Autologous Cell Therapy Enhancement of Microfracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Magnetic Resonance Imaging (MRI) for osteochondral defect filling
研究概览
简要总结
The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.
详细描述
Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.
Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.
Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing microfracture surgery for the repair of articular cartilage
- •Osteochondral defect Grade III or IV
- •Age 18 to 68 years
- •Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
- •Written informed consent
- •Ability to speak, read and write English or Spanish
排除标准
- •Inability to speak, read and write English or Spanish
- •Evidence of malignant disorder/neoplasm in past 24 months
- •History of basal cell carcinoma
- •History of smoking and not committed to give up
- •Chronic skin conditions
- •Connective, metabolic or skin disease
- •Evidence of active infection
- •Pregnancy or lactating for female subjects
- •Diabetes Type I or II
- •Current steroid use
- •Immunosuppressive medication
- •Renal failure (creatine > 1.8 mg/dL)
- •Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL)
- •Inflammatory joint diseases of the knee that indicate additional, conflating therapies
- •Joint infection within the past 6 months
- •Meniscal resection of greater than 50% prior to, or at time of procedure
- •Uncorrected joint instability
- •Joint malalignment > 5 degrees
研究组 & 干预措施
Autologous Cell
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
干预措施: Autologous Cell (Procedure)
Control
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
干预措施: Standard microfracture arthroscopic surgery (Procedure)
结局指标
主要结局
Magnetic Resonance Imaging (MRI) for osteochondral defect filling
时间窗: 12 months
Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.
次要结局
- Knee Injury and Osteoarthritis Outcomes Survey (KOOS)(12 months postop)
- Knee Range of Motion(up to 1 year)
- Pain Scores on Numerical Rating Scale(up to 1 year)
- Number of Patients with Adverse Events as a Measure of Safety(up to 1 year)