The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 325
- 试验地点
- 28
- 主要终点
- Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
研究概览
简要总结
The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;
- •Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.
排除标准
- •Prior fusion or decompressive laminectomy at any 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;
- •Grade II or greater spondylolisthesis;
- •Isthmic spondylolisthesis or spondylolysis (pars fracture);
- •Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
- •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 > 40;
- •Active or chronic infection - systemic or local;
- •Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
- •Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
- •Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
- •Patient is unwilling to complete his/her surveys.
结局指标
主要结局
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
时间窗: 5 years
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points
Patient has not had any major device related complications
时间窗: 5 years
Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.
Patient has not undergone any Epidural injections
时间窗: 5 years
Assessment of lumbar epidural injections
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
时间窗: 5 years
Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
次要结局
- Zurich Claudication Questionnaire (ZCQ)(5 years)
- Quality of Life(5 years)
- VAS Back Pain(5 years)
- VAS Leg Pain(5 years)