NCT01491516已完成不适用
A Pilot, Prospective, Non-Randomized Clinical Investigation of TELAMON P™ Implant With INFUSE® Bone Graft and the CD HORIZON® Spinal System for Posterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
Medtronic Spinal and Biologics0 个研究点目标入组 30 人开始时间: 2003年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Overall Success
研究概览
简要总结
The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™ Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in patients with symptomatic degenerative disc disease. The safety and effectiveness of the implant will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（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 and radiographic studies 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 preoperative back pain score of >= 25 based on the Preoperative Back and Leg Pain Questionnaire (intensity and duration).
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932).
- •Requires fusion of a single level disc space from L 1 to S
- •Is at least 18 years of age, inclusive, at the time of surgery.
- •Has not responded to non-operative treatment for a period of 6 months.
- •If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to not get pregnant 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.
- •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 excluding routine peri-operative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- •Has been previously diagnosed with osteopenia or osteomalacia.
- •Has any of the following that may be associated with a 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, 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 an overt or active bacterial infection, either local or systemic.
- •Has a documented titanium, titanium alloy, tantalum, tantalum alloy, or polyetheretherketone 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 for alcohol and/or drug abuse.
- •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), excluding routine perioperative antiinflammatory drugs.
- •Has a history of any autoimmune disease (e.g. Systemic Lupus Erythematosus or Dermatomyositis) .
- •Has a history of exposure to injectable collagen or silicone implants.
- •Has a history of hypersensitivity to protein pharmaceuticals (e.g. monoclonal antibodies or gamma globulins) or collagen.
- •Has received treatment with an investigational therapy (device and/or pharmaceutical) within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following the investigational treatment.
- •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 history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
研究组 & 干预措施
Investigational
Experimental
干预措施: TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System (Device)
结局指标
主要结局
Overall Success
时间窗: 24 month
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) success; 3. neurological status success; 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
- Disc Height Measurement(24 month)
- Pain Status (back pain, leg pain)(24 month)
- Patient Satisfaction(24 month)
- General Health Status (SF-36)(24 month)
- Patient Global Perceived Effect(24 month)
研究者
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