跳至主要内容
临床试验/NCT06185036
NCT06185036招募中不适用

Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Correlation coefficient of dGEMRIC indices and histological cartilage quality

研究概览

简要总结

In this study, the investigators seek to validate 3D model-based dGEMRIC (delayed gadolinium enhanced MRI of cartilage) values against histologic grading of cartilage quality, using osteochondral samples of the femoral head collected during hip replacement surgery.

详细描述

For patients with advanced hip joint degeneration visible on pelvic radiographs, joint-preserving surgery is often not an option, making joint replacement the primary treatment choice. However, for those with moderate signs of degeneration, the choice between joint-preserving surgery and replacement can be challenging. This decision often relies on imaging techniques such as preoperative direct MR arthrography.

Recent developments in medical imaging have led to new biochemical MRI sequences, such as dGEMRIC. These sequences are valuable for assessing the condition of cartilage before significant morphologic changes occur. By measuring glycosaminoglycan (GAG) content in cartilage, dGEMRIC provides early insight into cartilage degradation. Incorporating these sequences into standard MRI protocols allows the generation of dGEMRIC indices and the creation of 3D models of hip cartilage, improving the overall assessment of the hip joint.

The purpose of this study is to validate 3D model-based dGEMRIC values by comparing them to histologic assessments of cartilage degeneration. The hypothesis is that the dGEMRIC indices from the 3D MRI model will correlate with the histologic grading of cartilage quality in femoral cartilage samples obtained during hip replacement surgery.

This study aims to enroll 25 patients scheduled for total hip arthroplasty. Each participant will undergo preoperative biplanar hip radiographs and direct MR arthrography at 3 Tesla, including the dGEMRIC sequence, according the hospital's standard protocol.

Surgeries will performed by an experienced orthopaedic hip surgeon. The procedure will involve the femoral neck osteotomy, followed by the removal of the head-neck fragment, and the implantation of the hip prosthesis. Osteochondral samples will be taken from four areas of the femoral head. These will be analyzed using toluidine blue and safranin-O staining to assess cartilage damage.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with advanced hip osteoarthritis.
  • Preoperative hip MRI including biochemical sequence (MP2RAGE).
  • Indication for hip replacement.

排除标准

  • Patients without informed consent.
  • Age under 18 years.
  • Insufficient language understanding in German, French, or English.
  • Previous hip surgeries.
  • Neoplastic and inflammatory comorbidities of the hip.
  • Post-traumatic or pediatric deformities.
  • Avascular necrosis of the femoral head.
  • Inadequate MRI image quality (motion artifacts, extra-articular contrast media administration, delay (>45 minutes) between contrast injection and MRI imaging).

结局指标

主要结局

Correlation coefficient of dGEMRIC indices and histological cartilage quality

时间窗: Within 12 months after histological analysis

Linear regression analysis will be performed to assess the correlation between dGEMRIC scores and the histological evaluation of cartilage quality.

次要结局

  • dGEMRIC indices from 3D MRI cartilage model (T1 relaxation time in milliseconds)(Within 12 months after MRI/patient enrollment)
  • Intensity of Toluidine blue staining as a histological value of cartilage damage (Mankin grading 0-14)(Within 1-2 weeks after sample acquisition)
  • Intensity of Safranin-O staining as a histological value of cartilage damage (Relative red fraction of the RGB scale, 0-255)(Within 1-2 weeks after sample acquisition)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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