A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Single Alpha Numeric Evaluation (SANE)
研究概览
简要总结
This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 80 years.
- •Willing and able to give voluntary informed consent to participate in this investigation.
- •Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
- •Candidate for intra-articular knee injection.
- •BMI < 40
排除标准
- •Patients who have received intra-articular injection(s) in the last 3 months.
- •Patients who have undergone arthroscopic surgery on the study knee in the past year.
- •Patients who have undergone arthroplasty on the study knee.
- •Ligament instability
- •Diabetes (Type 1 or II)
- •Inflammatory arthropathies.
- •Fibromyalgia or chronic fatigue syndrome.
- •Female patient who is pregnant or nursing.
- •Chronic use of narcotics.
- •Any other reason (in the judgment of the investigator).
研究组 & 干预措施
BioDRestore™
BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
干预措施: BioD Restore (Device)
Corticosteroid
Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
干预措施: Kenalog (Drug)
结局指标
主要结局
Single Alpha Numeric Evaluation (SANE)
时间窗: Surgery to 12 months post-op.
Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.
Lysholm Knee Score
时间窗: Surgery to 12 months post-op.
Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Visual Analog Pain Score
时间窗: Surgery through 12 months post-op/
Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Veterans Rand 12 Item Health Survey
时间窗: Sugery to 12 months post-op
Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Surgery to 12 months post op
Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems.
次要结局
未报告次要终点