Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Difference in low back & leg pain
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back & leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 90 years of age
- •Patient is able to understand the aims and objectives of the trial and the trial procedures
- •Patient is willing to give written informed consent to the trial
- •Patient is able to follow up with regularly scheduled visits with and phone calls from Dr. Anderson and his research staff
- •Diagnosed with lumbar protruding disc
- •Suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options
排除标准
- •Participation in clinical trial involving therapy for back pain within 30 days of screening
- •Prior back surgery at the same level
- •Inability to walk independently (adaptive devices such as walkers or canes are allowed)
- •Relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company
- •Receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit
- •Pregnancy or planning to become pregnant during study period
- •Body Mass Index >50
- •Patients with chronic diseases such as Crohn's disease, severe renal failure (serum creatinine 2.5 mg/dL or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema
- •Severe anemia, hemoglobin <8.5 mg/dL
- •Active, local or systemic malignancy such as lung cancer or leukemia
- •Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 100 mmHg)
- •Severe hypoxia, with chronic oxygen or ventilation therapy
- •History of collagen vascular disease or sickle cell anemia
- •Active rheumatoid arthritis
- •Systemic antibiotic therapy for any indication within 10 days of screening
研究组 & 干预措施
Standard of Care
Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions
CLARIX™100
Subjects randomized to the CLARIX™100 arm will undergo a traditional lumbar discectomy, after which CLARIX™100 will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure.
干预措施: CLARIX™100 (Other)
CLARIX CORD 1K
Subjects randomized to the CLARIX CORD 1K arm will undergo a traditional lumbar discectomy, after which CLARIX CORD 1K will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure.
干预措施: CLARIX CORD 1K (Other)
结局指标
主要结局
Difference in low back & leg pain
时间窗: 5 years
To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the Oswestry Disability Index scales for both back \& leg pain
次要结局
未报告次要终点