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NCT Number: NCT07003035

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

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.

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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 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.

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, 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.

Treatment and study plan

Primary outcomes

  1. Knee Society Score (KSS)

    Time frame: 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 outcomes

  1. Pain Severity - Visual Analog Scale (VAS)

    Time frame: 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.

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

    Time frame: 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.

  3. Functional Improvement - SF-36 Health Survey

    Time frame: 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.

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

    Time frame: 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.

  5. Functional Improvement - Gait Analysis

    Time frame: 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.

  6. Prosthesis Positioning and Alignment

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

    Radiographic evaluation will assess implant positioning and limb alignment.

  7. 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

YujiakuoTHU

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Peking University Shougang Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Jun 4, 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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