A Pivotal Clinical Investigation of INFUSE® Bone Graft With a PEEK Interbody Spacer and an Anterior Cervical Plate in Patients With Cervical Degenerative Disc Disease at a Single Level.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 32
- 主要终点
- Rate of Overall Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.
详细描述
This pivotal clinical trial is being conducted to evaluate the safety and effectiveness of INFUSE® Bone Graft with the PEEK Interbody Spacer and Anterior Cervical Plate in patients with symptomatic cervical degenerative disc disease (DDD). The implant under investigation in this clinical trial is INFUSE® Bone Graft, the PEEK Interbody Spacer, and Anterior Cervical Plate. The device will be implanted using an anterior surgical approach. Safety and effectiveness data for patients in this study will be compared to that of historical controls. Historical control data will be taken from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION:
- •Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.
- •Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.
- •Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
- •At least 18 years of age and skeletally mature at the time of surgery.
- •A preoperative Neck Disability Index (NDI) score ≥
- •A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
- •If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.
- •Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
排除标准
- •EXCLUSION:
- •A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
- •Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
- •Previous surgical intervention at the involved level.
- •Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
- •Fused level adjacent to the level to be treated.
- •Severe pathology of the facet joints of the involved vertebral bodies.
- •Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
- •Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- •Overt or active bacterial infection, either local or systemic.
- •Insulin dependent diabetes.
- •Chronic or acute renal failure or prior history of renal disease.
- •Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
- •Is mentally incompetent. (if questionable, obtain psychiatric consult.)
- •Is a prisoner.
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
- •On oral or injectable steroids for 6 weeks or more at the time of enrollment.
- •A history of autoimmune disease.
- •History of exposure to injectable collagen or silicone implants.
- •History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- •Received any previous exposure to any/all BMPs either human or animal extraction.
- •History of allergy to bovine products.
- •History of any allergy resulting in anaphylaxis.
- •History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).
- •Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.
- •Received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.
结局指标
主要结局
Rate of Overall Success
时间窗: 24 months post-operation
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;" 5. no additional surgical procedure classified as a "failure."
次要结局
- Success Rate of Fusion(24 months post-operation)
- Success Rate of Neck Disability Index(24 months post-operation)
- Success Rate of Neurological Status(24 months post-operation)
- Neck Pain Success Rate(24 months post-operation)
- Arm Pain Success Rate(24 months post-operation)
- Success Rate of SF-36 PCS(24 months post-operation)
- Success Rate of SF-36 MCS(24 months post-operation)
- Operative Time(Time of operation, approximately 1.5 hrs.)
- Blood Loss(During the time of operation, approximately 1.5 hours.)
- Hospital Stay(During the time of hospital stay, average of 1 day.)
- Number of Patients Who Had Secondary Surgeries at the Index Level(24 months post-operation)