Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty

Официальное название

Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty: a Prospective Random Controlled Trial

Обзор

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.

Вмешательства

• Процедура subvastus
  Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.
• Процедура medial parapatellar
  Patients receive total knee arthroplasty with medial parapatellar approach to expose the knee joint

Первичные конечные точки

• Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]
• Knee Society Score(KSS) [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]
• Short Form 12 Health Survey Questionnaire(SF-12) [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]
• First Unassisted Straight Leg Raise(SLR) [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]

Вторичные конечные точки (4)

• Range of Motion of Knee Joint(ROM) [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]
• Visual Analogue Scale(VAS) [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]
• Myodynamia of Quadriceps Femoris [Срок оценки: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty]
• Shear Wave Elastography of Quadriceps Femoris [Срок оценки: 3 months after receiving total knee arthroplasty]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Orthopaedic Department of Peking University Third Hospital — Пекин

Публикации

• 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. PMID 38362087
• 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. PMID 32152747
• 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. PMID 34408867
• 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. PMID 30056128
• 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. PMID 28844632
• 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. PMID 39380847
• 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. PMID 34465902

Идентификаторы

NCT: NCT07742696 · PUTH00238

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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