Lumbar Fusion With Micro and Nano-textured Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Adaptix™ Versus PEEK Cages
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fusion rate at 6 months
研究概览
简要总结
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage with roughened micro and nano-textured titanium surfaces or the CAPSTONE® poly-ether-ether-ketone cage.
详细描述
The randomized controlled trial will prospectively evaluate the efficacy of Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system as compared to a Medtronic CAPSTONE® PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years postoperatively. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).
This single-centered study will enroll up to 100 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for combined interbody/posterolateral lumbar fusion surgery. The inclusion/exclusion criteria are listed below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).
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
- •Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Medtronic Adaptix™ titanium cage or Medtronic CAPSTONE® PEEK cage in conjunction with a 50:50 mixture of local autograft and GRAFTON™ DBM DBF, and supplementation with a pedicle screw system.
- •Subject must be over the age of 18 years old.
- •Subject has been unresponsive to conservative care for a minimum of 6 months.
- •The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
排除标准
- •Subjects with previous lumbar arthrodesis surgery.
- •Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF.
- •Subject has inadequate tissue coverage over the operative site.
- •Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
- •Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
- •Subject has an active local or systemic infection.
- •Subject has a metal sensitivity/foreign body sensitivity.
- •Subject is allergic to antibiotics (gentamicin) or processing solutions found in GRAFTON™.
- •Subject is morbidly obese, defined as a body mass index (BMI) greater than
- •Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
- •Subject is currently involved in another investigational drug or device study that could confound study data.
- •Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- •Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating.
- •Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
- •Subject is a prisoner.
研究组 & 干预措施
Medtronic Adaptix™ titanium implants
This arm will use Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).
干预措施: Medtronic Adaptix™ titanium implants (Device)
Medtronic CAPSTONE® PEEK cage
This arm will use Medtronic CAPSTONE® PEEK cage supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).
干预措施: Medtronic CAPSTONE® PEEK cage (Device)
结局指标
主要结局
Fusion rate at 6 months
时间窗: 6 months
A subject will be considered a success if fusion is a Grade BSF-3 at 6 months. The primary outcome measure of effectiveness will be determined by the fusion rate at 6 months post-operatively in subjects implanted with either titanium cage as compared to the PEEK cage.
次要结局
- Timing of fusion(24 months)
研究者
Andrew Grossbach
Principal Investigator
Ohio State University