Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Functional Imaging and Biomarkers
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- COMP
研究概览
简要总结
The proposed study will establish novel relationships between intra-articular MSC recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of PTOA after ACL injury and reconstruction.
详细描述
In efforts to study the pathoetiology of post-traumatic osteoarthritis (PTOA), we propose a collaborative, prospective cohort study of 38 patients undergoing primary anterior cruciate ligament (ACL) reconstruction after ACL rupture. We will assess the longitudinal progression of patient-reported outcomes, knee laxity, MRI-based articular cartilage morphology and composition, and serum-borne biomarkers of cartilage degeneration up to 1 year of follow-up. Furthermore, stem cell mobilization, chemokine and pro-inflammatory cytokine concentrations, and inflammatory cell recruitment into synovial tissue will be measured from intraoperatively-collected samples. We will perform mixed multivariate linear regression modeling to elucidate potentially novel relationships between patient demographics, anatomy, biological factors, and downstream alterations in articular cartilage morphology and composition. We request $200,000 in funding over a two-year duration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Males and females, aged 18 - 30 years
- •Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction
- •Surgical reconstruction performed using a single-bundle technique utilizing an autograft
- •No history of ipsilateral traumatic knee injury or fracture
- •No evidence of PCL injury or more than grade 1 injury to the MCL or LCL
排除标准
- •- BMI < 18.5 or >35 kg/m2
- •Injury occurred longer than 4 weeks before enrollment
- •Intra-articular steroid injection within 3 months of injury
- •Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions
结局指标
主要结局
COMP
时间窗: 12 months after operation
Cartilage Biomarker Analysis;
Cartilage morphology
时间窗: 12 months after operation
Quantitative MRI of cartilage morphology
Magnetic resonance imaging
时间窗: 12 months after operation
Quantitative MRI of Cartilage Composition
MMP-1
时间窗: 12 months after operation
Soft Tissue Protease and Protease Inhibitor Analysis in Synovial Fluid
Interleukin-1
时间窗: 12 months after operation
Chemokines and Pro-Inflammatory Cytokines in Synovial Fluid;
Objectives measure of knee stability
时间窗: 3 months, 6 months, 12 months
Knee stability (anterior-posterior laxity) will be measured utilizing the KT-2000 arthrometer, based on the side-to-side difference (SSD) observed between the injured and the healthy, contralateral knee. Subjects will be tested at 90 days, 180 days, and 1 year after surgery, with maximum manual force performed at 30 and 90 degrees of knee flexion.
colony-forming units (CFU)
时间窗: 12 months after operation
The CFU assay is a common means of analyzing MSC concentration in bodily fluids
次要结局
- Tegner Activity Scale(12 months after operation)
- International Knee Documentation Committee (IKDC) subjective Scale(12 months after operation)
- Lysholm Knee Scale(12 months after operation)