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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorPeking University Third Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • subvastus

    Procedure/Surgery

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

  • medial parapatellar

    Procedure/Surgery

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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: subvastus approachExperimental treatment 1 intervention
Group B: medial parapatellar approachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

The higher the score, the more severe the symptoms and the worse the postoperative functional recovery.

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

Knee Society Score(KSS)

The lower the score, the more severe the symptoms and the worse the postoperative functional recovery.

Time frame
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
3

Short Form 12 Health Survey Questionnaire(SF-12)

The higher score equals to the better postoperative satisfaction.

Time frame
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
4

First Unassisted Straight Leg Raise(SLR)

Record the time of the first postoperative unassisted straight leg raise of every patient.

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

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)

The higher the score, the stronger the patient's subjective pain perception.

Time frame
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
3

Myodynamia of Quadriceps Femoris

Surgeons will measure the patients' muscle strength of Quadriceps Femoris using manual muscle testing, based on Lovett Scale for Muscle Strength Assessment.

Time frame
From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
4

Shear Wave Elastography of Quadriceps Femoris

SWE displays the strength and hardness with precise values.

Time frame
3 months after receiving total knee arthroplasty

Other outcomes

Sponsors and contacts

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