- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07742696
Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty
29 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
84
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ran Zhao, MD
- Número de teléfono: +8613161866294
- Correo electrónico: 2411210441@pku.edu.cn
Ubicaciones de estudio
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Haidian
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Beijing, Haidian, Porcelana
- Orthopaedic Department of Peking University Third Hospital
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Contacto:
- Orthopaedic Department of Peking University Third Hospital
- Número de teléfono: +8613161866294
- Correo electrónico: 2411210441@pku.edu.cn
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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Comparador activo: 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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Periodo de tiempo: 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 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Range of Motion of Knee Joint(ROM)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de julio de 2026
Finalización primaria (Estimado)
15 de febrero de 2027
Finalización del estudio (Estimado)
15 de julio de 2029
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PUTH00238
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .