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NCT07742696

Overview

NCT ID: NCT07742696
Lead Sponsor: Peking University Third HospitalOTHER
Official Title: Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty: a Prospective Random Controlled Trial
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 15, 2026Estimated
Primary Completion Date: Feb 15, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 84Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Ran Zhao, MDContact
2411210441@pku.edu.cn+8613161866294

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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