Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 153
- 试验地点
- 17
- 主要终点
- Fusion Rates
研究概览
简要总结
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
详细描述
Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature between the ages of 20-80
- •Candidate for posterior lateral fusion between T1-S1 with autograft
- •Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis)
- •Symptoms of leg and/or back pain
- •Non-responsive to conservative/non-surgical treatment for at least three (3) months
- •Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits
排除标准
- •Active systemic or local infection
- •Use of interbody device
- •Mental illness
- •Incarceration
- •Alcohol or drug abuse
- •Severe osteoporosis or osteopenia
- •Use in the cervical spine
- •Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
- •Soft tissue deficit not allowing sound closure
- •Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
- •Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
- •Active malignancy or other significant medical comorbidities
- •Any medical or mental condition which would put the patient at high risk due to the severity of surgery
- •Inadequate pedicles of the thoracic, lumbar and sacral vertebrae
- •Patient unwilling or unable to follow postoperative instructions
结局指标
主要结局
Fusion Rates
时间窗: 24 months post surgery date
Fusion was defined by meeting three criteria: * rotation \< 5° between motion segments on flexion-extension radiographs * translation \< 3 mm between motion segments on flexion-extension radiographs * presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.
次要结局
未报告次要终点