Osteoarthritis
Conditions
Interventions
Biological Fixation Group:None
Cement Fixation Group:None
Sponsors
Red Cross Hospital Affiliated to Xi 'an Jiaotong University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >50 and <80 years, regardless of sex. Younger patients were required to have a compelling clinical indication for surgery; 2. Patients with skeletal maturity; 3. The prosthesis was indicated for end-stage knee diseases, including osteoarthritis, post-traumatic arthritis, osteonecrosis, and inflammatory arthropathies (all diagnosed according to internationally recognized clinical, radiographic, and rheumatologic classification criteria), as well as deformity correction, reconstruction after failure of a partial knee prosthesis, and fractures not amenable to other treatment techniques requiring total knee arthroplasty; 4. The affected limb was undergoing primary total knee arthroplasty; 5. Prior to surgery, the participant or legal guardian was willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Neuromuscular dysfunction (e.g., paralysis, myolysis, or muscle weakness) that could lead to postoperative knee instability or abnormal gait; 2. Mental incapacity or inability to understand the requirements of study participation; 3. Alcoholism, drug addiction, or substance abuse; 4. Anticipated poor compliance; 5. Obesity (BMI > 35 kg/m^2); 6. Known hypersensitivity to one or more implant materials; 7. Active infection in the knee or elsewhere in the body; 8. Severe osteoporosis, metabolic bone disease, radiation-induced bone disease, or tumors around the knee; 9. Pregnant or breastfeeding women; 10. Frailty or inability to tolerate surgery due to other systemic diseases; 11. Comorbid conditions that could limit participation, impair follow-up compliance, or compromise the scientific integrity of the study; 12. Participation in other drug, biologic, or medical device clinical trials prior to enrollment without reaching the primary endpoint time frame; 13. Any other condition deemed by the investigator to make the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score (KSS) Excellent and Good Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee Society Score (KSS);Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score;Prosthesis Survival Rate;Radiographic Parameters on X-ray Plain Films; | — |
Countries
China
Contacts
Public ContactMa Jianbing
Red Cross Hospital Affiliated to Xi 'an Jiaotong University
Outcome results
None listed