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Not yet recruiting NCT07003035

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

— Observational Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteoarthritis. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Knee Society Score (KSS) [Time frame: At baseline, 6 months, and 12 months post-surgery]
Secondary outcome measures (7)
  • Pain Severity - Visual Analog Scale (VAS) [Time frame: At baseline, 6 months, and 12 months post-surgery.]
  • Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: At baseline, 6 months, and 12 months post-surgery]
  • Functional Improvement - SF-36 Health Survey [Time frame: At baseline, 6 months, and 12 months post-surgery.]
  • Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: At baseline, 6 months, and 12 months post-surgery]
  • Functional Improvement - Gait Analysis [Time frame: At baseline, 6 months, and 12 months post-surgery]
  • Prosthesis Positioning and Alignment [Time frame: At baseline and 12 months post-surgery.]
  • Surgical Complication Rate [Time frame: At 12 months post-surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tsinghua Chang Gung Hospital — Beijing

Identifiers

NCT: NCT07003035 · 23705-4-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗