Meta-analysis of anterior cervical decompression and fusion ROI-CTM self-locking system in treatment of degenerative cervical spondylosis

doi:10.12307/2025.114

Abstract

Abstract: OBJECTIVE: Anterior cervical decompression and fusion is a classic surgical method for the treatment of degenerative cervical spondylosis. The use of nail plates increases the fusion rate and stability and indirectly leads to adjacent vertebral degeneration and postoperative dysphagia. In this paper, the clinical results and complications of ROI-CTM self-locking system and traditional cage combined with screw-plate internal fixation in the treatment of degenerative cervical spondylosis were compared by meta-analysis to provide evidence-based support for the selection of internal fixation methods in anterior cervical decompression and fusion.
METHODS: CNKI, WanFang, VIP, PubMed, Cochrane Library, Web of Science, and Embase databases were searched for Chinese and English literature on the application of ROI-CTM self-locking system and fusion cage combined with screw plate internal fixation in the treatment of degenerative cervical spondylosis. The retrieval time range was from inception to July 2023. Two researchers selected the literature strictly according to the inclusion and exclusion criteria. The Cochrane bias risk tool was used to evaluate the quality of randomized controlled trials. Newcastle-Ottawa Scale was used to assess the quality of cohort studies. Meta-analysis was performed using RevMan 5.4 software. Outcome indicators included operation time, intraoperative blood loss, Japanese Orthopaedic Association score, Neck Disability Index, C2-C7 Cobb angle, fusion rate, incidence of adjacent vertebral degeneration, cage subsidence rate, and incidence of dysphagia.
RESULTS: Thirteen articles were included, including eleven retrospective cohort studies and two randomized controlled trials, with 1 136 patients, 569 in the ROI-C group, and 567 in the cage combined with the nail plate group. Meta-analysis results showed that the operation time (MD=-15.52, 95%CI:-18.62 to -12.42, P < 0.000 01) and intraoperative blood loss (MD=-24.53, 95%CI:-32.46 to -16.61, P < 0.000 01) in the ROI-C group and the fusion device combined with nail plate group. Postoperative adjacent segment degeneration rate (RR=0.40, 95%CI:0.27-0.60, P < 0.000 01) and postoperative total dysphagia rate (RR=0.18, 95%CI:0.13-0.26), P < 0.000 01) were statistically different. The two groups had no significant difference in Japanese Orthopaedic Association score, Neck Disability Index, C2-C7 Cobb angle, fusion rate, or cage subsidence rate (P ≥ 0.05).
CONCLUSION: Applying an ROI-CTM self-locking system and traditional cage combined with plate internal fixation in anterior cervical decompression and fusion can achieve satisfactory clinical results in treating degenerative cervical spondylosis. The operation of the ROI-CTM self-locking system is more straightforward. Compared with a cage combined with plate internal fixation, the ROI-CTM self-locking system can significantly reduce the operation time and intraoperative blood loss and has obvious advantages in reducing the incidence of postoperative dysphagia and adjacent segment degeneration. The ROI-CTM self-locking system is recommended for patients with skip cervical spondylosis and adjacent vertebral disease. However, given its possible high settlement rate, using a fusion cage combined with screw-plate internal fixation is still recommended for patients with degenerative cervical spondylosis with multiple segments and high-risk factors of fusion cage settlement, such as osteoporosis and vertebral endplate damage.

Key words: anterior cervical approach, decompression fusion, anterior cervical decompression and fusion, cervical spondylosis, ROI-C, self-locking system, cage+screw-plate, meta-analysis

CLC Number:

Zhou Yanjie, Cao Chunfeng, Zhang Zhongzu, Niu Xiong, Wang Xin, Yang Zaihai, Zhou Liang, Li Bo. Meta-analysis of anterior cervical decompression and fusion ROI-CTM self-locking system in treatment of degenerative cervical spondylosis[J]. Chinese Journal of Tissue Engineering Research, 2025, 29(3): 617-627.

Figures/Tables 10

2.4 Meta分析结果 2.4.1 各组手术时间差异共12篇文献对比了手术时间[7，10-17，19-21]，有5篇文献按节段分亚组比较了手术时间[13-15，17，19]，其中4篇文献涉及2个手术时间组[13-15，19]，1篇文献涉及3个手术时间组[17]。亚组分析的数据在http://statstodo.com/CombineMeansSDs.php网站上将每个亚组的均值和标准差进行合并，使用合并后的均值和标准差进行数据分析[22]。 HOFSTETTER等[12]的数据采用的是mean±SEM，在RevMan软件中将数据转换为mean±SD后，进行数据分析。采用固定效应模型(P=0.15，I2=30%)。结果显示：两组手术时间差异有显著性意义(MD=-15.52，95%CI：-18.62至-12.42，P < 0.000 01)，见图4。 2.4.2 各组术中出血量差异共12篇文献对比了术中出血量[7，10-17，19-21]，有5篇文献按节段分亚组比较了手术出血量[13-15，17，19]，其中4篇文献涉及2个术中出血量组[13-15，19]，1篇文献涉及3个术中出血量组[17]。同样在http://statstodo.com/CombineMeansSDs.php网站上将亚组分析的均值和标准差进行合并，在RevMan软件中将HOFSTETTER等[12]的数据转换为Mean±SD后，再进行数据合并。各研究之间存在异质性(P < 0.000 01，I2=76%)，采用随机效应模型。结果显示：两组术中出血量差异有显著性意义(MD=-24.53，95%CI：-32.46至-16.61，P < 0.000 01)，见图5。 2.4.3 各组术前与术后JOA评分差异共8篇文献对比了术前JOA评分[7，10-11，13，15，17，19-20]，采用固定效应模型进行分析(P=0.40，I2=4%)，结果显示：两组术前JOA评分无显著性差异(MD=-0.01，95%CI：-0.22-0.21，P=0.96)。7篇文献对比两者术后1个月JOA评分[7，10-11，13，15，19-20]，10篇文献对比两者末次随访JOA评分[7，10-11，13-17，19，20]，各统计组之间具有统计学异质性(P=0.003，I2=63%)，采用随机效应模型。结果显示，两组术后1个月JOA评分(MD=-0.05，95%CI：-0.35-0.24，P=0.72)与末次JOA评分(MD=0.17，95%CI：-0.11-0.45，P=0.23)均无显著性差异，见图6。 2.4.4 各组术前与术后颈椎功能障碍指数差异共8篇文献对比两组术前颈椎功能障碍指数[7，10，11，13-15，17，19]，各研究之间存在异质性(P=0.14，I2=36%)，采用固定效应模型，合并结果显示：两组术前颈椎功能障碍指数无显著性差异(MD=0.27，95%CI：-0.44-0.98，P=0.46)。共有5篇文献对比了两组术后1个月颈椎功能障碍指数[7，10-11，13，15]，8篇文献对比了两组末次随访颈椎功能障碍指数[7，10-11，13-15，17，19]，采用随机效应模型(P=0.06，I2=41%)，结果显示：两组术后1个月颈椎功能障碍指数评分 (MD=0.23，95%CI：-0.72-1.17，P=0.64)与末次随访颈椎功能障碍指数评分指数评分 (MD=0.16，95%CI：-0.57-0.89，P=0.66，均无显著性差异，见图7。"

2.4.9 各组术后吞咽困难发生情况共4篇文献对比了两组术后吞咽困难发生情况[13，15-16，21]，4篇文献对比了两组术后1个月吞咽困难发生情况[10-11，13，21]，6篇文献对比了两组术后3个月吞咽困难发生情况[10，12-14，19，21]，9篇文献对比了两组术后末次随访吞咽困难发生情况[10，11，13-17，19，21]，采用固定效应模型进行分析(P=0.92，I2=0%)。结果显示：两组术后(RR=0.22，95%CI：0.12-0.39，P < 0.000 01)、术后1个月(RR=0.31，95%CI：0.17-0.57，P =0.000 2)、3个月(RR =0.10，95%CI：0.04-0.24，P < 0.000 01)、末次随访(RR=0.12，95%CI：0.05-0.30，P < 0.000 01)吞咽困难发生率差异均有显著性意义，总的吞咽困难发生率也有显著性意义(OR=0.18，95%CI：0.13-0.26，P < 0.000 01)，见图12。 2.5 亚组分析结果 2.5.1 手术时间按手术节段将手术时间分为单节段、双节段和多节段3个亚组进行分析。共有5篇文献记录了单节段的手术时间[10，13，15，17，19]，有6篇文献记录了双节段的手术时间[10，13，15，17，19，21]，2篇文献记录了多节段的手术时间[14，17]，其中LIU等[14]分别记录了3节段和4节段的手术时间，一并纳入多节段组。异质性较高(P < 0.000 01，I2=92%)，采用随机效应模型。结果显示：两组在单节段(MD=-14.32，95%CI：-18.88至-9.76，P < 0.000 01)、双节段(MD=-14.05，95%CI：-15.01至-13.09，P < 0.000 01)、多节段(MD=-23.76，95%CI：-29.67至-17.85，P < 0.000 01) 手术时间差异均有显著性意义，所有数据合并后两组手术时间差异也具有显著性意义(MD=-17.82，95%CI：-21.77至-13.86，P < 0.000 01)。3个亚组之间差异有显著性意义(P=0.006，I2=80.2%)，见图13。 2.5.2 术中出血量按手术节段将其分为单节段、双节段和多节段进行亚组分析。共有5篇文献记录了单节段的术中出血量[10，13，15，17，19]，有6篇文献记录了双节段的术中出血量[10，13，15，17，19，21]，2篇文献记录了多节段的术中出血量[14，17]，同样将LIU等[14]的数据一并纳入多节段组，采用随机效应模型(P=0.09，I2=54%)。结果显示：两组术中出血量在单节段(MD=-17.17，95%CI：-20.98至-13.35，P < 0.000 01)、双节段(MD=-18.48，95%CI：-27.97至-8.99，P=0.000 1)、多节段(MD=-17.04，95%CI：-23.58至-10.51，P < 0.000 01)均有显著性意义，所有数据合并后两组术中出血量差异也具有显著性意义(MD=-17.39，95%CI：-21.13至-13.66，P < 0.000 01)。3个亚组之间不存在统计学上的差异(P=0.97，I2=0%)，见图14。 2.6 敏感性分析结果将ZHOU等[18]和宋升等[20]的随机对照研究剔除后重新合并分析，发现在手术时间、术中出血量、融合率和术后邻近椎体退变异质性较前无明显改变，同时两组比较结果与之前一致，提示Meta分析结果可靠。对术后JOA评分和颈椎功能障碍指数进行敏感性分析，发现LI等[13]的研究可能为异质性来源，剔除该项研究后重新进行合并分析发现异质性明显减少(I2=0%)，采用固定效应模型分析，结果表明两组患者术后JOA评分和颈椎功能障碍指数仍无显著性差异(P > 0.05)，提示Meta分析结果相对可靠。对术中出血量和手术时间进行逐一剔除研究后重新合并分析，发现异质性较前无明显变化，未找到明显异质性来源。考虑到术中出血量和手术时间与术者经验、习惯和熟练程度及手术节段等高度相关，从而导致研究间异质性较大。对于术后融合器沉降进行逐一剔除研究后重新合并分析，发现Meta分析结果随之发生改变，提示Meta分析结果稳定性较差。考虑术后融合器沉降与术者的操作及骨密度等多种因素相关，可能是导致结果稳定性较差的原因，因该研究纳入的文献较少，关于两者术后融合器沉降率的高低，未来仍需进一步的研究。 "

References

[1] BOER LFR, ZORZETTO E, YEH F, et al. Degenerative cervical disorder-stand-alone cage versus cage and cervical plate: a systematic review. Global. Spine J. 2021; 11(2):249-255.
[2] OLIVER JD, GONCALVES S, KEREZOUDIS P, et al. Comparison of outcomes for anterior cervical discectomy and fusion with and without anterior plate fixation: a systematic review and meta-analysis. Spine. 2018;43(7):E413-E422.
[3] EPSTEIN NE. A Review of complication rates for anterior cervical diskectomy and fusion (ACDF). Surg Neurol Int. 2019;10:100.
[4] 宋燕美,赵改平,李鹏祥,等. ROI-C椎间融合器植入对颈椎生物力学的影响[J].医用生物力学,2018,33(2):114-120.
[5] BUCCI MN, OH D, COWAN RS, et al. The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes. Med Devices. 2017;10:61-69.
[6] IAMPREECHAKUL P, CHOOCHAIMANGKHALA P, TIRAKOTAI W, et al. Zero-profile anchored spacer (ROI-C) in the treatment of cervical adjacent segment disease. Asian J Neurosurg. 2022;17(2): 209-217.
[7] JIN ZY, TENG Y, WANG H Z, et al. Comparative analysis of cage subsidence in anterior cervical decompression and fusion: zero profile anchored spacer (ROI-C) vs. conventional cage and plate construct. Front. Surg. 2021;8:736680.
[8] XU J, HE Y, LI Y, et al. Incidence of subsidence of seven intervertebral devices in anterior cervical discectomy and fusion: a network meta-analysis. World Neurosurg. 2020;141:479-489.e4.
[9] GUO Z, WU X, YANG S, et al. Anterior cervical discectomy and fusion using zero-p system for treatment of cervical spondylosis: a meta-analysis. Pain Res Manag. 2021;2021:3960553.
[10] HE S, ZHOU Z, LV N, et al. Comparison of clinical outcomes following anterior cervical discectomy and fusion with zero-profile anchored spacer-ROI-C-fixation and combined intervertebral cage and anterior cervical discectomy and fusion: a retrospective study from a single center. Med Sci Monit. 2021;27:e931050.
[11] HE S, ZHOU Z, SHAO X, et al. Comparing the bridge-type zero-profile anchored spacer (ROI-C) interbody fusion cage system and anterior cervical discectomy and fusion (ACDF) with plating and cage system in cervical spondylotic myelopathy. Orthop Surg. 2022;14(6):1100-1108.
[12] HOFSTETTER CP, KESAVABHOTLA K, BOOCKVAR JA. Zero-profile anchored spacer reduces rate of dysphagia compared with ACDF with anterior plating. J Spinal Disord Tech. 2015;28(5): E284-E290.
[13] LI P, LEI R, GAN L, et al. Comparing clinical and radiographic outcomes between the self-locking stand-alone cage and conventional cage-plate construct: a five-year retrospective cohort study. Spine (Phila Pa 1976). 2023;48(1):56-66.
[14] LIU Y, WANG H, LI X, et al. Comparison of a zero-profile anchored spacer (ROI-C) and the polyetheretherketone (PEEK) cages with an anterior plate in anterior cervical discectomy and fusion for multilevel cervical spondylotic myelopathy. Eur Spine J. 2016;25(6):1881-1890.
[15] WANG Z, JIANG W, LI X, et al. The application of zero-profile anchored spacer in anterior cervical discectomy and fusion. Eur Spine J. 2015;24(1):148-154.
[16] XIONG X, LIU JM, CHEN WW, et al. Outcomes of different zero-profile spacers in the treatment of two-level cervical degenerative disk disease. Eur Spine J. 2023;32(7):2448-2458.
[17] ZHOU J, LI J, LIN H, et al. A comparison of a self-locking stand-alone cage and anterior cervical plate for ACDF: minimum 3-year assessment of radiographic and clinical outcomes. Clin Neurol Neurosurg. 2018;170:73-78.
[18] ZHOU J, LI J, LIN H, et al. Could self-locking stand-alone cage reduce adjacent-level ossification development after aneterior cervical discectomy and fusion? J Clin Neurosci. 2020;78:60-66.
[19] 曹泽岗,夏刚,万军,等.颈椎前路椎间盘切除椎间融合术:零切迹自锁式椎间融合系统与传统融合器联合钛板内固定对比分析[J].中国现代神经疾病杂志, 2022,22(8):687-695.
[20] 宋升,孙振中,姜为民,等.ROI-C与传统融合器联合钛板内固定治疗颈椎病:颈椎稳定性重建及椎间融合的比较[J].中国组织工程研究,2019,23(28): 4474-4478.
[21] 张俊辉,许华亮,昌宏,等.颈前路零切迹融合器ROI-C与前路钛板内固定治疗双节段脊髓型颈椎病的比较[J].中国组织工程研究,2020,24(21):3329-3335.
[22] SUN Z, LIU Z, HU W, et al. Zero-profile versus cage and plate in anterior cervical discectomy and fusion with a minimum 2 years of follow-up: a meta-analysis. World Neurosurg. 2018;120:e551-e561.
[23] 李秋园,孙中仪,田纪伟.颈前路减压融合两种内固定的进展[J].中国矫形外科杂志,2022,30(3):244-247.
[24] WANG Z, ZHU X, WANG Z, et al. Zero-P and ROI-C implants versus traditional titanium plate with cage to treat cervical spondylotic myelopathy: clinical and radiological results with 5 years of follow-up. BMC Musculoskeletal Disorders. 2023;24(1):539.
[25] TSALIMAS G, EVANGELOPOULOS DS, BENETOS IS, et al. Dysphagia as a postoperative complication of anterior cervical discectomy and fusion. Cureus. 2022;14(7):e26888.
[26] ALDAHAMSHEH O, ALHAMMOUD A, HALAYQEH S, et al. Stand-alone anchored spacer vs anterior plate construct in the management of adjacent segment disease after anterior cervical discectomy and fusion: a systematic review and meta-analysis of comparative studies. Global Spine J. 2023. doi: 10.1177/21925682231201787.
[27] MAZMUDAR A, PAZIUK T, TRAN KS, et al. Evaluating dysphagia duration and severity after acdf in patients with underlying dysphagia - a prospective, multicenter study. Global Spine J. 2023. doi: 10.1177/21925682231201249.
[28] NIU J, SONG D, LIU Y, et al. Revision surgery for symptomatic adjacent segment disc degeneration after initial anterior cervical fusion: is roi-c better than plate-cage construct? Biomed Res Int. 2021; 2021:6597754.
[29] LU Y, BAO W, WANG Z, et al. Comparison of the clinical effects of zero-profile anchored spacer (ROI-C) and conventional cage-plate construct for the treatment of noncontiguous bilevel of cervical degenerative disc disease (CDDD): a minimum 2-year follow-up. Medicine. 2018;97(5):e9808.
[30] ZHANG Z, LI Y, JIANG W. A comparison of zero-profile anchored spacer (ROI-C) and plate fixation in 2-level noncontiguous anterior cervical discectomy and fusion- a retrospective study. BMC Musculoskeletal Disorders. 2018;19(1):119.
[31] RYU HS, HAN MS, LEE SS, et al. Influence of subsidence after stand-alone anterior cervical discectomy and fusion in patients with degenerative cervical disease: a long-term follow-up study. Medicine. 2022;101(38):e30673.