EUCTR2017-000860-14-AT进行中（未招募）1 期
Patient and evaluator blinded non-inferiority study on safety, tolerability and lumbar fusion efficacy of a single administration of Osteogrow (rhBMP6 in autologous blood coagulum (ABC) carrier) in adult patients treated by posterolateral lumbar interbody fusion (PLIF) for degenerative disc disease
Genera Research Ltd0 个研究点目标入组 134 人开始时间: 2018年1月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 134
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients meeting ALL of the following criteria at screening will be eligible for participation in the study:
- •1. Willing and able to provide informed consent. A signed informed consent form must be provided before any study assessments are done. Patients must be fluent in the language that is spoken by the investigator and the trial staff and in which the informed consent is written.
- •2. Male or female, age =18 years. Females of childbearing potential must be using a highly effective method of birth control within 2 years following surgery and must have a negative urine pregnancy test prior to the randomization.
- •3. Degenerative disc disease (DDD) of L3-S1 segment accompanied by back pain of corresponding segment, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic analyses. Patients are non-responsive to conservative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
- •DDD is defined as presence of one or more of the following:
- •a.instability (defined as angulation 5° and/or translation 4 mm, based on flexion/extension radiographs
- •b.osteophyte formation
- •c.decreased disc height
- •d.thickening of ligamentous tissue
- •e.disc degeneration or herniation and/or facet joint degeneration
- •f.required fusion of a single level disc space from L3 to S1
- •g.preoperative Oswestry Disability Index score of 30
- •h.no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification
- •4. Patients not receiving platelet aggregation inhibitors at least 5 days prior to surgery.
- •5. Patients should be otherwise in good general condition as defined by absence of clinically relevant abnormalities identified at screening by a detailed medical history, full physical examination (including blood pressure and heart rate measurement), 12-lead ECG, and clinical laboratory tests.
- •6. Willing and able to be confined to the hospital/inpatient unit for at least 5 days (at least 10 days for the first 15 patients) postoperatively and to comply with all other follow-up procedures according to the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients meeting ANY of the following criteria at screening will NOT be eligible for participation in the study:
- •1. Previous lumbar spinal fusion procedure at the involved level
- •2. Required spinal fusion at more than one lumbar level
- •3. Previous treatment with bone morphogenetic proteins (e.g. Infuse or Ossigraft).
- •4. Primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level
- •5. Inflammatory and neoplastic diseases of the spine.
- •6. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin)
- •7. Conditions that might have been associated with diagnosis of osteoporosis including:
- •a. Postmenopausal Non-Black female over 60 years of age and weighing less than 140 pounds (63.5 kg).
- •b. Postmenopausal female that had sustained a nontraumatic hip, spine, or wrist fracture.
- •c. Male over the age of 70.
- •d. Male over the age of 60 that had 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 will be excluded from the study
- •8. Previous diagnosis of osteomalacia
- •9. Evidence or history of clinically significant hepatic disease (>3 x ULN for AST/ALT and total bilirubin) or other abnormalities in screening laboratory tests, which in the judgment of the investigator, would interfere with the patient’s participation in the study.
- •10. Presence or history of an uncontrolled, unstable, clinically significant medical condition (bone metabolic, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, and malignancy) that in the judgment of the investigator may interfere with the interpretation of safety.
- •11. History of symptomatic nephro- or urolithiasis within two years.
- •12. Medically evident and confirmed diabetes mellitus, if treated with insulin, or in case of inadequate glycemic control, as evident from hemoglobin A1c =8% and/or medical history indicative of recurring episodes of hypoglycemia.
- •13. Treatment with an investigational drug within 6 months or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- •14. Screening 12-lead ECG findings like sinus tachycardia, left ventricular hypertrophy, pathological Q waves or ST segment shift, atrial fibrillation, frequent premature ventricular complexes, pacemaker rhythm, or other, which in the investigator’s opinion represent a safety risk for spinal surgery.
- •15. Conditions that require postoperative medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, including routine perioperative non-steroidal anti-inflammatory drugs (except Metamizole which is allowed). This does not include low dose aspirin for prophylactic anticoagulation.
- •16. Overt or active bacterial infection, either local or systemic.
- •17. Documented titanium allergy or intolerance
- •18. Positive urine pregnancy test.
- •19. Breastfeeding a child.
- •20. Use within 7 days prior to surgery and postoperatively for 6 months of systemic corticosteroids except for dexamethasone for the first 2 days postoperatively.
- •21. Received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., systemic steroids or methotrexate);
- •22. Known serological evidence of human immunodeficiency virus (HIV) antibody
- •23. History of hepatitis B infection wit
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