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

NCT07742696 | Not Yet Recruiting

• 1 other identifier: PUTH00238
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

medial parapatellar approach; subvastus approach; total knee arthroplasty

Outcome Measures

Primary Outcomes (4)

• Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

  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)

  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)

  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)

  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

Secondary Outcomes (4)

• Range of Motion of Knee Joint(ROM)

  From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

• Visual Analogue Scale(VAS)

  From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

• Myodynamia of Quadriceps Femoris

  From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

• Shear Wave Elastography of Quadriceps Femoris

  3 months after receiving total knee arthroplasty

Study Arms (2)

subvastus approach

EXPERIMENTAL

Patients receive total knee arthroplasty with subvastus approach.

Procedure: subvastus

medial parapatellar approach

ACTIVE COMPARATOR

Patients receive total knee arthroplasty with medial parapatellar approach, which is classic, mature and with exact curative effect.

Procedure: medial parapatellar

Interventions

subvastus PROCEDURE

Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.

subvastus approach

medial parapatellar PROCEDURE

Patients receive total knee arthroplasty with medial parapatellar approach to expose the knee joint

medial parapatellar approach

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Orthopaedic Department of Peking University Third Hospital

Beijing, Haidian, China

Location

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Ran Zhao, MD

CONTACT

+8613161866294; 2411210441@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: August 3, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): July 15, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)