Harris Hip Score and SF-36 following metal-on-metal total hip arthroplasty and hip resurfacing - a randomized controlled trial with 5-years follow up including 75 patients

Peter Nyby Hersnaes,Kirill Gromov,Peter Henrik Gebuhr,Anders Troelsen,Kristian Stahl Otte

doi:10.1186/s12891-021-04671-1

Peter Nyby Hersnaes, Kirill Gromov + Show 3 more

Open Access

https://doi.org/10.1186/s12891-021-04671-1

Copy DOI

Abstract

BackgroundThe metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions.The purpose was to compare Harris Hip Score and SF-36 at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM hip resurfacing (MoM-HR).MethodsThe 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.ResultsSeventy-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.ConclusionHarris 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.Trial registrationClinicalTrials.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.

Highlights

The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century
We aimed to investigate the possible differences in Harris Hip Score and SF-36 in patients following single brand MoM-Hip resurfacing (HR) or single brand MoM-LDH-Total hip arthroplasty (THA) as well as radiological findings, metal ion concentrations and rate of revision at 5-years follow up
Regarding secondary outcomes: 25 patients in the MoMLDH-THA group and 20 patients in the MoM hip resurfacing (MoM-HR) group were available for metal ion concentration analysis at 5-years follow up excluding bilateral MoM hip replacement, lost to follow up, revision or died before 5years follow up

Summary

Introduction

The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century. Reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions. During the start of the twenty-first century the use of metal-on-metal large-diameter-head total hip arthroplasty (MoM-LDH-THA) and metal-on-metal hip resurfacing (MoM-HR) increased rapidly. Reports in the 2010s raised concerns regarding association between elevated metal ion concentration in blood and locally as well as systemic complications in patients with MoM hip implants [5,6,7]. Local complications due to metal wear from MoM hip implants are broadly referred to as adverse reaction to metal debris (ARMD) and includes joint failures associated with pain, large sterile effusion of the hip and macroscopic metallosis [11]. Identifying risk factors associated with high metal ion concentrations in patients who have received a MoM hip implant as well as whether or not there is a medium to long term clinical difference between MoM implant designs is of great importance

Objectives

Methods

Results

Discussion

Conclusion