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

NCT06990594 | Not Yet Recruiting

• 1 other identifier: 25034-0-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Society Score (KSS)

  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.

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

Secondary Outcomes (4)

• Pain Severity

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

• Functional Improvement

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

• Prosthesis Positioning and Alignment

  At baseline and 12 months post-surgery.

• Surgical Complication Rate

  At 12 months post-surgery.

Study Arms (1)

Cohort 1

A total of 120 participants will be enrolled, with 40 receiving total knee arthroplasty (TKA) using a personalized prosthesis, 40 receiving semi-personalized TKA, 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

The study population consists of 120 patients aged 50-80 years diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis, who require total knee arthroplasty (TKA). Participants will be recruited from multiple centers, including Beijing Tsinghua Chang Gung Hospital, Peking University Shougang Hospital, and Beijing Chaoyang Hospital. The study will compare personalized, semi-personalized, and conventional TKA procedures in terms of surgical outcomes, functional recovery, complication rates, and cost-effectiveness.

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.
• Active or recent severe infections or malignancy.
• History of drug or alcohol abuse in the past six months.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: 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: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (1)