Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design (FiMo_UKP)
2026年6月25日 更新者：Lenka Stroobant、Jan Yperman Hospital
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
研究概览
地位
招聘中
条件
详细说明
In knee surgery, two dominant designs exist for the medial unicompartmental knee prosthesis (UKP): the fixed bearing (FB) and mobile bearing (MB) designs.
The FB design is technically simpler to implant but has shown higher rates of early polyethylene wear in some studies.
MB implants theoretically offer advantages in joint kinematics and load distribution but carry a risk of insert dislocation and periprosthetic fractures.
An additional advantage of MB implants is the possibility of cementless implantation, potentially avoiding cement-related complications and reducing operative time.
研究类型
观察性的
注册 (估计的)
200
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。
学习联系方式
- 姓名：Lenka Stroobant
- 电话号码：+32496867115
- 邮箱：lenka.stroobant@ugent.be
学习地点
-
-
Oost-Vlaanderen
-
Ieper、Oost-Vlaanderen、比利时、8900
- 招聘中
- Orthopedic department
-
接触：
- Francois Hardeman, MD
- 电话号码：057 35 73 70
- 邮箱：francois.hardeman@yperman.net
-
-
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
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
Patients eligible for a unicompartmental medial knee prosthesis based on the eligibility criteria.
描述
Inclusion Criteria:
- Age between 50 and 80 years
- Indication for medial UKP
- Intact anterior cruciate ligament
- Good bone quality based on imaging
- ASA score ≤ 3
Exclusion Criteria:
- Inflammatory joint diseases
- Collateral ligament instability
- Simultaneous bilateral procedure
- BMI > 35
- History of fracture or osteotomy in the knee joint
- Neuromuscular diseases
- Oncological indications
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
队列和干预
团体/队列 |
|---|
|
Mobile UKP
Mobile unicompartmental knee prosthesis
|
|
Fixed UKP
Fixed unicompartmental knee prosthesis
|
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 |
|---|---|---|
|
OKS
大体时间：Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
|
Oxford Knee Score
|
Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AMI
大体时间：Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.
|
Arthrogenic Muscle Inhibition - DOI: 10.1002/ksa.12804
for grading
|
Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.
|
|
Surgery time
大体时间：Peroperatively
|
Operative time
|
Peroperatively
|
|
Complications
大体时间：Within 2 years postoperatively
|
Postoperative complications
|
Within 2 years postoperatively
|
|
Revision or reoperation
大体时间：Within 2 years postoperatively
|
Revision or reoperation
|
Within 2 years postoperatively
|
|
c-FCA
大体时间：6 weeks and 4 months postoperatively
|
Coronal Femoral Component Alignment - Varus/valgus alignment for the femoral component is measured on the AP radiograph in relation to the anatomical axis of the tibia.
0° degrees is considered neutral.
|
6 weeks and 4 months postoperatively
|
|
EQ-5D-5L
大体时间：Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
|
The 5-level EQ-5D version.
|
Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
|
|
NRS
大体时间：Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
|
Numeric Rating Scale
|
Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
|
|
KOOS-PS
大体时间：Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
|
Knee Injury and Osteoarthritis Outcome Score-Physical function Short form
|
Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
|
|
c-TCA
大体时间：6 weeks and 4 months postoperatively
|
Coronal Tibial Component Alignment - Varus/valgus alignment for the tibial component is measured on the AP radiograph in relation to the anatomical axis of the tibia.
0° is considered neutral.
|
6 weeks and 4 months postoperatively
|
|
s-FCA
大体时间：6 weeks and 4 months postoperatively
|
Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior tibial cortex.
A posteroinferior slope of 7° is considered neutral.
|
6 weeks and 4 months postoperatively
|
|
s-FCA
大体时间：6 weeks and 4 months postoperatively
|
Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior femoral cortex.
0° is considered neutral.
|
6 weeks and 4 months postoperatively
|
|
RLL
大体时间：6 weeks and 4 months postoperatively
|
Radiolucencies - Radiolucencies after UKR are divided into two types: physiological and pathological. The former are < 2 mm thick, well defined, and accompanied by a parallel radiodense line, whereas the latter are > 2 mm thick, ill defined, and lacking accompanying radiodense lines. The pattern observed should be recorded as well as their location, which is divided into six zones on the AP view of the tibial component and six zones on the lateral view of the femoral component. Evaluation based on the zones of the Knee Society. |
6 weeks and 4 months postoperatively
|
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)
2025年12月8日
初级完成 (估计的)
2029年12月31日
研究完成 (估计的)
2029年12月31日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年7月1日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- FiMO JYZ2025-10
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