A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 4
- 主要终点
- Incidence of Subsidence
研究概览
简要总结
The objective of this retrospective study is an investigational clinical follow-up, of patients treated with interbody fusion devices (IBFD), both expandable (EXP) and static (STC), according to their intended use and cleared labeling to understand IBFD design and technique characteristics that affect occurrence rates of subsidence.
Patients treated with IBFD's (both EXP and STC) according to their intended use and cleared labeling
- EXP IBFD's that expand in width and height demonstrate reduced occurrence of subsidence post-operatively when compared to EXP IBFD's that expand in height only and STC IBFD's.
- EXP IBFD's that are comprised of multi-material composition with Polyetheretherketone (PEEK) endplate contacting surfaces demonstrate reduced occurrence of subsidence on post-operative radiographs when compared to EXP and STC IBFD's that are primarily comprised of Ti with Ti endplate contacting surfaces.
- achieve radiographic fusion at a rate consistent with the state-of-the-art
- achieve significant improvements in pain and function compared to baseline
- experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery
- not demonstrate any intraoperative complications during the implant process
- operative approach does not correlate with increased rates of subsidence
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. The patient was treated with TLIF or PLIF surgery using the IBFD according to the cleared labeling, based on the surgeon's clinical judgment and patient-specific decision making. Based on the product labeling, the patient must:
- •Was at least 18 years of age and skeletally mature at the time of surgery
- •Had clinical and radiological evidence of DDD of the lumbar spine
- •Undergone treatment with the IBFD with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone at 1 or 2 contiguous levels from L2 to S1
排除标准
- •History of fusion surgery or large laminectomy at L2 to S1 prior to treatment with the IBFD(s) Spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
- •Surgery with the IBFD(s) at more than 2 contiguous levels
- •Surgery with the IBFD(s) at levels outside the range of L2 to S1
- •Treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space
- •Any contraindications listed in the cleared product labeling
- •Osteoporosis, Other Systemic Bone D.O. T score ≤ -1.5
- •Systemic Infection
- •H/O IV Drug Use
结局指标
主要结局
Incidence of Subsidence
时间窗: 24 months
Radiographic subsidence immediately postoperatively (first erect), at 12 months, and at 24 months as evaluated by an independent reviewer. Where subsidence is defined as ≥ 2mm cage penetration of the cephalad, caudal end plate, or both. Intraoperative subsidence will be classified when fluoroscopic images identify end plate violation, and postoperative subsidence is classified by the absence of violation on intraoperative fluoroscopy, but present on 12-month lateral radiographs and/or 24 months.
次要结局
- Visual Analog Scale (VAS) Scores for Leg Pain, if available(24 months)
- VAS Scores for Back Pain, if available(24 months)
- Incidence of End Plate Violation(12 months)
- Incidence of Fusion(24 months)
- Oswestry Disability Index (ODI) Scores, if available(24 months)
- Incidence of Device and/or Procedure-Related Adverse Events(24 months)