Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Degenerative Lesion of Articular Cartilage of Knee
- 发起方
- University of Colorado, Denver
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Health Scores on the KOOS Questionnaire
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.
详细描述
Patients enrolled in the ADSC cohort will undergo the following procedures: arthroscopic resection of approximately 5cc of the infrapatellar fat pad using a motorized shaver (standard use in arthroscopy). Fat will be collected in a sterile Aquavage Collection System (AV1200, MD Resources, Livermore, CA) and kept sealed until processing. Fat will then immediately be processed in the Harvest Adiprep System to separate a population of ADSCs. This system concentrates an average of 5 x 105 cells/ml. All specimens will be processed using routine sterile procedures within the operating room; cells destined for implantation will not leave the operating room. Concurrently, patients will undergo arthroscopy and similar preparation of the chondral defect and removal of the calcified cartilage layer. However, no puncture of the subchondral bone will be performed. A layer of fibrin glue (Tisseel) will be placed at the base of the defect to seal off any bleeding from the subchondral plate followed by the application of the acellular dermal matrix (Allopatch HD, MTF Corporation, Edison, NJ, USA)and ADSCs. An additional layer of Tisseel will then be applied over the cells and matrix. No additional fixation will be applied. The matrix and cells will be recessed below the articular surface by an average of 1mm. They will then complete outcome questionnaires and additional MRI scans at 6, 12, and 24 months post-operatively.
研究者
入排标准
入选标准
- •Must be between ages 18 and 50 years.
- •Must have a discrete, contained chondral defect less than 400mm\^2 located on the medial or lateral femoral condyle
- •Must have overall neutral lower limb mechanical alignment (\<5 degrees varus or valgus).
排除标准
- •Ages younger than 18 years and older than 50 years.
- •If they have undergone previous chondral procedures
- •If they have pre-existing osteoarthritis (Kellegren-Lawrence Grade ≥2)
- •If they have a BMI \>30.
结局指标
主要结局
Health Scores on the KOOS Questionnaire
时间窗: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
The Knee Osteoarthritis Outcome Score (KOOS), a standard outcome questionnaire for the assessment of health-related quality of life, will be completed.
次要结局
- Functionality Scores on the Lysholm Scale(Completed at baseline, 6 months, 12 months, and 24 months post-operatively.)
- Cartilage Composition Assessment by MRI Scan(Assessed at baseline, 6 months, 12 months, and 24 months post-operatively.)
- Pain Scores on the Visual Analog Scale (VAS)(Completed at baseline, 6 months, 12 months, and 24 months post-operatively.)
- Activity Level on the Tegner Activity Scale(Completed at baseline, 6 months, 12 months, and 24 months post-operatively.)
- Health Scores on Veterans-Rand (VR-12) Survey(Completed at baseline, 6 months, 12 months, and 24 months post-operatively.)