The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
研究概览
简要总结
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:
- Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy.
- Standard arthroscopic treatment (above) without cell transplant.
详细描述
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties.
Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment.
The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 and 70 years-old
- •Patient is scheduled to undergo one or a combination of the following procedures:
- •Meniscal debridement or partial menisectomy
- •Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
- •Removal of loose bodies
- •Chondroplasty
- •Synovectomy
- •Soft tissue releases for flexion or extension contracture.
- •Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
- •< 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain
- •Physical examination findings consistent with the proposed surgical procedure.
- •Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections
排除标准
- •Age < 35 or > 70 years old
- •Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
- •Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
- •Patient scheduled to undergo any concomitant surgical procedures with the exception of:
- •Meniscal debridement or partial menisectomy
- •Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
- •Removal of loose bodies
- •Chondroplasty
- •Synovectomy
- •Soft tissue releases for flexion or extension contracture
- •Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
- •Previous arthroscopy within 1 year
- •Subchondral edema
结局指标
主要结局
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
时间窗: The study will end after 24 month follow-up is completed in all participants.
Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
次要结局
- VR-12(6, 12, 24 months)
- Tegner score(6, 12, 24 months)
- Lysholm score(6, 12, 24 months)