A Prospective, Multi-Center, Non-Randomized Study to Assess Clinical Outcomes Using Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior Lumbar Interbody Fusion or Lateral Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Change in the Oswestry Disability Index (ODI)
研究概览
简要总结
This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and 24 month visit after surgery.
详细描述
Map3 is an allogeneic bone matrix which also contains demineralized cortical cancellous bone and multipotent adult progenitor cells (MAPC). MAPC-based cells are derived from allograft bone marrow, isolated from other cells and cryopreserved. Both the scaffold and cellular constituents are processed from the same donor but are provided in separate containers. Scaffold and cells combined constitute the implant and must be used together. The map3 implant is available in Strips allograft and Chips allograft configurations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •is at least 18 - 75 years of age and skeletally mature
- •must have symptomatic spondylosis, spondylolisthesis grade I or II, or degenerative disc disease (DDD) at one level from L2-S1 requiring a fusion
- •must be a candidate to use an allograft spacer
- •must be a candidate for bilateral pedicle screw placement
- •must have completed a minimum of six weeks (+/- two to four weeks of bracing) of unsuccessful conservative, non-operative care
- •must have discogenic back pain with or without leg pain DDD must be confirmed by MRI or CT scans followed by discography (if necessary)
- •must score at least 40 % on the Oswestry Disability Index
- •must score 4 or more on a 10 cm Visual Analog Scale for back pain or leg pain
- •must be able to comply with the protocol's follow-up schedule
- •must understand and sign the informed consent documenT
排除标准
- •symptomatic at more than one level
- •previous fusion surgery at any lumbar level with or without instrumentation.
- •any other bone grafting product other than study product and local autograft bone. e.g. rhBMP2, (recombinant human bone morphogenetic protein 2).
- •patients requiring any other interbody fusion device other than an allograft spacer (Bigfoot™, Crossfuse® Advantage). e.g. no PEEK IBF
- •more than 50% spondylolisthesis (Myerding grade III or more)
- •lumbar scoliosis greater than 11 degrees
- •osteoporosis* (T-score of -2.5 or lower), osteomalacia, Paget's disease or --metabolic bone disease.
- •spinal tumors
- •active arachnoiditis
- •fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- •impaired calcium metabolism
- •active infection or surgical site infection
- •rheumatoid arthritis or other autoimmune disease that affects bone healing (at the surgeon's discretion)
- •chronic steroid use except for chronic inhalers (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing
- •use of glucocorticoids > 10 mg/day
- •systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
- •morbid obesity defined as body mass index (BMI) >45 or a weight more than 100 lbs. over ideal body weight
- •uncontrolled diabetes documented with an Hbg A1C >9 or insulin dependent diabetics
- •smokers unless approved by Sponsor, including electronic cigarettes and vaporizers
- •within the past two (2) years, psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse any history or active cancer
- •pregnancy, or interested in becoming pregnant while participating in the study
- •participation in another investigational study within 30 days
结局指标
主要结局
Change in the Oswestry Disability Index (ODI)
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
次要结局
- Fusion(6 months, 12 months and 24 months)
- Changes in SF-36 scores.(Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Time to return to work(Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Changes in Visual Analog Scale (VAS) pain scores.(Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Changes in Lumbar Intervertebral Disc (LID) scores.(Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months)
- Changes in medication use(Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months)