A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 131
- 主要终点
- Number of Patients With Adverse Events AEs)
研究概览
简要总结
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
详细描述
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Safety will be assessed by the following: 1.) Evaluation of all adverse events including device related, procedure related and additional serious adverse events; 2.) Additional surgical intervention at the operative site including the need for removals, revisions, re-operations or supplemental fixation required to modify the device; and 3.) The incidence and severity of any psoas muscle injury, genital femoral nerve injury and lumbar plexus injury will be determined for all patients. Supplemental fixation of any kind may be included as long as the procedure is completed via a minimally invasive approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1
- •Inadequate response to conservative medical care over a period of at least 6 months
- •Willing and able to comply with the requirements of the protocol including follow-up requirements
- •Willing and able to sign a study specific informed consent
- •Skeletally mature and ≥ 18 years of age at the time of enrollment
排除标准
- •Previous anterior/posterior/lateral spine surgery at the index level
- •Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine
- •Active systemic infection or infection at the operative site
- •Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
- •Metabolic bone disease such as osteoporosis that contradicts spinal surgery
- •History of an osteoporotic fracture
- •History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
- •Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- •Known allergy to titanium, cobalt chrome or PEEK
- •Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
- •Current medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- •Pregnant, or intend to become pregnant, during the course of the study
- •Severe obesity (Body Mass Index > 40)
- •Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life
- •Involved in current or pending spinal litigation where permanent disability benefits are being sought
- •Incarcerated at the time of study enrollment
- •Current participation in an investigational study that may impact study outcomes
结局指标
主要结局
Number of Patients With Adverse Events AEs)
时间窗: Operative to 24 month
The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
Visual Analog Scale (VAS) Change From Baseline
时间窗: 24 months
Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.
次要结局
- Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)(time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months)
- Change in Health-Related Quality of Life From Baseline (Pre-op)(time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months)
- Change in Use of Narcotics Post-Surgery Compared to Baseline(Pre-operative to 24 months)
- Change in Oswestry Disability Index From Baseline (Pre-Operative)(time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months)
- Odom's Criteria(24 months)
- Surgery Time(During operation.)
- Estimated Blood Loss(During Operation)
- Number of Participants With Abnormal Neuromonitoring System Results(During operation)
- Length of Hospital Stay(From admission to discharge)
- Radiographic Assessments(12 mo to 24 mo)
- Anesthesia Time(During operation.)
- Patient Satisfaction(12 month and 24 month)
- Change in Work/School Status Compared to Baseline(Pre-operative to 24 months)