A Prospective, Randomized Clinical Investigation of rhBMP-2 and Compression Resistant Matrix With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 试验地点
- 28
- 主要终点
- Overall Success
研究概览
简要总结
The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.
详细描述
This clinical trial was conducted to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System for posterolateral fusion treatment of patients with symptomatic degenerative disc disease versus the control group of autogenous bone with the CD HORIZON® Spinal System.
The investigational treatment was the open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System. One investigational implant was placed across two adjacent transverse processes on each side of the spine during the spinal fusion procedure.
The control treatment was the bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
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
- None
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
- •Each patient participating in this clinical trial must meet all of the following inclusion criteria:
- •Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history of pain and radiographic studies:
- •Requires fusion of a single level disc space from L1 to S
- •Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
- •If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.
排除标准
- •A patient meeting any of the following criteria is to be excluded from this clinical trial:
- •Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
- •Had previous spinal fusion surgical procedure at the involved level.
- •Requires spinal fusion at more than one lumbar level.
- •Has been previously diagnosed with osteopenia.
- •Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- •Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
- •Has a history of exposure to injectable collagen or silicone implants.
- •Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP 2/CRM implantation.
- •Has received any previous exposure to any/all BMP's of either human or animal extraction.
研究组 & 干预措施
Control
The bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
干预措施: Autograft/CD HORIZON® Spinal System (Device)
Investigational
Open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.
干预措施: rhBMP-2/CRM/CD HORIZON® Spinal System (Device)
结局指标
主要结局
Overall Success
时间窗: 24 months
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a "failure."
次要结局
- Blood Loss(At the time of operation)
- Fusion(24 months)
- Overall Neurological Status(24 months)
- Pain/Disability Status(24 months)
- General Health Status(24 months)
- Leg Pain(24 months)
- Hospital Days(At the time of discharge)
- Back Pain(24 months)
- Operative Time(At the time of operation)