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NCT Number: NCT07742696

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

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.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Department of Peking University Third Hospital

Beijing, Haidian, China

Location contact

Orthopaedic Department of Peking University Third Hospital

CONTACT

[email protected]

+8613161866294

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

subvastus

Procedure

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

medial parapatellar

Procedure

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

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

    Time frame: 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.

  2. Knee Society Score(KSS)

    Time frame: 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.

  3. Short Form 12 Health Survey Questionnaire(SF-12)

    Time frame: 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.

  4. First Unassisted Straight Leg Raise(SLR)

    Time frame: 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.

Secondary outcomes

  1. Range of Motion of Knee Joint(ROM)

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

  2. Visual Analogue Scale(VAS)

    Time frame: 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.

  3. Myodynamia of Quadriceps Femoris

    Time frame: 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.

  4. Shear Wave Elastography of Quadriceps Femoris

    Time frame: 3 months after receiving total knee arthroplasty

    SWE displays the strength and hardness with precise values.

Study contacts

Contact information is provided by the study sponsor or research team.

Ran Zhao, MD

CONTACT

[email protected]

+8613161866294

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty: a Prospective Random Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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