Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approac… (NCT07742696) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty
China84 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Timeframe: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
2
Knee Society Score(KSS)
Timeframe: 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)
Timeframe: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty
4
First Unassisted Straight Leg Raise(SLR)
Timeframe: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty