A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System

Not yet recruiting

• Conditions: Osteoarthritis

• Registration Number: NCT07003035
• Lead Sponsor: YujiakuoTHU

Brief Summary

The purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.

Detailed Description

This study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (TKA) prostheses . The clinical study aims to assess the performance of the femoral, tibial, and meniscal components within a personalized TKA system.

This is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. 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

• Study First Submitted: 2025-03-18
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study Start: 2025-06-01
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions.
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 Knee Society Score is a standardized assessment tool to evaluate pain, range of motion, and functional ability following total knee arthroplasty. It includes two sub-scores: a clinical knee score and a functional score.; Each sub-score ranges from 0 to 100, with higher scores indicating better outcomes.

Secondary Outcome Measures

Name	Time	Method
Pain Severity - Visual Analog Scale (VAS)	At baseline, 6 months, and 12 months post-surgery.	Pain severity will be measured using the VAS, a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).; Higher scores indicate worse pain.
Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	At baseline, 6 months, and 12 months post-surgery	Pain will also be assessed using the WOMAC Pain Subscale, part of the validated WOMAC Index for knee osteoarthritis.; Each item is scored from 0 to 4, and the subscale total ranges from 0 (no pain) to 20 (maximum pain).; Higher scores indicate worse pain.
Functional Improvement - SF-36 Health Survey	At baseline, 6 months, and 12 months post-surgery.	Physical function will be assessed using the 36-Item Short Form Health Survey (SF-36). The Physical Functioning domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS)	At baseline, 6 months, and 12 months post-surgery	The KOOS is a validated tool assessing knee function across five domains. Each domain score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.
Functional Improvement - Gait Analysis	At baseline, 6 months, and 12 months post-surgery	Gait performance will be evaluated using temporospatial parameters such as gait speed (m/s), step length (cm), and cadence (steps/min), measured using standardized motion capture or pressure-sensitive walkways.
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