36）、努里克评分、日本骨科学会脊髓功能评分（mJOA）、综合成功率、并发症、患者总体满意度和镇痛药使用情况来评估临床结果。
在所有时间点，根据NDI和VAS观察到临床有高度显著改善（手臂：P < 0.0001；颈部：P < 0.001；头部：P = 0.002）。镇痛药使用可减少87.1%至95.2%。24个月后就诊次数减少了93.8%。患者总体满意度较高，78.4%至83.5%的患者表示满意。12个月时综合成功率为77.5%，24个月时为76.9%。本系列中无重大并发症。2例患者观察到假体轻微下沉，3例患者在24个月后出现融合。2例患者出现症状性椎间孔狭窄，因此进行了植入物取出和融合手术，2年翻修率为1.7%。
ROTAIO®颈椎间盘假体是治疗症状性退行性椎间盘疾病的一种安全有效的选择，显示出高度显著的临床改善和较高的患者总体满意度，2年翻修率非常低。
