Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- SC Medica
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- The rate of fusion
研究概览
简要总结
This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.
详细描述
The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patient is ≥ 18 years old at the time of the surgery
- •The first back operation in the patient's life was for degenerative lumbar spinal stenosis
- •Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw fixation or FACET FIXation implant.
- •Patient is able to understand the information related to the study
- •Patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data.
排除标准
- •Patient received FACET FIXation implant or Pedicle Screw fixation with supplemental interbody cages.
- •Unilateral Pedicle Screw or FACET FIXation implant.
- •Preoperative grade ≥II spondylolisthesis
- •Preoperative scoliotic deviations >25°.
- •Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).
- •Patient not covered by a social security scheme.
结局指标
主要结局
The rate of fusion
时间窗: 2 years
The proportion of patients achieving the primary endpoint will be evaluated. The rate of fusion in the radiographic assessment is considered successful if all of the following criteria are achieved : * Evidence of bridging bone between the facet joints (Facet Fixation implant) or the transverse processes (pedicle screws) via computed tomography scan. * and ≤ 3mm translational motion between vertebrae on flexion / extension via dynamic X-rays. * and no evidence of lucency surrounding the device (≤25%). The main analysis will compare the successful fusion rate at 2+ years post-operative between the group with the Facet Fixation and the group with pedicle screws, by a confidence interval approach.
次要结局
未报告次要终点