OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 22
- 主要终点
- Mean Change in Back Function Score at 24-months Compared to Pre-op
研究概览
简要总结
The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition requires an interbody spinal fusion procedure combined with posterior fixation.
详细描述
Seventy-six thousand posterior interbody fusions are performed annually in the U.S., and it has been estimated that at least 50% of those cases include supplemental posterior instrumentation. For interbody fusion with posterior fixation, spine surgeons currently place structural intervertebral spacers into the interbody space. These spacers may be pre-shaped devices constructed of allograft (cortical bone dowels or femoral rings) or non-metallic, radiolucent materials, or metallic cage devices. Autogenous bone graft and blood components (marrow, blood) are often added.
Use of morselized bone graft in orthopedic procedures is desirable because it is more rapidly incorporated during the course of bone healing. If the morselized graft pack can be effectively contained in the interbody space, the graft material can function as a structural spacer to provide anterior column support. Contained graft material can be tightly packed within the mesh to increase the graft's compressive strength. Unlike pre-shaped cortical grafts, the morselized pack conforms intimately to the host bone at the surgical site, ensuring good vascularization potential and reducing the osteoblast jumping distance for osteogenesis. In addition, the solidly packed graft retains intra-pack porosity, ensuring an osteoconductive scaffold to facilitate vascular and bony ingrowth.
It would be desirable to minimize autograft use because of associated post-op pain, to optimize contact between allograft and host bone, and to permit the surgeon to place or construct an effective structural intervertebral spacer with only minimal neural retraction required.
OptiMesh 1500S is intended to be used to contain the bone graft placed by spine surgeons into the interbody space to achieve spinal intervertebral body fusion. OptiMesh 1500S enables the use of morselized bone graft materials in spine fusion procedures instead of solid allograft materials, such as cortical bone dowels or femoral rings, or rigid synthetic materials.
In addition, the OptiMesh instrument system allows the surgeon to perform an interbody fusion through a small portal and to complete the entire fusion procedure from a posterior approach instead of a 360 degree anterior/ posterior procedure, which is often the case with the use of cages. The minimal access portal utilized for OptiMesh filling allows the device to be placed via a unilateral transforaminal or translaminar approach, versus the often-used bilateral approach required for many cages and cortical spacers. This flexibility permits the surgeon to adapt the surgical approach to the local anatomy of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Skeletally mature and be at least 18 years of age
- •Have degenerative disc disease (DDD) requiring one level fusion between L2 and S1, with DDD confirmed by subject history, physical exam, and radiographic studies with one or more of the following factors:
- •instability as defined by >3 mm translation or ≥5º rotation of flexion/ extension;
- •osteophyte formation of facet joints or vertebral endplates;
- •decreased disc height, on average 2 mm, but dependent on spinal level;
- •scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule;
- •herniated nucleus pulposus;
- •facet joint degeneration/changes; and/or
- •vacuum phenomenon;
- •Based on the VAS, subjects report pre-operative low back pain (>4 of 10) with duration of pain six-months or longer despite non-surgical treatment;
- •Capable of understanding and signing the consent form; and
- •Willing and able to comply with follow-up requirements
排除标准
- •A previous interbody fusion at the involved level;
- •Greater than grade 2 spondylolisthesis;
- •Systemic infection or active infection at the surgical site;
- •Active malignancy;
- •Body Mass Index of 40 or higher;
- •Significant metabolic bone disease (e.g. osteoporosis or osteomalacia) to a degree that spinal instrumentation is contraindicated;
- •Taking medications that may interfere with bone or soft tissue healing (e.g. long-term steroid use);
- •Alcohol or drug abuse;
- •Waddell Signs of Inorganic Behavior >3;
- •Currently in litigation regarding a spinal condition;
- •Known sensitivity to implant material;
- •A prisoner;
- •Pregnant or contemplating pregnancy during the 24-month follow-up period; and
- •Enrolled in another concurrent clinical trial.
结局指标
主要结局
Mean Change in Back Function Score at 24-months Compared to Pre-op
时间窗: 24 month
A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from "0" to "100" points. A score of "0" represents "No disability" and "100" represents "Total disability". The magnitude of change between the two timepoints is reported. A clinically meaningful improvement is defined as a 15 point reduction at 24-months compared to the pre-op score.
Number of Participants With a Serious Device and Procedure Related Adverse Event
时间窗: From Intra-op through the 24-month visit
The rate of serious device and procedure related adverse events are compared between the control and treatment arm from intraoperative through 24 months of follow-up.
Number of Participants Determined to be a Fusion Success at 24 Months Post-operative
时间窗: 24 month
Fusion Success is defined as \<5 degrees angulation, \<10% translation, and presence of bridging bone on CT.
Mean Change in Low Back Pain Score at 24-months Compared to Pre-op
时间窗: 24 month
A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 10 cm pain scale where a score of "0" represents "No Pain" and a score of "10" represents the "Worst Possible" pain. The magnitude of change in the 24-month score compared to the baseline score is calculated. A clinically meaningful change is defined as a 2 unit (cm) reduction at 24-months when compared to pre-op.
次要结局
- Left Leg Pain--Change From Preop at the 24-month Timepoint(24-month visit)
- Right Leg Pain Score--Change From Preop at the 24-month Timepoint(24-month visit)
- Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative(24-month visit)