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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_3 | Pages 78 - 78
23 Feb 2023
Bolam S Tay M Zaidi F Sidaginamale R Hanlon M Munro J Monk A
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The introduction of robotics for total knee arthroplasty (TKA) into the operating theatre is often associated with a learning curve and is potentially associated with additional complications. The purpose of this study was to determine the learning curve of robotic-assisted (RA) TKA within a multi-surgeon team.

This prospective cohort study included 83 consecutive conventional jig-based TKAs compared with 53 RA TKAs using the Robotic Surgical Assistant (ROSA) system (Zimmer Biomet, Warsaw, Indiana, USA) for knee osteoarthritis performed by three high-volume (> 100 TKA per year) orthopaedic surgeons. Baseline characteristics including age, BMI, sex and pre-operative Kellgren-Lawrence grade were well-matched between the conventional and RA TKA groups. Cumulative summation (CUSUM) analysis was used to assess learning curves for operative times for each surgeon. Peri-operative and delayed complications were reviewed.

The CUSUM analysis for operative time demonstrated an inflexion point after 5, 6 and 15 cases for each of the three surgeons, or 8.7 cases on average. There were no significant differences (p = 0.53) in operative times between the RA TKA learning (before inflexion point) and proficiency (after inflexion point) phases. Similarly, the operative times of the RA TKA group did not differ significantly (p = 0.92) from the conventional TKA group. There was no discernible learning curve for the accuracy of component planning using the RA TKA system. The average length of post-operative follow-up was 21.3 ± 9.0 months. There was no significant difference (p > 0.99) in post-operative complication rates between the groups.

The introduction of the RA TKA system was associated with a learning curve for operative time of 8.7 cases. Operative times between the RA TKA and conventional TKA group were similar. The short learning curve implies this RA TKA system can be adopted relatively quickly into a surgical team with minimal risks to patients.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_6 | Pages 25 - 25
1 May 2019
Langton D Sidaginamale R Wells S Wainwright B Holland J Deehan D Joyce T Jafri A Nargol A Natu S
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Introduction

We aimed to identify genes associated with the development of ALVAL at relatively low levels of wear.

Methods

At our unit all patients undergoing revision of a MoM hip prosthesis have periprosthetic tissue samples graded for ALVAL. Explants undergo volumetric wear testing of the bearing and taper surfaces. We identified patients with moderate/severe ALVAL who had been exposed to lower than the median wear rate of all recorded patients who had developed ALVAL (<3mm3/year). This was termed the “ALVAL” group. We then identified all patients whose tissues had shown no signs of ALVAL. The patients in the two groups were sent buccal DNA collection kits. DNA was examined using next generation sequencing. Alleleic frequencies in the two groups were compared using Fisher's test and compared to a background UK population group (n=8514). We then conducted binary logistic regression with patient age, sex, primary source of debris (taper/bearing) and HLA genotype as the predictors. With the hypothesis that a cobalt/albumin metalloprotein acts as the epitope, we used validated binding prediction software to determine the relative affinities of the binding grooves created by different DQA1/DQB1 genetic combinations for albumin derived peptides. Given the protection that male sex and younger age appears to confer against ALVAL, we hypothesized that testosterone peptides may compete for these binding sites.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 7 - 7
1 Jun 2016
Sidaginamale R O'Hare J Natu S Joyce T Lord J Nargol A Langton D
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Background

Some reports have suggested that debris generated from the head neck taper junction is more destructive than equivalent doses from metal bearing surfaces.

Methods

Part 1. We examined the relationship between the source (taper/bearing) and volume of metal debris on Cr and Co concentrations in corresponding blood and hip synovial fluid samples and the observed agglomerated particle sizes in excised tissues using regression analysis of prospectively collected data at a single revision unit. Part 2. We investigated variables most strongly associated with macroscopic soft tissue injury as documented at revision surgery using ordinal logistic regression. Independent variables included source and volume of CoCr exposure, Cr and Co joint fluid concentrations, joint fluid grade, ALVAL (Aseptic Lymphocytic Vasculitis Associated Lesion) grade, presence of vascular hyalinisation, agglomerated particle size, implant type, patient sex and age.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 5 - 5
1 Nov 2015
Langton D Killen M Sidaginamale R Bowsher J Savisaar C Nargol A Joyce T Lord J
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Introduction

In this study, we aimed to investigate the effect of the topography of the female taper surface on taper wear.

Patients/Materials & Methods

We measured volumetric material loss at the female taper surface of the first consecutive 36mm MoM hips received at our centre. The MoM hips were from a single manufacturer and possessed matching: head size (36mm); taper geometry (5.65 degree 12 14 tapers); and metallurgy (cobalt chrome female taper mated with a titanium stem). Volume loss was measured with a coordinate measuring machine using validated methods. Surface roughness was measured using a Surftest SJ400. There were 111 head tapers available for analysis. The majority had been revised secondary to ARMD, and a minority for loosening. The mean duration of implantation was 56 months. Volumetric wear values were log normalised in order to construct a multiple regression model to investigate the interaction of head offset, the head taper angle and the Rp value of the female taper surface. Rp is a roughness parameter, which is a measure of the peaks above the plateau of a surface.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 28 - 28
1 Jan 2013
Langton D Sidaginamale R Lord J Joyce T Natu S Nargol A
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Background

Previous studies have suggested that the modular junction of metal on metal (MoM) total hip replacements (THR) is an important source of metallic debris.

Methods

We carried out a prospective study using custom techniques to analyse one of the largest collections of failed contemporary MoM devices in the world. All explants from patients who had suffered adverse reactions to metal debris (ARMD) were included in this study. These explants included: 82 36mm THRs, and 147 resurfacing head THRs and 140 resurfacing arthroplasties from several manufactures. Volumetric wear analysis of the bearing surfaces and taper junctions was carried out using a coordinate measuring machine. The relationships between total metallic loss and metal ion concentrations and the macroscopic and histological tissue appearance of THR patients were compared to those in resurfacing patients. Mann Whitney test for non-parametric data was used to assess significant differences between groups.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 29 - 29
1 Jan 2013
Sidaginamale R Langton D Lord J Joyce T Nargol A
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Background

We have previously described the relationship between wear rates of MOM components and soft tissue necrosis. In this study we investigated the link between wear rates, metal ion concentrations and osteolysis.

Methods

All unilateral patients who underwent revision of hip resurfacings at our centre were included. Retrieved components were analysed using a coordinate measuring machine to determine total volumetric material loss and rates of wear. Given the accuracy of the wear calculations (which we have previously published), wear rates were considered “abnormal” if ≥3mm3/yr. ROC curves were constructed to determine a Co concentration which would be clinically useful to detect abnormal wear. During revision, the presence/absence of osteolysis was documented.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 7 - 7
1 Sep 2012
Gandhi J Sidaginamale R Mereddy P Langton D Joyce T Lord J Natu S Nargol A
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Background

The failure and subsequent withdrawal of the ASR device in both its resurfacing and THR form has been well documented. The National Joint Registry report of 2010 quoted figures of 12–13% failure at five years. Adverse reaction to metal debris (ARMD) is a poorly understood condition and patients developing severe metal reactions may go unrecognised for sometime.

Patients and Methods

In 2004 a single surgeons prospective study of the ASR bearing surface was undertaken. We present the ARMD failure rates of the ASR resurfacing and ASR THR systems. The diagnosis of ARMD was made by the senior author and was based on clinical history, examination, ultrasound findings, metal ion analysis of blood and joint fluid, operative findings and histopathological analysis of tissues retrieved at revision. Mean follow up was 52 months (24–81) and 70 patients were beyond 6 years of the procedure at the time of writing. Kaplan Meier survival analysis was carried out firstly with joints designated “failure” if the patient had undergone revision surgery or if the patient had been listed. A second survival analysis was carried out with a failure defined as a serum cobalt > 7µg/L. Full explant analysis was carried out for retrieved prostheses.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 8 - 8
1 Sep 2012
Mereddy P Sidaginamale R Gandhi J Langton D Logishetty R Cooke N Nargol A
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Introduction

Adverse reaction to metal debris (ARMD) is an increasingly recognised complication of metal-on-metal hip arthroplasty. A previous study described poor results following revision and recommended early intervention1. We determined the outcome of revision for ARMD and present the largest case series to date.

Methods

Between 2005 and 2010, 98 patients (101 hips) underwent revision for ARMD. The diagnosis of ARMD was based on clinical history, examination, appearance at revision and histology. Patients were reviewed at 3, 6 and 12 months and annually thereafter. Patient satisfaction, Harris hip scores (HHS) and metal ions were analysed.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 3 - 3
1 Sep 2012
Langton D Ghandi J Sidaginamale R Mereddy P Joyce T Lord J Natu S Nargol A
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Introduction

We conducted independent wear analysis of retrieved metal on metal (MoM) hip components from around the world. All patients with resurfaced hips who developed adverse reactions to metal debris (ARMD) were found to have increased wear of the bearing surfaces. This was untrue in patients with large diameter (?36mm) MoM total hip replacements. This led us to search for other factors leading to ARMD.

Methods

MoM THR explants retrieved from 78 patients suffering ARMD underwent full volumetric wear analysis of bearing surface and taper-junctions using coordinate measuring machine. Scanning electron microscopy (SEM) used to characterise material composition of specific areas.


Bone & Joint Research
Vol. 1, Issue 4 | Pages 56 - 63
1 Apr 2012
Langton DJ Sidaginamale R Lord JK Nargol AVF Joyce TJ

Objectives

An ongoing prospective study to investigate failing metal-on-metal hip prostheses was commenced at our centre in 2008. We report on the results of the analysis of the first consecutive 126 failed mated total hip prostheses from a single manufacturer.

Methods

Analysis was carried out using highly accurate coordinate measuring to calculate volumetric and linear rates of the articular bearing surfaces and also the surfaces of the taper junctions. The relationship between taper wear rates and a number of variables, including bearing diameter and orientation of the acetabular component, was investigated.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 398 - 398
1 Jul 2010
Sidaginamale R Leggetter P Bali N Pynsent P Dunlop D
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Introduction: The senior author undertakes single stage revision hip arthroplasty for cases with no preoperative evidence of infection based on history and examination, ESR and CRP results and negative results from selective aspirations. Despite this a large proportion of intra-operative samples are positive for infection. The purpose of our study is to look at the results of intra-operative histology and microbiology samples in these cases and to assess the subsequent incidence of infection.

Methods: Retrospective case study comprising of 230 single stage revision total hip arthroplasties carried out by a single surgeon over 5 year period (2003–2008). Intra-operatively tissue samples were taken from multiple sites and sent for both histology and microbiology. Microbiology results were reported at 24hrs, 48hrs, 7 days and 21 days and correlated with histology reports.

Results: From a total number of 230 patients, we had 98 left and 132 right hip revision arthroplasties. There were 95 men and 135 women with a mean age of 73 years (range 40–93). Intra-operative microbiology was negative in 108 patients (46.95%), of which 3 patients’ histology samples were consistent with infection. Of the 122 microbiology positive patients (53.04%), there were 8 histology samples consistent with infection. The most frequent growths were of Coagulase negative Staphylococcus (64 cases) and Propionibacterium (18 cases). 3 cases subsequently developed deep infection.

Discussion: This study highlights a significant discrepancy between intra-operative microbiology and intra-operative histology results. There is also a very high discrepancy between pre-operative assessment and intra-operative microbiological findings although the majority of cases subsequently did not show any clinical evidence of infection.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 395 - 395
1 Jul 2010
Bali N Leggetter P Sidaginamale R Pynsent P Dunlop D Pearson A
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Introduction: The Corail stem is a well proven femoral implant used for the past 22 years. It is the most common uncemented femoral stem used for total hip replacements in the UK. The stem was modified in 2004 with an increased neck taper to allow for an increased range of bearings and modular heads. This study reviews a series of primary total hip replacements using this recently modified Corail stem to assess if this implant is still performing to acceptable standards.

Method: A prospective patient database collated by 2 arthroplasty surgeons recorded data at the time of operation and subsequent follow up. All intra-operative and post-operative complications were recorded. Pre and postoperative oxford hip scores were analysed.

Results: 751 cases were reviewed. The average age was 63 with females accounting for 69%. The pinnacle cup was used in 83% of cases, with a polyethylene bearing in 48%. Survival of the stem at 3 years was 99.9% (1 periprosthetic fracture following a fall), the cup 99.6%, with overall survival of 99.5%. The most common intra operative complication was calcar fracture occurring in 0.9%. Dislocation occurred in 0.5%, subsidence in 0.3%, deep infection in 0.1% and leg length discrepancy requiring shoe raise in 0.1%. Average 3 year oxford hip score was 12.

Discussion: 3 year survival of both the femoral stem and the total hip replacement are above the quoted rates in the National Joint Registry’s 4th annual report for corail and uncemented stems (98.8% and 98.1% respectively), and also exceeds that of cemented stems (99.1%). The same report quotes similar rates of calcar fractures (0.8%), although we recorded no other perioperative complications. We conclude the new generation of Corail stem has excellent 3 year performance.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 420 - 420
1 Sep 2009
Amanan S Gella S Sidaginamale R Tillu A Parekh S
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Nerve blocks are a common form of peri-operative analgesia that is administered for patients undergoing joint Replacement surgeries. The long term sequel following these peripheral nerve blocks used in total knee replacement not reported in the literature. Nerve blocks given under the guidance of nerve stimulators are in practice in most of the hospitals and are considered safe.

We report a series of two cases with residual neurological deficit following these peripheral nerve blocks in total knee replacements. In both these cases the femoral, sciatic, obturator and lateral cutaneous nerve of thigh were blocked with 0.25% of Bupivacaine with the help of a nerve stimulator.

First patient post operatively had residual numbness in the right lower leg after 4 weeks of surgery. Nerve conduction studies confirmed absent response in right Saphenous and superficial peroneal nerves. Patient has no improvement in her neurological deficit even after 16 months post operatively. Further to this she developed complex regional pain syndrome on the affected side.

Second patient post operatively developed knee extensor weakness of grade II/V and loss of sensation in femoral nerve distribution. Nerve conduction studies confirmed severe femoral nerve damage around groin. She went through a turbulent phase, knee stiffness range of movements 0–20 degrees requiring Manipulation Under Anaesthesia, later Exploration and Release of adhesions which improved her range of movements to 0–95 degrees. At 12 months post operative the neurological status improved to grade 3/5 in knee extensors.

Conclusion: Long term Complications of Peripheral nerve blocks in total knee replacements are not reported in the literature. These complications though uncommon, unfortunately for patients affect the surgical outcomes. The purpose of this case series is not only to report complications but also to share our experience of managing these complications, their outcomes and relevant literature review.