NCT00678171已完成不适用
A Pilot Study to Evaluate an OP-1 Putty Spinal System and an Autograft Spinal System in Patients Requiring Transforaminal Lumbar Interbody Fusion of the Spine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Pain and function as measured by an Oswestry Disability Index, no revisions, removals or supplemental fixations, fusion success, defined as radiographic evidence of fusion, maintenance or improvement in lower extremity neurologic function
研究概览
简要总结
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
详细描述
This pilot study is a randomized, multi-center, prospective, controlled study of the efficacy and safety of OP-1 Putty Spinal System in patients requiring a single level transforaminal interbody fusion of the lumbar spine (TLIF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is willing and able to understand, sign and date the study-specific, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient informed consent and applicable privacy regulations.
- •The patient has a documented diagnosis of DDD with up to Grade I spondylolisthesis demonstrated by radiographic imaging (by plain film/discography within 12 weeks of surgery and/or computed tomography (CT scan/magnetic resonance imaging [MRI].
- •The patient requires single level lumbar fusion (L2 to S1)
排除标准
- •The patient has a history of previous surgery in the lumbar spine with or without attempted fusion {Note: a history of lumbar decompression surgery is permitted}.
- •The patient has Grade II, Grade III or Grade IV spondylolisthesis.
- •The patient has gross spinal instability measured on flexion/extension radiographs of >25% translation of the vertebrae, or ≥20 degrees of angular motion or has significant (>10%) scoliosis.
- •The patient is receiving treatment (before, during or after surgery) with a drug that interferes with bone metabolism or is being treated with a bone growth stimulator.
- •The patient has been treated in the last 6 months with radiation, chemotherapy, immunosuppression or systemic corticosteroids.
- •The patient has a history of, or has any malignancy or spinal tumor of any type, with the exception of a history of a treated basal or squamous cell carcinoma.
- •The patient is morbidly obese (defined as body mass index [BMI] > 35).
- •The patient currently uses tobacco products, within 3 weeks prior to time of treatment.
- •The patient is known to require at the time of treatment, additional surgery to the lumbar spinal region within the next 6 months or has symptomatic multilevel degenerative disease requiring possible instrumented fusion of more than one level.
- •The patient has previously been treated with or exposed to any Bone Morphogenetic Proteins (BMPs).
- •The patient is contraindicated for iliac crest autografting in that the Investigator believes the patient would be unable to provide sufficient quantity or adequate quality autograft (e.g., osteoporosis as defined by this protocol) from a unilateral iliac crest harvest.
- •The patient has a previous diagnosis of Paget's disease, osteomalacia or any other endocrine or metabolic bone disease that affects osteogenesis.
- •The patient has a documented history of osteoporosis or has a risk of osteoporosis as defined by an Osteoporosis Risk Assessment Instrument (ORAI) score of ≥ 9 and a DEXA Scan T score of ≥-2.5 standard deviations below the normal range within one year of enrollment.
结局指标
主要结局
Pain and function as measured by an Oswestry Disability Index, no revisions, removals or supplemental fixations, fusion success, defined as radiographic evidence of fusion, maintenance or improvement in lower extremity neurologic function
时间窗: 12 and 24 months post intervention
次要结局
- Quality of life determinations (SF-36), pain assessments (VAS), work status and assessment of additional radiographic parameters(12 and 24 months post intervention)
研究者
研究点 (10)
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