NCT03118505进行中（未招募）不适用
A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
Medtronic Spinal and Biologics17 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- Radiological Fusion Success
研究概览
简要总结
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative lumbar spine condition:
- •Requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4 consecutive levels from L2-S1; and
- •Diagnosed with: instability (up to and including Grade 2 spondylolisthesis, retrolisthesis, or lateral listhesis), stenosis with documented pre-operative instability, and/or recurrent disc herniation, any of which may have possible concomitant lumbar degenerative deformity (Cobb angle ≤ 30 degrees).
- •Preoperative ODI score ≥
- •Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
- •Most inferior treated spinal level is able to accommodate an interbody fusion device.
- •≥21 years of age at the time of signing the informed consent.
- •Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS).
- •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
- •Prior spinal fusion surgical procedure at the involved or adjacent spinal levels. (Prior non-fusion surgery at the target levels, including discectomy and/or single-level foraminotomy or laminectomy, is allowed.)
- •Prior lumbar disc arthroplasty.
- •Significant lumbar instability, defined as sagittal listhesis >Grade 2 at any involved level using Meyerding's Classification or lateral listhesis >25% lateral translation at any involved level.
- •Planned use of an internal or external bone growth stimulator.
- •Lumbar scoliosis >30 degrees.
- •Osteoporosis to a degree that spinal instrumentation is contraindicated or a history of atraumatic vertebral fracture.
- •Morbidly obese, as defined by a Body Mass Index (BMI) >
- •Presence of active malignancy or prior history of malignancy.
- •Overt or active bacterial infection, either local or systemic.
- •Has undergone systemic administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
- •Comorbidities precluding subject from being a surgical candidate.
- •History of autoimmune disease known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
- •History of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- •History of exposure to any recombinant proteins used for bone formation (i.e., 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).
- •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; gentamicin or glycerol (which may be present in trace amounts in the DBM products); and/or instrumentation materials (titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone [PEEK]).
- •History of any allergy resulting in anaphylaxis.
- •Is a prisoner.
- •Is mentally incompetent. If questionable, obtain psychiatric consult.
- •Treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
- •Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for one year following surgery.
- •Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk.
研究组 & 干预措施
Group 1
Experimental
Infuse Bone Graft [4.2 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation
干预措施: Infuse Bone Graft (Device)
Group 2
Experimental
Infuse Bone Graft [6 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation
干预措施: Infuse Bone Graft (Device)
Group 3
Experimental
Infuse Bone Graft [12 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation
干预措施: Infuse Bone Graft (Device)
Control
Active Comparator
Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation.
干预措施: Medtronic DBM (Device)
结局指标
主要结局
Radiological Fusion Success
时间窗: 12 months
Fusion at each treated level is defined as radiological fusion assessed by radiograph and CT. A subject will be considered a fusion success when the following criteria are met for each treated level: * Bilateral bridging bone (superior transverse process to the inferior transverse process) at each treated level (CT); * No more than 3mm translational motion and less than 5 degrees in angular motion at each treated level (flexion/extension radiographs); and * Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass (all radiograph views).
次要结局
- Neurological success rate at 12 and 24 months(12 and 24 months)
- Back pain success at 12 and 24 months(12 and 24 months)
- Leg pain success at 12 and 24 months(12 and 24 months)
- ODI score at 12 and 24 months(12 and 24 months)
- Leg pain score at 12 and 24 months(12 and 24 months)
- AEs related to the PLF grafting material or posterior fixation up to 24 months(24 months)
- Overall success rate at 12 and 24 months(12 and 24 months)
- ODI success rate at 12 and 24 months(12 and 24 months)
- Back pain score at 12 and 24 months(12 and 24 months)
- Radiological fusion success rate at 24 months(24 months)
- Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months(24 months)
研究者
研究点 (17)
Loading locations...
相似试验
终止
2 期
A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionNCT01725256Aires Pharmaceuticals, Inc.29
已完成
不适用
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back PainBack PainNCT01263054Halyard Health67
已完成
不适用
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective CraniotomyCerebrospinal Fluid LeakageNCT01295619Kuros Biosurgery AG41
已完成
不适用
Performance and Efficacy of the CardiacSense1 for Detection of Atrial FibrillationFibrillation AtriumNCT03477734CardiacSense Ltd.53
已完成
3 期
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)Iron Deficiency AnemiaNCT00982007American Regent, Inc.997