Knee osteoarthritis (KOA)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.age >=18 years, either sex, and scheduled to undergo bilateral TKA; 2.a confirmed diagnosis of primary, symptomatic bilateral knee osteoarthritis based on radiographic and clinical examinations, with fulfillment of the indications for total knee arthroplasty; 3.planned staged TKA at the same medical center, with both procedures performed by the same surgical team using the same surgical technique and prosthesis type; 4.provision of written informed consent;
Exclusion criteria
Exclusion criteria: 1.severe disorders of the spine, hip, or ankle joints; 2.inflammatory arthritis (e.g., rheumatoid arthritis), secondary arthritis (e.g., post-traumatic arthritis), or Charcot arthropathy; 3.neurologic disorders, such as diabetic peripheral neuropathy, Parkinson’s disease, and multiple sclerosis; 4.participants unable to communicate effectively because of a low educational level or language barriers; 5.a history of previous knee surgery; 6.chronic pain syndromes, including chronic headache, chronic low back pain, and fibromyalgia; 7.systemic inflammatory or autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus; 8.long-term use of opioids, sedative-hypnotics, or antidepressants; 9.alcohol dependence or withdrawal;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EQ-5D-3L scores 3 months after the second surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain scores during resting;Basic Activities of Daily Living;neurocognitive function;Adverse events;Consumption of analgesic drugs;Instrumental Activities of Daily Living;Oxford Knee Score;pain sensitization;EQ-5D-3L scores;depressive symptoms;Pain scores during exercise; | — |
Countries
China
Contacts
The Affiliated Hospital of Qingdao University