A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Secondary Surgical Intervention
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).
详细描述
This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. This is a first in human (FIH) study.
The study will enroll patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. The procedure will involve use of an intervertebral cage and fixation (plate and screws).
Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 3:3:2 to the LDGraft groups (investigational) or the allograft control group. Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion.
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
Participants will be blinded to the treatment assigned and received.
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
- •Skeletally mature adults ≥22 and ≤80 years at the time of surgery
- •Willing and able to give written informed consent and comply with study protocol and postoperative management program
- •Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following:
- •instability (as defined by ≥3mm translation or ≥5° angulation);
- •osteophyte formation of facet joints or vertebral endplates;
- •decreased disc height, on average by >2mm, but dependent upon the spinal level;
- •scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
- •herniated nucleus pulposus;
- •facet joint degeneration/changes; and/or
- •vacuum phenomenon.
- •Preoperative Oswestry Disability Index score ≥ 35
- •Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months
- •Participant is indicated for an ALIF approach to the lumbar spine
排除标准
- •Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
- •More than one level lumbar spine level requiring fusion
- •Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)
- •Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
- •Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
- •Presence of active malignancy
- •Requires bone growth stimulation in the lumbar spine
- •Active local or systemic infection
- •Spondylolisthesis greater than Grade 1 (25% translation)
- •Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')
- •Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis
- •Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study
- •Body Mass Index > 35
- •Insulin-dependent diabetes mellitus
- •Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0
- •Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta)
- •Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;
- •Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
- •In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product
- •Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion
- •Currently a prisoner
- •Involved in active litigation relating to his/her spinal condition or workers compensation claimants.
研究组 & 干预措施
Control Allograft Bone
干预措施: Allograft Bone (Other)
LDGraft 0.5mg/cc
干预措施: LDGraft (Device)
LDGraft 1.0mg/cc
干预措施: LDGraft (Device)
结局指标
主要结局
Secondary Surgical Intervention
时间窗: 12 months and 24 months
No index level secondary surgical intervention
Radiographic Fusion
时间窗: 12 months and 24 months
Radiographic fusion defined as evidence of bridging bone by CT scan
Oswestry Disability Index (ODI) Score
时间窗: 12 months and 24 months
At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline
Neurological Condition
时间窗: 12 months and 24 months
No new or worsening persistent lumbar spine neurological condition compared to baseline
Serious Device-Related Adverse Events
时间窗: 12 months and 24 months
No serious device-related adverse events
次要结局
- Visual Analog Score (VAS) Leg(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Oswestry Disability Index (ODI) Change(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Visual Analog Score (VAS) Change Back(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Radiographic Outcomes(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Visual Analog Score (VAS) Back(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Visual Analog Score (VAS) Change Leg(6 weeks, 3 months, 6 months, 12 months and 24 months)
- Oswestry Disability Index (ODI) Score(6 weeks, 3 months, 6 months, 12 months and 24 months)