A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- StimLabs
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
研究概览
简要总结
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
详细描述
The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
- •Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.
排除标准
- •Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
- •BMI greater than 45 kg/m2
- •Subject has had major surgery at the index level
- •Is an active smoker or stopped smoking in the last 6 months
- •Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
- •Active rheumatoid arthritis
- •Active, local or systemic malignancy such as lung cancer or leukemia
- •History of vascular disease or sickle cell anemia
- •Use of the following medications:
- •No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
- •No systemic treatments that may interfere with safety or efficacy assessments during the study
- •No immunosuppressants
- •No use of corticosteroids
- •Subject is pregnant or plans to become pregnant within 24 months of treatment
- •Subject does not provide full consent
- •Personal injury, workman's compensation or other legally-related treatment patients.
研究组 & 干预措施
Treatment
91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed.
干预措施: Other: Full-thickness placental allograft (Other)
Control
91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft.
结局指标
主要结局
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
时间窗: 24 months
Oswestry Disability Index (ODI)
次要结局
- Evaluation of post-microdiscectomy reherniation rate.(24 month)