JPRN-jRCTs032190039已完成未知
Accuracy and Safety of Percutaneous Pedicle Screw Placement with the Viper Prime(R) spine system in Japan: prospective, randomized active controlled Study
Ohmori Kazuo0 个研究点目标入组 80 人开始时间: 2019年6月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
As a Primary endpoint, the accuracy rate was 85.7% in VP arm and 75.0%. The difference in accuracy rate between arms was 10.7%, thus proving the non-inferiority of VP arm to CD arm. As a secondary endpoint, VP arm was significant different from CD arm in screw insertion time and in the number of fluoroscopes associated with screw insertion time. As a Safety Endpoint, no adverse events were reported in relation to the study products or the study treatment. No new safety concerns of note were identified.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •A) A male or female individual aged =>20 years.
- •B) A patient with a diagnosis of a spinal degenerative disease (e.g., degenerative disc disease, lumbar spinal stenosis, spondylolisthesis, or scoliosis), spinal tumors, or vertebral fracture.
- •C) A patient who are considered suitable for first instrumentation lumbosacral surgery with percutaneous pedicle screw and undergoing an instrumentation lumbosacral surgery involving at least one intervertebral segment, regardless of whether interbody fusion (e.g., MIS-TLIF, PLIF, LLIF or XLIF(R), or OLIF/ATP) is intended or not.
- •D) A patient who voluntarily participates in this trial and signed the informed consent form stating that patient information obtained from the trial can be provided to the investigator.
- •E) A patient who, in the opinion of the investigator or a subinvestigator, understands the purpose of the clinical trial and has the intention and abilities to comply with the procedures of the surgery and the clinical trial.
- •F) A patient who can read and understand the Japanese informed consent form.
排除标准
- •A) A pregnant or breastfeeding woman.
- •B) A patient who is undergoing a repeat surgery of the lumbar spine.
- •C) A patient with prior pedicle screw placement into the lumbar spine.
- •D) A patient with severe osteoporosis.
- •E) A patient with severe spinal deformity due to scoliosis.
- •F) A patient for whom a CT examination shows target pedicles are extremely narrow or there is a severe osteosclerotic change in a target pedicle.
- •G) A patient who is a drug or alcohol abuser (in the past 5 years) or who has a psychiatric disorder and, in the opinion of the investigator or a subinvestigator, may be unable to comply with the study requirements defined in the protocol.
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