A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Radiographic Fusion by CT Scan
研究概览
简要总结
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.
In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.
详细描述
In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Easypack Putty standalone on the assigned side of the spine and Demineralized Bone Matrix or Fibers mixed with local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Month 3, Month 6, and Month 12. An interim analysis will be performed once 30 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Easypack Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Easypack Putty will be used standalone in patients up to two-level degenerative disc disease with segmental mechanical spinal instability requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Discharge, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12.
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
- None
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 able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
- •Male or female patient ≥ 18 years old.
- •Patients with segmental mechanical spinal instability requiring arthrodesis surgery.
- •Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:
- •instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
- •decreased disc height by > 2 mm, but dependent upon the spinal level
- •Grade II or more listhesis
- •TLICS equal or greater than 5
- •Unstable burst fracture
- •Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.
排除标准
- •Requires > two-level fusion or expected to need secondary intervention within one year following surgery.
- •Had prior PLF fusion or attempted PLF fusion at the involved levels.
- •Had previous decompression at the involved levels.
- •Women who are or intend to become pregnant within the next 12 months.
- •To treat conditions in which general bone grafting is not advisable.
- •In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g. defect site stabilization is not possible).
- •In case of significant vascular impairment proximal to the graft site.
- •In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta, history of or active Pott's disease, stage >4 renal disease or Paget's Disease) that affect bone or wound healing.
- •In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
- •When intraoperative soft tissue coverage is not planned or possible.
- •Receiving treatment with medication interfering with calcium metabolism.
- •Has degenerative disc disease (DDD) related to a benign or malignant tumor.
- •Has history or presence of active malignancy.
- •Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
- •Is involved in active litigation relating to his/her spinal condition.
- •Has participated in an investigational study within 30 days prior to surgery for study devices.
研究组 & 干预措施
MagnetOs Easypack Putty
Interventions
- Procedure: Instrumented posterolateral spine fusion
- Device; MagnetOs Easypack Putty
干预措施: MagnetOs Easypack Putty (Device)
Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone
Interventions
- Procedure: Instrumented posterolateral spine fusion
- Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone
干预措施: Demineralized Bone Matrix or Fibers mixed with local autograft bone (Device)
结局指标
主要结局
Radiographic Fusion by CT Scan
时间窗: Month 12
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
次要结局
- Radiographic Fusion by Plain Radiographs(Month 6, Month 12)
- Radiographic Fusion by CT Scan(Month 6)
- Functional Outcome by Oswestry Disability Index Questionnaire(Screening, Week 2, Month 3, 6, and 12)
- Back and Leg Pain by Visual Analog Pain Scale Questionnaire(Screening, Week 2, Month 3, 6, and 12)
- Neurologic Status by Physical Exam(Screening, Week 2, Month 3, 6, and 12)
- Success Rate(Week 2, Month 3, 6, and 12)