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临床试验/NCT03497780
NCT03497780终止不适用

Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Synovial Inflammation, Functional Imaging, Clinical Outcomes, and Cartilage Biomarkers

University of Michigan1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentration

研究概览

简要总结

The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (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 post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.

详细描述

Overall Study Design: This is a prospective, longitudinal cohort study of patients undergoing primary ACL reconstruction following ACL rupture. Surgical treatment and treatment timelines do not deviate from the national and international standards of care. Enrolled patients for study participation will undergo assessments involving blood, urine, and synovial fluid collection, clinical evaluation involving questionnaires and joint laxity testing, and MRI analysis.

Patient Selection and Enrollment: The participating physicians at each site will identify potential subjects from their clinics' patients according to the inclusion/exclusion criteria listed below. Based on surgical volumes at both sites, patients generally undergo ACL reconstruction 8-12 weeks after initial screening. In the preoperative timeframe, all patients will undergo standard physical therapy to address pain, swelling, and motion deficits, as is standard of care at both institutions. Arthroscopic ACL reconstruction will be performed by Dr. Bedi at the University of Michigan, by Professor Ao at Peking University, and by 5 additional surgeons at Peking University. All surgeons will utilize a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.

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

入选标准

  • 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 Posterior Cruciate Ligament injury or more than grade 1 injury to the Medial or Lateral Collateral Ligament

排除标准

  • Body Mass Index < 18.5 or >35 - 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
  • Pregnant women as they are not eligible for surgery

结局指标

主要结局

Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentration

时间窗: Baseline (preop), 12 months

One-year change in the serum concentration of COMP, a biomarker of articular cartilage degeneration.

Change in Articular cartilage surface roughness

时间窗: Baseline (preop), 12 months

One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.

Change in International Knee Documentation Committee (IKDC) score

时间窗: Baseline (preop), 12 months

One year change in IKDC, a patient-reported outcome measure specific to knee injuries.

次要结局

  • Change in concentration of biomarkers of inflammation and cartilage metabolism.(Baseline (preop), 12 months)
  • Change in patient-reported outcome measures(Baseline (preop), 12 months)
  • Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI.(Baseline (preop), 12 months)
  • Change in knee laxity(Baseline (preop), 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tristan Maerz

Research Investigator

University of Michigan

研究点 (1)

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