A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 17
- 主要终点
- Participants With Improved Patient Function
研究概览
简要总结
The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature patients at least 18 years of age with symptomatic single level degenerative disc disease (DDD) at L4/L5 only.
DDD is defined as discogenic back pain with or without leg pain; with degeneration of the disc as confirmed by patient history, physical examination, radiographic studies showing: decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive discography at the affected level.
These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level and should have failed at least six months of conservative, non-operative care.
Demonstrate non-inferiority compared to ProDisc.
详细描述
STUDY DESIGN:
Multicenter, prospective, randomized (1:1), controlled study comparing the artificial nucleus to ProDisc. After implanting artificial nucleus in two patients during the training session, enrollment of randomized patients shall begin. The study is expected to be completed in four years.
NUMBER OF INVESTIGATIONAL SITES and INVESTIGATORS:
10 - 20 investigational sites, 1 to 2 investigators per site, approximately 20-40 patients per site
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
- Single (Participant)
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
- •is at least 18 years of age and skeletally mature
- •must have symptomatic single level degenerative disc disease at L4/5 requiring surgical treatment
- •must have completed a minimum of six months of unsuccessful conservative, non-operative care
- •must have discogenic back pain with or without leg pain
- •must show radiographic confirmation using plain films, MRI, CT, myelogram or discography of one of the following: decreased disc height when compared to the adjacent level, contained herniated nucleus, or vacuum phenomenon (dark disc)
- •must score at least 40% on the Oswestry Disability Index
- •must score at least 4 on a 10cm Visual Analog Scale for back pain
- •is able to comply with the protocol's follow-up schedule
- •must understand and sign the informed consent document
排除标准
- •symptomatic DDD at more than one level
- •previous fusion at any lumbar level or laminectomy at the target level (discectomy, Intradiscal Electrothermal Annuloplasty, laminotomy, or nucleolysis performed > 6 months ago are permitted)
- •clinically compromised vertebral bodies, at the affected level due to previous trauma, i.e., compression or burst fracture
- •pars defect
- •involved vertebral endplate dimensionally smaller than 34.5 mm in the medial-lateral direction and/or 27 mm in the anterior-posterior direction
- •disc height less than 5 mm at the target level
- •bony stenosis
- •lytic spondylolisthesis, spondylolisthesis greater than 3mm
- •lumbar scoliosis greater than 11 degrees.
- •osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
- •Schmorl's nodes, an incomplete annulus, or endplates that are not intact
- •spinal tumors
- •symptomatic facet joint disease
- •free fragment herniation confirmed radiographically
- •isolated radicular compression syndrome, especially due to a disc herniation
- •arachnoiditis
- •active infection or surgical site infection
- •is using any medication known to interfere with bone/soft tissue healing
- •rheumatoid arthritis or other autoimmune disease
- •systemic disease such as AIDS, HIV, hepatitis
- •morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight
- •psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse
- •active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years
- •documented allergies to metal or plastic; i.e., cobalt, chromium, molybdenum, polyethylene, titanium or polyetheretherketone
- •pregnancy, or interested in becoming pregnant within the next two years
- •involvement in an investigational drug or device study within 30 days
研究组 & 干预措施
NuBac
NuBac device implanted at the L4/5 level
干预措施: NuBac (Device)
Prodisc-L
Prodisc-L implanted at the L4/5 level.
干预措施: Prodisc-L (Device)
结局指标
主要结局
Participants With Improved Patient Function
时间窗: 24 months
The comparison of results was based on the proportion of participants with improved outcomes. The primary efficacy variable was treatment success based on the following criteria: 1. Oswestry Disability Index score improved by at least 15 points 2. Device success 3. Neurological success 4. Absence of major complications 5. Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure.
次要结局
未报告次要终点