A Prospective Non-current Concurrent Controlled Evaluation of Open and MAS® PLIF for the Treatment of Symptomatic Lumbar Degenerative Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Complications
研究概览
简要总结
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.
详细描述
The objective of this evaluation is to collect and compare short-term factors related to the morbidity of approach using traditional posterior-approach interbody fusion techniques and a less invasive exposure for the same procedure. Perioperative measures and early outcomes will be documented to demonstrate differences in procedural requirements, safety, and early recovery. A total of 100 subjects will be consecutively enrolled in this prospective study from as many as 8 centers. Patients who, in the surgeon investigator's opinion, require instrumented lumbar interbody fusion and have consented to PLIF surgery for their conditions will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria in order to be considered for enrollment.
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
- •Subjects must meet all inclusion criteria to be eligible for enrollment into this observational study:
- •Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
- •18+ years of age at the date of written informed consent;
- •Able to undergo surgery based on physical exam, medical history and surgeon judgment;
- •Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;
- •Signed and dated informed consent form.
排除标准
- •Subjects presenting with any of the following will not be included in this observational study:
- •Mental or physical condition that would limit the ability to comply with study requirements;
- •Spine abnormality requiring treatment at more than two levels;
- •Prior surgery at operative or adjacent level(s);
- •Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
- •Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
- •Participating in another clinical study that would confound study data.
结局指标
主要结局
Complications
时间窗: 6-weeks
All complications will be compiled and their incidence and relationship to the product and/or surgical procedure will be tabulated for comparison.
次要结局
- Clinical Outcomes(6-weeks)
- Radiographic Outcomes(6-weeks)