A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® XLIF Decade™ Plate System for the Treatment of Patients With Pathologic Conditions of the Thoracic and/or Lumbar Spine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Radiographic fusion success
研究概览
简要总结
The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
详细描述
This study is a prospective, single-arm, multicenter study to evaluate the safety and performance of the XLIF Decade Plate in patients undergoing a thoracic and/or lumbar interbody fusion, at one or two levels, with supplemental fixation using a lateral plate. Consecutive patients at a given site who meet all eligibility requirements will be asked to consent to participate in the study. Eligible patients include those with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo XLIF surgery with lateral plating using the Decade Plate. At least 75 subjects will be enrolled and will be followed for 24 months after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients who are ≥18 years of age at the time of consent
- •Planned interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for
- •degenerative disc disease
- •spondylolisthesis
- •scoliosis, kyphosis, lordosis
- •spinal stenosis
- •spondylolysis
- •pseudoarthrosis or failed previous spine surgery
- •Able to undergo surgery based on physical exam, medical history, and surgeon judgment
- •Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study
排除标准
- •Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study
- •Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- •Use of bone growth stimulators postoperatively
- •Active smoking within 6 weeks before surgery
- •Patient has known sensitivity to materials implanted
- •Systemic or local infection (latent or active) or signs of local inflammation
- •Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
- •Pregnant, or plans to become pregnant during the study
- •Patient is a prisoner
- •Patient is participating in another clinical study that would confound study data
结局指标
主要结局
Radiographic fusion success
时间窗: 24 months
Proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative
Complication of interbody implant
时间窗: 24 months
Rate of device-related complications (i.e., safety) attributable to the use of the Decade Plate System
次要结局
- Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.(24 months)
- Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.(24 months)
- Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).(24 months)
- Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for back/leg pain measured by visual analog scale (VAS).(24 months)
- Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10.(24 months)
- Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the Oswestry disability index.(24 months)
- Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.(24 months)