A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 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 clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.
详细描述
This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
- •One level requiring surgical treatment
- •C3-C4 disc to C6-C7 disc level involvement
- •Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
- •No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
- •Preop Neck Disability index score ≥ 30
- •Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire
- •Not pregnant at time of surgery
- •Willing and able to comply with study plan and able to understand and sign patient informed consent
排除标准
- •Any other cervical spinal condition requiring surgical treatment at the involved level
- •Documented or diagnosed cervical instability defined by radiographs showing
- •Sagittal plane translation > 3.5mm or
- •Sagittal plane angulation > 20 degrees.
- •More than one cervical level requiring surgery
- •A fused level adjacent to the level to be treated
- •Severe pathology of the facet joint of involved bodies
- •Previous surgery at the involved level
- •Previously diagnosed osteopenia or osteomalacia
- •Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)
- •Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
- •Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
- •Male over the age of 70
- •Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
- •If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.
- •Presence of spinal metastases
- •Overt or active bacterial infection, either local or systemic
- •Severe insulin dependent diabetes
- •Chronic or acute renal failure or history of renal disease
- •Temperature > 101º F oral at surgery
- •Documented allergy to stainless steel, titanium or a titanium alloy
- •Mentally incompetent
- •Is a prisoner
- •Is pregnant
- •Is an alcohol and/or drug abuser
- •Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories)
- •A history of endocrine or metabolic disorder known to affect osteogenesis
- •A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy.
- •Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.
结局指标
主要结局
Rate of Overall Success
时间窗: 24 months
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; 2. Maintenance or improvement in neurological status; 3. Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height ≥ -2mm"; 4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 5. No secondary surgical procedure classified as a "failure."
次要结局
- Success Rate of SF-36 PCS(24 months)
- Blood Loss(During the time of operation, approximately 1.5 hours.)
- Success Rate of Neck Disability Index(24 months)
- Rate of Disc Height Success(24 months)
- Success Rate of SF-36 MCS(24 months)
- Rate of Secondary Surgery at Index Level(24 months post-operation)
- Change of General Health Status -- SF-36 PCS From Baseline(Baseline and 24 months post-operation)
- Success Rate of Neurological Status(24 months)
- Arm Pain Success Rate(24 months)
- Gait Success Rate(24 months)
- Change of Arm Pain Score From Baseline(Baseline and 24 months post-operation)
- Neck Pain Success Rate(24 months)
- Hospital Stay(During the time of hospital stay, average of 1 day.)
- Change of Neck Pain Score From Baseline(Baseline and 24 months post-operation)
- Operative Time(Time of operation, approximately 1.5 hrs.)
- Change of Neck Disability Index Score From Baseline(Baseline and 24 months post-operation)
- Change of General Health Status -- SF-36 MCS From Baseline(Baseline and 24 months post-operation)