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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
subvastus
Procedure/SurgeryPatients receive total knee arthroplasty with subvastus approach to expose the knee joint.
medial parapatellar
Procedure/SurgeryPatients receive total knee arthroplasty with medial parapatellar approach to expose the knee joint
Treatment groups
Trial outcomes
Primary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
The higher the score, the more severe the symptoms and the worse the postoperative functional recovery.
Knee Society Score(KSS)
The lower the score, the more severe the symptoms and the worse the postoperative functional recovery.
Short Form 12 Health Survey Questionnaire(SF-12)
The higher score equals to the better postoperative satisfaction.
First Unassisted Straight Leg Raise(SLR)
Record the time of the first postoperative unassisted straight leg raise of every patient.
Secondary outcomes
Range of Motion of Knee Joint(ROM)
Visual Analogue Scale(VAS)
The higher the score, the stronger the patient's subjective pain perception.
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.
Shear Wave Elastography of Quadriceps Femoris
SWE displays the strength and hardness with precise values.
Sponsors and contacts
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