Clinical Effect of Allogeneic Meniscus Transplantation
2021年7月4日 更新者：Peking University Third Hospital
In this study, patients who underwent allogeneic meniscus transplantation and meniscus resection were followed up for more than 10years to evaluate the long-term efficacy and explore the cartilage protective role of meniscus transplantation.
研究概览
详细说明
To investigate the long-term clinical effect of allogeneic meniscus transplantation, IKDC score, Lysholom score, Tegner score, VAS score, etc. were used to compare the clinical effects of allogeneic meniscus transplantation, and the progress of knee joint degeneration and cartilage injury was evaluated through X-ray and MRI.
研究类型
介入性
注册 (实际的)
38
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing
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Beijing、Beijing、中国、100191
- Institute of Sports Medicine, Peking University Third Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 46年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
The age is less than 50 years; the force line is basically normal (≤ ± 3°); the joint is stable or the joint stability is corrected at the same time during the operation; the joint degeneration or large area cartilage damage. In the transplantation group, 10 patients experienced pain or swelling in the joint space of the affected side for an average of 35 months after meniscus resection, and then received meniscus transplantation. The other 8 patients underwent meniscus transplantation at the same time as meniscus resection. Patients in the resection group received meniscus transplantation at the same time. Symptoms, signs, and magnetic resonance imaging (MRI) were diagnosed as a meniscus tear and the judgment during the operation could not be preserved, so a total meniscus was performed.
Exclusion Criteria:
Severe knee synovial disease; severe joint degeneration or extensive cartilage damage; improper force lines; severely unstable joints that cannot be corrected; both meniscuses are removed; the other knee joint has a history of severe trauma or surgery.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Meniscus Allograft Transplantation
The patient underwent Meniscus Allograft Transplantation
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patients received surgery of Meniscus Allograft Transplantation
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有源比较器：Meniscectomy
The patient underwent Meniscectomy
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patients received surgery of Meniscectomy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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磁共振成像 (MRI)
大体时间：手术前
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所有 MRI 扫描均使用 3.0-T MRI 扫描仪（带有 TIM 系统的 Magnetom Trio，Siemens Healthcare）获得。
在所有患者中获得了五个切片厚度为 4 mm 的常规 MRI 序列。
移植间室关节软骨的术前和术后评估采用 Yulish 评分 41（0 级 = 正常；1 级 = 正常轮廓 6 异常信号；2 级 = 表面磨损、侵蚀或溃疡 <50%；3 级= >50% 但 <100% 的部分厚度缺损；4 级 = 全层软骨损失）。
T2 加权快速自旋回波序列冠状面中同种异体半月板移植物的信号按 0 到 3 的等级分级。
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手术前
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射线照片
大体时间：手术前
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在最终随访时，所有患者还获得了同侧和对侧的 45° 屈曲负重 AP 射线照片。
下肢全长的 X 光片用于评估对齐。
在正位X线片中，测量移植侧股骨髁与胫骨平台之间的最短距离，并将其指定为关节间隙高度。
计算同侧和对侧之间的差异以确定关节间隙变窄。
此外，Kellgren-Lawrence (K-L) 分级用于评估膝关节的骨关节炎状态。
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手术前
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Radiographs
大体时间：10 years after the operation
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All patients also obtained 45° flexion weightbearing AP radiographs of both the ipsilateral and contralateral sides at final follow-up.
The radiograph of the total length of the lower limbs was used to evaluate alignment.
In the AP plain radiographs, the shortest distance between the femoral condyle and tibial plateau of the transplanted side was measured and designated as the joint space height.
The difference between the ipsilateral and contralateral sides was calculated to identify joint space narrowing.
In addition, Kellgren-Lawrence (K-L) grading was used to assess the osteoarthritic status of the knee.
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10 years after the operation
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Magnetic resonance imaging (MRI)
大体时间：10 years after the operation
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All MRI scans were obtained with a 3.0-T MRI scanner (Magnetom Trio with TIM system, Siemens Healthcare).
Five routine MRI sequences with a section thickness of 4 mm were obtained in all patients.
Preoperative and postoperative evaluations of the articular cartilage of the transplanted compartment were performed with the Yulish score41 (grade 0 = normal; grade 1 = normal contour 6 abnormal signal; grade 2 = superficial fraying, erosion, or ulceration of <50%; grade 3 = partial-thickness defect of >50% but <100%; grade 4 = full-thickness cartilage loss).
The signal of the meniscus allograft in the coronal plane of the T2-weighted fast spin echo sequence was graded on a scale of 0 to 3.
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10 years after the operation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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visual analog scale (VAS) scores
大体时间：Before and 10 to 15 years after the operation
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visual analog scale (VAS) scores was applied to evaluate knee pain.
0 points means no pain, 10 points means severe pain.
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Before and 10 to 15 years after the operation
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International Knee Documentation Committee (IKDC) score
大体时间：Before and 10 to 15 years after the operation
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At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of the subjective and objective symptoms of the knee joint system.
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Before and 10 to 15 years after the operation
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Tegner score
大体时间：Before and 10 to 15 years after the operation
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This score is widely used by exercise assessors for patients with knee joint disease.
This scoring method divides the patient's exercise level into 0-10 points, 0 as disability, and 10 as being able to participate in national competitive sports.
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Before and 10 to 15 years after the operation
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Lysholm score
大体时间：Before and 10 to 15 years after the operation
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This score is often used together with the Tegner score.
The scores of this scoring system are generally high and focus more on the assessment of daily activities rather than sports.
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Before and 10 to 15 years after the operation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2005年2月1日
初级完成 (实际的)
2021年4月1日
研究完成 (实际的)
2021年4月1日
研究注册日期
首次提交
2021年6月27日
首先提交符合 QC 标准的
2021年7月4日
首次发布 (实际的)
2021年7月13日
研究记录更新
最后更新发布 (实际的)
2021年7月13日
上次提交的符合 QC 标准的更新
2021年7月4日
最后验证
2021年6月1日
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