NCT02285725已完成不适用
Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
Joseph E. Broyles0 个研究点目标入组 21 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Change in International Knee Documentation Committee (IKDC) score
研究概览
简要总结
This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis.
排除标准
- •Inflammatory arthritis
- •Body mass index (BMI) greater than 35
- •Presence of significant varus or valgus knee instability or unusually stiff knee
- •Greater than 50% deviation of the mechanical axis
- •Presence of active cardiac disease
- •Presence of active pulmonary disease
- •Prior septic arthritis of the involved joint
- •Presence of active bacterial or Mycobacterial infection
- •Presence of a known hypercoagulable state
- •Pregnant or lactating females
- •Subject known to be positive for hepatitis B, hepatitis C, or HIV
- •Known allergy to hyaluronic acid
- •Patients who are unable or unwilling to participate fully in post-operative physical therapy
- •Patients with a contraindication to MRI scanning
- •Any disorder that compromises ability to give consent or comply with study procedures
- •Patients who are felt to be at significantly increased risk for elective orthopedic surgery
- •Non-ambulatory patients
- •Patients with cognitive impairment
结局指标
主要结局
Change in International Knee Documentation Committee (IKDC) score
时间窗: Change from baseline at 5 years post-operatively
次要结局
- MRI appearance of repair cartilage(2 and 5 years post-operatively)
- Joint Space Changes(2 and 5 years post-operatively)
- Frequency of adverse events requiring additional procedures(Continuously for 5 years post-operatively)
研究者
Joseph E. Broyles
Joseph E. Broyles, M.D.
Bone and Joint Clinic of Baton Rouge
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