Osteoarthritis
Conditions
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.
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.
Interventions
None listed
Sponsors
Peking University Shougang Hospital
Beijing Chao Yang Hospital
YujiakuoTHU
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Inclusion criteria
1. Patients aged 50-80 years. 2. Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty. 3. Willing and able to provide informed consent.
Exclusion criteria
1. History of prior knee surgery or knee replacement. 2. Severe knee deformity (valgus \>20° or varus \>15°) or instability. 3. Severe contracture (\>25° flexion contracture). 4. Undergoing total knee revision surgery. 5. Rheumatoid arthritis diagnosis. 6. BMI \>35. 7. Neuromuscular disorders affecting knee stability or gait. 8. Pregnancy or lactation. 9. Presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions. 10. Active or recent severe infections or malignancy. 11. History of drug or alcohol abuse in the past six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. |
| Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. |
| Functional Improvement - SF-36 Health Survey | 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. |
| Pain Severity - Visual Analog Scale (VAS) | 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. |
| Prosthesis Positioning and Alignment | At baseline and 12 months post-surgery. | Radiographic evaluation will assess implant positioning and limb alignment. |
| Surgical Complication Rate | At 12 months post-surgery. | The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded. |
| Functional Improvement - Gait Analysis | 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. |
Countries
China
Outcome results
None listed