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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 12 - 12
12 Dec 2024
Langton D Bhalekar R Wells S Nargol M Natu S Nargol A Waller S Pabbruwe M Sidaginamale R
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Objectives

Several studies have reported elevated blood cobalt (Co) and chromium (Cr) concentrations in patients with total knee replacements (TKRs). Up to 44% of tissue samples taken from patients with failed TKRs exhibit histological evidence of metal sensitivity/ALVAL. In simulated conditions, metal particles contribute approximately 12% of total wear debris in TKR. We carried out this investigation to determine the source and quantity of metal release in TKRs.

Design and Methods

We analysed 225 explanted fixed-bearing TKRs (Attune, Genesis II, NexGen, PFC, and Vanguard) revised for any indication. These were analysed using peer-reviewed [coordinate measuring machine (CMM)] methodology to measure the volumetric wear of the polyethylene (PE) bearing surfaces and trays. The trays were analysed using 2D profilometry (surface roughness-Ra) and light microscopy. Histological and blood metal ion concentration analyses were performed in a sub-sample of patients.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 3 - 3
12 Dec 2024
Bhalekar R Wells S Nargol M Nargol A Waller S Wildberg L Sidaginamale R Langton DJ
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Objectives

Unicompartmental knee replacement (UKR) is a conservative option for degenerative disease, with mobile (Oxford UKR) and fixed bearing (Physica ZUK) the most commonly used devices. The primary reasons for revising UKRs include disease progression (36.9%), loosening (31.7%), and pain (7.5%). Loosening typically occurs due to osteolysis caused by wear particles from the polyethylene (PE) inserts. There is limited published literature which has quantified volumetric material loss from the PE inserts of cemented fixed-bearing UKRs. This study aimed to quantify bearing wear and backside deformation of these PE components.

Design and Methods

At our national retrieval centre, we measured changes volumetric bearing wear and backside deformation of 31 explanted fixed-bearing Physica ZUK UKR PE inserts using a peer-reviewed methodology based on coordinate measuring machine analysis. These explants had been revised for any indication [Females (19) and Males (12)]. The location of the wear scars was identified and mapped. We compared the volumetric wear from the bearing surface with contemporary total knee replacement (TKR) inserts.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 13 - 13
12 Dec 2024
Langton D Bhalekar R Wells S Nargol M Natu S Nargol A Waller S Pabbruwe M Sidaginamale R
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Objectives

We identified an unusual pattern of backside deformation on polyethylene (PE) inserts of contemporary total knee replacements (TKRs). The PE backside's margins were inferiorly deformed in TKRs with NexGen central-locking trays. This backside deformation was significantly associated with tray debonding. Furthermore, recent studies have shown high rate of tray debonding in PS NexGen TKRs. Subsequently, a field safety notice was issued regarding the performance of this particular device combination and the Option tray has been withdrawn from use. Therefore, we hypothesised that the backside deformation of PS inserts may be greater than that of CR inserts.

Design and Methods

At our national implant retrieval centre, we used peer-reviewed techniques to analyse changes in the bearing wear rate and backside surface deformation of NexGen PE inserts using coordinate measuring machines [N=84 (CR-43 and PS-41) TKRs with non-augmented-trays]. Multiple regression was used to determine which variable had the greatest influence on backside deformation. The amount of cement cover on trays was quantified as a %of the total surface using Image-J software.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 19 - 19
7 Aug 2023
Langton D Bhalekar R Wells S Nargol M Waller S Wildberg L Tilley S Nargol A
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Abstract

Introduction

At our national explant retrieval unit, we identified an unusual pattern of backside-deformation on polyethylene (PE) inserts of contemporary total-knee-replacements (TKRs). The PE backside's margins were inferiorly deformed in TKRs with central-locking trays. We reported that this backside-deformation appeared to be linked to tray debonding. Moreover, recent studies have shown high-rate of tray debonding in PS NexGen TKRs. Therefore, we hypothesised that backside deformation on PS inserts may be more than on CR inserts.

Methodology

We used peer-reviewed techniques to analyse changes in the bearing (wear rate) and backside surfaces (deformation) of PE inserts using coordinate measuring machines [N=61 NexGen (CR-39 and PS-22) TKRs with non-augmented-trays]. Multiple regression was used to determine which variable had the greatest influence on backside-deformation. The amount of cement cover on trays was quantified as a %of the total surface using Image-J software.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 14 - 14
7 Aug 2023
Langton D Bhalekar R Wells S Nargol M Haston S Natu S Nargol A
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Abstract

Introduction

Several studies have reported significant cobalt(Co) and chromium(Cr) elevations in the blood of patients with total-knee-replacements (TKRs), and histological signs of metal sensitivity have been reported in up to 44% of patients undergoing revision of their TKRs. We carried out this investigation to determine the source and quantity of metal release in TKRs.

Methodology

We identified all TKRs with polished CoCr trays (N=59) [Vanguard=29, Attune=4 and PFC=26]. These were analysed using peer-reviewed [coordinate-measuring-machine (CMM)] methodology to measure the volumetric wear of the polyethylene (PE) bearing surfaces and trays. The trays were analysed using 2D-profilometry (surface roughness-Ra) and 4D-microscopy. Histological and blood metal ion concentration analyses were performed.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 31 - 31
1 Apr 2022
Langton D Bhalekar R Joyce T Shyam N Nargol M Pabbruwe M Su E Nargol A
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Cobalt chrome alloy is commonly used in joint replacement surgery. However, it is recognised that some patients develop lymphocyte mediated delayed type hypersensitivity (DTH) responses to this material, which may result in extensive bone and soft tissue destruction.

Phase 1. United Kingdom: From an existing database, we identified extreme phenotype patient groups following metal on metal (MoM) hip resurfacing or THR: ALVAL with low wearing prostheses; ALVAL with high wear; no ALVAL with high wear; and asymptomatic patients with implants in situ for longer than ten years. Class I and II HLA genotype frequency distributions were compared between these patients’ groups, and in silico peptide binding studies were carried out using validated methodology.

Phase 2. United Kingdom: We expanded the study to include more patients, including those with intermediary phenotypes to test whether an algorithm could be developed incorporating “risk genotypes”, patient age, sex and metal exposure. This model was trained in phase 3.

Phase 3. United Kingdom, Australia, United States. Patients from other centres were invited to give DNA samples. The data set was split in two. 70% was used to develop machine learning models to predict failure secondary to DTH. The predictions were tested using the remaining blinded 30% of data, using time-dependent AUROCs, and integrated calibration index performance statistics.

A total of 606 DNA samples, from 397 males and 209 female patients, were typed. This included 176 from patients with failed prostheses, and 430 from asymptomatic patients at a mean of >10 years follow up. C-index and ROC(t) scores suggested a high degree of discrimination, whilst the IBS indicated good calibration and further backed up the indication of high discriminatory ability. At ten years, the weighted mean survival probability error was < 4%.

At present, there are no tests in widespread clinical use which use a patient's genetic profile to guide implant selection or inform post-operative management. The algorithm described herein may address this issue and we suggest that the application may not be restricted to the field of MoM hip arthroplasty.