ChiCTR2600125876 版本V1.0 版本创建时间2026/06/01 15:12:23 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600125876 

最近更新日期：

Date of Last Refreshed on：

 2026-06-01 15:12:06 

注册时间：

Date of Registration：

 2026-06-01 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

增材制造椎间融合器用于颈椎、胸腰椎椎体间融合的安全性及有效性评价——前瞻性、多中心、随机、平行对照、非劣效性临床研究

Public title：

Evaluation of the Safety and Effectiveness of Additive Manufacturing Intervertebral Fusion Devices for Cervical and Thoracolumbar Interbody Fusion: A Prospective, Multi-center, Randomized, Parallel-controlled, Non-inferiority Clinical Study

注册题目简写：

增材制造椎间融合器

English Acronym：

Additive Manufacturing Interbody Fusion Device

研究课题的正式科学名称：

增材制造椎间融合器用于颈椎、胸腰椎椎体间融合的安全性及有效性评价——前瞻性、多中心、随机、平行对照、非劣效性临床研究

Scientific title：

Evaluation of the Safety and Effectiveness of Additive Manufacturing Intervertebral Fusion Devices for Cervical and Thoracolumbar Interbody Fusion: A Prospective, Multi-center, Randomized, Parallel-controlled, Non-inferiority Clinical Study

研究课题代号(代码)：

Study subject ID：

 FLKJ-ZCZZZJRHQ

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李洪艳 

研究负责人：

张迪 

Applicant：

Hong Yan.Li 

Study leader：

Di Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 134 2629 3759

研究负责人电话：

Study leader's
telephone：

+86 185 3311 2872

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 fgb@fulekeji.com

研究负责人电子邮件：

Study leader's E-mail：

 fgb@fulekeji.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市富乐科技开发有限公司

研究负责人通讯地址：

河北省石家庄市桥西区自强路139号

Applicant address：

Beijing Fule Science & Technology Development Co., Ltd.

Study leader's address：

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei

申请注册联系人邮政编码：

Applicant postcode：

 101204

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京市富乐科技开发有限公司

Applicant's institution：

Beijing Fule Science & Technology Development Co., Ltd.

研究负责人所在单位：

河北医科大学第三医院

Affiliation of the Leader：

The Third Hospital of Hebei Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 器-2024-036-1; 器-2024-036-2; 器-2024-036-3

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

河北医科大学第三医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Third Hospital of Hebei Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-08-13 00:00:00

伦理委员会联系人：

张迪

Contact Name of the ethic committee：

Di.Zhang

伦理委员会联系地址：

河北省石家庄市桥西区自强路139号

Contact Address of the ethic committee：

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 311 8860 3325

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 lunli88603632@163.com

研究实施负责（组长）单位：

河北医科大学第三医院

Primary sponsor：

The Third Hospital of Hebei Medical University

研究实施负责（组长）单位地址：

河北省石家庄市桥西区自强路139号

Primary sponsor's address：

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

北京市富乐科技开发有限公司

具体地址：

北京市平谷区马坊工业区西区50号101204

Institution
hospital：

Beijing Fule Science & Technology Development Co., Ltd.

Address：

No. 50, Mafang West Industry Zone, Pinggu District, 101204, Beijing, China

经费或物资来源：

北京市富乐科技开发有限公司

Source(s) of funding：

Beijing Fule Science & Technology Development Co., Ltd.

研究疾病：

颈椎、胸腰椎椎体间融合手术  

Target disease：

Cervical and Thoracolumbar Interbody Fusion Surgery

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本临床试验通过比较试验医疗器械北京市富乐科技开发有限公司生产的增材制造椎间融合器与对照医疗器械北京市富乐科技开发有限公司生产的PEEK椎间融合器，用于颈椎、胸腰椎椎体间融合手术，来评估试验器械在临床应用中的安全性和有效性。  

Objectives of Study：

This clinical trial evaluates the safety and effectiveness of the investigational device in clinical application by comparing the additive-manufactured intervertebral fusion device produced by Beijing Fule Technology Development Co., Ltd. with the control medical device, the PEEK intervertebral fusion device produced by Beijing Fule Technology Development Co., Ltd., for cervical and thoracolumbar interbody fusion surgeries.

药物成份或治疗方案详述：

【产品性能及主要结构组成】 该产品采用化学成分符合GBT 13810 标准规定的TC4 合金粉末材料通过激 光选区熔融制造技术制成。产品为中空结构，外圈设计为类骨小梁的多孔结构，上、 下端面分别设计了多个防滑齿。交付状态分为灭菌和非灭菌两种包装, 灭菌包装产 品经辐照灭菌，有效期为4 年。非灭菌包装产品有效期为8 年。 【产品的适用范围】 该产品预期与脊柱内固定系统配合使用，用于颈椎（C2/3-C7/T1）、胸腰椎 （T1/2-L5/S1）融合手术时提供椎体间的稳定支撑，维持椎间隙高度，利于椎间融合。 【安装和使用说明】 1．制定手术方案，确定所需的手术入路根据X 光片确定融合器的型号和大小。 2．使用标准手术入路，暴露将要融合的椎体。按照指定适应症的相应手术操作进行融合区域准备工作，使用磨钻修整上椎体下缘和下椎体上缘，使之与试模和假体的边缘相吻合。 3．根据椎间隙的高度、椎间隙准备技术以及患者解剖形态选择试模。将试模沿正确的头尾端方向正确定位，置入椎间隙，根据最合适的试模确定所需融合器的规格。 4．用撑开器或撑开螺钉撑开椎间隙，调整至合适的椎间高度。 5．应用植入器械将自体植骨填充的融合器安装在持取器上，植入椎间隙。 6．使用脊柱钉棒或钉板产品进行辅助固定，放置引流管，常规缝合切口。 7．术后患者佩带支具，配合医生进行康复治疗。 

Description for medicine or protocol of treatment in detail：

[Product Performance and Main Structural Components] This product is made of TC4 alloy powder material that meets the chemical composition requirements of the GBT 13810 standard, manufactured using laser selective melting technology. The product has a hollow structure, with the outer ring designed as a bone-like trabecular porous structure, and both the upper and lower end surfaces designed with multiple anti-slip teeth. The product is delivered in either sterilized or non-sterilized packaging. Sterilized packaging products are sterilized by irradiation and have a shelf life of 4 years. Non-sterilized packaging products have a shelf life of 8 years. [Scope of Application] This product is intended to be used in conjunction with a spinal internal fixation system, providing intervertebral stability during cervical (C2/3-C7/T1) and thoracolumbar (T1/2-L5/S1) fusion surgeries, maintaining intervertebral height, and facilitating intervertebral fusion. [Installation and Usage Instructions] 1. Formulate the surgical plan, determine the required surgical approach, and select the model and size of the interbody fusion cage based on X-rays. 2. Use the standard surgical approach to expose the vertebrae to be fused. Prepare the fusion area according to the surgical procedure specified for the indication, and use a burr to trim the inferior edge of the upper vertebra and the superior edge of the lower vertebra so that they match the edges of the trial mold and prosthesis. 3. Choose the trial mold according to the intervertebral height, intervertebral preparation technique, and the patient’s anatomical shape. Properly position the trial mold along the correct cranial-caudal direction and insert it into the intervertebral space. Determine the required size of the fusion cage based on the most suitable trial mold. 4. Use a distractor or distraction screws to open the intervertebral space and adjust to the proper intervertebral height. 5. Using implantation instruments, place the fusion cage filled with autologous bone onto the holder and implant it into the intervertebral space. 6. Perform auxiliary fixation using spinal screws and rods or plates, place a drainage tube, and routinely suture the incision. 7. Postoperatively, the patient should wear a brace and undergo rehabilitation in collaboration with the doctor. 

纳入标准：

1.年龄在18－75周岁（含18周岁和75周岁）者，性别不限； 2.因椎间盘退变引起椎间盘突出和/或椎体节段不稳，需进行椎体间融合手术者； 3.颈椎（C2/3-C7/T1）或胸腰椎（T1/2—L5/S1），一个或两个节段需要进行椎体间融合者； 4.至少经非手术保守治疗4周无效（研究者认为符合手术指征的急症者除外）者； 5.自愿参与临床试验并签署知情同意书者。

Inclusion criteria

1. Aged 18–75 years (inclusive of 18 and 75 years), gender not limited; 2. Lumbar disc herniation and/or vertebral segment instability caused by intervertebral disc degeneration, requiring interbody fusion surgery; 3. Cervical spine (C2/3–C7/T1) or thoracolumbar spine (T1/2–L5/S1), with one or two segments requiring interbody fusion; 4. Ineffective after at least 4 weeks of non-surgical conservative treatment (except for patients considered emergencies meeting surgical indications by the investigator); 5. Voluntarily willing to participate in the clinical trial and sign the informed consent form.

排除标准：

1.存在明显的局部或全身严重感染者； 2.存在可能导致术后护理期间出现难以接受的固定失败或并发症风险的任何精神或神经肌肉及血管疾病者； 3.合并心、脑、肝（AST/ALT＞正常值上限3倍）、肾（Scr＞正常值上限1.5倍）、造血系统、内分泌系统等严重原发性疾病，或总体健康状况不良，存在如冠心病、高血压等常规全麻手术禁忌症，且研究者判断不适合试验者； 4.手术部位没有足够软组织覆盖者； 5.存在骨质疏松症、骨软化症或类似的骨密度降低、脊柱肿瘤（包括转移瘤），脊柱骨折，且研究者判断不适合参与研究者； 6.存在会导致植入物固定失败或者植入物本身因负荷过重而损坏的肥胖症者（BMI≥30kg/m2）； 7.由于疾病、感染或以往的手术操作而影响现存骨量，使之不能给植入装置提供足够的支撑和/或固定，并影响骨性融合者； 8.存在周围血管疾病、代谢性疾病、长期酗酒、滥用药物等病史者； 9.不能保证在骨折愈合期间戒烟者； 10.长期服用影响骨、软组织愈合的药物（如化疗药物、皮质类固醇激素，甲泼尼龙除外）者； 11.使用生长因子或连续使用镇静催眠药、非甾体类消炎药3个月以上者； 12.骨骼不成熟，正在发育中者； 13.明确的或怀疑对产品材料或对异物过敏者； 14. 正在接受放射治疗者； 15.妊娠/哺乳期，或计划在试验期间怀孕者； 16.3个月内参加过其他临床试验者； 17.研究者判断不适合入选者（如小儿麻痹后遗症等）。

Exclusion criteria：

1. Presence of obvious local or systemic severe infection; 2. Presence of any mental, neuromuscular, or vascular disease that may result in unacceptable fixation failure or complications during postoperative care; 3. Severe primary diseases involving the heart, brain, liver (AST/ALT > 3 times the upper limit of normal), kidneys (Scr > 1.5 times the upper limit of normal), hematopoietic system, endocrine system, etc., or overall poor health, including routine contraindications to general anesthesia such as coronary heart disease or hypertension, and judged by the investigator as unsuitable for the study; 4. Insufficient soft tissue coverage at the surgical site; 5. Presence of osteoporosis, osteomalacia, or similar bone density reduction, spinal tumors (including metastases), spinal fractures, and judged by the investigator as unsuitable for participation; 6. Obesity (BMI >=30 kg/m2) that may lead to fixation failure or implant damage due to excessive load; 7. Existing bone quantity affected by disease, infection, or previous surgery, rendering it insufficient to support and/or fix the implant and affecting bone fusion; 8. History of peripheral vascular disease, metabolic disease, chronic alcoholism, or drug abuse; 9. Inability to guarantee smoking cessation during fracture healing; 10. Long-term use of drugs affecting bone or soft tissue healing (e.g., chemotherapeutic drugs, corticosteroids except methylprednisolone); 11. Use of growth factors or continuous use of sedative-hypnotic drugs or non-steroidal anti-inflammatory drugs for more than 3 months; 12. Skeletally immature individuals still in development; 13. Known or suspected allergy to the product material or foreign substances; 14. Currently undergoing radiotherapy; 15. Pregnant or breastfeeding, or planning pregnancy during the study; 16. Participation in another clinical trial within the past 3 months; 17. Investigator judgment deeming the candidate unsuitable for inclusion (e.g., sequelae of poliomyelitis).

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-04 00:00:00 至 To 2025-04-28 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 52

Group：

Experimental group

Sample size：

干预措施：

试验组使用增材制造钛合金椎间融合器

干预措施代码：

 ICD-9-CM-3

Intervention：

The experimental group adopts additively manufactured titanium alloy interbody fusion cages

Intervention code：

组别：

对照组

样本量：

 52

Group：

Control group

Sample size：

干预措施：

对照组使用同厂家 PEEK 材质椎间融合器

干预措施代码：

 ICD-9-CM-3

Intervention：

Tthe control group uses PEEK interbody fusion cages manufactured by the same manufacturer.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

 石家庄市 

Country：

China

Province：

Hebei

City：

Shijiazhuang City

单位(医院)：

 河北医科大学第三医院 

单位级别：

 三甲 

Institution
hospital：

The Third Hospital of Hebei Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

 西安市 

Country：

China

Province：

Shaanxi

City：

Xi'an

单位(医院)：

 陕西省人民医院 

单位级别：

 三甲 

Institution
hospital：

Shaanxi Provincial People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

 洛阳市 

Country：

China

Province：

Henan

City：

Luoyang

单位(医院)：

 河南省洛阳正骨医院（河南省骨科医院） 

单位级别：

 三甲 

Institution
hospital：

Luoyang Orthopaedic-Traumatological Hospital of Henan Province

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

融合有效率

指标类型：

主要指标

Outcome：

Fusion efficiency

Type：

Primary indicator

测量时间点：

访视5（术后第6个月±7天）

测量方法：

主要评价指标（盲态研究者评价）：融合有效率（访视5） 融合有效率=融合成功病例数/总病例数×100% 符合以下两个标准视为融合有效： （1） Brantigan和Steffee的影像学融合标准中4或5级； （2） X线动力位：屈伸角度变化＜2°，椎间平移差值=0mm

Measure time point of outcome：

Visit 5 (6 months post-operation +/- 7 days)

Measure method：

Main Evaluation Indicators(Blind study evaluator): Fusion Effectiveness Rate (Visit 5) Fusion Effectiveness Rate = Number of Successful Fusion Cases / Total Cases × 100% Considered effective fusion if the following two criteria are met: (1) Grade 4 or 5 according to Brantigan and Steffee's radiographic fusion criteria; (2) X-ray dynamic view: flexion-extension angle change < 2°, intervertebral translation difference = 0 mm

指标中文名：

融合有效率

指标类型：

次要指标

Outcome：

Fusion efficiency

Type：

Secondary indicator

测量时间点：

访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

次要评价指标（治疗研究者评价）：融合有效率（访视5） 融合有效率=融合成功病例数/总病例数×100% 符合以下两个标准视为融合有效： （1） Brantigan和Steffee的影像学融合标准中4或5级； （2） X线动力位：屈伸角度变化＜2°，椎间平移差值=0mm

Measure time point of outcome：

Visit 4 (3 months post-surgery +/- 7 days), Visit 5 (6 months post-surgery +/- 7 days)

Measure method：

Secondary Evaluation Indicators (Assessed by Treatment Researchers): Fusion Efficiency (Visit 5) Fusion efficiency = Number of successfully fused cases / Total number of cases × 100% Considered effective fusion if the following two criteria are met: (1) Grade 4 or 5 according to Brantigan and Steffee's radiographic fusion criteria; (2) X-ray dynamic views: change in flexion-extension angle < 2°, intervertebral translation difference = 0 mm

指标中文名：

JOA功能评分

指标类型：

次要指标

Outcome：

Japanese Orthopaedic Association Scores

Type：

Secondary indicator

测量时间点：

访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

包括颈椎JOA评分和下腰痛JOA评分。其中颈椎JOA评分包括上肢运动功能、下肢运动功能、感觉和膀胱功能四部分，总分17分；下腰痛JOA评分包括主观症状（下腰痛、腿痛、步态）、临床体征（直腿抬高、感觉障碍、运动障碍）、日常活动受限度和膀胱功能四个部分，总分29分。分值越低则功能障碍越明显。

Measure time point of outcome：

Visit 3 (before discharge / post-operative Day 7 +/-3 days), Visit 4 (post-operative Month 3 +/- 7 days), Visit 5 (post-operative Month 6 +/- 7 days)

Measure method：

Including cervical JOA score and low back pain JOA score. The cervical JOA score includes four parts: upper limb motor function, lower limb motor function, sensation, and bladder function, with a total score of 17 points; the low back pain JOA score includes four parts: subjective symptoms (low back pain, leg pain, gait), clinical signs (straight leg raise, sensory disturbance, motor disturbance), degree of limitation in daily activities, and bladder function, with a total score of 29 points. Th

指标中文名：

疼痛评分（VAS）

指标类型：

次要指标

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

测量时间点：

访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

本次临床研究疼痛评分（VAS）为颈部或者腰部疼痛情况，根据手术部位的不同评价并记录。将疼痛严重程度从轻到重标为0 - 10分，其中0表示无不适，10表示难以忍受的疼痛。受试者自行评价手术区自上次访视迄今最严重的一次疼痛。若疼痛难以忍受，受试者可以合并服用止痛药物，但服用止痛药物的受试者评分一律记为“9”。分别记录受试者每次访视的疼痛评分（VAS），比较两组受试者间的疼痛评分（VAS）及疼痛变化情况

Measure time point of outcome：

Visit 3 (before discharge / post-operative Day 7 +/-3 days), Visit 4 (post-operative Month 3 +/- 7 days), Visit 5 (post-operative Month 6 +/- 7 days)

Measure method：

In this clinical study, the pain score (VAS) refers to neck or back pain, evaluated and recorded according to the surgical site. The severity of pain is rated from 0 to 10, with 0 indicating no discomfort and 10 indicating unbearable pain. Subjects rate the worst pain they have experienced in the surgical area since the last visit. If the pain is unbearable, subjects may take analgesic medication; however, the pain score for subjects taking analgesics is uniformly recorded as '9'. The pain score

指标中文名：

椎间隙高度

指标类型：

次要指标

Outcome：

Intervertebral disc height

Type：

Secondary indicator

测量时间点：

访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

测量的椎间隙高度，比较两组受试者椎间隙高度以及椎间隙高度的恢复值（访视点与术前的高度差值）与丢失值（访视点与术后的高度差值）。

Measure time point of outcome：

Visit 3 (before discharge / post-operative Day 7 +/-3 days), Visit 4 (post-operative Month 3 +/- 7 days), Visit 5 (post-operative Month 6 +/- 7 days)

Measure method：

Measure the intervertebral disc height, compare the intervertebral disc height between the two groups of subjects, as well as the recovery value of the intervertebral disc height (the difference between the height at the visit and preoperative height) and the lost value (the difference between the height at the visit and postoperative height).

指标中文名：

不良事件（AE）及严重不良事件（SAE）的发生率（%）和事件例次

指标类型：

副作用指标

Outcome：

Incidence and number of cases of adverse events and serious adverse events

Type：

Adverse events

测量时间点：

访视2（第0天）、访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

定义：不良事件是指在临床试验过程中出现的不利的医学事件，无论是否与器械相关。 严重不良事件是指临床试验过程中发生的导致死亡或者健康状况严重恶化，包括致命的疾病或者伤害、身体结构或者身体功能的永久性缺陷、需住院治疗或者延长住院时间、需要进行医疗或者手术介入以避免对身体结构或者身体功能造成永久性缺陷；导致胎儿窘迫、胎儿死亡 或者先天性异常、先天缺损等事件

Measure time point of outcome：

Visit 2 (Day 0), Visit 3 (before discharge/Postoperative Day 7 +/-3 days), Visit 4 (3 months postoperative +/-7 days), Visit 5 (6 months postoperative +/-7 days)

Measure method：

Definition: An adverse event refers to any unfavorable medical occurrence that arises during a clinical trial, regardless of whether it is related to the device. A serious adverse event refers to an event that occurs during a clinical trial resulting in death or a significant deterioration of health, including fatal diseases or injuries, permanent defects in bodily structure or function, the necessity for hospitalization or extended hospital stay, or requiring medical or surgical intervention to

指标中文名：

器械缺陷的发生率（%）和频次

指标类型：

副作用指标

Outcome：

Incidence (%) and frequency of device defects

Type：

Adverse events

测量时间点：

访视2（第0天）、访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

在临床试验过程中出现的研究器械缺陷，如标识错误、器械故障等

Measure time point of outcome：

Visit 2 (Day 0), Visit 3 (before discharge/Postoperative Day 7 +/-3 days), Visit 4 (3 months postoperative +/-7 days), Visit 5 (6 months postoperative +/-7 days)

Measure method：

Defects in research devices that occur during clinical trials, such as labeling errors, device malfunctions, etc.

指标中文名：

并发症的发生率（%）和事件例次

指标类型：

副作用指标

Outcome：

Incidence of complications (%) and number of events

Type：

Adverse events

测量时间点：

访视2（第0天）、访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）

测量方法：

指的是受试者在原发病发展出现的另一种新症状或疾病，或者诊疗行为的介入使受试者在原发病的基础上增添了新的症状或疾病。并发症的发生与疾病进展或诊疗行为之间存在因果关系，包括但不限于：感染（对局限于筋膜浅层的感染）、植入物松动

Measure time point of outcome：

Visit 2 (Day 0), Visit 3 (before discharge/Postoperative Day 7 +/-3 days), Visit 4 (3 months postoperative +/-7 days), Visit 5 (6 months postoperative +/-7 days)

Measure method：

It refers to the occurrence of another new symptom or disease in the subject during the progression of the primary disease, or the intervention of diagnostic and therapeutic actions causing the subject to develop new symptoms or diseases on the basis of the primary disease. The occurrence of complications has a causal relationship with disease progression or diagnostic and therapeutic actions, including but not limited to: infection (limited to superficial fascial infections), and implant loosen

指标中文名：

生命体征

指标类型：

副作用指标

Outcome：

Vital signs

Type：

Adverse events

测量时间点：

访视2（术前）、访视3（出院前/术后第7天±3天）、访视4（术后第3个月±7天）、访视5（术后第6个月±7天）。

测量方法：

受试者在手术前后生命体征（体温、呼吸、血压、心率）改变具有临床意义的情况。报告手术前后生命体征指标具有临床意义的改变的受试者例数及百分比

Measure time point of outcome：

Visit 2 (Day 0), Visit 3 (before discharge/Postoperative Day 7 +/-3 days), Visit 4 (3 months postoperative +/-7 days), Visit 5 (6 months postoperative +/-7 days)

Measure method：

Cases in which subjects experienced clinically significant changes in vital signs (temperature, respiration, blood pressure, heart rate) before and after surgery. Report the number and percentage of subjects with clinically significant changes in vital signs before and after surgery.

指标中文名：

实验室检查

指标类型：

副作用指标

Outcome：

Laboratory Test

Type：

Adverse events

测量时间点：

访视3（出院前/术后第7天±3天）

测量方法：

受试者在进行手术前后实验室检查指标（血常规、血生化）改变具有临床意义的情况。报告手术前后生命体征指标具有临床意义的改变的受试者例数及百分比。

Measure time point of outcome：

Visit 3 (before discharge / 7th day after surgery +/- 3 days)

Measure method：

Situations in which changes in laboratory test indicators (blood routine, blood biochemistry) before and after surgery are clinically significant in subjects. Report the number and percentage of subjects with clinically significant changes in laboratory test indicators before and after surgery.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

静脉血

Sample Name：

Blood"

Tissue：

venous blood

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destruction after use

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验采用分层随机方法，以临床试验机构和治疗部位（胸腰椎和颈椎）为分层因素，采用基于网络的中央随机系统（即基于网络的交互式网络应答系统，Interactive Web Response System，IWRS），对筛选合格的受试者进行随机分组，随机分组时间为签署知情同意且通过入组筛选后。随机化分组保证了除处理因素外，其他可能产生混杂效应的非处理因素在各组中尽可能保持一致，以保持各组的均衡性；1：1 的随机化分组保证了每位受试者都有同等的机会被分配到试验组或者对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This trial uses a stratified randomization method, with clinical trial sites and treatment sites (thoracolumbar and cervical spine) as stratification factors. A web-based central randomization system (i.e., Interactive Web Response System, IWRS) is used to randomly assign eligible subjects. Randomization occurs after signing the informed consent and passing the enrollment screening. Randomized grouping ensures that, apart from the treatment factor, other non-treatment factors that may cause confounding effects are kept as consistent as possible across groups to maintain group balance. A 1:1 randomization ratio ensures that each subject has an equal chance of being assigned to the experimental group or the control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

非盲法

Blinding：

Non-blind

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

试验结束后完成数据汇总归档，预计 12 个月内，采用受限申请制共享。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

After the experiment is completed, data will be compiled and archived, and it is expected to be shared under a restricted application system within 12 months.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-06-01 15:12:06