1级和2级全椎间盘置换术临床结果比较：一项前瞻性、随机、对照、多中心IDE临床试验的四年结果
Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial.
作者信息
Bae Hyun W, Kim Kee D, Nunley Pierce Dalton, Jackson Robert J, Hisey Michael S, Davis Reginald J, Hoffman Gregory A, Gaede Steven E, Danielson Guy O, Peterson Daniel L, Stokes John M, Araghi Ali
机构信息
*Cedars-Sinai Spine Center, Los Angeles, CA †Department of Neurological Surgery, University of California, Davis, Sacramento, CA ‡Spine Institute of Louisiana, Shreveport, LA §Orange County Neurosurgical Associates, Laguna Hills, CA ¶Texas Back Institute, Plano, TX ‖Greater Baltimore Neurosurgical Associates, Baltimore, MD **Orthopaedics Northeast, Fort Wayne, IN ††Oklahoma Spine & Brain Institute, Tulsa, OK ‡‡Precision Spine Care, Tyler, TX §§Austin Brain & Spine, Austin, TX ¶¶Seton Spine & Scoliosis Center, Austin, TX; and ‖‖The Core Institute, Phoenix, AZ.
出版信息
Spine (Phila Pa 1976). 2015 Jun 1;40(11):759-66. doi: 10.1097/BRS.0000000000000887.
STUDY DESIGN
A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine.
OBJECTIVE
To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up.
SUMMARY OF BACKGROUND DATA
Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications.
METHODS
Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery.
RESULTS
Preoperative characteristics were statistically similar for the 1- and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1- and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group.
CONCLUSION
A 4-year post hoc comparison of 1- and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates.
LEVEL OF EVIDENCE
研究设计
一项前瞻性、随机、多中心的美国食品药品监督管理局医疗器械豁免研究，采用全椎间盘置换术作为颈椎1个或2个连续节段退变性椎间盘疾病的手术治疗方法。
目的
通过48个月的随访，评估单节段或2个连续节段全椎间盘置换术的安全性和有效性。
背景数据总结
颈椎全椎间盘置换术已被证明在24个月时是颈椎前路椎间盘切除融合术的一种安全有效的替代方法。其保留运动功能的能力可避免加速相邻节段病变，从而降低相关并发症的发生率。
方法
在24个地点，患者按2:1的比例随机分组（全椎间盘置换术[TDR]：颈椎前路椎间盘切除融合术[ACDF]）。最终，164例患者接受了单节段TDR，225例患者接受了2个连续节段的TDR。另外24例患者（15例单节段，9例双节段）作为培训病例接受了TDR治疗。结果指标包括颈部功能障碍指数、视觉模拟量表颈部和手臂疼痛评分、简短健康调查问卷（SF-12）心理综合评分（MCS）和身体综合评分（PCS）、活动范围、主要并发症发生率和二次手术率。患者在术后4年内定期接受随访检查。
结果
1级和2级患者组的术前特征在统计学上相似。4年随访率分别为83.1%（1级）和89.0%（2级）。在所有临床结果指标方面，1级和2级TDR组之间没有统计学上的显著差异。与术前评分相比，两个TDR组在每次随访时均有显著改善。2级TDR组报告了1例移位病例。
结论
对同时参加24中心美国食品药品监督管理局医疗器械豁免临床试验的1级和2级TDR患者进行4年的事后比较表明，两组在临床结果、总体并发症发生率和后续手术率方面没有统计学差异。
证据级别
1级
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