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The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1416 - 1425
1 Dec 2024
Stroobant L Jacobs E Arnout N Van Onsem S Tampere T Burssens A Witvrouw E Victor J

Aims

Approximately 10% to 20% of knee arthroplasty patients are not satisfied with the result, while a clear indication for revision surgery might not be present. Therapeutic options for these patients, who often lack adequate quadriceps strength, are limited. Therefore, the primary aim of this study was to evaluate the clinical effect of a novel rehabilitation protocol that combines low-load resistance training (LL-RT) with blood flow restriction (BFR).

Methods

Between May 2022 and March 2024, we enrolled 45 dissatisfied knee arthroplasty patients who lacked any clear indication for revision to this prospective cohort study. All patients were at least six months post-surgery and had undergone conventional physiotherapy previously. The patients participated in a supervised LL-RT combined with BFR in 18 sessions. Primary assessments included the following patient-reported outcome measures (PROMs): Knee injury and Osteoarthritis Outcome Score (KOOS); Knee Society Score: satisfaction (KSSs); the EuroQol five-dimension five-level questionnaire (EQ-5D-5L); and the pain catastrophizing scale (PCS). Functionality was assessed using the six-minute walk Test (6MWT) and the 30-second chair stand test (30CST). Follow-up timepoints were at baseline, six weeks, three months, and six months after the start.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1399 - 1407
1 Dec 2024
Fujii M Tanaka S Kawano S Ueno M Nagamine S Mawatari M

Aims

This study aimed to determine clinical outcomes; relationships between postoperative anterior, lateral, and posterior acetabular coverage and joint survival; and prognostic factors for joint survival after transposition osteotomy of the acetabulum (TOA).

Methods

Data from 616 patients (800 hips) with hip dysplasia who underwent TOA between November 1998 and December 2019 were reviewed. The median follow-up period was 8.9 years (IQR 5 to 14). A medical notes review was conducted to collect demographic data, complications, and modified Harris Hip Score (mHHS). Radiological indicators of acetabular coverage included lateral centre-edge angle (LCEA), anterior wall index (AWI), and posterior wall index (PWI). The cumulative probability of TOA failure (progression to Tönnis grade 3 or conversion to total hip arthroplasty) was estimated using the Kaplan-Meier product-limited method. A multivariate Cox proportional hazards model was used to identify predictors for failure.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1369 - 1371
1 Dec 2024
Tabu I Ivers R Costa ML

In the UK, multidisciplinary teamwork for patients with hip fracture has been shown to reduce mortality and improves health-related quality of life for patients, while also reducing hospital bed days and associated healthcare costs. However, despite rapidly increasing numbers of fragility fractures, multidisciplinary shared care is rare in low- and middle-income countries around the world. The HIPCARE trial will test the introduction of multidisciplinary care pathways in five low- and middle-income countries in South and Southeast Asia, with the aim to improve patients’ quality of life and reduce healthcare costs.

Cite this article: Bone Joint J 2024;106-B(12):1369–1371.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1451 - 1460
1 Dec 2024
Mandalia K Le Breton S Roche C Shah SS

Aims

A recent study used the RAND Corporation at University of California, Los Angeles (RAND/UCLA) method to develop anatomical total shoulder arthroplasty (aTSA) appropriateness criteria. The purpose of our study was to determine how patient-reported outcome measures (PROMs) vary based on appropriateness.

Methods

Clinical data from a multicentre database identified patients who underwent primary aTSA from November 2004 to January 2023. A total of 390 patients (mean follow-up 48.1 months (SD 42.0)) were included: 97 (24.9%) were classified as appropriate, 218 (55.9%) inconclusive, and 75 (19.2%) inappropriate. Patients were classified as “appropriate”, “inconclusive”, or “inappropriate”, using a modified version of an appropriateness algorithm, which accounted for age, rotator cuff status, mobility, symptomatology, and Walch classification. Multiple pre- and postoperative scores were analyzed using Pearson’s chi-squared test and one-way analysis of variance (ANOVA). Postoperative complications were also analyzed.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1377 - 1384
1 Dec 2024
Fontalis A Yasen AT Giebaly DE Luo TD Magan A Haddad FS

Periprosthetic joint infection (PJI) represents a complex challenge in orthopaedic surgery associated with substantial morbidity and healthcare expenditures. The debridement, antibiotics, and implant retention (DAIR) protocol is a viable treatment, offering several advantages over exchange arthroplasty. With the evolution of treatment strategies, considerable efforts have been directed towards enhancing the efficacy of DAIR, including the development of a phased debridement protocol for acute PJI management. This article provides an in-depth analysis of DAIR, presenting the outcomes of single-stage, two-stage, and repeated DAIR procedures. It delves into the challenges faced, including patient heterogeneity, pathogen identification, variability in surgical techniques, and antibiotics selection. Moreover, critical factors that influence the decision-making process between single- and two-stage DAIR protocols are addressed, including team composition, timing of the intervention, antibiotic regimens, and both anatomical and implant-related considerations. By providing a comprehensive overview of DAIR protocols and their clinical implications, this annotation aims to elucidate the advancements, challenges, and potential future directions in the application of DAIR for PJI management. It is intended to equip clinicians with the insights required to effectively navigate the complexities of implementing DAIR strategies, thereby facilitating informed decision-making for optimizing patient outcomes.

Cite this article: Bone Joint J 2024;106-B(12):1377–1384.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1372 - 1376
1 Dec 2024
Kennedy JW Meek RMD

Hip fractures pose a major global health challenge, leading to high rates of morbidity and mortality, particularly among the elderly. With an ageing population, the incidence of these injuries is rising, exerting significant pressure on healthcare systems worldwide. Despite substantial research aimed at establishing best practice, several key areas remain the subject of ongoing debate. This article examines the latest evidence on the place of arthroplasty in the surgical treatment of hip fractures, with a particular focus on the choice of implant, the use of cemented versus uncemented fixation, and advances in perioperative care. Cite this article: Bone Joint J 2024;106-B(12):1372–1376


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1477 - 1484
1 Dec 2024
Wang Y Shen L Xie D Long H Chen H Wei J Zeng C Lei G

Aims

For displaced femoral neck fractures (FNFs) in geriatric patients, there remains uncertainty regarding the effect of total hip arthroplasty (THA) compared with hemiarthroplasty (HA) in the guidelines. We aimed to compare 90-day surgical readmission, in-hospital complications, and charges between THA and HA in these patients.

Methods

The Hospital Quality Monitoring System was queried from 1 January 2013 to 31 December 2019 for displaced FNFs in geriatric patients treated with THA or HA. After propensity score matching, which identified 33,849 paired patients, outcomes were compared between THA and HA using logistic and linear regression models.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1363 - 1368
1 Dec 2024
Chen DB Wood JA Griffiths-Jones W Bellemans J Haddad FS MacDessi SJ

As advancements in total knee arthroplasty progress at an exciting pace, two areas are of special interest, as they directly impact implant design and surgical decision making. Knee morphometry considers the three-dimensional shape of the articulating surfaces within the knee joint, and knee phenotyping provides the ability to categorize alignment into practical groupings that can be used in both clinical and research settings. This annotation discusses the details of these concepts, and the ways in which they are helping us better understand the individual subtleties of each patient’s knee.

Cite this article: Bone Joint J 2024;106-B(12):1363–1368.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1431 - 1442
1 Dec 2024
Poutoglidou F van Groningen B McMenemy L Elliot R Marsland D

Lisfranc injuries were previously described as fracture-dislocations of the tarsometatarsal joints. With advancements in modern imaging, subtle Lisfranc injuries are now more frequently recognized, revealing that their true incidence is much higher than previously thought. Injury patterns can vary widely in severity and anatomy. Early diagnosis and treatment are essential to achieve good outcomes. The original classification systems were anatomy-based, and limited as tools for guiding treatment. The current review, using the best available evidence, instead introduces a stability-based classification system, with weightbearing radiographs and CT serving as key diagnostic tools. Stable injuries generally have good outcomes with nonoperative management, most reliably treated with immobilization and non-weightbearing for six weeks. Displaced or comminuted injuries require surgical intervention, with open reduction and internal fixation (ORIF) being the most common approach, with a consensus towards bridge plating. While ORIF generally achieves satisfactory results, its effectiveness can vary, particularly in high-energy injuries. Primary arthrodesis remains niche for the treatment of acute injuries, but may offer benefits such as lower rates of post-traumatic arthritis and hardware removal. Novel fixation techniques, including suture button fixation, aim to provide flexible stabilization, which theoretically could improve midfoot biomechanics and reduce complications. Early findings suggest promising functional outcomes, but further studies are required to validate this method compared with established techniques. Future research should focus on refining stability-based classification systems, validation of weightbearing CT, improving rehabilitation protocols, and optimizing surgical techniques for various injury patterns to ultimately enhance patient outcomes.

Cite this article: Bone Joint J 2024;106-B(12):1431–1442.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1393 - 1398
1 Dec 2024
Morris WZ Haider S Hinds ST Podeszwa D Ellis H Osborne L Anable N Sucato D

Aims

There has been limited literature regarding outcomes of acetabular rim syndrome (ARS) with persistent acetabular os in the setting of acetabular dysplasia. The purpose of this study was to characterize a cohort of adolescent and young adult patients with ARS with persistent os and compare their radiological and clinical outcomes to patients with acetabular dysplasia without an os.

Methods

We reviewed a prospective database of patients undergoing periacetabular osteotomy (PAO) for symptomatic acetabular dysplasia between January 1999 and December 2021 to identify hips with preoperative os acetabuli, defined as a closed triradiate cartilage but persistence of a superolateral os acetabulum. A total of 14 hips in 12 patients with persistent os acetabuli (ARS cohort) were compared to 50 randomly selected ‘control’ hips without persistent os acetabuli. Preoperative and postoperative radiographs were measured for markers of dysplasia: lateral centre-edge angle, anterior centre-edge angle, acetabular inclination, and migration index. Union of the os was determined in patients with ≥ six months’ follow-up. Patient-reported outcome measures (PROMs) included the University of California, Los Angeles (UCLA) activity score and modified Harris Hip Score (mHHS, maximum score 80) completed at one year postoperatively.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1263 - 1272
1 Nov 2024
Amador IE Hao KA Buchanan TR Damrow DS Hones KM Simcox T Schoch BS Farmer KW Wright TW LaMonica TJ King JJ Wright JO

Aims

We sought to compare functional outcomes and survival between non-smokers, former smokers, and current smokers who underwent anatomical total shoulder arthroplasty (aTSA) in a large cohort of patients.

Methods

A retrospective review of a prospectively collected shoulder arthroplasty database was performed between August 1991 and September 2020 to identify patients who underwent primary aTSA. Patients were excluded for preoperative diagnoses of fracture, infection, or oncological disease. Three cohorts were created based on smoking status: non-smokers, former smokers, and current smokers. Outcome scores (American Shoulder and Elbow Surgeons (ASES), Constant-Murley score, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), University of California, Los Angeles activity scale (UCLA)), range of motion (external rotation (ER), forward elevation (FE), internal rotation, abduction), and shoulder strength (ER, FE) evaluated at two- to four-year follow-up were compared between cohorts. Evaluation of revision-free survival was performed using the Kaplan-Meier method to final follow-up.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1240 - 1248
1 Nov 2024
Smolle MA Keintzel M Staats K Böhler C Windhager R Koutp A Leithner A Donner S Reiner T Renkawitz T Sava M Hirschmann MT Sadoghi P

Aims

This multicentre retrospective observational study’s aims were to investigate whether there are differences in the occurrence of radiolucent lines (RLLs) following total knee arthroplasty (TKA) between the conventional Attune baseplate and its successor, the novel Attune S+, independent from other potentially influencing factors; and whether tibial baseplate design and presence of RLLs are associated with differing risk of revision.

Methods

A total of 780 patients (39% male; median age 70.7 years (IQR 62.0 to 77.2)) underwent cemented TKA using the Attune Knee System) at five centres, and with the latest radiograph available for the evaluation of RLL at between six and 36 months from surgery. Univariate and multivariate logistic regression models were performed to assess associations between patient and implant-associated factors on the presence of tibial and femoral RLLs. Differences in revision risk depending on RLLs and tibial baseplate design were investigated with the log-rank test.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1312 - 1320
1 Nov 2024
Hamoodi Z Sayers A Whitehouse MR Rangan A Kearsley-Fleet L Sergeant J Watts AC

Aims. The aim of this study was to review the provision of total elbow arthroplasties (TEAs) in England, including the incidence, the characteristics of the patients and the service providers, the types of implant, and the outcomes. Methods. We analyzed the primary TEAs recorded in the National Joint Registry (NJR) between April 2012 and December 2022, with mortality data from the Civil Registration of Deaths dataset. Linkage with Hospital Episode Statistics-Admitted Patient Care (HES-APC) data provided further information not collected by the NJR. The incidences were calculated using estimations of the populations from the Office for National Statistics. The annual number of TEAs performed by surgeons and hospitals was analyzed on a national and regional basis. Results. A total of 3,891 primary TEAs were included. The annual incidence of TEA was between 0.72 and 0.82 per 100,000 persons before 2020 and declined to 0.4 due to a decrease in elective TEAs during the COVID-19 pandemic, with a slight recovery in 2022. Older patients, those of white ethnicity and females, were more likely to undergo TEA. Those who underwent elective TEA had a median wait of between 89 (IQR 41 to 221) and 122 days (IQR 74 to 189) in the years before 2021, and this increased to 183 days (IQR 66 to 350) in 2021. The number of TEAs performed by surgeons per annum remained unchanged, with a median of two (IQR 1 to 3). The median annual number of TEAs per region was three to six times higher than the median annual case load of the highest volume hospital in a region. Patients in the lowest socioeconomic group had a higher rate of serious adverse events and mortality (11%) when undergoing TEA for acute trauma. Conclusion. In England, TEA is more common in older age groups, those of white ethnicity, and females. The COVID-19 pandemic affected the incidence of elective TEA and waiting times, and the provision of TEA has not yet recovered. The Getting it Right First Time recommendation of centralizing services to one centre per region could result in up to a six-fold increase in the number of TEAs being performed in some centres. Cite this article: Bone Joint J 2024;106-B(11):1312–1320


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1284 - 1292
1 Nov 2024
Moroder P Poltaretskyi S Raiss P Denard PJ Werner BC Erickson BJ Griffin JW Metcalfe N Siegert P

Aims

The objective of this study was to compare simulated range of motion (ROM) for reverse total shoulder arthroplasty (rTSA) with and without adjustment for scapulothoracic orientation in a global reference system. We hypothesized that values for simulated ROM in preoperative planning software with and without adjustment for scapulothoracic orientation would be significantly different.

Methods

A statistical shape model of the entire humerus and scapula was fitted into ten shoulder CT scans randomly selected from 162 patients who underwent rTSA. Six shoulder surgeons independently planned a rTSA in each model using prototype development software with the ability to adjust for scapulothoracic orientation, the starting position of the humerus, as well as kinematic planes in a global reference system simulating previously described posture types A, B, and C. ROM with and without posture adjustment was calculated and compared in all movement planes.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1327 - 1332
1 Nov 2024
Ameztoy Gallego J Diez Sanchez B Vaquero-Picado A Antuña S Barco R

Aims

In patients with a failed radial head arthroplasty (RHA), simple removal of the implant is an option. However, there is little information in the literature about the outcome of this procedure. The aim of this study was to review the mid-term clinical and radiological results, and the rate of complications and removal of the implant, in patients whose initial RHA was undertaken acutely for trauma involving the elbow.

Methods

A total of 11 patients in whom removal of a RHA without reimplantation was undertaken as a revision procedure were reviewed at a mean follow-up of 8.4 years (6 to 11). The range of motion (ROM) and stability of the elbow were recorded. Pain was assessed using a visual analogue scale (VAS). The functional outcome was assessed using the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), and the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Radiological examination included the assessment of heterotopic ossification (HO), implant loosening, capitellar erosion, overlengthening, and osteoarthritis. Complications and the rate of further surgery were also recorded.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1333 - 1341
1 Nov 2024
Cheung PWH Leung JHM Lee VWY Cheung JPY

Aims. Developmental cervical spinal stenosis (DcSS) is a well-known predisposing factor for degenerative cervical myelopathy (DCM) but there is a lack of consensus on its definition. This study aims to define DcSS based on MRI, and its multilevel characteristics, to assess the prevalence of DcSS in the general population, and to evaluate the presence of DcSS in the prediction of developing DCM. Methods. This cross-sectional study analyzed MRI spine morphological parameters at C3 to C7 (including anteroposterior (AP) diameter of spinal canal, spinal cord, and vertebral body) from DCM patients (n = 95) and individuals recruited from the general population (n = 2,019). Level-specific median AP spinal canal diameter from DCM patients was used to screen for stenotic levels in the population-based cohort. An individual with multilevel (≥ 3 vertebral levels) AP canal diameter smaller than the DCM median values was considered as having DcSS. The most optimal cut-off canal diameter per level for DcSS was determined by receiver operating characteristic analyses, and multivariable logistic regression was performed for the prediction of developing DCM that required surgery. Results. A total of 2,114 individuals aged 64.6 years (SD 11.9) who underwent surgery from March 2009 to December 2016 were studied. The most optimal cut-off canal diameters for DcSS are: C3 < 12.9 mm, C4 < 11.8 mm, C5 < 11.9 mm, C6 < 12.3 mm, and C7 < 13.3 mm. Overall, 13.0% (262 of 2,019) of the population-based cohort had multilevel DcSS. Multilevel DcSS (odds ratio (OR) 6.12 (95% CI 3.97 to 9.42); p < 0.001) and male sex (OR 4.06 (95% CI 2.55 to 6.45); p < 0.001) were predictors of developing DCM. Conclusion. This is the first MRI-based study for defining DcSS with multilevel canal narrowing. Level-specific cut-off canal diameters for DcSS can be used for early identification of individuals at risk of developing DCM. Individuals with DcSS at ≥ three levels and male sex are recommended for close monitoring or early intervention to avoid traumatic spinal cord injuries from stenosis. Cite this article: Bone Joint J 2024;106-B(11):1333–1341


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1348 - 1360
1 Nov 2024
Spek RWA Smith WJ Sverdlov M Broos S Zhao Y Liao Z Verjans JW Prijs J To M Åberg H Chiri W IJpma FFA Jadav B White J Bain GI Jutte PC van den Bekerom MPJ Jaarsma RL Doornberg JN

Aims

The purpose of this study was to develop a convolutional neural network (CNN) for fracture detection, classification, and identification of greater tuberosity displacement ≥ 1 cm, neck-shaft angle (NSA) ≤ 100°, shaft translation, and articular fracture involvement, on plain radiographs.

Methods

The CNN was trained and tested on radiographs sourced from 11 hospitals in Australia and externally validated on radiographs from the Netherlands. Each radiograph was paired with corresponding CT scans to serve as the reference standard based on dual independent evaluation by trained researchers and attending orthopaedic surgeons. Presence of a fracture, classification (non- to minimally displaced; two-part, multipart, and glenohumeral dislocation), and four characteristics were determined on 2D and 3D CT scans and subsequently allocated to each series of radiographs. Fracture characteristics included greater tuberosity displacement ≥ 1 cm, NSA ≤ 100°, shaft translation (0% to < 75%, 75% to 95%, > 95%), and the extent of articular involvement (0% to < 15%, 15% to 35%, or > 35%).


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1231 - 1239
1 Nov 2024
Tzanetis P Fluit R de Souza K Robertson S Koopman B Verdonschot N

Aims. The surgical target for optimal implant positioning in robotic-assisted total knee arthroplasty remains the subject of ongoing discussion. One of the proposed targets is to recreate the knee’s functional behaviour as per its pre-diseased state. The aim of this study was to optimize implant positioning, starting from mechanical alignment (MA), toward restoring the pre-diseased status, including ligament strain and kinematic patterns, in a patient population. Methods. We used an active appearance model-based approach to segment the preoperative CT of 21 osteoarthritic patients, which identified the osteophyte-free surfaces and estimated cartilage from the segmented bones; these geometries were used to construct patient-specific musculoskeletal models of the pre-diseased knee. Subsequently, implantations were simulated using the MA method, and a previously developed optimization technique was employed to find the optimal implant position that minimized the root mean square deviation between pre-diseased and postoperative ligament strains and kinematics. Results. There were evident biomechanical differences between the simulated patient models, but also trends that appeared reproducible at the population level. Optimizing the implant position significantly reduced the maximum observed strain root mean square deviations within the cohort from 36.5% to below 5.3% for all but the anterolateral ligament; and concomitantly reduced the kinematic deviations from 3.8 mm (SD 1.7) and 4.7° (SD 1.9°) with MA to 2.7 mm (SD 1.4) and 3.7° (SD 1.9°) relative to the pre-diseased state. To achieve this, the femoral component consistently required translational adjustments in the anterior, lateral, and proximal directions, while the tibial component required a more posterior slope and varus rotation in most cases. Conclusion. These findings confirm that MA-induced biomechanical alterations relative to the pre-diseased state can be reduced by optimizing the implant position, and may have implications to further advance pre-planning in robotic-assisted surgery in order to restore pre-diseased knee function. Cite this article: Bone Joint J 2024;106-B(11):1231–1239


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1216 - 1222
1 Nov 2024
Castagno S Gompels B Strangmark E Robertson-Waters E Birch M van der Schaar M McCaskie AW

Aims

Machine learning (ML), a branch of artificial intelligence that uses algorithms to learn from data and make predictions, offers a pathway towards more personalized and tailored surgical treatments. This approach is particularly relevant to prevalent joint diseases such as osteoarthritis (OA). In contrast to end-stage disease, where joint arthroplasty provides excellent results, early stages of OA currently lack effective therapies to halt or reverse progression. Accurate prediction of OA progression is crucial if timely interventions are to be developed, to enhance patient care and optimize the design of clinical trials.

Methods

A systematic review was conducted in accordance with PRISMA guidelines. We searched MEDLINE and Embase on 5 May 2024 for studies utilizing ML to predict OA progression. Titles and abstracts were independently screened, followed by full-text reviews for studies that met the eligibility criteria. Key information was extracted and synthesized for analysis, including types of data (such as clinical, radiological, or biochemical), definitions of OA progression, ML algorithms, validation methods, and outcome measures.


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).