rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Mean Oswestry Disability Index (ODI) Score
研究概览
简要总结
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
详细描述
The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:
- Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
- Comparable inpatient length of stay (LOS)
- Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
- Comparable fusion rates, evaluated via CT scan I year postoperatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
盲法说明
The surgical team, including the surgeons, will be blinded to the treatment options until decompression/instrumentation have been completed. The patients and all staff, including hospital nursing staff, case management, and physical therapists, will be blinded as to which bone graft treatment the patient received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older;
- •Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;
- •Willing to provide informed consent, participate in study, and comply with study protocol.
排除标准
- •Pregnant or contemplating pregnancy prior to surgery;
- •Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
- •Surgery involving more than 2 vertebral levels;
- •Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).
- •Lactating women
- •Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin
- •Immune compromised patients
研究组 & 干预措施
Intervention group - 5cc Vivigen and local autograft
干预措施: 5cc Vivigen and local autograft (Biological)
Control group - small kit rhBMP-2 with local autograft
干预措施: Small kit rhBMP-2 with local autograft (Biological)
结局指标
主要结局
Mean Oswestry Disability Index (ODI) Score
时间窗: Up to 1 year post surgery
The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)
次要结局
- Mean Postoperative Leg/Back Pain Score(Average of 3 days in hospital)
- Mean Inpatient Length of Stay(Average of 3 days in hospital)
- Fusion Rates, Evaluated Via CT Scan I Year Postoperatively(1 year post surgery)