- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07742696
Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty
29. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
84
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ran Zhao, MD
- Telefonnummer: +8613161866294
- E-post: 2411210441@pku.edu.cn
Studiesteder
-
-
Haidian
-
Beijing, Haidian, Kina
- Orthopaedic Department of Peking University Third Hospital
-
Ta kontakt med:
- Orthopaedic Department of Peking University Third Hospital
- Telefonnummer: +8613161866294
- E-post: 2411210441@pku.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: subvastus approach
Patients receive total knee arthroplasty with subvastus approach.
|
Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.
|
|
Aktiv komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
|
First Unassisted Straight Leg Raise(SLR)
Tidsramme: 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.
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From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of Motion of Knee Joint(ROM)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. juli 2026
Primær fullføring (Antatt)
15. februar 2027
Studiet fullført (Antatt)
15. juli 2029
Datoer for studieregistrering
Først innsendt
6. juli 2026
Først innsendt som oppfylte QC-kriteriene
29. juli 2026
Først lagt ut (Faktiske)
3. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PUTH00238
Plan for individuelle deltakerdata (IPD)
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Nei
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