Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults - A Randomized, Prospective, Multicenter Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 24
- 主要终点
- Change from baseline Subsidence and Fusion rate
研究概览
简要总结
Rigid interbody fusion device in bulk configuration has been widely used in anterior cervical discectomy and fusion (ACDF) surgery. It is a randomized, prospective, multicenter clinical study to compare rigid and non-rigid fusion device in ACDF for cervical degenerative disc disease.
详细描述
This study is a randomized, prospective, multicenter clinical trial comparing rigid (PEEK) interbody fusion device with non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in ACDF surgery at 11 clinical sites. ACDF was performed with stand-alone interbody fusion device and artificial bone graft (hydroxyapatite/tricalcium phosphate). Patients have 1-level or 2-level cervical degenerative disc disease approved for ACDF surgery by National Health Insurance, which is the blind, third-party, administrative approved and insurance reimbursement for surgical indication. Total 180 patients were enrolled, and 180 patients were randomized into either investigational device (non-rigid) group or the control (rigid) group in a 2:1 ratio. After confirming a patient's eligibility and having the patient sign an informed consent form, the site investigator or study coordinator call the coordinator at National Taiwan University Hospital for the randomization. Each patient will be then assigned to 1 of the treatment group according to a randomized schedule. Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively. Measured outcomes included overall success, Neck Disability Index (NDI), VAS neck and arm pain, adjacent range of motion, patient satisfaction, anxiety score, SF-12 MCS/PCS, major complications, subsequent surgery rate, and subsidence and fusion rate on radiological examinations. The primary endpoint was a FDA composite definition of success comprising clinical improvement and absence of major complications and secondary surgery events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 - 69 years;
- •Symptomatic cervical degenerative disc disease in one or two levels between C3-7 with radiculopathy or myeloradiculopathy and/or decrease muscle strength and/or abnormal sensation and/or abnormal reflexes;
- •Deficit confirmed by CT, MRI, or X-ray;
- •NDI Score of ≥ 30/100;
- •Unresponsive to non-operative treatment of at least 6 weeks or presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative treatment;
- •No prior surgical procedures at the operative level and non-prior fusions at any cervical level;
- •Physically and mentally able and willing to comply with the protocol;
- •Signed informed consent;
排除标准
- •Patient does not meet the indication of Anterior Cervical Discectomy and Fusion (ACDF), which is under the surveillance. (Surgical indication of ACDF is approved by National Health Insurance Administration Ministry of Health and Welfare, a blinded third-party authority).
- •More than two vertebral levels required surgery;
- •Immobile levels between C1 and C7 from any cause;
- •Any prior surgery at the operative level or any prior fusion at any cervical level;
- •T-score less than -1.5 (osteoporosis evaluation)
- •Paget's disease, osteomalacia, or any other metabolic bone disease other than osteoporosis;
- •Active infection of surgical site or history of anticipated treatment for systemic infection including HIV
- •Active malignancy: a history of any invasive malignancy (except carcinoma in situ and non-melanoma skin cancer), unless treated with curative intent with no clinical signs or symptoms of malignancy in the past 5 years;
- •Marked instability of the cervical spine on resting lateral or flexion-extension radiographs;
- •Known allergy to device materials including titanium or polyetheretherketone (PEEK);
- •Segmental kyphosis of greater than 11 degrees at treatment or adjacent levels
- •Rheumatoid arthritis, lupus, or other autoimmune disease;
- •Any diseases or conditions that would preclude accurate clinical evaluation;
- •Daily, high-dose oral and/or inhaled steroid or a history of chronic use of high dose steroids;
- •Body Mass Index (BMI) > 35
- •Smoking more than one pack of cigarettes per day;
结局指标
主要结局
Change from baseline Subsidence and Fusion rate
时间窗: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Subsidence and fusion rate on radiological.
Change from baseline Adjacent range of motion
时间窗: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Adjacent range of motion on radiological.
Change from baseline postoperative condition (if patients have major complications)
时间窗: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
No adverse events (AEs) classified as major complications by Research Ethics Committee.
Change from baseline postoperative condition (if patients have subsequent surgeries)
时间窗: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
No subsequent surgical intervention.
Change from baseline Neck Disability Index (NDI)
时间窗: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
An improvement in Neck Disability Index (NDI) score of at least 30 points for a patient with a preoperative NDI score of 60 or greater; or an improvement of at least 50% of preoperative NDI score for patients with a preoperative score of less than 60.
次要结局
- Patient Satisfaction Questionnaire(Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.)
- Visual analogue scale (neck and arm and chest pain)(Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.)
- Anxiety score(Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.)
- Depression Score(Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.)
- Short form-12 mental component scale and physical component scale (SF-12 MCS/PCS) score(Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.)
- Number of days using Non-steroidal anti-inflammatory analgesics(NSAIDs)(Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.)