METHODS: The study was conducted between November 2006 to January 2012 in a tertiary health care center in Denmark. Patients with primary or secondary osteoarthritis were randomly assigned to receive a Magnum (MoM-LDH-THA) or a Recap (MoM-HR) prosthesis. Randomization was computer generated and allocation was concealed in an opaque envelope. Neither patients nor care provider were blinded. Primary outcome was Harris Hip Score at 5-years follow up.
RESULTS: Seventy-five were included and allocated to the MoM-LDH-THA (n = 39) and MoM-HR (n = 36) group. The study was prematurely stopped due to numerous reports of adverse events in patients with MoM hip replacements. Thirty-three in the MoM-LDH-THA and 25 in the MoM-HR group were available for primary outcome analysis. Median Harris Hip Score was 100 (IQR: 98-100) for MoM-LDH-THA and 100 (IQR: 93-100) for MoM-HR (p = 0.486). SF-36 score was high in both groups with no significant difference between groups.
CONCLUSIONS: Harris Hip Score and SF-36 score was excellent in both groups with no significant difference at 5-years follow up. Our findings suggest that there is no clinical important difference between the two prostheses implanted 5 years after implantation.
BACKGROUND: ClinicalTrials.gov, NCT04585022 , Registered 23 September 2020 - Retrospectively registered. This study was not prospectively registered in a clinical trial database since it was not an entirely implemented standard procedure in the international orthopedic society when the study was planned.