RAMP Study: A Prospective Randomized Study Comparing Two Lumbar Fusion Procedures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Efficacy
研究概览
简要总结
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.
详细描述
Study Treatment Arms:
The transacral lumbar interbody fusion (including 1L+ and 2L+) is a minimally invasive technique that uses a transacral approach to achieve fusion at the L5-S1 or L4-L5-S1 spinal levels. The transforaminal lumbar interbody fusion (TLIF) is performed by using a posterior unilateral or bilateral incision in which the lumbar spine is accessed. Both study procedures are approved for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
Study Design, Objective:
The study objective is to demonstrate non-inferiority between the transacral lumbar interbody fusion procedure and the transforaminal lumbar interbody fusion procedure (TLIF) by meeting the primary and secondary study endpoints as listed below.
Study design, Endpoints:
研究设计
- 研究类型
- Observational
- 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
- •Male or female subject that is eligible for both study procedures only at the L4-L5-S1 or L5-S1 levels with bilateral pedicle screws;
- •The subject has a diagnosis of one or more of the following conditions at the L4-L5-S1 or L5-S1 levels:
- •Spinal stenosis;
- •Spondylolisthesis;
- •Degenerative Disc Disease (DDD) defined as back pain and/or radicular pain with degeneration of the disc as confirmed by history, physical examination and radiographic studies, either by CT, MRI, plain film, myelography, or discography;
- •Adult 18 years of age or older;
- •The subject has undergone at least 6 consecutive months of Conservative Care Therapy(ies);
- •The subject is able and willing to give written informed consent and to comply with the requirements of this study protocol.
排除标准
- •Coagulopathy;
- •Bowel disease (e.g. Crohn's, ulcerative colitis);
- •Severe scoliosis (curves > 60°);
- •Sacral agenesis;
- •Spondylolisthesis greater than Grade 1 at the L4-L5-S1 levels, or greater than Grade 2 at the L5-S1 level;
- •Spinal tumor (or history of sacral tumor);
- •History of fracture at L4, L5 and/or S1 vertebral bodies;
- •The subject has undergone a prior fusion procedure of the lumbar spine;
- •Osteoporosis; or, if the subject is at high risk for development of osteoporosis, further screening to be conducted at Investigator's discretion;
- •Per the Investigator, body weight is exclusionary only if concomitant medical issues are present that preclude the subject from being a candidate for spinal surgery; The subject is a current cigarette smoker;
- •For women of childbearing potential, pregnancy at the time of enrollment, or planning to become pregnant during the course of the study;
- •The subject has a history of substance abuse (illegal drugs, prescription drugs, or alcohol) that, in the Investigator's opinion, may interfere with protocol assessments and/or the subject's ability to comply with the protocol;
- •Per the Investigator, the subject is in poor general health or undergoing any concurrent disease process that would place the subject in excessive risk to surgery (e.g. significant circulatory problems, cardiac disease, history of bowel surgery);
- •The subject is participating in another spine study, which, in the opinion of the Investigator, could skew results;
- •The subject is involved in litigation related to their back condition;
- •The subject is contraindicated to receive either study procedure;
- •The subject is contraindicated to receive bilateral pedicle screws;
- •The subject has a history of allergy to any component of the devices or biologic material to be implanted in either procedure;
- •The subject is a prisoner, transient, or an illegal alien.
结局指标
主要结局
Efficacy
时间窗: 24 months post-operative
Efficacy: Fusion of the targeted vertebral bodies (L4-L5-S1 or L5-S1) will be assessed individually at 24 months as determined by Central Radiographic Reviewer's (orthopedic surgeon) interpretation of high resolution Computed Tomography (CT) Scan.
次要结局
未报告次要终点