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

NCT07003035 | Not Yet Recruiting

• 1 other identifier: 23705-4-02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Society Score (KSS)

  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.

  At baseline, 6 months, and 12 months post-surgery

Secondary Outcomes (7)

• Pain Severity - Visual Analog Scale (VAS)

  At baseline, 6 months, and 12 months post-surgery.

• Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  At baseline, 6 months, and 12 months post-surgery

• Functional Improvement - SF-36 Health Survey

  At baseline, 6 months, and 12 months post-surgery.

• Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS)

  At baseline, 6 months, and 12 months post-surgery

• Functional Improvement - Gait Analysis

  At baseline, 6 months, and 12 months post-surgery

Study Arms (1)

Cohort 1

A total of 80 participants will be enrolled, with 40 receiving personalized total knee arthroplasty and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit adult patients aged 50-80 years who are undergoing total knee arthroplasty for end-stage knee osteoarthritis or related conditions. Participants will be selected from multiple hospital centers to ensure a diverse patient population.

You may qualify if:

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

You may not qualify if:

• History of prior knee surgery or knee replacement.
• Severe knee deformity (valgus \>20° or varus \>15°) or instability.
• Severe contracture (\>25° flexion contracture).
• Undergoing total knee revision surgery.
• Rheumatoid arthritis diagnosis.
• BMI \>35.
• Neuromuscular disorders affecting knee stability or gait.
• Pregnancy or lactation.
• Presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions.
• Active or recent severe infections or malignancy.
• History of drug or alcohol abuse in the past six months.

Sponsors & Collaborators

• YujiakuoTHU: lead
• Peking University Shougang Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CN (1)