Methods
comprehension disorders, ischemic osteonecrosis, alcoholism, neuromuscular insufficiency, traumatic arthritis, drug abuse, substance abuse
RHEUMATOID ARTHRITIS, OSTEOARTHRITIS
From June 2021 to December 2022, a prospective randomized clinical trial was conducted at Honghui Hospital affiliated to Xi'An Jiaotong University to investigate the safety and efficacy of PEEK knee prostheses for TKA. The study was approved by the local ethics committee (NO. 2021-008-001) and registered at Chinese Clinical Trial Registry (ChiCTR2100047563) in accordance with the Helsinki Declaration. All patients provided written consent prior to enrollment.Patients in the age range of 50–80 years who met the inclusion criteria and were planned for elective primary TKA were enrolled in this study. The inclusion criteria were clinical diagnosis of osteoarthritis, rheumatoid arthritis, traumatic arthritis, or ischemic osteonecrosis. The exclusion criteria were neuromuscular insufficiency, comprehension disorders, alcoholism, drug abuse, substance abuse, BMI > 35 kg/mIn this study, patients were block randomized using sealed envelopes to ensure unbiased allocation into two groups: PEEK knee implants (PEEK group) and CoCrMo knee implants (CoCrMo group). The envelopes were opened in the presence of the surgeon, just before surgery in the operating theater. The patients were kept unaware of the group to which they had been allocated, in order to avoid any potential biases.