Metal Ion Release With Large-Diameter Metal-on-Metal Hip Arthroplasty

doi:10.1016/j.arth.2009.12.013

The Journal of Arthroplasty

Volume 26, Issue 2, February 2011, Pages 282-288

https://doi.org/10.1016/j.arth.2009.12.013 Get rights and content

Abstract

Preoperative and postoperative ion concentrations were measured in 29 metal-on-metal, large-diameter head total hip arthroplasty (LDH-THA) patients. Mean chromium, cobalt (Co), and titanium levels from LDH-THA were 1.3, 2.2, and 2.7 μg/L at 12 months. The open femoral head design showed significantly higher Co concentrations than the closed design (3.0 vs 1.8 μg/L, P = .037). Compared with previously published ion levels from a hip resurfacing system presenting the same bearing characteristics, Co levels were significantly higher in LDH-THA (2.2 vs 0.7 μg/L, P < .001). This study has demonstrated that the addition of a sleeve with modular junctions and an open femoral head design of LDH-THA causes more Co release than bearing surface wear (157% and 67%, respectively). Even if no pathologic metal ion threshold level has been determined, efforts should be made to minimize its release. We recommend modification or abandonment of the modular junction and femoral head open design for this specific LDH-THA system.

Section snippets

Patient Cohort

Subjects with unilateral degenerative hip joint disease in whom a LDH-THA was planned (LDH Durom; Zimmer, Warsaw, Ind) were asked to participate in the study (date of surgery between August 2005 and December 2007). Twenty-nine patients accepted to be study subjects. The exclusion criteria were the presence of other metallic implants (ie, other joint arthroplasty, internal fixation device), renal insufficiency, and known cutaneous metal allergy. The reasons for incomplete data were late change

LDH-THA Results

Preoperative and postoperative Cr, Co, and Ti concentrations in whole blood are summarized in Table 2 and Fig. 3. Significant increases in Cr, Co, and Ti were found at all postoperative evaluations (P ≤ .001) when compared with preoperative levels. Between the 6-month and 12-month follow-up, no significant variation in Cr, Co, and Ti concentrations occurred (P = .644, P = .229, and P = .511). At 1 year, Cr levels were 1.9 times higher than preoperative values and rose by a factor of 20.1 for Co

Discussion

Metal ion evaluation in the postoperative period serves as an indicator of bearing performance and is also important in determining device safety. Nevertheless, Co, Cr, and Ti threshold levels, which can be correlated to clinical complications, have not been established; so increased levels can only be regarded as theoretical concerns 44, 45. In this study, LDH-THA presented elevated Cr, Co, and Ti blood levels at all postoperative evaluations (P ≤ .001) when compared with preoperative data.

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Cited by (105)

Markers of hip implant degradation: analytical considerations and clinical interpretation
2023, Biomarkers of Hip Implant Function
The wear and corrosion of hip implants release metallic debris into the periprosthetic tissue and bloodstream, increasing the levels of metal ions in the patient’s blood and urine. Measurement of systemic metal concentrations can be used to assess the performance of metal-on-metal bearings, reveal abnormal wear, identify defective implants, and estimate the risk of local adverse reactions to metal debris. The choice of specimen type, sampling protocol, sample preparation technique, and analytical methodology can heavily influence the reliability and clinical interpretation of the results and needs to be carefully considered. In this chapter, we summarise the most important implant degradation mechanisms and discuss the pre- and post-analytical challenges associated with the determination of cobalt, chromium, and titanium levels in patients with hip implants, with a focus on how the results can guide clinical management.
Influence of beam power on the surface architecture and corrosion behavior of electron-beam treated Co-Cr-Mo alloys
2021, Nuclear Instruments and Methods in Physics Research, Section B: Beam Interactions with Materials and Atoms
We present results of the influence of the electron beam power on the structure, surface roughness, and corrosion of electron-beam surface-treated Co-Cr-Mo alloys. The structure of the samples is characterized using X-ray diffraction (XRD), Scanning Electron Microscopy (SEM), and energy-dispersive X-ray spectroscopy (EDX). Atomic force microscopy (AFM) is used for the evaluation of the surface topography. The corrosion resistance is studied by an electrochemical test. The EBST process leads to a transformation in the phase composition, from a double-phase structure of ε and γ to a single-phase gamma structure. Higher values of the beam power lead to the elimination of pores and other structural defects, as well as a formation of preferred crystallographic orientation. The EBST causes a slight increase in the surface roughness and significantly more symmetrical surface topography. Also, the corrosion resistance was greatly improved after electron-beam surface treatment with higher values of the electron beam power.
Catastrophic failure of femoral stem modular junction when combined with metal-on-metal bearing in comparison to ceramic-on-ceramic: A retrospective cohort study
2021, Revue de Chirurgie Orthopedique et Traumatologique
Le relargage d’ions métalliques par les couples de frottement métal-métal (M-M) ou les jonctions modulaires tête-col des prothèses totales de hanche (PTH) sont reconnus comme une cause majeure de réaction indésirable aux débris métalliques (RIDM). Aucune étude n’a à ce jour comparé les effets de ces couples de friction sur les concentrations sanguines d’ions métalliques et les taux de RIDM lorsque combinés avec une tige fémorale à col modulaire. Ainsi, nous avons réalisé une étude comparant un groupe de prothèses M-M et céramique-sur-céramique (C-C) implantées avec une tige non-cimentée à col modulaire afin : (1) d’évaluer la différence dans le relargage d’ions métalliques (2) de comparer les taux de RIDM et de révision et (3) de comparer les scores HOOS et de Harris.
Les niveaux d’ions métalliques et les taux de complications seront plus élevés dans le groupe M-M.
Trente hanches ont reçu la même tige fémorale courte avec col modulaire en alliage de cobalt-chrome (CoCr). Dix-sept ont reçu des surfaces de frottement C-C (36 mm) et 13 une articulation de grand diamètre (GD) M-M (moyenne 50 mm, 44–54 mm). Les deux groupes ont eu leurs niveaux sanguins de Co et Cr mesurés au dernier suivi ou avant la chirurgie de révision (si applicable) et ont été comparés à 41 individus témoins sans implants. Les RIDM, taux de révision et autres complications ont été recensées. Les résultats fonctionnels entre les groupes ont été comparés avec les scores HOOS et Harris Hip.
Les concentrations sanguines moyennes de Co et Cr étaient significativement plus élevées dans le groupe M-M (p < 0,001 pour Co et Cr) : 12,7 μg/L (2,5–40,7) versus 1,9 μg/L (0,1–10,6) pour le Co et 8,2 μg/L (2,8–40,6) versus 1,2 μg/L (0,2–4,6) pour le Cr. Le groupe M-M a eu un taux de révision de 9/13 (69 %) associé à des RIDM avec une corrosion de la jonction tige-col dans tous les cas. En comparaison, le groupe C-C n’a eu aucune révision (p < 0,001) Les résultats fonctionnels au dernier suivi n’étaient pas statistiquement différents entre les groupes Harris : C-C = 94,1 ± 8,4 vs. M-M 91,8 ± 14,8 (p = 0,22) et HOOS : C-C 90,2 ± 10,7 vs. M-M 75,6 ± 21,7 (p = 0,08).
Dans notre étude, les tiges à col modulaire CoCr associées avec une articulation M-M ont présenté un problème de corrosion de la jonction modulaire se manifestant par des niveaux d’ions métalliques Cr et Co systémiques significativement plus élevés que les mêmes tiges en association avec un couple C-C. Pour les PTH modulaires avec couple M-M la corrosion de la jonction modulaire fut associée à un taux de révisions liées à la RIDM dramatique, avec corrosion à la jonction tige-col présente systématiquement. Des travaux seraient nécessaires pour comprendre les effets des couples de friction M-M sur la jonction tige-col et les mécanismes de corrosion associés.
III ; étude comparative cas témoin.
Catastrophic failure of femoral stem modular junction when combined with metal-on-metal bearing in comparison to ceramic-on-ceramic: A retrospective cohort study
2021, Orthopaedics and Traumatology: Surgery and Research
Metal ion release from total hip arthroplasty's (THA) metal-on-metal (MoM) bearing surfaces or head-neck modular junction (trunnionosis) has been identified as a major cause of adverse reaction to metal debris (ARMD). No study has compared the effects of these bearing couples when combined with modular neck femoral stems (MNFS) (i.e. did a modular CoCr have a higher effect than large MoM bearings on whole blood ion concentrations and ARMD). Therefore we did a retrospective comparative analysis of prospectively collected data aiming to: (1) assess the difference in metal ion release between a group of MoM and CoC bearings implanted with a non-cemented MNFS; (2) compare the ARMD and the related revision rates between the two bearing types; (3) compare the patients’ HOOS and Harris Hip scores.
Metal ion levels and complications rate will be higher in MoM group.
Thirty hips received the same short MNFS with modular CoCr. Seventeen had CoC bearing (16 = 36 mm) and 13 large diameter head (LDH) MoM bearing (mean = 50 mm, 44-54 mm) Both groups had whole blood Cobalt (Co) and Chromium (Cr) concentrations measurements at last follow up or before revision surgery (if any) and were compared to 41 control individuals without implants. ARMD, revision rates and other complications were censed. Functional outcome differences between operative groups were assessed with HOOS and Harris Hip scores.
Mean whole blood Co and Cr were 1.9 μg/L (0.1–10.6 min–max) and 1.2 μg/L (0.2–4.6 min–max) in the CoC group and 12.7 μg/L (2.5–40.7 min–max) and 8.2 μg/L (2.8–40.6 min–max) for MoM group. Controls presented whole blood Co and Cr levels of 0.2 μg/L (0.04–0.2 min–max) and 0.6 μg/L (0.1–0.7 min–max) respectively. CoC had significantly higher whole blood metal ion concentrations than controls, while MoM had significantly higher concentrations than both (p < 0.001). MoM had a 9/13 (69%) revision rate due to ARMD (with stem-neck junction corrosion and wear were present in all cases) while the CoC had none. Functional scores at last follow up did not statistically differ between groups (Harris: CoC = 94.1 ± 8.4 vs MoM 91.8 ± 14.8 (p = 0.22) and CoC HOOS 90.2 ± 10.7 vs 75.6 ± 21.7 (p = 0.08)).
In our study, MNFS with CoCr modular neck released metal ion systemically, as shown in CoC THAs, but when combined with MoM LDH bearings, that elevation was significantly higher. In MNFS MoM, these high metal ion levels translated into a dramatic ARMD related revision rate where stem-neck junction corrosion and wear were present in all cases. More research is required to understand the effects of MoM bearing on neck-stem junctions, and its mechanisms of corrosion.
III; retrospective comparative study.
No radiological and biological sign of trunnionosis with large diameter head ceramic bearing total hip arthroplasty after 5 years
2021, Revue de Chirurgie Orthopedique et Traumatologique
La « trunnionite » de la prothèse totale de la hanche (PTH) avec couple métal sur métal avec tête de grand diamètre (TGD) a été liée à des taux systémiques élevés d’ions chrome (Cr) et cobalt (Co) et à des réactions indésirables aux débris métalliques (RIDM). L’innocuité de la PTH composée d' une TGD, d’un couple céramique (CoC) et une tige fémorale en titane (Ti) n’est pas encore validée à moyen terme. Cette étude avait pour but de déterminer : 1) si le taux sanguin d’ions Ti des patients porteurs d’une PTH TGD CoC après un minimum de 5 ans de suivi se situe dans les valeurs attendues pour une PTH en Ti similaire, 2) si le taux de Ti augmente significativement dans le temps ; ce qui suggérerait un usure de la jonction modulaire tête-col, 3) si des manifestations cliniques ou radiographiques de dysfonctionnement de l’implant sont présentes.
Les taux sanguins de Ti d’une PTH TGD CoC reflètent indirectement la corrosion passive des implants et sont stables dans le temps.
Nous rapportons les taux sanguins de Ti, Cr et Co à 5 ans minimum de 57 patients ayant une PTH TGD CoC primaire unilatérale avec des tailles de tête allant de 36 à 48 mm et une tige fémorale ainsi qu’un composant acétabulaire en Ti. Chez 25 patients, une mesure antérieure (1–3 ans) du taux d’ions Ti était disponible et fut comparée à leurs derniers résultats de suivi (> 5 ans) afin de détecter une éventuelle modification dans le temps. Il est admis que le taux moyen de Ti dans les PTHs en Ti asymptomatiques est d’environ 2,0 μg/L et nous avons établi un seuil de sécurité à 10 μg/L.
Au suivi moyen de 79 mois, le taux moyen de Ti était de 1,9 μg/L (1,2–4,4) et tous les sujets avaient des valeurs inférieures au seuil de sécurité de 10 μg/L. Dans le sous-groupe de 25 cas ayant fait l’objet d’une mesure antérieure, nous avons constaté une diminution des taux moyens de Ti entre 20 mois et 78 mois de suivi (2,2 μg/L [1,6–3,9] contre 2,0 μg/L [1,4–2,8], p = 0,007). Au dernier recul, aucune relation statistiquement significative n’a été observée entre le taux de Ti et le diamètre du couple de frottement (ρ = 0,046, p = 0,0734) ou la présence ou non d’un manchon adaptateur en Ti (p = 0,454) : 1,94 μg/L (1,20–2,80) avec, contre 1,90 μg/L (1,20–4,40) sans. Au dernier suivi, aucun patient n’a présenté de signe d’ostéolyse radiographique, ni de signe de RIDM ou n’a été réopéré. La plupart des patients présentaient des résultats cliniques excellents, 98 % d’entre eux ayant signalé une limitation fonctionnelle mineure (29 %) ou nulle (69 %) et 44 % percevaientt leur PTH comme une articulation naturelle. Trois patients (3/57, 5 %) ont présenté un grincement temporaire et 18/57 (31 %) ont signalé un cliquetis.
Avec la PTH TGD CoC testée, les taux de Ti sanguins étaient faibles et secondaires à la corrosion passive inévitable et sans issue des surfaces de l’implant. La mesure à moyen terme du Ti chez les sujets porteurs d’une PTH TGD CoC n’a révélé aucun signe indirect de « trunnionite ».
IV, étude rétrospective.
No radiological and biological sign of trunnionosis with Large Diameter Head Ceramic Bearing Total Hip Arthroplasty after 5 years
2021, Orthopaedics and Traumatology: Surgery and Research
Citation Excerpt :
Moreover, none of our subject had value above 10 ug/L which could be seen as a safety threshold below what no adverse reaction is expected) [18]. According to our second objective, it is known that modular junction wear and corrosion is a continuous and progressive process starting early after implantation [4,28]. So assessing ion level modification over time is a good way to identify a problematic implant [18].
Trunnionosis of large diameter (LDH) metal-on-metal total hip arthroplasty (THA) was linked to high systemic chromium (Cr) and cobalt (Co) ion levels and local adverse reactions to metal debris (ARMD). The safety of CoC LDH THA is not yet available at mid-term. Measuring whole blood Ti level of ceramic on ceramic (CoC) LDH THA with a titanium (Ti) stem is an indirect way to assess the performance of its head-neck taper modular junction. Therefore, we wanted to determine: (1) if the whole blood Ti ion levels in patients with LDH CoC THA after a minimum of 5 years of implantation is within the expected values for similar well performing Ti THA, (2) if Ti level scientifically increases over time, which would suggest the presence of a progressive modular head/neck junction wear process, (3) if clinical or radiographical manifestations of implant dysfunction are present?
Ti blood levels of LDH CoC THA will indirectly reflect the expected levels due to passive corrosion of the implants and will be stable over time.
We report the whole blood Ti, Cr, and Co levels at 5 years minimum for 57 patients with unilateral primary LDH CoC THA with head sizes ranging from 36 to 48 mm using Ti stem and acetabular component. To compare Ti ion levels modification over time, in 25 patients were a previous measurement (1–3 years) was available, we compared it to their last follow-up results (> 5 years). Mean Ti level in well performing Ti THAs is recognized to be around 2.0 ug/L. Although, there are no universally accepted Ti levels associated with problematic implant, we used safety threshold of 10 ug/L. Clinical and radiological outcomes were recorded at last follow-up.
At 79 months mean follow-up, all mean Ti levels were 1.9 μg/L (min 1.2, max 4.4) and all subject had values below the safety threshold of 10 ug/L. In the subgroup of 25 cases with a previous measurement, there was a decrease in mean Ti levels between 20 months and 78 months follow-up (2.2 μg/L (1.6–3.9) versus 2.0 μg/L (1.4–2.8), p = 0.007). No statistically significant relation was observed between Ti level at last FU and bearing diameter (rho = 0.046, p = 0.0734) or the presence or absence of a Ti adaptor sleeve (p = 0.454): 1.94 ug/L (min 1.20, max 2.80) versus 1.90 ug/L (min 1.20, max 4.40). At last follow up, no patients presented osteolysis signs on radiographs, clinical signs of ARMD or were reoperated. Most patients had excellent clinical with 98% of them reporting minor (29%) or no functional limitation (69%) and 44% perceive their THA as a natural hip joint. However, 3/57patients (5%) temporarily experienced hip squeaking and 18/57 (31%) reported clicking sound.
With the tested LDH CoC THA, Ti levels were low and related the uneventful and unavoidable passive corrosion of implant surfaces. Mid-term measurement of Ti in subjects with LDH CoC did not reveal any indirect signs of trunnionosis, which should already be observable by this time.
IV, retrospective study.

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Metal Ion Release With Large-Diameter Metal-on-Metal Hip Arthroplasty

Abstract

Section snippets

Patient Cohort

LDH-THA Results

Discussion

Rev Chir Orthop Reparatrice Appar Mot

J Arthroplasty

J Orthop Res

J Arthroplasty

J Arthroplasty

J Arthroplasty

Orthop Clin North Am

J Orthop Res

J Arthroplasty

J Arthroplasty

J Arthroplasty

J Arthroplasty

Rev Chir Orthop Reparatrice Appar Mot

J Arthroplasty

J Arthroplasty

J Arthroplasty

J Arthroplasty

Experience with the Metasul total hip bearing system

Clin Orthop

Analysis of 118 second-generation metal-on-metal retrieved hip implants

J Bone Joint Surg Br

Serum cobalt levels after metal-on-metal total hip arthroplasty

J Bone Joint Surg Am

The effectiveness of metal on metal hip resurfacing: a systematic review of the available evidence published before 2002

BMC Health Serv Res

The relationship between activity and ions in patients with metal-on-metal bearing hip prostheses

J Bone Joint Surg Am

Metal-on-metal: articulations for the new millennium

Instr Course Lect

Metal-on-metal versus polyethylene in hip arthroplasty: a randomized clinical trial

Clin Orthop

Metal degradation products: a cause for concern in metal-metal bearings?

Clin Orthop Relat Res