Articular Cartilage Regeneration With Autologous Peripheral Blood Stem Cells Versus Hyaluronic Acid: A Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies
研究概览
简要总结
The purpose of this study was to compare histologic and MRI evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)
详细描述
The purpose of this study was to compare histologic and magnetic resonance imaging (MRI) evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have signed informed consent form
- •Patients with only unilateral isolated or multiple knee articular cartilage lesions demonstrated MRI scanning, with up to one previous operation on that knee
- •Patients who are either male or female aged between 18 to 50 years old, corresponding to availability of normative International Knee Documentation Committee (IKDC) data.
- •Female patients of childbearing age must have negative pregnancy tests and are advised to take contraceptive precautions throughout the study.
排除标准
- •Patients with bilateral knee lesions
- •Patients with the presence of ligamentous injury which would require reconstruction, varus or valgus deformity greater than 10 degrees, previous open total menisectomy requiring osteotomy, and cases that require complex surgery prior to cartilage regeneration
- •Patients with significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g. steroid intake, anticoagulation), and poorly controlled diabetes mellitus with a baseline HbA1c more than 8
- •Patients with significant peripheral vascular disease as indicated by absent dorsalis pedis or posterior tibial pulses.
- •Patients who cannot read English will be excluded from the study as they will be unable to complete the study questionnaires in an objective manner
- •Female patients who are pregnant
- •Patients with any contradictions to MRI scanning
- •Patients with body mass index (BMI) of over 35
研究组 & 干预措施
PBSC and Hyaluronic Acid
Peripheral blood stem cells and hyaluronic acid injections
干预措施: Peripheral blood stem cells and hyaluronic acid injections (Biological)
Hyaluronic Acid
Hyaluronic Acid
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies
时间窗: 18 months
次要结局
- Improved long term functional outcome of subchondral drilling surgery in the knee joint(18 months)
研究者
Dr. Khay-Yong Saw
Consultant Orthopaedic Surgeon
Kuala Lumpur Sports Medicine Centre