A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis

Not yet recruiting

• Conditions: Osteoarthritis

• Registration Number: NCT06990594
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

The purpose of this study is to evaluate the clinical benefits of different types of total knee arthroplasty (TKA) in osteoarthritis treatment. The study aims to compare surgical outcomes, functional recovery, complication rates, and cost-effectiveness among personalized, semi-personalized, and conventional TKA in a multi-center, bidirectional cohort study.

Detailed Description

This study aims to assess the performance of personalized, semi-personalized, and conventional total knee arthroplasty (TKA) procedures across different patient groups.

This is a prospective cohort and controlled study involving 120 patients, including 40 in the experimental group receiving personalized TKA, 40 receiving semi-personalized TKA, and 40 in the control group receiving conventional TKA. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-17
• Study First Submitted QC: 2025-05-17
• Last Update Submitted: 2025-05-17
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-06-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients aged 50-80 years.
2. Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
3. Willing and able to provide informed consent.

Exclusion Criteria

1. History of prior knee surgery or knee replacement.
2. Severe knee deformity (valgus >20° or varus >15°) or instability.
3. Severe contracture (>25° flexion contracture).
4. Undergoing total knee revision surgery.
5. Rheumatoid arthritis diagnosis.
6. BMI >35.
7. Neuromuscular disorders affecting knee stability or gait.
8. Pregnancy or lactation.
9. Presence of significant comorbidities posing unacceptable risk.
10. Active or recent severe infections or malignancy.
11. History of drug or alcohol abuse in the past six months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Society Score (KSS)	At baseline, 6 months, and 12 months post-surgery	The KSS is a standardized assessment tool used to evaluate knee function and pain following total knee arthroplasty. It includes an objective knee score and a functional score, measuring alignment, stability, and range of motion.

Secondary Outcome Measures

Name	Time	Method
Pain Severity	At baseline, 6 months, and 12 months post-surgery	Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess pain levels pre- and post-surgery.
Functional Improvement	At baseline, 6 months, and 12 months post-surgery.	Functional improvement will be measured using SF-36 Health Survey, Knee Injury and Osteoarthritis Outcome Score (KOOS), and gait analysis.
Prosthesis Positioning and Alignment	At baseline and 12 months post-surgery.	Radiographic evaluation will assess implant positioning and limb alignment.
Surgical Complication Rate	At 12 months post-surgery.	The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China