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Chinese Journal of Reparative and Reconstructive Surgery logoLink to Chinese Journal of Reparative and Reconstructive Surgery
. 2025 Sep;39(9):1187–1195. [Article in Chinese] doi: 10.7507/1002-1892.202505049

颈椎前路椎间盘切除融合术中零切迹3D打印椎间融合器与钛板融合器固定的疗效比较

Effectiveness comparison of anterior cervical discectomy and fusion with zero-profile three-dimensional-printed interbody fusion Cage and titanium plate fusion Cage

Yuwei LI 1, Xiuzhi LI 2, Bowen LI 3, Yunling GU 1, Tiantian YANG 1, Lei ZHAO 1, Wei CUI 1, Shifeng GU 1, Haijiao WANG 1,*
PMCID: PMC12440701  PMID: 40948012

Abstract

Objective

To compare the effectiveness of a zero-profile three-dimensiaonal (3D)-printed microporous titanium alloy Cage and a conventional titanium plate combined with a polyether-ether-ketone (PEEK)-Cage in the treatment of single-segment cervical spondylotic myelopathy (CSM) by anterior cervical discectomy and fusion (ACDF).

Methods

The clinical data of 83 patients with single-segment CSM treated with ACDF between January 2022 and January 2023 were retrospectively analyzed, and they were divided into 3D-ZP group (35 cases, using zero-profile 3D-printed microporous titanium alloy Cage) and CP group (48 cases, using titanium plate in combination with PEEK-Cage). There was no significant difference in gender, age, disease duration, surgical intervertebral space, and preoperative Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) score, neck disability index (NDI), vertebral height at the fusion segment, Cobb angle, and other baseline data between the two groups (P>0.05). The operation time, intraoperative blood loss, hospital stay, complications, interbody fusion, and prosthesis subsidence were recorded and compared between the two groups. VAS score, NDI, and JOA score were used to evaluate the improvement of pain and function before operation, at 3 months after operation, and at last follow-up, and the vertebral height at the fusion segment and Cobb angle were measured by imaging. The degree of dysphagia was assessed by the Bazaz dysphagia scale at 1 week and at last follow-up.

Results

The operation was successfully completed in all the 83 patients. There was no significant difference in intraoperative blood loss and hospital stay between the two groups (P>0.05), but the operation time in the 3D-ZP group was significantly shorter than that in the CP group (P<0.05). Patients in both groups were followed up 24-35 months, with an average of 25.3 months, and there was no significant difference in the follow-up time between the two groups (P>0.05). The incidence and grade of dysphagia in CP group were significantly higher than those in 3D-ZP group at 1 week after operation and at last follow-up (P<0.05). There was no dysphagia in 3D-ZP group at last follow-up. There was no complication such as implant breakage or displacement in both groups. The intervertebral fusion rates of 3D-ZP group and CP group were 65.71% (23/35) and 60.42% (29/48) respectively at 3 months after operation, and there was no significant difference between the two groups [OR (95%CI)=1.256 (0.507, 3.109), P=0.622]. The JOA score, VAS score, and NDI significantly improved in the 3D-ZP group at 3 months and at last follow-up when compared with preoperative ones (P<0.05), but there was no significant difference between the two groups (P>0.05). There was no significant difference in the improvement rate of JOA between the two groups at last follow-up (P>0.05). At 3 months after operation and at last follow-up, the vertebral height at the fusion segment and Cobb angle significantly improved in both groups, and the two indexes in 3D-ZP group were significantly better than those in CP group (P<0.05). At last follow-up, the incidence of prosthesis subsidence in 3D-ZP group (8.57%) was significantly lower than that in CP group (29.16%) (P<0.05).

Conclusion

The application of zero-profile 3D-printed Cage and titanium plate combined with PEEK-Cage in single-segment ACDF can both reconstruct the stability of cervical spine and achieve good effectiveness. Compared with the latter, the application of the former in ACDF can shorten the operation time, reduce the incidence of prosthesis subsidence, and reduce the incidence of dysphagia.

Keywords: Cervical spondylotic myelopathy, anterior cervical discectomy and fusion, three-dimensional printing, Cage, microporous titanium alloy

颈椎前路椎间盘切除融合术（anterior cervical discectomy and fusion，ACDF）因其直接减压神经结构和重建稳定性的优势，已成为治疗脊髓型颈椎病（cervical spondylotic myelopathy，CSM）的经典术式[1-3]。内植物的选择一直是影响手术效果的关键因素之一，目前ACDF术中常用内固定材料为颈前路钛板联合椎间融合器（Cage），其中聚醚醚酮（polyether-ether-ketone，PEEK）Cage因具有良好的生物相容性被广泛应用[4-6]，但其光滑表面缺乏骨诱导活性，需在中央植入自体骨或同种异体骨颗粒，并且与椎体终板解剖形态匹配度低，难以达到紧密贴合，导致界面应力集中，远期易出现假体移位、下沉等问题，影响手术效果[6-7]。此外，传统钛板固定虽能提供即时稳定性，但存在术后吞咽困难、邻近节段退变等并发症风险[8-10]。

近年3D打印技术的快速发展为Cage的设计带来了革命性突破。3D打印微孔钛合金Cage不仅具备优异的机械强度和生物相容性，其多孔结构还可模拟人体骨小梁，促进骨长入，实现生物融合[10-11]。值得注意的是，通过调整微孔参数，3D打印Cage的弹性模量可接近椎体皮质骨与松质骨，有效减少应力遮挡效应[12-13]。然而，现有3D打印Cage仍需依赖钛板辅助固定，无法实现自稳定，增加了手术复杂性和并发症风险。零切迹3D打印Cage作为一种创新设计，融合了3D打印技术与零切迹理念的双重优势。本研究拟通过回顾性对照研究，比较零切迹3D打印微孔钛合金Cage与传统PEEK-Cage联合钛板固定治疗单节段CSM的临床疗效，为临床治疗方式选择提供参考。报告如下。

1. 临床资料

1.1. 一般资料

患者纳入标准：① 年龄18～90岁CSM患者；② 行单节段ACDF。排除标准：① 合并严重肝、肾、脑、心血管、呼吸和内分泌等系统疾病，不能承受手术者；② 合并局部或全身感染者；③ 骨质疏松症，骨密度T值≤−2.5患者；④ 对本研究植入物（钛金属或PEEK）过敏者。

2022年1月—2023年1月漯河市中心医院共83例患者符合选择标准纳入研究。所有患者术前均行颈椎正侧位、动力位X线片、颈椎CT、颈椎MRI检查明确病变范围及手术节段间隙。患者均表现为渐进性四肢感觉、运动或括约肌功能障碍等典型脊髓受压症状，其中手指麻木41例（49.4%），双手持物无力24例（28.9%）、颈肩部疼痛65例（78.3%）、胸腹部束带感41例（49.4%）、行走不稳57例（68.7%），大小便障碍12例（14.5%）。侧位X线片示颈椎不同程度退变、骨质增生及病变椎间隙狭窄，其中生理曲度变直32例（38.6%）、后凸畸形17例（20.5%）。CT及MRI示病变椎间盘向后突出、硬膜囊受压，手术节段间隙位于C3、4～C6、7，其中MRI T2加权像示脊髓出现高信号29例（34.9%）。

根据使用的Cage类型分为3D-ZP组（35例，使用零切迹3D打印微孔钛合金Cage）和CP组（48例，使用钛板联合PEEK-Cage）。两组患者性别、年龄、病程、手术节段间隙及术前日本骨科协会（JOA）评分、疼痛视觉模拟评分（VAS）、颈椎功能障碍指数（NDI）、融合节段椎体高度、Cobb角等基线资料比较差异均无统计学意义（P>0.05）。见表1。

表 1.

Comparison of baseline data between the two groups

两组患者基线资料比较

基线资料
Baseline data		 3D-ZP组（n=35）
3D-ZP group (n=35)		 CP组（n=48）
CP group (n=48)		 统计量
Statistical value		 P值
P value
性别（男/女，例） 23/12 31/17 χ2=0.011 0.915
年龄（x±s，岁） 49.74±16.32 55.08±16.36 t=1.459 0.146
病程（x±s，年） 2.31±1.18 2.35±0.95 t=0.170 0.886
手术节段间隙（C3、4/C4、5/C5、6/C6、7，例） 6/11/8/10 8/14/10/16 χ2=0.222 0.974
术前JOA评分（x±s） 9.6±2.0 9.3±2.1 t=0.708 0.481
术前VAS评分（x±s） 5.3±1.6 4.9±1.4 t=1.038 0.302
术前NDI（x±s） 50.5±11.9 47.8±11.4 t=1.047 0.298
术前融合节段椎体高度（x±s，mm） 31.37±1.05 31.41±1.16 t=0.182 0.856
术前Cobb角（x±s，°） 4.68±1.20 4.50±1.12 t=0.718 0.475
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1.2. 植入材料及内固定器械

① 零切迹3D打印微孔钛合金Cage（北京爱康宜诚医疗器材有限公司），采用三维制图软件Unigraphics设计多孔钛合金Cage的三维模型，将模型数据导入3D打印设备（Arcam AB公司，瑞典）。该Cage为柱状结构；Cage上面（头侧面）为弧形，符合下终板的解剖弧形结构，有6° 前凸角；下面为斜形，上、下面有8° 的夹角；螺钉为锁定螺钉，矢状面有31° 内斜角度，冠状面有45° 上下斜角度。该Cage为非定制的通用型，高度从4 mm开始以1 mm为单位递增至10 mm；前后径12.5 mm、左右径15 mm，有12 mm×15 mm和13.5 mm×17.5 mm两种规格；孔隙率80%、孔径结构（800±200）μm，弹性模量（2.5±0.2）GPa，压缩强度（63.0±4.7）MPa。② PEEK-Cage（北京市富乐科技开发有限公司）为圆柱状结构，前后径12 mm、左右径14 mm，高度从4 mm开始以1 mm为单位递增至9 mm。③ 颈前路钢板（北京市富乐科技开发有限公司）长22.5～110.0 mm（每2.5毫米递增1个型号，共35个型号），厚1.8 mm。见图1。

图 1.

Implant materials and internal fixation instruments

植入材料及内固定器械

a. 零切迹3D打印微孔钛合金Cage　从左至右依次为Cage侧面观、锁定螺钉矢状面和冠状面及微观结构（扫描电镜×60）；b. PEEK-Cage；c. 钛板

a. Zero-profile 3D-printed microporous titanium alloy Cage　From left to right for lateral view of the Cage, sagittal and coronal views of the locking screws, and microstructure (Scanning electron microscopy×60); b. PEEK-Cage; c. Titanium plate

图 1

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1.3. 手术方法

患者于全身麻醉下取仰卧位，作右侧横切口，逐层进入显露手术节段。透视确认需行手术减压的椎间隙后，Caspar撑开器撑开病变椎间隙，切除椎间盘、刮除上下终板软骨，应用角度刮匙和薄椎板咬骨钳去除椎体后缘的增生骨赘，切除后纵韧带，显露硬脊膜，并探查有无脱出的髓核。彻底脊髓减压后，测试椎间隙高度。3D-ZP组植入合适高度的零切迹3D打印钛合金Cage（将刮除的少量骨赘植入中央小圆孔内），上、下各拧入1枚锁定螺钉。CP组在合适高度的PEEK-Cage内植入刮除的骨赘及同种异体骨（上海安久生物科技有限公司），然后植入椎间隙，选择长度适当的钛板，4枚螺钉固定。检查无活动性出血后，冲洗切口，放置引流管，关闭切口。术后第2天戴颈托行床边活动，指导患者渐进性功能锻炼并于术后3周去除颈托。

1.4. 疗效评价标准

① 记录并比较两组患者手术时间、术中出血量、住院时间及并发症发生情况。② 术前、术后3个月及末次随访时采用VAS评分评估患者疼痛缓解程度，NDI评估颈椎功能障碍程度，JOA评分（17分法）评估颈椎神经功能状态并按以下公式计算末次随访时JOA评分改善率：（末次随访时评分−术前评分）/（17−术前评分）×100%。③ 术后1周及末次随访时，采用Bazaz吞咽困难评级[14]评估患者术后吞咽困难程度：0级，无吞咽困难；1级，轻度吞咽困难；2级，中度吞咽困难；3级，重度吞咽困难。④ 观察椎间融合情况。椎间融合标准：a. 通过颈椎过屈、过伸侧位X线片观察，融合节段及棘突间无异常活动；b. 颈椎X线片观察示Cage两端与椎体上、下接触面之间结合紧密无明显透亮带；c. X线片及CT示出现骨性连接、骨小梁形成。符合以上2条即可判定为椎间融合[11]。⑤ 影像学测量：术前、术后3个月及末次随访时，于颈椎侧位X线片上测量融合节段椎体高度及Cobb角[11]。⑥ 假体沉降观察：术前、术后1周、术后3个月、末次随访时，于颈椎侧位X线片上测量手术节段的椎间前缘高度和后缘高度。末次随访时与术后1周相比，不论前、后缘，椎间高度下降≥3 mm即视为发生假体沉降[11，15]。

1.5. 统计学方法

采用SPSS19.0统计软件进行分析。计量资料经Kolmogorov-Smirnov正态性检验，均符合正态分布，数据以均数±标准差表示，组间比较采用独立样本t检验；两组多时间点比较采用重复测量方差分析，若不满足球形检验，采用Greenhouse-Geisser法进行校正，同一组别不同时间点比较采用Bonferroni法，同一时间点不同组别间比较采用多因素方差分析。计数资料组间比较采用四格表卡方检验、列联表卡方检验或Fisher确切概率法。等级资料组间比较采用秩和检验。检验水准取双侧α=0.05。

2. 结果

83例患者均顺利完成手术，两组术中出血量及住院时间比较差异无统计学意义（P>0.05），但3D-ZP组手术时间少于CP组，差异有统计学意义（P<0.05）。两组患者均获随访，随访时间24～35个月，平均25.3个月；3D-ZP组随访时间为（30.03±3.50）个月，CP组为（29.54±3.78）个月，差异无统计学意义（t=0.957，P=0.052）。术后1周和末次随访时CP组吞咽困难发生率及吞咽困难等级均明显高于3D-ZP组，差异有统计学意义（P<0.05）；末次随访时3D-ZP组无吞咽困难发生。两组均无内植物断裂、移位等并发症发生。术后3个月3D-ZP组和CP组椎间融合率分别为65.71%（23/35）、60.42%（29/48），差异无统计学意义 ［OR=1.256（0.507，3.109），P=0.622）］；术后12个月两组均达椎间骨性融合。术后3个月和末次随访时，3D-ZP组JOA评分、VAS评分、NDI均较术前显著改善，差异有统计学意义（P<0.05），但两组间差异均无统计学意义（P>0.05）；其中末次随访时两组JOA改善率差异亦无统计学意义（P>0.05）。术后3个月和末次随访时，两组融合节段椎体高度和Cobb角均较术前显著改善，3D-ZP组两指标均优于CP组，差异均有统计学意义（P<0.05）。末次随访时，3D-ZP组假体沉降率明显低于CP组，差异有统计学意义（P<0.05）。见表2，图2～4。

表 2.

Comparison of outcome indicators between the two groups

两组患者结局指标比较

结局指标
Outcome indicator		 3D-ZP组（n=35）
3D-ZP group (n=35)		 CP组（n=48）
CP group (n=48)		 效应值（95%CI）
Effect value (95%CI)		 P值
P value
手术时间（x±s，min） 66.51±11.93 78.04±20.50 MD=11.527（3.819，19.234） 0.004
术中出血量（x±s，mL） 107.85±24.80 105.27±22.29 MD=5.197（–7.754，12.926） 0.620
住院时间（x±s，d） 9.62±1.75 9.83±1.76 MD=0.204（–0.983，0.573） 0.602
吞咽困难等级（0/1/2/3，例）
　术后1周 30/5/0/0 23/14/8/3 － 0.001
　末次随访 35/0/0/0 37/9/2/0 － 0.005
吞咽困难发生 ［例（%）］
　术后1周 5（14.29） 25（52.08） OR=0.153（0.051，0.462） 0.001
　末次随访 0（0） 11（22.92） － 0.005
末次随访JOA评分改善率（x±s，%） 70.39±15.93 64.13±20.53 MD=0.081（–0.002，0.163） 0.056
末次随访假体沉降 ［例（%）］ 3（8.57） 14（29.16） OR=0.228（0.060，0.867） 0.028
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图 2.

Change trend of each index in the two groups

两组各指标变化趋势

a. JOA评分；b. VAS评分；c. NDI；d. 融合节段椎体高度；e. Cobb角

a. JOA score; b. VAS score; c. NDI; d. Vertebral height of fusion segment; e. Cobb angle

图 2

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图 4.

A 79-year-old male patient in the CP group with CSM at C4, 5

CP组患者，男，79岁，C4、5 CSM

a～d. 术前颈椎正、侧位及过伸、过屈位X线片示颈椎退变、后凸，C4、5不稳，C5、6前缘鸟嘴样增生；e. 术前颈椎CT矢状位示颈椎曲度变平直并后凸，C4椎体向前滑脱，C5、6前缘鸟嘴样增生；f. 术前颈椎MRI-T2矢状位示C4、5椎间盘突出，相应脊髓前后方均受压；g、h. 术后1周颈椎正、侧位X线片示钛板和Cage位置良好；i. 术后1周颈椎MRI-T2矢状位示颈脊髓受压解除，C4、5水平脊髓前后方脑脊液均通畅；j～m. 术后1年颈椎正、侧位及过伸、过屈X线片示钛板和Cage位置良好；n. 术后1年颈椎MRI-T2矢状位示颈脊髓受压解除，C4、5水平脊髓前后方脑脊液均通畅；o. 术后1年颈椎CT矢状位示C4、5椎间融合

a-d. Preoperative anteroposterior, lateral, flexion, and extension cervical spine X-ray films demonstrating degenerative kyphosis, C4, 5 instability, and beak-like osteophytes at C5, 6; e. Preoperative sagittal CT confirming cervical kyphosis, C4 anterolisthesis, and anterior osteophytes at C5, 6; f. Preoperative T2-weighted sagittal MRI showing C4, 5 disc herniation causing circumferential spinal cord compression; g, h. Anteroposterior and lateral X-ray films confirming proper implant positioning; i. T2-weighted sagittal MRI at 1 week after operation demonstrating complete cord decompression with patent cerebrospinal fluid spaces at C4, 5; j-m. Anteroposterior, lateral, flexion, and extension cervical spine X-ray films at 1 year after operation showing stable instrumentation; n. T2-weighted sagittal MRI at 1 year after operation showed that the cervical spinal cord compression was relieved, and the cerebrospinal fluid was unobstructed in the anterior and posterior parts of the spinal cord at C4, 5; o. Sagittal CT at 1 year after operation confirming solid fusion at C4, 5

图 4

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图 3.

A 40-year-old male patient in the 3D-ZP group with segmental CSM at C6, 7

3D-ZP组患者，男，40岁，C6、7 CSM

a～d. 术前颈椎正、侧位及过伸、过屈位X线片示颈椎生理性前曲并平直；e. 术前颈椎CT矢状位示颈椎曲度变平直并后凸；f. 术前颈椎MRI-T2矢状位示C6、7椎间盘突出，脊髓受压；g～i. 术后1周颈椎正、侧位X线片及CT矢状位示Cage位置良好；j. 术后1周颈椎MRI-T2矢状位示颈脊髓受压解除，C6、7水平脊髓前方脑脊液通畅；k～o. 术后1年颈椎正、侧位及过伸、过屈X线片及CT矢状位示Cage位置良好

a-d. Preoperative anteroposterior, lateral, flexion, and extension cervical spine X-ray films demonstrating loss of physiological lordosis; e. Preoperative sagittal CT showing straightened cervical alignment with focal kyphosis; f. Preoperative T2-weighted sagittal MRI revealing C6, 7 disc herniation compressing the spinal cord; g-i. Anteroposterior and lateral cervical spine X-ray films and sagittal CT at 1 week after operation confirming optimal Cage positioning; j. T2-weighted sagittal MRI at 1 week after operation confirming spinal cord decompression with patent cerebrospinal fluid space anterior to the cord at C6, 7; k-o. Anteroposterior, lateral, flexion, and extension cervical spine X-ray films and sagittal CT at 1 year after operation showing maintained Cage position

图 3

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3. 讨论

ACDF作为治疗CSM的“金标准”术式，其成功高度依赖内植物的生物力学性能与生物相容性。目前使用最多的是钛板联合PEEK-Cage。PEEK材料虽具有生物惰性、弹性模量接近骨皮质等优点，但其表面光滑、缺乏骨整合活性，需依赖自体骨或同种异体骨填充以促进椎体间融合。临床研究显示[16-18]，PEEK-Cage的骨接触面积有限，界面应力集中易导致假体沉降，发生率为20%～30%；本研究中CP组假体沉降率29.16%与此一致，凸显其力学劣势。3D打印Cage采用钛合金（Ti-6Al-4V）材料，不仅具有良好的机械强度、耐腐蚀性和生物相容性，而且通过调整微孔大小，使其具有与椎体皮质骨和松质骨接近的弹性模量[19-20]。同时，3D打印Cage的上表面为弧形、下表面为斜形，接近人体椎体间上、下终板的形态，利于与上、下终板充分接触，达到与椎体终板完全贴合的效果。然而，该Cage仍需使用钛板固定，钛板虽能提供即时稳定性，但存在以下问题：① 术后吞咽困难：钛板厚度（≥1.8 mm）及螺钉突出可能压迫食管，文献报道其发生率高达48.57%[10，18，21-22]；② 邻近节段退变：钛板跨越椎体前缘，可能改变颈椎应力分布，尤其是接触相邻节段椎间盘时，可加速相邻椎间盘的退变[21-24]；③ 手术复杂度提高：需广泛显露手术固定节段椎体，增加软组织损伤风险，且术中需反复透视确认螺钉位置，延长手术时间。

3D打印微孔钛合金Cage整合了零切迹设计与3D打印微孔钛合金材料的双重优势，其创新性体现在以下几点：① 微孔结构促进骨整合：孔径为（800±200）μm、孔隙率为80%的仿骨小梁结构为骨细胞长入提供了理想环境；其压缩强度为（63.0±4.7）MPa、弹性模量为（2.5±0.2）GPa，接近松质骨，可有效减少应力遮挡[19-20]。② 解剖型终板匹配：上、下面分别设计为6° 前凸的弧形与斜面，与椎体终板形态契合，接触面积较PEEK-Cage增加，显著降低界面压强。③ 自稳定设计：内置锁定螺钉实现即刻稳定，无需额外钛板固定，减少对食管及软组织的机械压迫。④ 前方设计有微型挡片，可限制Cage在椎间隙放入过深，无需透视确认Cage放入深度，节省手术时间。⑤ 不需要取骨或使用同种异体骨，只需将咬除的椎体前后缘骨赘放入中间微孔即可。⑥ 不需要术中透视确认螺钉位置，只需术前在CT上测量螺钉长度，减去4～6 mm，一般使用12～14 mm螺钉，即能够拧入椎体骨质内，特别适用于颈胸交界处等不能清晰透视的部位。⑦ 钛合金微孔表面具有诱导骨长入的生物活性，可为成骨细胞的黏附及分化提供有利环境[19-20]。

本研究显示，两组患者术后JOA评分、NDI及VAS评分均较术前显著改善（P<0.05），且组间差异无统计学意义（P>0.05），表明两种术式在神经功能恢复方面效果相当。然而，3D-ZP组在以下几方面更具优势：① 手术效率显著提升。3D-ZP组手术时间少于CP组，分析原因在于简化了操作步骤，仅需植入Cage并拧入2枚锁定螺钉，省略了钛板安装及多枚螺钉固定过程；减少了透视依赖，螺钉长度通过术前CT精准测量、放入椎间隙深度依靠Cage前方挡片确定。② 并发症发生率显著降低。a. 吞咽困难：术后1周CP组发生率为52.08%，3D-ZP组仅为14.29%；末次随访时CP组仍有22.92%残留症状，而3D-ZP组完全消失。这与零切迹设计避免食管压迫直接相关[25-26]，而且3D-ZP组减少前路软组织剥离，保护颈长肌及食管周围筋膜，是吞咽困难发生率锐减的关键。b. 假体沉降：末次随访时3D-ZP组假体沉降率为8.57%，显著低于CP组的29.16%，我们分析认为微孔结构增强骨长入、解剖型终板接触分散应力是主要原因。③ 功能改善趋势更优。尽管两组JOA改善率差异无统计学意义，但3D-ZP组改善率较CP组高6.26%，提示其可能在长期随访中体现更优的生物力学稳定性。本研究还发现，3D-ZP组与CP组术后存在影像学差异，术后3个月及末次随访时，3D-ZP组融合节段椎体高度显著优于CP组；此外，3D-ZP组末次随访时Cobb角较CP组更接近生理曲度。融合节段椎体高度和Cobb角的良好维持可能与微孔结构减少弹性模量与椎体的皮质骨和松质骨相匹配有关。

3D打印Cage应用技巧与注意事项：① 终板保护性处理：仅刮除软骨终板，保留骨性终板的完整性。过度切除将导致Cage陷入松质骨，增加沉降风险。② 椎间隙撑开“适度化”原则：Cage高度以相邻正常椎间隙高度平均值为参考（建议增加≤2 mm），避免过度撑开。术中使用Caspar撑开器临时维持，植入Cage放松撑开器后即刻稳定。③ 螺钉植入：术前CT测量椎体前后径，计算螺钉长度。螺钉45° 斜向终板、内斜31° 植入，可避开相邻椎间盘、增强抗拔出强度，兼具生物力学稳定性并可避让神经、血管。④ 椎体前缘修整：咬平融合节段椎体前缘骨赘，以确保Cage挡板与椎体前缘平整贴合，防止挡板内陷过深或突出刺激食管。⑤ 减压效率：使用磨钻或超声刮匙去除椎体后缘弧形增生骨赘，可快速扩大椎管容积，减少术中出血。

本研究的局限性和不足：① 样本量及随访时间均有限，未能评估远期相邻节段退变及异位骨化进展；② 钛合金伪影可能影响CT对骨融合的判断，需结合动态X线片及临床症状进行综合评估；③ 严重骨质疏松（T值≤−2.5）及终板缺损患者未被纳入本研究，此类人群的假体沉降风险需进一步研究；④ 本研究未能将零切迹3D打印Cage和零切迹非3D打印Cage进行比较，未体现3D打印Cage的性能；⑤ 零切迹3D打印Cage的定制化生产可能增加费用，未与CP组进行成本效益对比。

综上述，零切迹3D打印微孔钛合金Cage通过仿生设计、微孔骨整合及自稳定固定，实现了ACDF术式的优化。其显著缩短手术时间、降低吞咽困难及假体沉降率的优势，为单节段CSM提供了更安全、高效的治疗选择。未来需通过多中心大样本研究验证其长期疗效，并探索其在多节段病变、复杂颈椎畸形中的应用潜力。

利益冲突　在课题研究和文章撰写过程中不存在利益冲突；经费支持没有影响文章观点和对研究数据客观结果的统计分析及其报道

伦理声明　研究方案经漯河市中心医院伦理委员会批准（LH-KY-2022-001-118）

作者贡献声明　李玉伟：研究设计、实施及文章撰写；李修智、李博文、谷运岭、杨恬甜、赵磊、崔巍、谷世锋：研究实施、病例随访、数据整理和统计；李修智：文献检索、文章校对；王海蛟：对文章的知识性内容作批评性审阅、修改及审校

类型 优惠价（元/人）
2025 年 8 月 31 日前（含）成功缴费		 标准价（元/人）
2025 年 9 月 1 日起
普通人员 1 200 1 500
中国康复医学会会员 1 200 1 200
中国康复医学会学生会员 600 1 000
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Funding Statement

河南省医学科技攻关项目（LHGJ20210952）；河南省重点研发与推广专项（232102310244）

Medical Science and Technological Project of Henan Province (LHGJ20210952); Key Research & Development and Promotion Project of Henan Province (232102310244)

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Articles from Chinese Journal of Reparative and Reconstructive Surgery are provided here courtesy of Sichuan University

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