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- Essai clinique NCT07742696
Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty
29 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
84
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ran Zhao, MD
- Numéro de téléphone: +8613161866294
- E-mail: 2411210441@pku.edu.cn
Lieux d'étude
-
-
Haidian
-
Beijing, Haidian, Chine
- Orthopaedic Department of Peking University Third Hospital
-
Contact:
- Orthopaedic Department of Peking University Third Hospital
- Numéro de téléphone: +8613161866294
- E-mail: 2411210441@pku.edu.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: subvastus approach
Patients receive total knee arthroplasty with subvastus approach.
|
Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.
|
|
Comparateur actif: medial parapatellar approach
Patients receive total knee arthroplasty with medial parapatellar approach, which is classic, mature and with exact curative effect.
|
Patients receive total knee arthroplasty with medial parapatellar approach to expose the knee joint
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Délai: 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.
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
Knee Society Score(KSS)
Délai: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
The lower the score, the more severe the symptoms and the worse the postoperative functional recovery.
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
Short Form 12 Health Survey Questionnaire(SF-12)
Délai: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
The higher score equals to the better postoperative satisfaction.
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
First Unassisted Straight Leg Raise(SLR)
Délai: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
Record the time of the first postoperative unassisted straight leg raise of every patient.
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Range of Motion of Knee Joint(ROM)
Délai: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
|
Visual Analogue Scale(VAS)
Délai: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
The higher the score, the stronger the patient's subjective pain perception.
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
Myodynamia of Quadriceps Femoris
Délai: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
Surgeons will measure the patients' muscle strength of Quadriceps Femoris using manual muscle testing, based on Lovett Scale for Muscle Strength Assessment.
|
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
Shear Wave Elastography of Quadriceps Femoris
Délai: 3 months after receiving total knee arthroplasty
|
SWE displays the strength and hardness with precise values.
|
3 months after receiving total knee arthroplasty
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 juillet 2026
Achèvement primaire (Estimé)
15 février 2027
Achèvement de l'étude (Estimé)
15 juillet 2029
Dates d'inscription aux études
Première soumission
6 juillet 2026
Première soumission répondant aux critères de contrôle qualité
29 juillet 2026
Première publication (Réel)
3 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PUTH00238
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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