NCT01491542已完成不适用
A Pilot Prospective Randomized Clinical Investigation of INFUSE® Bone Graft and MASTERGRAFT® Granules With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
Medtronic Spinal and Biologics0 个研究点目标入组 46 人开始时间: 2003年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Overall Success
研究概览
简要总结
The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic degenerative disc disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following:
- •instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension radiographs);
- •osteophyte formation;
- •decreased disc height;
- •thickening of ligamentous tissue;
- •disc degeneration or herniation; and/or
- •facet joint degeneration.
- •Has preoperative Oswestry score ≥
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932).
- •Requires fusion of a single level disc space from L1 to S
- •Is at least 18 years of age, inclusive, 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 6 months.
- •If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year following surgery.
- •Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
排除标准
- •Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
- •Had previous spinal fusion surgical procedure at the involved level or an adjacent level.
- •Requires spinal fusion at more than one lumbar level.
- •Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- •Has a documented history of osteopenia or osteomalacia.
- •Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.)
- •Postmenopausal non-black female over 60 years of age and weighs less than 140 pounds.
- •Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
- •Male over the age of
- •Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture,then the patient is excluded from the study.
- •Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- •Has overt or active bacterial infection, either local or systemic.
- •Has a documented titanium alloy allergy or intolerance.
- •Is mentally incompetent. If questionable, obtain psychiatric consult.
- •Has a 'Waddell Signs of Inorganic Behavior'score of 3 or greater.
- •Is a prisoner.
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment or alcohol and/or drug abuse.
- •ls a tobacco user at the time of surgery.
- •Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
- •Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis).
- •Has a history of exposure to implanted collagen or silicone implants.
- •Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- •Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS/MASTERGRAFT® Granules implantation.
- •Has received any previous exposure to any/all BMP's of either human or animal extraction.
- •Has a history of allergy to bovine products or a history of anaphylaxis.
- •Has a history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease,renal osteodystrophy, Ehlers- Danlos syndrome,or osteogenesis imperfecta).
结局指标
主要结局
Overall Success
时间窗: 24 months
A patient will be considered an overall success if all of the following conditions are met: 1. Fusion; 2. Postoperative Oswestry score improvement of at least 15% from preoperative; 3. Maintenance or improvement in neurological status; 4. No serious adverse event classified as implant associated or implant surgical procedure associated; 5. No additional surgical procedure classified as a "failure".
次要结局
- General Health Status (SF-36)(24 months)
- Patient Global Perceived Effect(24 months)
- Patient Satisfaction(24 months)
- Pain Status (back pain, leg pain)(24 months)
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