Safety and efficacy of a novel knee prosthesis for knee arthroplasty: study protocol for a prospective, single-center, randomized, positive parallel controlled, non-inferiority, clinical trial

Abstract

Background and objectives: Total knee arthroplasty is the main treatment for end-stage knee disease. However, knee prostheses are mostly imported from overseas, making the price expensive. Furthermore, ethnic differences mean that these prostheses designed for Westerners are not designed to meet the needs of Orientals. According to the anatomical characteristics of the knee in Chinese subjects, Wuhan Yijiabao Biomaterial Co., Ltd. has developed a new knee prosthesis system. This system uses cobalt-chrome-molybdenum and high cross-linked polyethylene as the active friction interface, which has excellent wear resistance. This trial is designed to verify the efficacy and safety of this novel knee prosthesis in total knee arthroplasty in Chinese patients. Design: A prospective, single-center, randomized, positive parallel controlled, non-inferiority, clinical trial. Methods: Seventy-two patients at Taihe Hospital, Shiyan, China with knee disease who are scheduled to undergo knee arthroplasty will be equally randomized into the trial group or the control group using a randomized block design. The trial and control groups will undergo knee arthroplasty with knee prostheses purchased from Wuhan Yijiabao Biomaterial Co., Ltd., Wuhan, China (newly developed) and Beijing AKEC Medical Co., Ltd., Beijing, China (approved by the China Food and Drug Administration), respectively. All patients will be followed up for 12 months. Outcome measures: The primary outcome will be the recovery of knee function as assessed by the rate of excellent and good Hospital for Special Surgery knee scores at postoperative 12 months (± 15 days). The secondary outcomes will be: the morphology of the knee as revealed by anteroposterior and lateral radiographic views taken preoperatively, and at postoperative 2 weeks (± 5 days), 6 weeks (± 15 days), 3 months (± 15 days), 6 months (± 15 days), and 12 months (± 15 days); the incidence of adverse reactions at postoperative 2 weeks (± 5 days), 6 weeks (± 15 days), 3 months (± 15 days), 6 months (± 15 days), and 12 months (± 15 days); and the correlation between various types of adverse reactions and each knee prosthesis type. Discussion: This trial is designed to verify the efficacy and safety of knee prosthesis during total knee arthroplasty. Ethics and dissemination: The study protocol has been approved by the Ethics Committee of Taihe Hospital of Shiyan of China, approval number 2016(34). Participant recruitment began in February 2017 and will be finished in September 2017. Data analysis will be completed in November 2018. Results will be presented at national and international meetings and submitted for publication to peer-reviewed journals. Trial registration: ClinicalTrials.gov identifier: NCT03184129.