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The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1375 - 1383
3 Oct 2020
Zhang T Sze KY Peng ZW Cheung KMC Lui YF Wong YW Kwan KYH Cheung JPY

Aims. To investigate metallosis in patients with magnetically controlled growing rods (MCGRs) and characterize the metal particle profile of the tissues surrounding the rod. Methods. This was a prospective observational study of patients with early onset scoliosis (EOS) treated with MCGRs and undergoing rod exchange who were consecutively recruited between February 2019 and January 2020. Ten patients were recruited (mean age 12 years (SD 1.3); 2 M:8 F). The configurations of the MCGR were studied to reveal the distraction mechanisms, with crucial rod parts being the distractable piston rod and the magnetically driven rotor inside the barrel of the MCGR. Metal-on-metal contact in the form of ring-like wear marks on the piston was found on the distracted portion of the piston immediately outside the barrel opening (BO) through which the piston rod distracts. Biopsies of paraspinal muscles and control tissue samples were taken over and away from the wear marks, respectively. Spectral analyses of the rod alloy and biopsies were performed to reveal the metal constituents and concentrations. Histological analyses of the biopsies were performed with haematoxylin and eosin staining. Results. Titanium (Ti), vanadium (V), and neodymium (Nd) concentrations in the biopsies taken near the wear marks were found to be significantly higher than those in the control tissue samples. Significantly increased Nd concentrations were also found in the tissues near the barrel of the MCGR. Chronic inflammation was revealed by the histological studies with fibrosis and macrophage infiltration. Black particles were present within the macrophages in the fibrotic tissues. Conclusion. Ti and V were generated mainly at the BO due to metal-on-metal contact, whereas the Nd from the rotor of the MCGR is likely released from the BO during distraction sessions. Phagocytotic immune cells with black particles inside raise concern regarding the long-term implications of metallosis. Cite this article: Bone Joint J 2020;102-B(10):1375–1383


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 8 | Pages 1025 - 1030
1 Aug 2009
Ollivere B Darrah C Barker T Nolan J Porteous MJ

The rate and mode of early failure in 463 Birmingham hip resurfacings in a two-centre, multisurgeon series were examined. Of the 463 patients two have died and three were lost to follow-up. The mean radiological and clinical follow-up was for 43 months (6 to 90). We have revised 13 resurfacings (2.8%) including seven for pain, three for fracture, two for dislocation and another for sepsis. Of these, nine had macroscopic and histological evidence of metallosis. The survival at five years was 95.8% (95% confidence interval (CI) 94.1 to 96.8) for revision for all causes and 96.9% (95% CI 95.5 to 98.3) for metallosis. The rate of metallosis related revision was 3.1% at five years. Risk factors for metallosis were female gender, a small femoral component, a high abduction angle and obesity. We do not advocate the use of the Birmingham Hip resurfacing procedure in patients with these risk factors


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 4 | Pages 502 - 505
1 Apr 2008
Khan WS Agarwal M Malik AA Cox AG Denton J Holt EM

Metallosis after shoulder replacement has not previously been described in the literature. We report a patient who developed extensive metallosis after implantation of an uncemented Nottingham shoulder replacement. He underwent a revision procedure. Examination of the retrieved prosthesis showed that the titanium porous coating was separating from the humeral stem and becoming embedded in the ultra-high-molecular-weight polyethylene glenoid component, resulting in abrasive wear of the humeral component. There was metallosis despite exchange of the modular humeral head. Both components had to be exchanged to resolve the problem


The Bone & Joint Journal
Vol. 107-B, Issue 1 | Pages 58 - 64
1 Jan 2025
Carender CN Bedard NA Fruth KM Taunton MJ Pagnano MW Abdel MP

Aims. The purpose of this study was to directly compare the Modular Dual Mobility (MDM) Mobile Bearing Hip System (Stryker, USA) and large femoral heads (LFHs) in revision total hip arthroplasties (THAs) at mid-term follow-up, with specific emphasis on survival free of re-revision for dislocation, any re-revision, dislocation, and the risk of metal-related complications. Methods. We identified 299 revision THAs performed at a single tertiary care academic institution from March 2011 to July 2014. Aseptic loosening of the acetabular component (n = 65), dislocation (n = 58), and reimplantation as part of a two-stage exchange protocol (n = 57) were the most common reasons for index revision. MDM constructs were used in 123 cases, and LFHs were used in 176 cases. Mean age was 66 years (28 to 93), mean BMI was 31 kg/m. 2. (18 to 55), and 45% (n = 136) were female. Mean follow-up was seven years (2 to 12). Results. The ten-year survival free of re-revision for dislocation was 99% (95% CI 95 to 100) in the MDM cohort and 91% (95% CI 84 to 96) in the LFH cohort, with a significantly increased risk of re-revision for dislocation in the LFH cohort (HR 7.1 (95% CI 1.3 to 40.8); p = 0.023). The ten-year survival free of any re-revision was 92% (95% CI 82 to 99%) in the MDM cohort and 84% (95% CI 74 to 90) in the LFH cohort with a significantly increased risk of any re-revision in the LFH cohort (HR 2.6 (95% CI 1.1 to 5.9); p = 0.024). The ten-year survival free of any dislocation was 95% (95% CI 85 to 99) in the MDM cohort and 87% (95% CI 78 to 92) in the LFH cohort with a significantly increased risk of any dislocation in the LFH cohort (HR 2.7 (95% CI 1.1 to 6.3); p = 0.028). There were no re-revisions or reoperations for metallosis or corrosion in the MDM cohort. Conclusion. In this head-to-head comparison, revision THAs with a MDM construct safely and effectively lowered the risk of re-revision for dislocation, any re-revision, and any dislocation compared to LFH at mid-term follow-up. There were no re-revisions or reoperations for metallosis or corrosion in the MDM cohort. Cite this article: Bone Joint J 2025;107-B(1):58–64


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 3 | Pages 352 - 357
1 Apr 2000
Milošev L Antolič V Minovič A Cör A Herman S Pavlovčič V Campbell P

We describe three prostheses with cemented titanium-alloy stems and Al. 2. O. 3. ceramic femoral heads which had to be revised after a mean period of implantation of 78 months. In each case, the neck of the prosthesis had been so severely worn that the profile was elliptical rather than circular. There was severe metallosis of the periprosthetic tissues. Metal particles isolated from the tissues were approximately one nanometre in size and the ratios of titanium, aluminium and vanadium in the particles were the same as in the original alloy. Histologically, the high concentration of metal particles masked the presence of high-density polyethylene (HDP) debris, but again particles about one nanometre in size were isolated from the tissues. The severe necrobiosis and necrosis noted were consistent with other reports of the presence of extensive wear particles in periprosthetic tissues. Wear is presumed to have occurred as a result of mismatch between the shape or size of the taper cone and the femoral head, or to changes in the geometry of loading due to migration of the cup. To facilitate early intervention, patients with this design of prosthesis should be monitored radiologically


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1248 - 1255
1 Oct 2019
Pineda A Pabbruwe MB Kop AM Vlaskovsky P Hurworth M

Aims. The aim of this study was to conduct the largest low contact stress (LCS) retrieval study to elucidate the failure mechanisms of the Porocoat and Duofix femoral component. The latter design was voluntarily recalled by the manufacturer. Materials and Methods. Uncemented LCS explants were divided into three groups: Duofix, Porocoat, and mixed. Demographics, polyethylene wear, tissue ingrowth, and metallurgical analyses were performed. Results. In 104 implants, a decrease in the odds of loosening and an increase in metallosis and tissue staining in the Duofix group relative to Porocoat group was detected (p = 0.028). There was an increased presence of embedded metallic debris in the Duofix group (p < 0.001). Decreased tissue ingrowth was associated with the Duofix surface (p < 0.001). The attached beads had reduced microhardness, indicative of adverse thermal processing, which resulted in bead shedding, particulate debris, and metallosis. Conclusion. Hydroxyapatite coating of the LCS femoral component produced unexpected results and led to its recall. The root cause was likely a combination of retained alumina grit and a reduction in bead microhardness (mechanical strength) resulting in increased particle debris, metallosis, and early revision. The Duofix LCS femoral component was not equivalent to the Porocoat version despite its approval through the Food and Drug Administration (FDA) 510(k) equivalance approval process. Regulation of the introduction of modified existing devices needs to be improved and the Duofix LCS should have been considered to be a new device for which equivalence had not been demonstrated at the point of introduction. Cite this article: Bone Joint J 2019;101-B:1248–1255


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1662 - 1667
1 Dec 2016
Teoh KH von Ruhland C Evans SL James SH Jones A Howes J Davies PR Ahuja S

Aims. We present a case series of five patients who had revision surgery following magnetic controlled growing rods (MGCR) for early onset scoliosis. Metallosis was found during revision in four out of five patients and we postulated a mechanism for rod failure based on retrieval analysis. Patients and Methods. Retrieval analysis was performed on the seven explanted rods. The mean duration of MCGR from implantation to revision was 35 months (17 to 46). The mean age at revision was 12 years (7 to 15; four boys, one girl). Results. A total of six out of seven rods had tissue metallosis and pseudo-capsule surrounding the actuator. A total of four out of seven rods were pistoning. There were two rods which were broken. All rods had abrasive circumferential markings. A significant amount of metal debris was found when the actuators were carefully cut open. Analytical electron microscopy demonstrated metal fragments of predominantly titanium with a mean particle size of 3.36 microns (1.31 to 6.61). Conclusion. This study highlights concerns with tissue metallosis in MCGR. We recommend careful follow-up of patients who have received this implant. Cite this article: Bone Joint J 2016;98-B:1662–7


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 205 - 209
1 Feb 2011
Willis-Owen CA Keene GC Oakeshott RD

Metallosis is a rare cause of failure after total knee replacement and has only previously been reported when there has been abnormal metal-on-metal contact. We describe 14 patients (15 knees) whose total knee replacement required revision for a new type of early failure caused by extensive metallosis. A modification of a cementless rotating platform implant, which had previously had excellent long-term survival, had been used in each case. The change was in the form of a new porous-beaded surface on the femoral component to induce cementless fixation, which had been used successfully in the fixation of acetabular and tibial components. This modification appeared to have resulted in metallosis due to abrasive two-body wear. The component has subsequently been recalled and is no longer in use. The presentation, investigation, and findings at revision are described and a possible aetiology and its implications are discussed


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 10 | Pages 1344 - 1350
1 Oct 2010
Carrothers AD Gilbert RE Jaiswal A Richardson JB

Despite the increasing interest and subsequent published literature on hip resurfacing arthroplasty, little is known about the prevalence of its complications and in particular the less common modes of failure. The aim of this study was to identify the prevalence of failure of hip resurfacing arthroplasty and to analyse the reasons for it. From a multi-surgeon series (141 surgeons) of 5000 Birmingham hip resurfacings we have analysed the modes, prevalence, gender differences and times to failure of any hip requiring revision. To date 182 hips have been revised (3.6%). The most common cause for revision was a fracture of the neck of the femur (54 hips, prevalence 1.1%), followed by loosening of the acetabular component (32 hips, 0.6%), collapse of the femoral head/avascular necrosis (30 hips, 0.6%), loosening of the femoral component (19 hips, 0.4%), infection (17 hips, 0.3%), pain with aseptic lymphocytic vascular and associated lesions (ALVAL)/metallosis (15 hips, 0.3%), loosening of both components (five hips, 0.1%), dislocation (five hips, 0.1%) and malposition of the acetabular component (three hips, 0.1%). In two cases the cause of failure was unknown. Comparing men with women, we found the prevalence of revision to be significantly higher in women (women = 5.7%; men = 2.6%, p < 0.001). When analysing the individual modes of failure women had significantly more revisions for loosening of the acetabular component, dislocation, infection and pain/ALVAL/metallosis (p < 0.001, p = 0.004, p = 0.008, p = 0.01 respectively). The mean time to failure was 2.9 years (0.003 to 11.0) for all causes, with revision for fracture of the neck of the femur occurring earlier than other causes (mean 1.5 years, 0.02 to 11.0). There was a significantly shorter time to failure in men (mean 2.1 years, 0.4 to 8.7) compared with women (mean 3.6 years, 0.003 to 11.0) (p < 0.001)


The Bone & Joint Journal
Vol. 98-B, Issue 1_Supple_A | Pages 10 - 13
1 Jan 2016
Brooks PJ

Hip resurfacing has been proposed as an alternative to traditional total hip arthroplasty in young, active patients. Much has been learned following the introduction of metal-on-metal resurfacing devices in the 1990s. The triad of a well-designed device, implanted accurately, in the correct patient has never been more critical than with these implants. . Following Food and Drug Administration approval in 2006, we studied the safety and effectiveness of one hip resurfacing device (Birmingham Hip Resurfacing) at our hospital in a large, single-surgeon series. We report our early to mid–term results in 1333 cases followed for a mean of 4.3 years (2 to 5.7) using a prospective, observational registry. The mean patient age was 53.1 years (12 to 84); 70% were male and 91% had osteoarthritis. Complications were few, including no dislocations, no femoral component loosening, two femoral neck fractures (0.15%), one socket loosening (0.08%), three deep infections (0.23%), and three cases of metallosis (0.23%). There were no destructive pseudotumours. Overall survivorship at up to 5.7 years was 99.2%. Aseptic survivorship in males under the age of 50 was 100%. We believe this is the largest United States series of a single surgeon using a single resurfacing system. Cite this article: Bone Joint J 2016;98-B (1 Suppl A):10–13


The Bone & Joint Journal
Vol. 95-B, Issue 11_Supple_A | Pages 88 - 91
1 Nov 2013
Su EP Su SL

Surface hip replacement (SHR) is generally used in younger, active patients as an alternative conventional total hip replacement in part because of the ability to preserve femoral bone. This major benefit of surface replacement will only hold true if revision procedures of SHRs are found to provide good clinical results. A retrospective review of SHR revisions between 2007 and 2012 was presented, and the type of revision and aetiologies were recorded. There were 55 SHR revisions, of which 27 were in women. At a mean follow-up of 2.3 years (0.72 to 6.4), the mean post-operative Harris hip score (HHS) was 94.8 (66 to 100). Overall 23 were revised for mechanical reasons, nine for impingement, 13 for metallosis, nine for unexplained pain and one for sepsis. Of the type of revision surgery performed, 14 were femoral-only revisions; four were acetabular-only revisions, and 37 were complete revisions. We did not find that clinical scores were significantly different between gender or different types of revisions. However, the mean post-operative HHS was significantly lower in patients revised for unexplained pain compared with patients revised for mechanical reasons (86.9 (66 to 100) versus 99 (96 to 100); p = 0.029). There were two re-revisions for infection in the entire cohort. Based on the overall clinical results, we believe that revision of SHR can have good or excellent results and warrants a continued use of the procedure in selected patients. Close monitoring of these patients facilitates early intervention, as we believe that tissue damage may be related to the duration of an ongoing problem. There should be a low threshold to revise a surface replacement if there is component malposition, rising metal ion levels, or evidence of soft-tissue abnormalities. Cite this article: Bone Joint J 2013;95-B, Supple A:88–91


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 9 | Pages 1158 - 1163
1 Sep 2008
De Haan R Campbell PA Su EP De Smet KA

We have reviewed 42 patients who had revision of metal-on-metal resurfacing procedures, mostly because of problems with the acetabular component. The revisions were carried out a mean of 26.2 months (1 to 76) after the initial operation and most of the patients (30) were female. Malpositioning of the acetabular component resulted in 27 revisions, mostly because of excessive abduction (mean 69.9°; 56° to 98°) or insufficient or excessive anteversion. Seven patients had more than one reason for revision. The mean increase in the diameter of the component was 1.8 mm (0 to 4) when exchange was needed. Malpositioning of the components was associated with metallosis and a high level of serum ions. The results of revision of the femoral component to a component with a modular head were excellent, but four patients had dislocation after revision and four required a further revision


The Bone & Joint Journal
Vol. 106-B, Issue 5 Supple B | Pages 118 - 124
1 May 2024
Macheras GA Argyrou C Tzefronis D Milaras C Tsivelekas K Tsiamtsouris KG Kateros K Papadakis SA

Aims

Accurate diagnosis of chronic periprosthetic joint infection (PJI) presents a significant challenge for hip surgeons. Preoperative diagnosis is not always easy to establish, making the intraoperative decision-making process crucial in deciding between one- and two-stage revision total hip arthroplasty (THA). Calprotectin is a promising point-of-care novel biomarker that has displayed high accuracy in detecting PJI. We aimed to evaluate the utility of intraoperative calprotectin lateral flow immunoassay (LFI) in THA patients with suspected chronic PJI.

Methods

The study included 48 THAs in 48 patients with a clinical suspicion of PJI, but who did not meet European Bone and Joint Infection Society (EBJIS) PJI criteria preoperatively, out of 105 patients undergoing revision THA at our institution for possible PJI between November 2020 and December 2022. Intraoperatively, synovial fluid calprotectin was measured with LFI. Cases with calprotectin levels ≥ 50 mg/l were considered infected and treated with two-stage revision THA; in negative cases, one-stage revision was performed. At least five tissue cultures were obtained; the implants removed were sent for sonication.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 775 - 782
1 Jul 2023
Koper MC Spek RWA Reijman M van Es EM Baart SJ Verhaar JAN Bos PK

Aims

The aims of this study were to determine if an increasing serum cobalt (Co) and/or chromium (Cr) concentration is correlated with a decreasing Harris Hip Score (HHS) and Hip disability and Osteoarthritis Outcome Score (HOOS) in patients who received the Articular Surface Replacement (ASR) hip resurfacing arthroplasty (HRA), and to evaluate the ten-year revision rate and show if sex, inclination angle, and Co level influenced the revision rate.

Methods

A total of 62 patients with an ASR-HRA were included and monitored yearly postoperatively. At follow-up, serum Co and Cr levels were measured and the HHS and the HOOS were scored. In addition, preoperative patient and implant variables and the need for revision surgery were recorded. We used a linear mixed model to relate the serum Co and Cr levels to different patient-reported outcome measures (PROMs). For the survival analyses we used the Kaplan-Meier and Cox regression model.


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 17 - 23
1 Mar 2024
LaValva SM LeBrun DG Canoles HG Ren R Padgett DE Su EP

Aims

Professional dancers represent a unique patient population in the setting of hip arthroplasty, given the high degree of hip strength and mobility required by their profession. We sought to determine the clinical outcomes and ability to return to professional dance after total hip arthroplasty (THA) or hip resurfacing arthroplasty (HRA).

Methods

Active professional dancers who underwent primary THA or HRA at a single institution with minimum one-year follow-up were included in the study. Primary outcomes included the rate of return to professional dance, three patient-reported outcome measures (PROMs) (modified Harris Hip Score (mHHS), Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR), and Lower Extremity Activity Scale (LEAS)), and postoperative complications.


The Bone & Joint Journal
Vol. 106-B, Issue 5 Supple B | Pages 98 - 104
1 May 2024
Mallett KE Guarin Perez SF Taunton MJ Sierra RJ

Aims

Dual-mobility (DM) components are increasingly used to prevent and treat dislocation after total hip arthroplasty (THA). Intraprosthetic dissociation (IPD) is a rare complication of DM that is believed to have decreased with contemporary implants. This study aimed to report incidence, treatment, and outcomes of contemporary DM IPD.

Methods

A total of 1,453 DM components were implanted at a single academic institution between January 2010 and December 2021: 695 in primary and 758 in revision THA. Of these, 49 presented with a dislocation of the large DM head and five presented with an IPD. At the time of closed reduction of the large DM dislocation, six additional IPDs occurred. The mean age was 64 years (SD 9.6), 54.5% were female (n = 6), and mean follow-up was 4.2 years (SD 1.8). Of the 11 IPDs, seven had a history of instability, five had abductor insufficiency, four had prior lumbar fusion, and two were conversions for failed fracture management.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 312 - 318
1 Apr 2024
Sheth NP Jones SA Sanghavi SA Manktelow A

The advent of modular porous metal augments has ushered in a new form of treatment for acetabular bone loss. The function of an augment can be seen as reducing the size of a defect or reconstituting the anterosuperior/posteroinferior columns and/or allowing supplementary fixation. Depending on the function of the augment, the surgeon can decide on the sequence of introduction of the hemispherical shell, before or after the augment. Augments should always, however, be used with cement to form a unit with the acetabular component. Given their versatility, augments also allow the use of a hemispherical shell in a position that restores the centre of rotation and biomechanics of the hip. Progressive shedding or the appearance of metal debris is a particular finding with augments and, with other radiological signs of failure, should be recognized on serial radiographs. Mid- to long-term outcomes in studies reporting the use of augments with hemispherical shells in revision total hip arthroplasty have shown rates of survival of > 90%. However, a higher risk of failure has been reported when augments have been used for patients with chronic pelvic discontinuity.

Cite this article: Bone Joint J 2024;106-B(4):312–318.


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 540 - 547
1 Jun 2024
Nandra RS Elnahal WA Mayne A Brash L McBryde CW Treacy RBC

Aims

The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon’s consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years.

Methods

The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 269 - 276
1 Mar 2023
Tay ML Monk AP Frampton CM Hooper GJ Young SW

Aims

Unicompartmental knee arthroplasty (UKA) has higher revision rates than total knee arthroplasty (TKA). As revision of UKA may be less technically demanding than revision TKA, UKA patients with poor functional outcomes may be more likely to be offered revision than TKA patients with similar outcomes. The aim of this study was to compare clinical thresholds for revisions between TKA and UKA using revision incidence and patient-reported outcomes, in a large, matched cohort at early, mid-, and late-term follow-up.

Methods

Analyses were performed on propensity score-matched patient cohorts of TKAs and UKAs (2:1) registered in the New Zealand Joint Registry between 1 January 1999 and 31 December 2019 with an Oxford Knee Score (OKS) response at six months (n, TKA: 16,774; UKA: 8,387), five years (TKA: 6,718; UKA: 3,359), or ten years (TKA: 3,486; UKA: 1,743). Associations between OKS and revision within two years following the score were examined. Thresholds were compared using receiver operating characteristic analysis. Reasons for aseptic revision were compared using cumulative incidence with competing risk.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1223 - 1230
1 Nov 2024
Dugdale EM Uvodich ME Pagnano MW Berry DJ Abdel MP Bedard NA

Aims

The prevalence of obesity is increasing substantially around the world. Elevated BMI increases the risk of complications following total hip arthroplasty (THA). We sought to evaluate trends in BMI and complication rates of obese patients undergoing primary THA over the last 30 years.

Methods

Through our institutional total joint registry, we identified 15,455 primary THAs performed for osteoarthritis from 1990 to 2019. Patients were categorized according to the World Health Organization (WHO) obesity classification and groups were trended over time. Cox proportional hazards regression analysis controlling for confounders was used to investigate the association between year of surgery and two-year risk of any reoperation, any revision, dislocation, periprosthetic joint infection (PJI), venous thromboembolism (VTE), and periprosthetic fracture. Regression was stratified by three separate groups: non-obese; WHO Class I and Class II (BMI 30 to 39 kg/m2); and WHO Class III patients (BMI ≥ 40 kg/m2).