A prospective, randomized, single-blind, multicenter, noninferior clinical trial to evaluate the safety and efficacy of the PEEK knee prosthesis for total knee arthroplasty

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2021
INTERVENTION: Experimental group:PEEK knee prosthesis;Control group:Smith & Nephew knee prosthesis; CONDITION: FA20 /FA01 Rheumatoid arthritis/Osteoarthritis of the knee PRIMARY OUTCOME: KSS score''excellent rate''; SECONDARY OUTCOME: Success rate of postoperative imaging implantation;Prosthesis survival;Incidence of adverse events in total knee arthroplasty; INCLUSION CRITERIA: 1. Subjects aged 50‐80 years, and the gender is not limited. Young subjects should have urgent needs for surgery; 2. The subject's bones are mature; 3. The subject has indications for total knee replacement, such as: non‐inflammatory degenerative joint disease (such as osteoarthritis, traumatic arthritis or avascular necrosis); inflammatory degenerative joint disease (including rheumatoid arthritis); correction of functional deformities; 4. The affected limb on the test side is the first to receive total knee replacement; 5. Before surgery, subjects or guardians are willing and able to sign the informed consent.
Epistemonikos ID: 9295e7e4b533aa246c84514654c6e43c7fdbfd1b
First added on: Dec 20, 2022