RHINE™ Cervical Disc Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 主要终点
- Neck Disability Index (NDI) change from baseline
研究概览
简要总结
A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels. The primary objectives of the RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments and surgical technique; confirm device performance in terms of clinical and radiographic outcomes; confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices.
详细描述
A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels ( C3-C7). The primary objectives of the RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments and surgical technique; confirm device performance in terms of clinical and radiographic outcomes; confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices. Device- and procedure-related adverse events, serious adverse events, and secondary surgeries will be monitored throughout. AEs will be characterized by severity, seriousness and relationship to device. Investigator reports of serious adverse events and any AE trends will be reviewed by a medical monitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient requires reconstruction of the disc from C3 to C7 following discectomy at 1 or 2 (contiguous) levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels.
- •The patient has failed at least 6 weeks of non-operative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation.
- •Self-reports a pre-operative upper extremity (right or left) VAS pain score ≥ 20 (0-100).
- •Self-reports pre-operative NDI score ≥ 30% (raw score of ≥ 15/50).
- •Willing and able to comply with the protocol requirements including follow-up visit schedule.
- •Willing and able to sign a study specific informed consent.
排除标准
- •More than two cervical levels requiring surgery, or has two levels requiring surgery that are not adjacent.
- •Previous surgical intervention at the target level(s)
- •Any of the following at the target level(s):
- •Significant cervical anatomical deformity, e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
- •Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes characterized by any of the following: bridging osteophytes, marked reduction or absence of motion (< 2 degrees change from flexion to extension), collapse of the intervertebral disc space of greater than 50% of its normal height (compared to adjacent levels)
- •Radiographic signs of subluxation > 3.5 mm
- •Angulation of the disc space more than 11 degrees greater than adjacent segments
- •Significant kyphotic deformity (> 5 degrees) at a single level or significant reversal of lordosis (not corrected with extension)
- •Fused level adjacent to a level to be treated
- •Axial neck pain is the patient's solitary symptom
- •Severe pathology of the facet joints of the involved vertebral bodies
- •Previous diagnosis of osteopenia or osteomalacia
- •Has any of the following risk factors that may be associated with a diagnosis of osteoporosis.
- •Spinal metastases
- •Extreme obesity (BMI ≥ 40)
- •Overt or active bacterial infection, either local or systemic
- •Severe insulin dependent diabetes
- •Chronic or acute renal failure or prior history of renal disease
- •Fever (temp > 38.3° C oral) at the time of surgery
- •Documented allergy or intolerance to titanium or polyurethane
- •Reported concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
- •Any medical condition that may interfere with the postoperative management program or preclude meaningful patient self-assessments, e.g., advanced emphysema, progressive neurological disease, or Alzheimer's disease
- •Any medical condition that may result in patient death prior to study completion, e.g., unstable cardiac disease, active malignancy
- •History of an endocrine or metabolic disorder known to affect osteogenesis
- •Active immunosuppressive disorder that may predispose patient to infection
- •Participating in or planning to participate in another clinical study that might influence the treatment outcomes or ability to comply with the study requirements
- •Member of a vulnerable population such as, mentally incompetent, prisoner
- •Pregnant, nursing, considering becoming pregnant during the study, or is of childbearing potential and unwilling to use an accepted form of birth control during the study.
- •History or suspicion of substance abuse or currently undergoing substance abuse treatment
- •In the judgment of the Investigator, patient is not likely to be able to fulfill the requirements of the study.
结局指标
主要结局
Neck Disability Index (NDI) change from baseline
时间窗: Pre-operative, 6 months, 12 months, 24 months and 60 months
Evaluation of the change in function will be scored using the Neck Disability Index (NDI) at all time points compared to baseline (pre-operative). NDI is a subject-completed, condition-specific functional status questionnaire with 10 questions. Each question is scored from 0 to 5, summed to a total and multiplied by 2 to get a score from 0 to 100. A 15 point change in NDI score compared with baseline (pre-operative score) will be used as the measure for a clinically significant change.
Number of Patients with Adverse Events (AEs)
时间窗: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months
AEs will be monitored throughout the study and characterized by seriousness, severity and relationship to the device and procedure, at a minimum.
Radiographic Outcomes
时间窗: Pre-operative, 6-12 weeks, 6 months, 12 months, 24 months and 60 months
Anteroposterior \& Lateral ( or MRI at Pre-operative ) and Flexion and Extension x-rays will be taken at all time points. An independent radiologist will review and assess all radiographs including: range of motion, translation, intervertebral height, device height, device positioning/migration, heterotopic ossification and adjacent segment degeneration.
次要结局
- Secondary Surgeries (Surgical Interventions)(Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months and 60 months)
- Functional / Economic Impact - Prolo Scale(Pre-operative, 6 months, 12 months, 24 months annd 60 months)
- Global Assessment(6 months, 12 months, 24 months and 60 months)
- Patient treatment success (PTS)(24 months)
- Estimated blood loss(During Operation)
- Surgery time(During Operation)
- Pain: Neck, Right Arm, Left Arm, Worst arm Visual analog Scale Change form Baseline(Pre-operative, 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months)
- Quality of life (SF-36)(Pre-operative, 6 months, 12 months, 24 months annd 60 months)
- Neurological function(Pre-operative, 6 months, 12 months, 24 months annd 60 months)
- Patient satisfaction(6 months, 12 months, 24 months and 60 months)
- Use of NSAIDS and other pain Medications.(Pre-operative, 6 months, 12 months, 24 months annd 60 months)
- Length of hospital stay(At discharge, estimated average of 3-6 days after surgery)
- Surgeon satisfaction with instruments and surgical technique(At discharge, estimated average of 3-6 days after surgery)