Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 46
- 主要终点
- Overall success at 24 months
研究概览
简要总结
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively.
Overall a maximum of 600 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
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)
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
- •A subject must meet all of the following inclusion criteria to participate in this study:
- •Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by:
- •History of radiating leg or buttock pain, paresthesia, numbness or weakness, or
- •History of neurogenic claudication.
- •Has a history of low back pain.
- •Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
- •Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
- •Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
- •Recurrent disc herniation
- •Has preoperative Oswestry Disability Index score ≥
- •Has to meet either inclusion criteria 5 or 6 to qualify for the study:
- •Has preoperative back and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire.
- •Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.
- •Is at least 18 years of age and skeletally mature at the time of surgery.
- •Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
- •Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.
排除标准
- •A subject will be excluded from participating in this study for any of the following reasons:
- •E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g. fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
- •E.2 Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
- •E.3 Planned use of an internal or external bone growth stimulator.
- •E.4 Lumbar scoliosis >30 degrees.
- •E.5 Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. (If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA will need to be obtained.)
- •E.6 Morbidly obese, as defined by a Body Mass Index (BMI) >
- •E.7 Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
- •E.8 Overt or active bacterial infection, either local to surgical space or systemic.
- •E.9 Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.
- •This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
- •Use of steroidal inhalers is allowed pre- and post-operatively
- •Short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as ≤ two weeks. Use of steroids for longer than two weeks post-operatively through the 24-month follow-up visit is prohibited.
- •E.10 Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
- •E.11 Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
- •E.12 Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- •E.13 Known exposure to any recombinant proteins used for bone formation (e.g., Infuse™ Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
- •E.14 Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g.,monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
- •E.15 History of any allergy resulting in anaphylaxis.
- •E.16 Is a prisoner.
- •E.17 Is mentally incompetent. If questionable, obtain psychiatric consult.
- •E.18 Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
- •E.19 Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.
- •E.20 A documented diagnosis of substance use disorder as defined by the DSM-5.22 (Nicotine use is allowed.)
- •E.21 Pursuing worker's compensation or active litigation for spinal fusion procedure.
- •E.22 Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.
研究组 & 干预措施
Group #1
Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
干预措施: Infuse™ Bone Graft (Infuse™) (Device)
Group #1
Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
干预措施: Intervertebral body fusion device and Medtronic posterior Fixation Systems (Device)
Group #2
Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
干预措施: Infuse™ Bone Graft (Infuse™) (Device)
Group #2
Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
干预措施: Intervertebral body fusion device and Medtronic posterior Fixation Systems (Device)
Control
Local bone autograft and supplemented with cancellous allograft as needed.
干预措施: Intervertebral body fusion device and Medtronic posterior Fixation Systems (Device)
结局指标
主要结局
Overall success at 24 months
时间窗: 24 months
Overall success is defined as the participant who meet the following five criteria: * Pain/disability (ODI) success, defined as at least a 15-point improvement from baseline; * Fusion success as defined in primary outcome 2. * Neurological success, defined as maintenance or improvement in neurological status; * No SAE related to the TLIF grafting material or interbody device; and * No secondary surgeries at index level that are related to the TLIF grafting material or interbody device
Fusion success at 24 months
时间窗: 24 Months
Fusion success at each treatment level must demonstrate: * Evidence of bridging bone via CT. Solid fusion is based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level(s) in at least 1 of the following locations: right lateral, left lateral, anterior, posterior, or through the intervertebral body fusion device. * No evidence of motion as defined by less than 2 mm translational motion and less than 3° in angular motion at each treated level (flexion/extension radiographs).
次要结局
- Time to fusion(From surgery to 24 Months)
- ODI success(24 months)
- Leg pain success(24 months)
- Back pain success(24 months)
- Neurological success(24 months)
- Serious Adverse Events(up to 24 months)
- Secondary Surgery(up to 24 months)