NCT02694250撤回不适用
Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw in Patients With Cervical Radiculopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 14
- 主要终点
- Assess the radiographic outcome data on fusion status, device retention, and maintenance of segmental lordosis at the index level utilizing DTRAX Cervical Cage with DTRAX Bone Screw used in the treatment of cervical radiculopathy
研究概览
简要总结
This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of degenerative disc disease at one disc level with accompanying radicular symptoms in the cervical (neck) spine.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject diagnosed with one level cervical spondylosis with radiculopathy in C3-C7, defined as follows:
- •a. Radiographically (at least one): i. degenerated disc on MRI and/or CT; ii. decreased disc height on MRI and/or CT; and/or iii. foraminal stenosis, as demonstrated by MRI and/or CT. b. Clinically: radicular symptoms (at least one): i. arm/shoulder pain; ii. decreased reflexes; iii. decreased strength; and/or iv. decreased sensation.
- •Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
- •Subject is 35-80 years of age, inclusive.
- •Subject is unresponsive to 6 weeks conservative, nonoperative treatment, or clinically indicated sooner due to the presence of progressive symptoms or signs of nerve root in spite of combined nonoperative management.
- •Preoperative Neck Disability Index (NDI) score of >
- •Preoperative Neck pain or Arm pain score of > 6 on Neck and Arm VAS Pain Scales.
- •Subject is a male or non-pregnant, non-lactating female.
- •Subject must have the ability to understand and voluntarily provide written, informed consent.
- •Subject is able to meet the proposed follow-up schedule.
- •Subject is able to follow the postoperative management program.
排除标准
- •Any previous cervical spinal surgery.
- •Subject has known osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease OR subject has sustained a vertebral compression or nontraumatic hip or wrist fracture.
- •Subject has overt or active spinal and/or systemic infection.
- •Subject has cervical spondylolisthesis > 3.5mm or rotator subluxation.
- •Subject has cervical myelopathy.
- •Subject has a chronic pain syndrome.
- •Subject has radicular findings with major motor impairment.
- •Subject has a condition that requires postoperative medications that interfere with fusion or the stability of the implant, such as steroids (ie. corticosteroids, methotrexate, immunosuppressives).
- •Subject is mentally incompetent.
- •Subject is a prisoner.
- •Subject is pregnant.
- •Subject abuses alcohol or drugs.
- •Subject has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level.
- •Subject has insulin dependent diabetes.
- •Subject has chronic or acute renal failure or prior history of renal disease.
- •Subject has documented allergy or intolerance to stainless steel, titanium, or a titanium alloy.
- •Subject has or is planning to receive drugs which may interfere with bone metabolism within two weeks prior to or six months following the date of surgery.
- •Subject has history of an endocrine or metabolic disorder known to affect osteogenesis.
- •Subject has had treatment with an investigational therapy within 28 days prior to surgery or such treatment is planned during the 16 weeks following implantation of DTRAX Cervical Cage with DTRAX Bone Screw.
- •Subject is involved in or planning spinal litigation or Workmen's Compensation claim.
- •Subject is morbidly obese, defined as body mass index (BMI) >
- •Subject has a medical condition or extenuating circumstance that, in the Investigator's opinion, would prevent the subject from complying with postoperative follow-up visits.
结局指标
主要结局
Assess the radiographic outcome data on fusion status, device retention, and maintenance of segmental lordosis at the index level utilizing DTRAX Cervical Cage with DTRAX Bone Screw used in the treatment of cervical radiculopathy
时间窗: Baseline throughout 24 months post-operatively
次要结局
- Assess the clinical outcome data based Neck Disability Index (NDI)(Baseline throughout 24 months post-operatively)
- Safety information will be evaluated by collecting the type, frequency, severity, and device and procedure-relatedness of adverse events(Baseline throughout 24 months post-operatively)
- Assess the clinical outcome data based SF-12 v2 Health Survey(Baseline throughout 24 months post-operatively)
- Assess the clinical outcome data based the Visual Analogue Scale (Neck and Arm VAS)(Baseline throughout 24 months post-operatively)
研究者
研究点 (14)
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