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Does the use of the largest possible metal head increase the wear of vitamin E-doped cross-linked polyethylene? Two-year results from a randomized controlled trial

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@article{11cae9e42ca74b7dbb88ef92dffc631c,
title = "Does the use of the largest possible metal head increase the wear of vitamin E-doped cross-linked polyethylene?: Two-year results from a randomized controlled trial",
abstract = "AIMS: We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty.METHODS: In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes.RESULTS: At two years, 44 patients in each group were available for RSA assessment. The median total two-year proximal head penetration was -0.02 mm (IQR -0.09 to 0.07; p = 0.548) for the largest possible head and -0.01 mm (IQR -0.07 to 0.10; p = 0.525) for 32 mm heads. Their difference was not statistically significant (p = 0.323). Neither group demonstrated a bedding-in period. The median steady-state volumetric wear rates were 6.1 mm3/year (IQR -59 to 57) and 3.5 mm3/year (-21 to 34) respectively, and did not differ between the groups (p = 0.848). There were no statistically significant differences in periacetabular radiolucencies or patient-reported outcomes.CONCLUSION: The use of the largest possible metal head did not increase vitamin E-doped cross-linked polyethylene wear compared with 32 mm heads at two years. Linear wear was negligible and volumetric wear rates were very low in both head size groups. There was a tendency towards higher values of volumetric wear in large heads that warrants longer-term evaluation before any definite conclusions about the association between head size and wear can be drawn. Cite this article: Bone Joint J 2021;103-B(7):1206-1214.",
keywords = "Aged, Arthroplasty, Replacement, Hip/instrumentation, Chromium Alloys, Female, Hip Prosthesis, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Polyethylene/chemistry, Porosity, Prosthesis Design, Prosthesis Failure, Radiostereometric Analysis, Single-Blind Method, Surface Properties, Vitamin E/administration & dosage, Head, Arthroplasty, Bearing size, Hip, Vitamin E, Wear",
author = "Georgios Tsikandylakis and Mortensen, {Kristian R L} and Kirill Gromov and Maziar Mohaddes and Henrik Malchau and Anders Troelsen",
year = "2021",
month = jul,
doi = "10.1302/0301-620X.103B7.BJJ-2020-2064.R1",
language = "English",
volume = "103-B",
pages = "1206--1214",
journal = "Bone and Joint Journal",
issn = "2049-4394",
publisher = "British Editorial Society of Bone and Joint Surgery",
number = "7",

}

RIS

TY - JOUR

T1 - Does the use of the largest possible metal head increase the wear of vitamin E-doped cross-linked polyethylene?

T2 - Two-year results from a randomized controlled trial

AU - Tsikandylakis, Georgios

AU - Mortensen, Kristian R L

AU - Gromov, Kirill

AU - Mohaddes, Maziar

AU - Malchau, Henrik

AU - Troelsen, Anders

PY - 2021/7

Y1 - 2021/7

N2 - AIMS: We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty.METHODS: In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes.RESULTS: At two years, 44 patients in each group were available for RSA assessment. The median total two-year proximal head penetration was -0.02 mm (IQR -0.09 to 0.07; p = 0.548) for the largest possible head and -0.01 mm (IQR -0.07 to 0.10; p = 0.525) for 32 mm heads. Their difference was not statistically significant (p = 0.323). Neither group demonstrated a bedding-in period. The median steady-state volumetric wear rates were 6.1 mm3/year (IQR -59 to 57) and 3.5 mm3/year (-21 to 34) respectively, and did not differ between the groups (p = 0.848). There were no statistically significant differences in periacetabular radiolucencies or patient-reported outcomes.CONCLUSION: The use of the largest possible metal head did not increase vitamin E-doped cross-linked polyethylene wear compared with 32 mm heads at two years. Linear wear was negligible and volumetric wear rates were very low in both head size groups. There was a tendency towards higher values of volumetric wear in large heads that warrants longer-term evaluation before any definite conclusions about the association between head size and wear can be drawn. Cite this article: Bone Joint J 2021;103-B(7):1206-1214.

AB - AIMS: We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty.METHODS: In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes.RESULTS: At two years, 44 patients in each group were available for RSA assessment. The median total two-year proximal head penetration was -0.02 mm (IQR -0.09 to 0.07; p = 0.548) for the largest possible head and -0.01 mm (IQR -0.07 to 0.10; p = 0.525) for 32 mm heads. Their difference was not statistically significant (p = 0.323). Neither group demonstrated a bedding-in period. The median steady-state volumetric wear rates were 6.1 mm3/year (IQR -59 to 57) and 3.5 mm3/year (-21 to 34) respectively, and did not differ between the groups (p = 0.848). There were no statistically significant differences in periacetabular radiolucencies or patient-reported outcomes.CONCLUSION: The use of the largest possible metal head did not increase vitamin E-doped cross-linked polyethylene wear compared with 32 mm heads at two years. Linear wear was negligible and volumetric wear rates were very low in both head size groups. There was a tendency towards higher values of volumetric wear in large heads that warrants longer-term evaluation before any definite conclusions about the association between head size and wear can be drawn. Cite this article: Bone Joint J 2021;103-B(7):1206-1214.

KW - Aged

KW - Arthroplasty, Replacement, Hip/instrumentation

KW - Chromium Alloys

KW - Female

KW - Hip Prosthesis

KW - Humans

KW - Male

KW - Middle Aged

KW - Patient Reported Outcome Measures

KW - Polyethylene/chemistry

KW - Porosity

KW - Prosthesis Design

KW - Prosthesis Failure

KW - Radiostereometric Analysis

KW - Single-Blind Method

KW - Surface Properties

KW - Vitamin E/administration & dosage

KW - Head

KW - Arthroplasty

KW - Bearing size

KW - Hip

KW - Vitamin E

KW - Wear

UR - http://www.scopus.com/inward/record.url?scp=85110185348&partnerID=8YFLogxK

U2 - 10.1302/0301-620X.103B7.BJJ-2020-2064.R1

DO - 10.1302/0301-620X.103B7.BJJ-2020-2064.R1

M3 - Journal article

C2 - 34192938

VL - 103-B

SP - 1206

EP - 1214

JO - Bone and Joint Journal

JF - Bone and Joint Journal

SN - 2049-4394

IS - 7

ER -

ID: 66570487