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一项前瞻性多国研究中 Prestige LP 颈椎间盘置换术后的生活质量

Quality of Life Following Prestige LP Cervical Disc Arthroplasty in a Prospective Multicountry Study.

作者信息

Stulik Jan, Ronai Marton, Rudinsky Bruno, Zarzycki Daniel, Latka Dariusz, Matejka Jiri, Baeesa Saleh

机构信息

Department of Spondylosurgery, University Clinic Motol, Praha, Czech Republic.

Department of Orthopaedics, National Center for Spinal Disorders, Budapest, Hungary.

出版信息

Int J Spine Surg. 2019 Jun 30;13(3):221-229. doi: 10.14444/6030. eCollection 2019 Jun.

Abstract

BACKGROUND

To describe routine surgical practice using Prestige LP Cervical Disc (Prestige disc) and patient outcomes for degenerative cervical disc disease in a multicenter 2-year prospective, observational study.

METHODS

Patient demographics and intraoperative data were collected; quality of life (QoL) (EQ-5D, EQ-VAS, and neck disability index), average disc height, and adverse events were assessed pre- and postoperatively at 3, 6, 12, and 24 months.

RESULTS

One hundred and ninety-four patients were enrolled (190 patients implanted; female: 67%; mean age: 44.0 years; mean body mass index: 25.6). Disc herniation was the most frequent indication for cervical arthroplasty (80.5%). Thirty-seven percent of patients experienced pain for >1 year prior to baseline assessment. Mean procedure duration was 87.1 minutes, and mean blood loss was 43.8 mL. The majority (71.0%) of Prestige discs were implanted at level C5 to C6, while 16.3% of patients received implants at 2 levels. There was a significant improvement from baseline to 3, 6, 12, and 24 months of follow-up in all QoL assessments. After implantation, the mean disc height at the affected level increased by 0.19 from baseline (0.22) to 3 months (0.41) and remained constant up to 24 months ( < .001). Mean disc height of levels above and below the implant remained comparable at baseline and follow-up. A total of 63 adverse events (44 patients) was recorded, of which 7 (11.1%) were related to the Prestige disc, instrumentation, or procedure; 41 (65.1%) were unrelated; and 15 (23.8%) had an unknown relation.

CONCLUSIONS

In line with published findings, our study shows significant improvement in outcomes in the first 3 months after Prestige disc implantation with improvements maintained throughout the study.

摘要

背景

在一项为期2年的多中心前瞻性观察研究中,描述使用Prestige LP颈椎间盘(Prestige椎间盘)的常规手术操作及退行性颈椎间盘疾病患者的预后。

方法

收集患者人口统计学资料和术中数据;在术前以及术后3、6、12和24个月评估生活质量(QoL)(EQ-5D、EQ-VAS和颈部残疾指数)、平均椎间盘高度和不良事件。

结果

共纳入194例患者(190例植入;女性:67%;平均年龄:44.0岁;平均体重指数:25.6)。椎间盘突出是颈椎置换术最常见的适应证(80.5%)。37%的患者在基线评估前疼痛超过1年。平均手术时间为87.1分钟,平均失血量为43.8毫升。大多数(71.0%)Prestige椎间盘植入于C5至C6节段,而16.3%的患者接受了2个节段的植入。在所有生活质量评估中,从基线到随访3、6、12和24个月均有显著改善。植入后,患节段的平均椎间盘高度从基线时的0.22增加到3个月时的0.41,增加了0.19,直至24个月保持稳定(P<0.001)。植入节段上下节段的平均椎间盘高度在基线和随访时保持相当。共记录63例不良事件(44例患者),其中7例(11.1%)与Prestige椎间盘、器械或手术相关;41例(65.1%)无关;15例(23.8%)关系不明。

结论

与已发表的研究结果一致,我们的研究表明,Prestige椎间盘植入后的前3个月预后有显著改善,且在整个研究过程中均保持改善。

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