A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 32
- 主要终点
- coflex performance compared to IDE
研究概览
简要总结
A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.
详细描述
A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.
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
- •Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
- •Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
- •Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
- •Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
- •Skeletally mature
- •Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
- •Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
- •Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.
排除标准
- •Prior fusion or decompressive laminectomy at index lumbar level.
- •Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
- •Severe facet hypertrophy that requires extensive bone removal which would cause instability.
- •Isthmic spondylolisthesis or spondylolysis (pars fracture).
- •Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
- •Osteoporsis or is at increased risk of osteoporosis.
- •Back or leg pain of unknown etiology.
- •Axial back pain only, with no leg, buttock, or groin pain.
- •Morbid obesity defined as a body mass index >
- •Known allergy to titanium, titanium alloys, or MR contrast agents.
- •Active or chronic infection - systemic or local.
- •Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
研究组 & 干预措施
The coflex® Interlaminar Technology
The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.
干预措施: coflex® Interlaminar Technology (Device)
Decompression
Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.
干预措施: Decompression (Procedure)
结局指标
主要结局
coflex performance compared to IDE
时间窗: 24and 60 Months
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
Composite Clinical Success (CCS)
时间窗: 24 Month
* No secondary surgical interventions * No lumbar epidural injection, nerve block procedures at index level to treat spinal stenosis at any lumbar level * 15 point improvement in ODI in subjects with no interventions or injections * No new or increasing sensor or motor deficit * No major device related adverse events
coflex performance compared to decompression alone from ESCADA study.
时间窗: 24 Months
To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.
次要结局
- Neurological Status(Baseline, 6 weeks, 12, 24, 36, 48, 60 Months)
- Medication Usage(24 Month)
- Change in Oswestry Disability Index (ODI)(Baseline, 24 and 60 months)
- Change in Visual Analog Scale (VAS) for low back pain(Baseline, 24 and 60 Months)
- Change in Visual Analog Scale (VAS) for leg pain(Baseline, 24 and 60 Months)
- Radiographic Assessments(6 weeks, 12, 24, 60 Months)
- Modified CCS(24 Month)