A Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Radiographic measurements prior to surgery and at follow-up visits
研究概览
简要总结
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
The primary objectives are:
- To evaluate the safety of the EARP surgical technique and devices during LIF surgeries.
- To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.
详细描述
This multi-center post-marketing study will include consecutive patients who meet eligibility criteria, are scheduled to undergo a LIF procedure using the EARP Interbody System and EARP Nerve Cuff Electrode, and agree to participate. The study will include patients deemed appropriate for the procedure per the site's judgment, which may include patients with off-label use of the devices. Patients who consent to study participation and meet study criteria will undergo surgery according to site standard procedure. The EARP Nerve Cuff Electrode will be used to monitor nerve roots during surgery. Radiographic imaging will document the fusion status and various disk space parameters, and the Oswestry Disability Index (ODI) will be used to assess function and pain. Data will be collected from standard site follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery. Economic data will be collected to quantify the economics of the EARP Interbody System for LIF procedures.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing LIF between L2-S1
排除标准
- •BMI >40 kg/m2
- •Pregnant or plans on becoming pregnant in the near future
- •Surgery requires combination of EARP with another lumbar interbody fusion technique (PLIF, TLIF, ALIF, OLIF, LLIF) or posterolateral fusion at another level
- •History of lumbar interbody pseudoarthrosis at planned operative level
- •Lumbar spondylolisthesis ≥ grade 3
- •Osteoporotic vertebral compression fracture treated or untreated at planned operative site
- •History of lumbar spinal metastasis
- •Acute lumbar spine trauma requiring immediate intervention
- •Owestry Disability Index (ODI) 81-100%
- •Presence of personality disorder or major psychiatric illness
- •History of allergy to titanium, platinum, PEEK, aluminum, stainless steel or silicone
- •Any additional factor that makes the patient an unsuitable candidate for the study in the opinion of the principal investigator
结局指标
主要结局
Radiographic measurements prior to surgery and at follow-up visits
时间窗: From enrollment until the end of follow-up at 12 months
Radiographic measurements including X-Ray, CT Scans, and MRIs if available
To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries
时间窗: From surgery until the end of follow up at 12 months
Adverse Device Events and surgical complications due to the devices
次要结局
- Assess the ability of the EARP fusion system to reduce pain and restore function(Baseline to final follow-up visit at 12 months)
- Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode(During Surgery)
- Quantify health economic factors associated with the EARP fusion system for LIF procedures(From surgery to end of follow up at 12 months)