A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With Fusion Success
研究概览
简要总结
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
详细描述
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
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)
盲法说明
Study participants will not know which posterior lumbar cage they receive.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is skeletally mature
- •Subject has one or more of the following diagnoses:
- •Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to S1
- •a. DDD may include up to Grade 1 spondylolisthesis at the involved level(s)
- •Degenerative Scoliosis for which the interbody fusion device will be used as an adjunct to fusion
- •Subject has received 6 months of non-operative therapy
- •Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent
- •Subject agrees to comply with visit schedule and study assessments
- •Provision of signed and dated informed consent form
- •Subject stated willingness to comply with all study procedures and availability for the duration of the study
- •Subject is in good general health as evidenced by medical history
排除标准
- •Subject is obese (BMI > 40)
- •Subject is sensitive to titanium materials
- •Subject has an active infection at the operative site
- •Subject has marked local inflammation
- •Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis
- •Subject has any mental, trauma, or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
- •Subject has any open wounds
- •Subject is pregnant or plans to become pregnant during the course of the study
- •Subject has inadequate tissue coverage over the operative site.
- •Subject has an neuromuscular deficit which places an unsafe load on the device during the healing period
- •Subject has any condition of senility, mental illness, or substance abuse
- •Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count.
- •Subject has prior fusion at the levels to be treated
- •Subject is incarcerated
结局指标
主要结局
Number of Participants With Fusion Success
时间窗: 12 Months
CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint
次要结局
- Change in Low Back Function(Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation)
- Change in Quality of Life: EQ-5d(Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation)
- Change in Visual Analogue Scale(Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation)
- Ambulatory Status(Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation)
- Change in Quality of Life: SF-36 PCS(Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.)
- Number of Participants That Return to Work(Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation)
- Number of Participants With Serious Adverse Events(6 weeks; 3 months; 6 months; and 12 months post operation)
研究者
Juan Jimenez
Principal Investigator
Riverside Medical Center