Prospective, Multicenter Evaluation of ProteiOS® Allograft Derived Growth Factor in Transforaminal Lumbar Interbody Fusion (TLIF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 主要终点
- Rate of Fusion Success (via Computed Tomography (CT) analysis)
研究概览
简要总结
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF). Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS). The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin. Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed. A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.
详细描述
Transforaminal lumbar interbody fusion (TLIF) is a widely used technique for degenerative lumbar spine pathology. Prospective, randomized evidence on fusion outcomes, patient-reported outcomes, safety, and healthcare utilization for ProteiOS in TLIF is currently limited to retrospective data. This study randomizes participants 2:1 to ProteiOS versus a within-category control (standard graft material, no ProteiOS), with central, blinded, independent radiographic review of CT and X-ray fusion outcomes. The primary endpoint is CT-confirmed interbody fusion (BSF-3) at 12 months, tested for non-inferiority (margin = 5 percentage points, assumed fusion rates 95% ProteiOS vs. 89% control, 80% power, one-sided α = 0.025, Farrington-Manning likelihood score method). Secondary endpoints include fusion at 6 and 24 months, X-ray-based interbody and posterolateral fusion assessment (Lenke classification for PLF), patient-reported outcomes at 3, 6, and 24 months, adverse events, and healthcare utilization
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 (Outcomes Assessor)
盲法说明
Participants and investigators/surgeons are not blinded (surgeon must know which graft material to use intraoperatively).
The central imaging core laboratory (independent, board-certified musculoskeletal/neuroradiologists performing BSF fusion grading) is blinded to treatment arm, site identity, clinical status, and prior imaging.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, skeletally mature at time of surgery
- •Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon
- •For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF
- •Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum/annulus hypertrophy, facet arthrosis/osteophyte, spinal canal or foraminal stenosis, or vertebral translation >3 mm)
- •Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings
- •Preoperative back pain ≥4 on a 0-10 VAS
- •Preoperative leg pain ≥3 on a 0-10 VAS, consistent with radiculopathy or neurogenic claudication
- •Preoperative ODI score ≥30
- •Failure of ≥6 months non-operative treatment (may be waived for progressive neurological deficit, new/worsening motor weakness, bowel/bladder dysfunction, or cauda equina syndrome)
- •Willing and able to comply with follow-up schedule and provide written informed consent
排除标准
- •Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material
- •Prior lumbar spine fusion surgery at a level currently scheduled for surgery
- •Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted)
- •Osteoporosis/osteopenia (≤2.5 SD below age-matched mean)
- •Use of rhBMP-2 (Infuse) or other active biologics
- •Active or systemic infection, malignancy, or severe metabolic bone disease
- •Chronic steroid use (>10 days)
- •Revision fusion at index levels
- •Participation in another interventional clinical study within 30 days of consent
- •Known pregnancy or intent to become pregnant during the study
研究组 & 干预措施
TLIF - ProteiOS (Treatment)
Influx™ demineralized cortical fibers combined 1:1 with ProteiOS®, ≥50% of total graft volume per level (5-15 cc total), optional cancellous allograft chip augmentation. If PLF indicated: 100% cortical fiber graft + ProteiOS + local bone in Fibrant PAK containment bag.
干预措施: Allograft-derived growth factor (ProteiOS®) (Other)
TLIF - Control
5-15 cc locally harvested autograft, optional mineralized cancellous allograft chip augmentation, no ProteiOS. If PLF indicated: cortical fiber graft + local bone in Fibrant PAK containment bag.
干预措施: Standard of Care (SOC) (Other)
ALIF - ProteiOS (Treatment)
Same ProteiOS-based mixture as TLIF treatment arm
干预措施: Allograft-derived growth factor (ProteiOS®) (Other)
ALIF - Control
Same control graft composition as TLIF control arm
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Rate of Fusion Success (via Computed Tomography (CT) analysis)
时间窗: 12 months
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan. BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
Patient Reported Outcome: Oswestry Disability Index (ODI)
时间窗: 12 Months
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability), assessed at 12 months; mean scores compared between treatment and control arms.
Patient Reported Outcome: Neurological
时间窗: 12 Months
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council \[MRC\] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
Patient Reported Outcome: Visual Analog Scale (VAS)
时间窗: 12 Months
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain), assessed at 12 months; mean scores compared between treatment and control arms.
次要结局
- Healthcare Utilization: ICU Time(Up to 24 Months)
- Fusion (via Computed Tomography (CT))(6 and 24 months)
- Fusion (x ray)(3, 6, 12, 24 months)
- Adverse Events(24 months)
- Patient Reported Outcome: Visual Analog Scale (VAS)(3, 6, 24 Months)
- Patient Reported Outcome: Neurological(3, 6, 24 Months)
- Patient Reported Outcome: Oswestry Disability Index (ODI)(3, 6, 24 Months)
- Healthcare utilization: Frequency of Hospital Visits(Up to 24 months)
- Healthcare Utilization: Length of Hospital Stay(Up to 24 months)