Clinical Application and Evaluation of a New Combined Hip Prosthesis System: A Multicenter Randomized Controlled Non-inferiority Study

Abstract

Background: To evaluate the efficacy and safety of a new hip prosthetic system compared with the control group.Methods: A total of 140 patients (140 hips) who met the inclusion criteria in three clinical institutions were selected. The main outcome were to judge the excellent and good rate of Harris score in the experimental group and the control group 5 years after operation, and whether the lower limit of the 95% confidence interval of the difference between the two groups was greater than the non-inferior threshold (the non-inferior cutoff value was-10%). The secondary outcome were the comparison of Harris scores, the number of adverse events, safety test and evaluation, the results of X-ray films and the concise health status questionnaire (SF-36) between the two groups before operation and after operation.Results: During the 5-year follow-up, the excellent and good rates of Harris scores in the experimental group and the control group were 96.8% and 96.7% respectively, and the rate difference was 0.1%. The lower limit of the 95% confidence interval was -8.9%, which was greater than the non-inferiority boundary value (the non-inferiority boundary value was-10%). There was no significant difference in Harris score, adverse events, safety test, imaging, and SF-36 analysis between the two groups before operation and after operation.Conclusion: The new combined hip prosthesis system meets the requirements of clinical safety and effectiveness, and is worth popularizing in clinical application.Trial registration: researchregistry, researchregistry5771. Registered 1 July 2020 - Retrospectively registered. https://www.researchregistry.com/ researchregistry5771