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Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty
29 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
84
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ran Zhao, MD
- Telefoonnummer: +8613161866294
- E-mail: 2411210441@pku.edu.cn
Studie Locaties
-
-
Haidian
-
Beijing, Haidian, China
- Orthopaedic Department of Peking University Third Hospital
-
Contact:
- Orthopaedic Department of Peking University Third Hospital
- Telefoonnummer: +8613161866294
- E-mail: 2411210441@pku.edu.cn
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: subvastus approach
Patients receive total knee arthroplasty with subvastus approach.
|
Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.
|
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Range of Motion of Knee Joint(ROM)
Tijdsspanne: 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)
Tijdsspanne: 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
|
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Myodynamia of Quadriceps Femoris
Tijdsspanne: 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
|
|
Shear Wave Elastography of Quadriceps Femoris
Tijdsspanne: 3 months after receiving total knee arthroplasty
|
SWE displays the strength and hardness with precise values.
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3 months after receiving total knee arthroplasty
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
15 juli 2026
Primaire voltooiing (Geschat)
15 februari 2027
Studie voltooiing (Geschat)
15 juli 2029
Studieregistratiedata
Eerst ingediend
6 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 juli 2026
Eerst geplaatst (Werkelijk)
3 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PUTH00238
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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