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NCT Number: NCT06990594

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Knee Society Score (KSS)

    Time frame: 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 outcomes

  1. Pain Severity

    Time frame: 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.

  2. Functional Improvement

    Time frame: 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.

  3. Prosthesis Positioning and Alignment

    Time frame: At baseline and 12 months post-surgery.

    Radiographic evaluation will assess implant positioning and limb alignment.

  4. Surgical Complication Rate

    Time frame: At 12 months post-surgery.

    The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Peking University Shougang Hospital

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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