Prospective, Randomized, Data Registry Study of MOBIS II Structural Titanium (ST) Interbody Cage Compared to MOBIS Peek Cage for the Treatment of Spondylolisthesis and Degenerative Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Fusion rates
研究概览
简要总结
Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1
详细描述
The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patient should have completed at least six (6) months of non-operative treatment. Patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S
- •The patient has documented conservative (non-operative) treatment for at least 6 months.
- •The patient has a VAS back pain of ≥ 60 mm.
- •The patient has an ODI ≥ 40%.
- •The patient is at least 18 years of age and skeletally mature.
- •The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
- •The patient is willing and able to comply with study requirements.
- •The patient has agreed to participate in the study.
排除标准
- •The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s).
- •The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
- •The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
- •The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation.
- •The patient has an active infection.
- •The patient is pregnant or is planning on becoming pregnant in the next two years.
- •The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
- •The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium.
- •The patient is currently enrolled in an investigational spine study.
- •The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
- •The patient has symptomatic fibrous arachnoiditis
结局指标
主要结局
Fusion rates
时间窗: 24 Months
Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans
次要结局
- Patient Reported Outcomes: Oswestry Disability Index(Through 24 Months)
- Patient Reported Outcomes: Visual Analog Scale (VAS)(Through 24 Months)
- Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L(Through 24 Months)
- Subsidence(24 Months)