Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty
2026年7月29日 更新者:Peking University Third Hospital
Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty: a Prospective Random Controlled Trial
This study aims to compare the effects of the medial parapatellar approach (MP) and the subvastus approach (SV) on postoperative clinical function in total knee arthroplasty (TKA).
A total of 84 patients, who visit the Joint Surgery Department of Peking University Third Hospital and are diagnosed with end-stage knee osteoarthritis and require unilateral, primary total knee arthroplasty, will be recruited.
The patients will be randomly assigned to two groups, with 42 patients in each group.
TKA will be performed using the MP and SV approaches respectively.
Postoperative data such as quadriceps muscle strength, the time of first unassisted straight leg raise (SLR), joint range of motion (ROM), KSS score, WOMAC score, SF-12 score, VAS score, and shear wave elastography (SWE) of the medial thigh muscle will be collected.
The patients will be followed up for 2 years postoperatively to compare the short-term and long-term clinical functional outcomes of the two surgical approaches.
研究概览
研究类型
介入性
注册 (估计的)
84
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。
学习联系方式
- 姓名:Ran Zhao, MD
- 电话号码:+8613161866294
- 邮箱:2411210441@pku.edu.cn
学习地点
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Haidian
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Beijing、Haidian、中国
- Orthopaedic Department of Peking University Third Hospital
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接触:
- Orthopaedic Department of Peking University Third Hospital
- 电话号码:+8613161866294
- 邮箱:2411210441@pku.edu.cn
-
-
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
描述
Inclusion Criteria:
- Patients aged 50 to 80 who are diagnosed with end-stage knee osteoarthritis that require unilateral primary total knee arthroplasty;
- Patients who are determined by clinical and laboratory tests to have no absolute surgical contraindications;
- Patients with good compliance, willing and able to undergo follow-up observations as required and sign the informed consent form;
Exclusion Criteria:
- Patients with a history of surgery on the affected knee joint in the past;
- Patients with neuromuscular diseases;
- Patients scheduled for knee joint replacement revision surgery;
- Patients with active knee joint infection or systemic infection;
- Patients who receive primary joint replacement due to non-knee osteoarthritis, such as rheumatoid arthritis, tuberculous arthritis, traumatic arthritis, etc;
- Patients with valgus or varus deformity of the knee joint greater than 15°;
- Patients with knee flexion deformity greater than 15°;
- Patients whose heart and lung functions are determined by clinical and laboratory tests to be unable to tolerate surgery;
- Patients with mental disorders who are unable to cooperate with treatment;
- Patients who is lactating or pregnant;
- Patients who are unwilling to participate in this study and did not sign the informed consent form;
- Patients with poor compliance and inability to cooperate in completing the follow-up observers at critical times;
- For any reason, the researchers believe that the subject is unlikely to complete this study.
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 |
|---|---|
|
实验性的:subvastus approach
Patients receive total knee arthroplasty with subvastus approach.
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Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.
|
|
有源比较器:medial parapatellar approach
Patients receive total knee arthroplasty with medial parapatellar approach, which is classic, mature and with exact curative effect.
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Patients receive total knee arthroplasty with medial parapatellar approach to expose the knee joint
|
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 |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
The higher the score, the more severe the symptoms and the worse the postoperative functional recovery.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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Knee Society Score(KSS)
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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The lower the score, the more severe the symptoms and the worse the postoperative functional recovery.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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Short Form 12 Health Survey Questionnaire(SF-12)
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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The higher score equals to the better postoperative satisfaction.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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First Unassisted Straight Leg Raise(SLR)
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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Record the time of the first postoperative unassisted straight leg raise of every patient.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Range of Motion of Knee Joint(ROM)
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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|
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Visual Analogue Scale(VAS)
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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The higher the score, the stronger the patient's subjective pain perception.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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Myodynamia of Quadriceps Femoris
大体时间:From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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Surgeons will measure the patients' muscle strength of Quadriceps Femoris using manual muscle testing, based on Lovett Scale for Muscle Strength Assessment.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
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Shear Wave Elastography of Quadriceps Femoris
大体时间:3 months after receiving total knee arthroplasty
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SWE displays the strength and hardness with precise values.
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3 months after receiving total knee arthroplasty
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Aladraii AA, Allehaibi LZ, Fattani AA, Alkhudairy TA, Al-Margan AM, Al-Dubai SAR, Mohammed AA, Mohorjy DK, Alqarni AS. Functional Outcome of Subvastus versus Medial Parapatellar Approaches for Total Knee Replacement in Patients with Knee Osteoarthritis: A Prospective Cohort Study. Saudi J Med Med Sci. 2024 Jan-Mar;12(1):35-39. doi: 10.4103/sjmms.sjmms_237_23. Epub 2024 Jan 15.
- Migliorini F, Aretini P, Driessen A, El Mansy Y, Quack V, Tingart M, Eschweiler J. Better outcomes after mini-subvastus approach for primary total knee arthroplasty: a Bayesian network meta-analysis. Eur J Orthop Surg Traumatol. 2020 Aug;30(6):979-992. doi: 10.1007/s00590-020-02648-9. Epub 2020 Mar 10.
- Khan MNH, Abbas K, Faraz A, Ilyas MW, Shafique H, Jamshed MH, Hashmi P. Total knee replacement: A comparison of the subvastus and medial parapatellar approaches. Ann Med Surg (Lond). 2021 Aug 8;68:102670. doi: 10.1016/j.amsu.2021.102670. eCollection 2021 Aug.
- Wu Y, Zeng Y, Bao X, Xiong H, Hu Q, Li M, Shen B. Comparison of mini-subvastus approach versus medial parapatellar approach in primary total knee arthroplasty. Int J Surg. 2018 Sep;57:15-21. doi: 10.1016/j.ijsu.2018.07.007. Epub 2018 Jul 26.
- Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.
- Hosseini-Monfared P, Mirahmadi A, Amiri S, Minaie R, Ghafouri MH, Kazemi SM. Comparable long-term functional outcomes of subvastus and medial parapatellar approach in total knee arthroplasty: A 10-year follow-up study. J Exp Orthop. 2024 Oct 8;11(4):e70035. doi: 10.1002/jeo2.70035. eCollection 2024 Oct.
- Mahmoudian A, Lohmander LS, Mobasheri A, Englund M, Luyten FP. Early-stage symptomatic osteoarthritis of the knee - time for action. Nat Rev Rheumatol. 2021 Oct;17(10):621-632. doi: 10.1038/s41584-021-00673-4. Epub 2021 Aug 31.
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 (估计的)
2026年7月15日
初级完成 (估计的)
2027年2月15日
研究完成 (估计的)
2029年7月15日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月29日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月29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
- PUTH00238
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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不
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