The Delta III and Delta Xtend reverse shoulder arthroplasty-risk of revision and failure mechanisms: a report on 3650 cases from the Norwegian Arthroplasty Register 1994-2021.

BACKGROUND: The Delta reverse shoulder arthroplasty (RSA) is commonly used worldwide and is the most frequently used RSA in Norway. The aim of this registry-based study was to report 10- and 20-year implant survival, risk of revision, and reasons for revision in 2 consecutive time periods for Delta III (1994-2010) and Delta Xtend (2007-2021) prostheses. METHODS: We included 3650 primary RSAs reported to the Norwegian Arthroplasty Register: 315 Delta III (42% cemented stems) and 3335 Delta Xtend (88% cemented stems). We used Kaplan-Meier analyses to investigate implant survival. The reasons for revision were compared for the 2 designs and fixation technique. Factors that could influence the risk of revision, such as implant design, fixation technique, and patient factors, were investigated using Cox regression analyses with adjustments for age, sex, and diagnosis. RESULTS: Patients operated with Delta III were more likely to be diagnosed with inflammatory disease or fracture sequela, whereas acute fracture, osteoarthritis, and cuff arthropathy were the most frequent indications for Delta Xtend. Ten-year survival was 93.0% (95% confidence interval [CI]: 87.0-99.0) (cemented stem) and 81.6% (95% CI: 75.3-87.9) (uncemented stem) for Delta III and 94.7% (95% CI: 93.3-96.1) (cemented stem) and 95.7% (95% CI: 88.3-100) (uncemented stem) for Delta Xtend. Twenty-year survival for Delta III (uncemented stem) was 68.2% (95% CI: 58.8-77.6). Compared with DeltaXtend (cemented stem) at 10-year follow-up, we found a higher risk of revision for Delta III (uncemented stem) (hazard ratio [HR]: 2.9, 95% CI: 1.7-5.0), whereas no significant difference was found for Delta III (cemented stem) and Delta Xtend (uncemented stem). The most common reason for revision of Delta III (uncemented stem) was glenoid loosening followed by deep infection and instability. Instability was the most frequent revision cause for Delta Xtend (both cemented and uncemented stem). Men had an overall higher revision risk than women (HR: 2.8 [95% CI: 2.0-3.9]), and patients with fracture sequela had increased risk for revision (HR: 2.8, 95% CI: 1.7-4.7) compared with patients with osteoarthritis. DISCUSSION: We found that Delta III (uncemented stem) had a higher risk of revision compared with Delta Xtend (cemented stem). The risk of revision for glenoid component loosening was lower for Delta Xtend, but revisions due to instability/dislocation are still a concern. This register study cannot determine whether the differences found were caused by differences in implant design or other factors that changed during the study period. Risk of revision may have been affected by the indication for primary operation.

Patients with total hip arthroplasty were more physically active 9.6 years after surgery: a case-control study of 429 hip arthroplasty cases and 29,272 participants from a population-based health study.

BACKGROUND AND PURPOSE: Few studies report on long-term levels of physical activity after THA compared with a control population. This case-control study aimed to find the long-term habitual level of leisure-time physical activity after THA and compare it with a large control group. PATIENTS AND METHODS: A randomized sample of 856 patients, treated with primary THA, were identified from the Norwegian Arthroplasty Register. 429 (50%) responded to a questionnaire with a mean follow-up time of 9.6 years. We compared them with a control group of 29,272 (64%) from a population-based health study. Physical activity was measured with a questionnaire and categorized into groups according to the general recommendations for physical activity. RESULTS: 245 (63%) of the THA cases reported a level of leisure-time physical activity meeting the general recommendations, compared with 10,803 (39%) in the control group. The difference persisted at all ages (50-90 years). In sex, age, and BMI-adjusted regression models the chance of meeting the physical activity recommendations was higher in the THA group than in the control group (OR 2.9, 95% confidence interval 2.4-3.6). CONCLUSION: The majority of the patients with THA reported a level of leisure-time physical activity meeting the general recommendations for physical activity. THA patients were more physically active in their leisure time than a control group representing a normal population.

Promoting cemented fixation of the femoral stem in elderly female hip arthroplasty patients and elderly hip fracture patients: a retrospective cohort study from the Norwegian Arthroplasty Register and the Norwegian Hip Fracture Register.

BACKGROUND AND PURPOSE: Uncemented stems increase the risk of revision in elderly patients. In 2018, we initiated a national quality improvement project aiming to increase the proportion of cemented stems in elderly female total hip arthroplasty (THA) and hip fracture hemiarthroplasty (HA) patients. We aimed to evaluate the association of this project on the frequency of cemented stems and the risk of secondary procedures in the targeted population. METHODS: 10,815 THAs in female patients ≥ 75 years in the Norwegian Arthroplasty Register and 19,017 HAs in hip fracture patients ≥ 70 years in the Norwegian Hip Fracture Register performed in 2015-2017 and 2019-2021 at all Norwegian hospitals were included in this retrospective cohort study. The quality improvement project was implemented at 19 hospitals (8,443 patients). 1-year revision risk (THAs) and reoperation risk (HAs) were calculated for uncemented and cemented stems by Kaplan-Meier and Cox adjusted hazard rate ratios (aHRRs) with all-cause revision/reoperation as main endpoint. RESULTS: The use of cemented stem fixation in the targeted population increased from 26% to 80% for THAs and from 27% to 91% for HAs. For THAs, the 1-year revision rate decreased from 3.7% in 2015-2017 to 2.1% in 2019-2021 (aHRR 0.7, 95% confidence interval [CI] 0.5-0.9) at the intervention hospitals. For HAs, the reoperation rate decreased from 5.9% in 2015-2017 to 3.3% in 2019-2021 (aHRR 0.6, CI 0.4-0.8) at the intervention hospitals. CONCLUSION: The quality improvement project resulted in a significant increase in the proportion of cemented stems and reduced risk of secondary procedures for both THAs and HAs.

How good are surgeons at disclosing periprosthetic joint infection at the time of revision, based on pre- and intra-operative assessment? A study on 16,922 primary total hip arthroplasties reported to the Norwegian Arthroplasty Register.

BACKGROUND AND PURPOSE: Revision due to infection, as reported to the Norwegian Arthroplasty Register (NAR), is a surrogate endpoint to periprosthetic joint infection (PJI). We aimed to find the accuracy of the reported causes of revision after primary total hip arthroplasty (THA) compared with PJI to see how good surgeons were at disclosing infection, based on pre- and intraoperative assessment. PATIENTS AND METHODS: We investigated the reasons for revision potentially caused by PJI following primary THA: infection, aseptic loosening, prolonged wound drainage, and pain only, reported to the NAR from surgeons in the region of Western Norway during the period 2010-2020. The electronic patient charts were investigated for information on clinical assessment, treatment, biochemistry, and microbiological findings. PJI was defined in accordance with the Musculoskeletal Infection Society (MSIS) definition. Sensitivity, specificity, and accuracy were calculated. RESULTS: 363 revisions in the NAR were eligible for analyses. Causes of revision were (reported/validated): infection (153/177), aseptic loosening (139/133), prolonged wound drainage (37/13), and pain only (34/40). The sensitivity for reported revision due to infection compared with PJI was 80%, specificity was 94%, and accuracy-the surgeons' ability to disclose PJI or non-septic revision at time of revision-was 87%. The accuracy for the specific revision causes was highest for revision due to aseptic loosening (95%) and pain only (95%), and lowest for revision due to prolonged wound drainage (86%). CONCLUSION: The accuracy of surgeon-reported revisions due to infection as representing PJI was 87% in the NAR. Our study shows the importance of systematic correction of the reported cause of revision in arthroplasty registers, after results from adequately taken bacterial samples.

Cementing techniques for total knee arthroplasty in Norwegian hospitals; a questionnaire-based study.

BACKGROUND: Cementing technique in total knee arthroplasty (TKA) may influence implant survival. There is limited knowledge about the results with clinically used techniques. The aim of this study was to investigate cementing techniques for TKA in Norwegian hospitals, to compare widely used techniques to recommendations from the literature, and to investigate variation within hospitals. METHODS: A questionnaire requesting information about cementing techniques were distributed to all Norwegian orthopedic surgeons performing TKAs regularly in 2020. Data was analyzed using descriptive statistical methods. RESULTS: We acquired 121 responses out of 257 surgeons. They were from 45 out of 56 hospitals, and at least half of the TKA surgeons from 20 hospitals, constituting 79 surgeons. All responders used pulsatile lavage. Cement application to both the tibial plateau and stem (full cementation) was practiced by 61%. Application of cement to both implant and bone was done by 70% of surgeons. Techniques to improve cement penetration were used by 86%. Only 35% of surgeons aimed to get a cement mantle thickness between 3-5 mm. Flexing the knee joint to remove excess cement was done by 82%. We found that in 55% of 20 hospitals the surgeons did not agree on the use of common guidelines in their ward. CONCLUSIONS: The majority of the responders used recommended techniques from the literature when cementing TKA. At more than half of the eligible hospitals, surgeons disagreed about their hospitals' use of common guidelines. Focusing on developing evidence-based guidelines would be beneficial for TKA-quality.

No difference in risk of revision due to infection between clindamycin and cephalosporins as antibiotic prophylaxis in cemented primary total knee replacements: a report from the Norwegian Arthroplasty Register 2005-2020.

BACKGROUND AND PURPOSE: Systemic antibiotic prophylaxis with clindamycin, which is often used in penicillin- or cephalosporin-allergic patients', has been associated with a higher risk of surgical revision for deep prosthetic joint infection (PJI) than cloxacillin in primary total knee replacement (TKR). We aimed to investigate whether clindamycin increases the risk of surgical revisions due to PJI compared with cephalosporins in primary cemented TKR. PATIENTS AND METHODS: Data from 59,081 TKRs in the Norwegian Arthroplasty Register (NAR) 2005-2020 was included. 2,655 (5%) received clindamycin and 56,426 (95%) received cephalosporins. Cox regression analyses were performed with adjustment for sex, age groups, diagnosis, and ASA score. Survival times were calculated using Kaplan-Meier estimates and compared using Cox regression with revision for PJI as endpoint. The cephalosporins cefalotin and cefazolin were also compared. RESULTS: Of the TKRs included, 1.3% (n = 743) were revised for PJI. 96% (n = 713) had received cephalosporins and 4% (n = 30) clindamycin for perioperative prophylaxis. Comparing cephalosporins (reference) and clindamycin, at 3-month follow-up the adjusted hazard ratio rate (HRR) for PJI was 0.7 (95% confidence interval [CI] 0.4-1.4), at 1 year 0.9 (CI 0.6-1.5), and at 5 years 0.9 (CI 0.6-1.4). Analysis using propensity score matching showed similar results. Furthermore, comparing cefalotin (reference) and cefazolin, HRR was 1.0 (CI 0.8-1.4) at 3 months and 1.0 (CI 0.7-1.3) at 1-year follow-up. CONCLUSION: We found no difference in risk of revision for PJI when using clindamycin compared with cephalosporins in primary cemented TKRs. It appears safe to continue the use of clindamycin in penicillin- or cephalosporin-allergic patients.

Increasing risk of revision due to infection after primary total hip arthroplasty: results from the Nordic Arthroplasty Register Association.

BACKGROUND AND PURPOSE: The incidence of periprosthetic joint infection after total hip arthroplasty (THA) may be increasing. We performed time-trend analyses of risk, rates, and timing of revision due to infection after primary THAs in the Nordic countries from the period 2004-2018. PATIENTS AND METHODS: 569,463 primary THAs reported to the Nordic Arthroplasty Register Association from 2004 to 2018 were studied. Absolute risk estimates were calculated by Kaplan-Meier and cumulative incidence function methods, whereas adjusted hazard ratios (aHR) were assessed by Cox regression with the first revision due to infection after primary THA as primary endpoint. In addition, we explored changes in the time span from primary THA to revision due to infection. RESULTS: 5,653 (1.0%) primary THAs were revised due to infection during a median follow-up time of 5.4 (IQR 2.5-8.9) years after surgery. Compared with the period 2004-2008, the aHRs for revision were 1.4 (95% confidence interval [CI] 1.3-1.5) for 2009-2013, and 1.9 (CI 1.7-2.0) for 2014-2018. The absolute 5-year rates of revision due to infection were 0.7% (CI 0.7-0.7), 1.0% (CI 0.9-1.0), and 1.2% (CI 1.2-1.3) for the 3 time periods respectively. We found changes in the time span from primary THA to revision due to infection. Compared with 2004-2008, the aHR for revision within 30 days after THA was 2.5 (CI 2.1-2.9) for 2009-2013, and 3.4 (CI 3.0-3.9) for 2013-2018. The aHR for revision within 31-90 days after THA was 1.5 (CI 1.3-1.9) for 2009-2013, and 2.5 (CI 2.1-3.0) for 2013-2018, compared with 2004-2008. CONCLUSION: The risk of revision due to infection after primary THA almost doubled, both in absolute cumulative incidence and in relative risk, throughout the period 2004-2018. This increase was mainly due to an increased risk of revision within 90 days of THA. This may reflect a "true" increase (i.e., frailer patients or more use of uncemented implants) and/or an "apparent" increase (i.e., improved diagnostics, changed revision strategy, or completeness of reporting) in incidence of periprosthetic joint infection. It is not possible to disclose such changes in the present study, and this warrants further research.

Does choice of bearings influence the survival of cementless total hip arthroplasty in patients aged 20-55 years? Comparison of 21,594 patients reported to the Nordic Arthroplasty Register Association dataset 2005-2017.

BACKGROUND AND PURPOSE: The bearings with the best survivorship for young patients with total hip arthroplasty (THA) should be identified. We compared hazard ratios (HR) of revision of primary stemmed cementless THAs with metal-on-metal (MoM), ceramic-on-ceramic (CoC), and ceramic-on-highly-crosslinked-polyethylene (CoXLP) with that of metal-on-highly-crosslinked-polyethylene (MoXLP) bearings in patients aged 20-55 years with primary osteoarthritis or childhood hip disorders. PATIENTS AND METHODS: From the Nordic Arthroplasty Register Association dataset we included 1,813 MoM, 3,615 CoC, 5,947 CoXLP, and 10,219 MoXLP THA in patients operated on between 2005 and 2017 in a prospective cohort study. We used the Kaplan-Meier estimator for THA survivorship and Cox regression to estimate HR of revision adjusted for confounders (including 95% confidence intervals [CI]). MoXLP was used as reference. HRs were calculated during 3 intervals (0-2, 2-7, and 7-13 years) to meet the assumption of proportional hazards. RESULTS: Median follow-up was 5 years for MoXLP, 10 years for MoM, 6 years for CoC, and 4 years for CoXLP. 13-year Kaplan-Meier survival estimates were 95% (CI 94-95) for MoXLP, 82% (CI 80-84) for MoM, 93% (CI 92-95) for CoC, and 93% (CI 92-94) for CoXLP bearings. MoM had higher 2-7 and 7-13 years' adjusted HRs of revision (3.6, CI 2.3-5.7 and 4.1, CI 1.7-10). MoXLP, CoC, and CoXLP had similar HRs in all 3 periods. The 7-13-year adjusted HRs of revision of CoC and CoXLP were statistically non-significantly higher. CONCLUSION: In young patients, MoXLP for primary cementless THA had higher revision-free survival and lower HR for revision than MoM bearings. Longer follow-up is needed to compare MoXLP, CoC, and CoXLP.

The use of antibiotic-loaded bone cement and systemic antibiotic prophylactic use in 2,971,357 primary total knee arthroplasties from 2010 to 2020: an international register-based observational study among countries in Africa, Europe, North America, and Oceania.

BACKGROUND AND PURPOSE: Antibiotic-loaded bone cement (ALBC) and systemic antibiotic prophylaxis (SAP) have been used to reduce periprosthetic joint infection (PJI) rates. We investigated the use of ALBC and SAP in primary total knee arthroplasty (TKA). PATIENTS AND METHODS: This observational study is based on 2,971,357 primary TKAs reported in 2010-2020 to national/regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, the Netherlands, New Zealand, Norway, Romania, South Africa, Sweden, Switzerland, the UK, and the USA. Aggregate-level data on trends and types of bone cement, antibiotic agents, and doses and duration of SAP used was extracted from participating registries. RESULTS: ALBC was used in 77% of the TKAs with variation ranging from 100% in Norway to 31% in the USA. Palacos R+G was the most common (62%) ALBC type used. The primary antibiotic used in ALBC was gentamicin (94%). Use of ALBC in combination with SAP was common practice (77%). Cefazolin was the most common (32%) SAP agent. The doses and duration of SAP used varied from one single preoperative dosage as standard practice in Bolzano, Italy (98%) to 1-day 4 doses in Norway (83% of the 40,709 TKAs reported to the Norwegian arthroplasty register). CONCLUSION: The proportion of ALBC usage in primary TKA varies internationally, with gentamicin being the most common antibiotic. ALBC in combination with SAP was common practice, with cefazolin the most common SAP agent. The type of ALBC and type, dose, and duration of SAP varied among participating countries.

Poor survivorship of total ankle replacements. 1368 cases from the period 1994-2021 in the Norwegian arthroplasty register.

BACKGROUND AND PURPOSE: The aim of the study was to present the performance of total ankle replacements (TAR) in a national register. METHODS: All surgeons in the country report to the Norwegian Arthroplasty Register. The completeness of primary TARs in NAR was 79-90% in the years 2017-2020. Cox regression analyses and the Kaplan-Meier method were used to study implant survival and revision risk. RESULTS: 1368 primary TAR´s were implanted in 1266 patients during the period 1994-2021. The last few years saw a marked decrease in the incidence of TARs. The overall survival at 5 years was 81.1% (80.9-81.3) and 69.3% (66.4-72.2) at 10 years. Higher age was strongly associated with better survival. Current prosthesis designs had a better survival than earlier designs ((HRR 0.7, 95% CI 0.6-0.9) CONCLUSION: Revision rates were high in our registry, but current implants had better survival. Younger age increased the risk of revision. LEVEL OF EVIDENCE: Level II: prospective cohort study.

The unmet need for treatment of children with musculoskeletal impairment in Malawi.

BACKGROUND: More than a billion people globally are living with disability and the prevalence is likely to increase rapidly in the coming years in low- and middle-income countries (LMICs). The vast majority of those living with disability are children residing in LMICs. There is very little reliable data on the epidemiology of musculoskeletal impairments (MSIs) in children and even less is available for Malawi. Previous studies in Malawi on childhood disability and the impact of musculoskeletal impairment (MSI) on the lives of children have been done but on a small scale and have not used disability measurement tools designed for children. Therefore in this study, we aimed to estimate the MSI prevalence, causes, and the treatment need among children aged 16 years or less in Malawi. METHODS: This study was carried out as a national cross sectional survey. Clusters were selected across the whole country through probability proportional to size sampling with an urban/rural and demographic split that matched the national distribution of the population. Clusters were distributed around all 27-mainland districts of Malawi. Population of Malawi was 18.3 million from 2018 estimates, based on age categories we estimated that about 8.9 million were 16 years and younger. MSI diagnosis from our randomized sample was extrapolated to the population of Malawi, confidence limits was calculated using normal approximation. RESULTS: Of 3792 children aged 16 or less who were enumerated, 3648 (96.2%) were examined and 236 were confirmed to have MSI, giving a prevalence of MSI of 6.5% (CI 5.7-7.3). Extrapolated to the Malawian population this means as many as 576,000 (95% CI 505,000-647,000) children could be living with MSI in Malawi. Overall, 46% of MSIs were due to congenital causes, 34% were neurological in origin, 8.4% were due to trauma, 7.8% were acquired non-traumatic non-infective causes, and 3.4% were due to infection. We estimated a total number of 112,000 (80,000-145,000) children in need of Prostheses and Orthoses (P&O), 42,000 (22,000-61,000) in need of mobility aids (including 37,000 wheel chairs), 73,000 (47,000-99,000) in need of medication, 59,000 (35,000-82,000) in need of physical therapy, and 20,000 (6000-33,000) children in need of orthopaedic surgery. Low parents' educational level was one factor associated with an increased risk of MSI. CONCLUSION: This survey has uncovered a large burden of MSI among children aged 16 and under in Malawi. The burden of musculoskeletal impairment in Malawi is mostly unattended, revealing a need to scale up both P&O services, physical & occupational therapy, and surgical services in the country.

Incidence and risk factors of intraoperative periprosthetic femoral fractures during primary total hip arthroplasty: 218,423 cases reported to the Norwegian Arthroplasty Register between 1987 and 2020.

BACKGROUND AND PURPOSE: Intraoperative periprosthetic femoral fractures (IPFFs) can occur during primary total hip arthroplasty (THA). We describe the incidence of IPFFs during THA in Norway and estimate potential risk factors that could be associated with IPFF Patients and methods - Data from the Norwegian Arthoplasty Register (1987-2020) was used: 2,268 IPFFs from 218,423 primary THAs in 172,598 patients. The following factors were analyzed: sex, age, diagnosis, previous operation on the same hip, surgical approach, and stem fixation technique. Association of these factors with IPFF risk was assessed using multivariable Poisson regression. RESULTS: IPFF occurred during 2,268 operations with an incidence of 1.0% among all primary THAs. The risk of IPFF was associated with female sex (relative risk 1.8; 99% CI 1.5-2.1), age 80-90 years and age over 90 years (compared with age 60-70 years: 1.3; CI 1.0-1.6 and 2.6; CI 1.6-4.3, respectively), non-osteoarthritis diagnoses (2.2; CI 1.9-2.6), previous surgery to the same hip (1.8; CI 1.5-2.2), lateral approach (compared with the posterior approach: 1.5; CI 1.1-2.0), and cementless stem fixation (2.7; CI 2.0-3.6). INTERPRETATION: Surgeons should be aware of the factors associated with an increased risk of IPFF: female sex, age above 80 years, non-osteoarthritis diagnoses, and previous surgery to the same hip. Cemented stem fixation and posterior approach should be favored in high-risk patients, such as elderly women.

Risk factors for revision surgery due to dislocation within 1 year after 111,711 primary total hip arthroplasties from 2005 to 2019: a study from the Norwegian Arthroplasty Register.

BACKGROUND AND PURPOSE: Dislocation of a hip prosthesis is the 3rd most frequent cause (after loosening and infection) for hip revision in Norway. Recently there has been a shift in surgical practice including preferred head size, surgical approach, articulation, and fixation. We explored factors associated with the risk of revision due to dislocation within 1 year and analyzed the impact of changes in surgical practice. PATIENTS AND METHODS: 111,711 cases of primary total hip arthroplasty (THA) from the Norwegian Arthroplasty Register were included (2005-2019) after primary THA with either 28 mm, 32 mm, or 36 mm femoral heads, or dualmobility articulations. A flexible parametric survival model was used to calculate hazard ratios for risk factors. Kaplan-Meier survival rates were calculated. RESULTS: There was an increased risk of revision due to dislocation with 28 mm femoral heads (HR 2.6, 95% CI 2.0-3.3) compared with 32 mm heads. Furthermore, there was a reduced risk of cemented fixation (HR 0.6, CI 0.5-0.8) and reverse hybrid (HR 0.6, CI 0.5-0.8) compared with uncemented. Also, both anterolateral (HR 0.5, CI 0.4-0.7) and lateral (HR 0.6, CI 0.5-0.7) approaches were associated with a reduced risk compared with the posterior approach. The time-period 2010-2014 had the lowest risk of revision due to dislocation. The trend during the study period was towards using larger head sizes, a posterior approach, and uncemented fixation for primary THA. INTERPRETATION: Patients with 28 mm head size, a posterior approach, or uncemented fixation had an increased risk of revision due to dislocation within 1 year after primary THA. The shift from lateral to posterior approach and more uncemented fixation was a plausible explanation for the increased risk of revision due to dislocation observed in the most recent time-period. The increased risk of revision due to dislocation was not fully compensated for by increasing femoral head size from 28 to 32 mm.

How Does Implant Survivorship Vary with Different Corail Femoral Stem Variants? Results of 51,212 Cases with Up to 30 Years Of Follow-up from the Norwegian Arthroplasty Register.

BACKGROUND: The Corail® cementless stem (DePuy Synthes) has been used in Norway since 1987 and is one of the most frequently used stems in THA worldwide. Although the published survival results of the standard Corail stem have been good, little is known about the long-term (more than 20 years) survival of other stem design variants. Further, some changes were made to the extramedullary part of the stem in 2003, and the effect of these changes on survival is unknown. QUESTIONS/PURPOSES: (1) What is the survival up to 30 years of the standard collarless Corail femoral stem, and were extramedullary changes (slimmer, polished and rectangular neck, shorter taper) associated with differences in survivorship? (2) How does the 10-year survival and the risk of revision of other Corail stem variants, including the standard collared stem, coxa vara collared stem, and high offset collarless stem, compare with those of the standard collarless stem? (3) Which factors are associated with an increased risk of revision of the Corail stem, and are there any differences in those factors among the four stem variants? METHODS: Data for this study were drawn from the Norwegian Arthroplasty Register. Since 1987, THAs have been registered in the Norwegian Arthroplasty Register with completeness of data greater than 97% for primary THAs and 93% for revisions. To study survivorship with up to 30 years of follow-up (1987 to 2018; median 7.7-year follow-up), and to compare the original stem with stems with extramedullary modifications, we included 28,928 standard collarless Corail stems in 24,893 patients (mean age at time of implantation 62 years; 66% [16,525 of 24,893] were women). To compare the newer stem variants with the standard collarless stem (2008 to 2018), we included 20,871 standard collarless, 10,335 standard collared, 6760 coxa vara collared, and 4801 high offset collarless stems. Survival probabilities were estimated using the Kaplan-Meier method with endpoints of stem revision, revision due to aseptic stem loosening, and periprosthetic fracture. The endpoint of all noninfectious causes of THA revision (including cup revision) was additionally analyzed for the long-term comparison. The proportion of patients who died was limited, and there was no difference in death rate between the groups compared. Therefore, we believe that competing events were not likely to influence survivorship estimates to a large degree. To compare different stem variants and evaluate factors that could be associated with the risk of revision, we calculated hazard ratios using Cox regression analyses with adjustments for gender, age group, surgical approach, diagnosis, and stem size. RESULTS: The 30-year Kaplan-Meier survival of the standard collarless stem was 88.4% (95% confidence interval 85.4% to 91.4%), 93.3% (95% CI 91.1% to 95.5%), and 94.4% (95% CI 92.0% to 96.8%) using stem revision for any noninfectious cause, aseptic loosening, and periprosthetic fracture of the femur as endpoints, respectively. There was no difference in survival between the original stem and the modified stem. The 10-year Kaplan-Meier survivorship free of stem revision (all causes including infection) was 97.6% (95% CI 97.2% to 98.0%) for the standard collarless stem, 99.0% (95% CI 98.8% to 99.2%) for the standard collared stem, 97.3% (95% CI 96.3% to 98.3%) for the coxa vara collared stem, and 95.0% (95% CI 93.6% to 96.4%) for the high offset collarless stem. Compared with the standard collarless stem, the standard collared stem performed better (HR 0.4 [95% CI 0.3 to 0.6]; p < 0.001) and the high offset collarless stem performed more poorly (HR 1.4 [95% CI 1.1 to 1.7]; p = 0.006) with any stem revision as the endpoint, and similar results were found with revision for aseptic stem loosening and periprosthetic fracture as endpoints. Controlling for the noted confounders, the standard collared stem had a lower revision risk. The high offset collarless stem had an increased stem revision risk for any reason (HR 1.4 [95% CI 1.1 to 1.7]; p = 0.006) and aseptic loosening (HR 1.6 [95% CI 1.1 to 2.3]; p = 0.022). Other factors associated with an increased risk of stem revision for all stem variants were being a man (HR 1.7 [95% CI 1.4 to 2.0]; p < 0.001), age 70 to 79 years and 80 years and older compared with the age group of 50 to 59 years (HR 1.6 [95% CI 1.2 to 2.0]; p < 0.001 and HR 1.9 [95% CI 1.4 to 2.6]; p < 0.001, respectively), the anterior approaches (direct anterior Smith-Petersen and anterolateral Watson-Jones combined) compared with the posterior approach (HR 1.4 [95% CI 1.1 to 1.7]; p = 0.005), as well as a preoperative nonosteoarthritis diagnosis (HR 1.3 [95% CI 1.0 to 1.6]; p = 0.02) and small stem sizes (sizes 8-11) compared with the medium sizes (sizes 12-15) (HR 1.4 [95% CI 1.1 to 1.6]; p = 0.001). The very small sizes (8 and 9) were associated with a 2.0 times higher risk of revision (95%. CI 1.4 to 2.6; p < 0.01) compared with all other sizes combined. CONCLUSION: When using the uncemented Corail stem, surgeons can expect good results with up to 30 years of follow-up. Our results should be generalizable to the typical surgeon at the average hospital in a comparable setting. From our results, using a collared variant would be preferable to a collarless one. Due to an increased risk of periprosthetic fracture, caution with the use of the uncemented Corail stem in patients older than 70 years, especially in women, is warranted. Poorer stem survival should also be expected with the use of small stem sizes. The risk of periprosthetic fractures for the Corail uncemented stem versus cemented stems in different age categories has not been extensively examined, nor has the use of a collar for different age groups and genders, and both should be subjects for further investigation. LEVEL OF EVIDENCE: Level III, therapeutic study.

Cost utility analysis of intramedullary nailing and skeletal traction treatment for patients with femoral shaft fractures in Malawi.

Background and purpose - In Malawi, both skeletal traction (ST) and intramedullary nailing (IMN) are used in the treatment of femoral shaft fractures, ST being the mainstay treatment. Previous studies have found that IMN has improved outcomes and is less expensive than ST. However, no cost-effectiveness analyses have yet compared IMN and ST in Malawi. We report the results of a cost-utility analysis (CUA) comparing treatment using either IMN or ST.Patients and methods - This was an economic evaluation study, where a CUA was done using a decision-tree model from the government healthcare payer and societal perspectives with an 1-year time horizon. We obtained EQ-5D-3L utility scores and probabilities from a prospective observational study assessing quality of life and function in 187 adult patients with femoral shaft fractures treated with either IMN or ST. The patients were followed up at 6 weeks, and 3, 6, and 12 months post-injury. Quality adjusted life years (QALYs) were calculated from utility scores using the area under the curve method. Direct treatment costs were obtained from a prospective micro costing study. Indirect costs included patient lost productivity, patient transportation, meals, and childcare costs associated with hospital stay and follow-up visits. Multiple sensitivity analyses assessed model uncertainty.Results - Total treatment costs were higher for ST ($1,349) compared with IMN ($1,122). QALYs were lower for ST than IMN, 0.71 (95% confidence interval [CI] 0.66-0.76) and 0.77 (CI 0.71-0.82) respectively. Based on lower cost and higher utility, IMN was the dominant strategy. IMN remained dominant in 94% of simulations. IMN would be less cost-effective than ST at a total procedure cost exceeding $880 from the payer's perspective, or $1,035 from the societal perspective.Interpretation - IMN was cost saving and more effective than ST in the treatment of adult femoral shaft fractures in Malawi, and may be an efficient use of limited healthcare resources.

Increasing but levelling out risk of revision due to infection after total hip arthroplasty: a study on 108,854 primary THAs in the Norwegian Arthroplasty Register from 2005 to 2019.

Background and purpose - Focus on prevention, surveillance, and treatment of infection after total hip arthroplasty (THA) in the last decade has resulted in new knowledge and guidelines. Previous publications have suggested an increased incidence of surgical revisions due to infection after THA. We assessed whether there have been changes in the risk of revision due to deep infection after primary THAs reported to the Norwegian Arthroplasty Register (NAR) over the period 2005-2019.Patients and methods - Primary THAs reported to the NAR from January 1, 2005 to December 31, 2019 were included. Adjusted Cox regression analyses with the first revision due to deep infection after primary THA were performed. We investigated changes in the risk of revision as a function of time of primary THA. Time was stratified into 5-year periods. We studied the whole population of THAs, and the subgroups: all-cemented, all-uncemented, reverse hybrid (cemented cup), and hybrid THAs (cemented stem). In addition, we investigated factors that were associated with the risk of revision, and changes in the time span from primary THA to revision.Results - Of the 108,854 primary THAs that met the inclusion criteria, 1,365 (1.3%) were revised due to deep infection. The risk of revision due to infection, at any time after primary surgery, increased through the period studied. Compared with THAs implanted in 2005-2009, the relative risk of revision due to infection was 1.4 (95% CI 1.2-1.7) for 2010-2014, and 1.6 (1.1-1.9) for 2015-2019. We found an increased risk for all types of implant fixation. Compared to 2005-2009, for all THAs, the risk of revision due to infection 0-30 days postoperatively was 2.2 (1.8-2.8) for 2010-2014 and 2.3 (1.8-2.9) for 2015-2019, 31-90 days postoperatively 1.0 (0.7-1.6) for 2010-2014 and 1.6 (1.0-2.5) for 2015-2019, and finally 91 days-1 year postoperatively 1.1 (0.7-1.8) for 2010-2014 and 1.6 (1.0-2.6) for 2015-2019. From 1 to 5 years postoperatively, the risk of revision due to infection was similar to 2005-2009 for both the subsequent time periodsInterpretation - The risk of revision due to deep infection after THA increased throughout the period 2005-2019, but appears to have levelled out after 2010. The increase was mainly due to an increased risk of early revisions, and may partly have been caused by a change of practice rather than a change in the incidence of infection.

Total hip arthroplasties in the Dutch Arthroplasty Register (LROI) and the Nordic Arthroplasty Register Association (NARA): comparison of patient and procedure characteristics in 475,685 cases.

Background and purpose - Collaborations between arthroplasty registries are important in order to create the possibility of detecting inferior implants early and improve our understanding of differences between nations in terms of indications and outcomes. In this registry study we compared patient and procedure characteristics, and revision rates in the Nordic Arthroplasty Register Association (NARA) database and the Dutch Arthroplasty Register (LROI).Patients and methods - All total hip arthroplasties (THAs) performed in 2010-2016 were included from the LROI (n = 184,862) and the NARA database (n = 290,823), which contains data from Denmark, Norway, Sweden, and Finland. Descriptive statistics and Kaplan-Meier survival analyses based on all reasons for revision and stratified by fixation were performed and compared between countries.Results - In the Netherlands, the proportion of patients aged < 55 years (9%) and male patients (34%) was lower than in Nordic countries (< 55 years 11-13%; males 35-43%); the proportion of osteoarthritis (OA) (87%) was higher compared with Sweden (81%), Norway (77%), and Denmark (81%) but comparable to Finland (86%). Uncemented fixation was used in 62% of patients in the Netherlands, in 70% of patients in Denmark and Finland, and in 28% and 19% in Norway and Sweden, respectively. The 5-year revision rate for THAs for OA was lower in Sweden (2.3%, 95% CI 2.1-2.5) than in the Netherlands (3.0%, CI 2.9-3.1), Norway (3.8%, CI 3.6-4.0), Denmark (4.6%, CI 4.4-4.8), and Finland (4.4%, CI 4.3-4.5). Revision rates in Denmark, Norway, and Finland were higher for all fixation groups.Interpretation - Patient and THA procedure characteristics as well as revision rates evinced some differences between the Netherlands and the Nordic countries. The Netherlands compared best with Denmark in terms of patient and procedure characteristics, but resembled Sweden more in terms of short-term revision risk. Combining data from registries like LROI and the NARA collaboration is feasible and might possibly enable tracking of potential outlier implants.

Metal ion levels in the blood of patients with metal-on-metal hip prostheses. / Metallionenivåer i blod fra pasienter med metall-mot-metall-hofteprotese.

BACKGROUND: A BHR (Birmingham hip resurfacing) prosthesis was implanted in 445 people in Norway. Adverse reactions can arise as a result of the release of metal ions from metal-on-metal joint surfaces made from cobalt-chromium alloy. The aim of the study was to analyse the release of metal ions during the first five years after surgery in patients with a BHR prosthesis and to investigate whether this was linked to clinical complications. MATERIAL AND METHOD: Forty-four male patients (median age 53 years) implanted with a BHR prosthesis at the Coastal Hospital at Hagevik in the period October 2009 to May 2013 were monitored by means of blood samples before implantation and three months, one year, three years and five years afterwards. Analyses of cobalt and chromium in whole blood were performed. Function scoring was used to clinically assess the prosthetic joint. RESULTS: Metal ion concentrations increased between the surgery date and one year later (p < 0.001), and subsequently remained stable. After five years, the median concentrations (min.- max.) of cobalt and chromium were 1.1 µg/L (0.4-6.3 µg/L) and 1.4 µg/L (0.4-11.7 µg/L) respectively for unilateral prostheses (n = 36), and 2.3 µg/L (1.6-28.5 µg/L) and 2.6 µg/L (1.7-14.1 µg/L) respectively for bilateral prostheses (n = 8). Five patients underwent revision surgery, while other patients had good hip function. INTERPRETATION: Patients with a BHR prosthesis had a significant increase in cobalt and chromium in their blood one to five years after surgery, but the median levels were still well below the threshold value of 7 µg/L, which indicates an increased risk of complications.

What Is the Frequency of Fracture of Ceramic Components in THA? Results from the Norwegian Arthroplasty Register from 1997 to 2017.

BACKGROUND: Ceramic bearings in THA have been used to reduce wear and, more recently, to avoid metals in the bearing because of the risk of metal ions adverse effects. Potential disadvantages to ceramic bearings are their brittleness and the ceramic fracture risk, which may lead to revision surgery. The frequency of revision for a fracture ceramic bearing, however, has not been thoroughly studied. QUESTIONS/PURPOSES: (1) What is the frequency of revision for a fractured ceramic bearing in ceramic-on-polyethylene (CoP) and ceramic-on-ceramic (CoC) THAs, and is there any difference between alumina ceramics and alumina matrix composites (AMC)? (2) What are the factors associated with this complication? (3) To what extent did the patients who underwent revision for a fractured ceramic bearing undergo subsequent revisions, and for what reason? METHODS: The Norwegian Arthroplasty Register has collected data on hip arthroplasty since 1987 and has a completeness of reporting of 97.3% for primary THAs and 93.3% for revision. From 1997 to 2017, 146,171 primary THAs were registered in the Norwegian Arthroplasty Register. Of these, 31,479 had a CoP articulation and 5790 had a CoC articulation. Two manufacturers produced ceramic heads; one produced 25,678 alumina heads and the other made 2465 alumina heads. All 7901 AMC heads were made by the same manufacturer. Patients who underwent CoP THA were a median (range) of 63 years old (11 to 98) and CoC THA were a median (range) 61 years old (17 to 95); 38% (11,833 of 31,479) of the patients who underwent CoP THA and 41% (2379 of 5790) of the patients who underwent CoC THA were males. Femoral heads made of alumina (n = 28,143), zirconia (n = 1225), and AMC (n = 7901) ceramics were used. To assess revision frequency, we identified patients who underwent revision because of fracture of a ceramic head and/or liner, and calculated the Kaplan-Meier survivorship free of revision for fracture in CoC and CoP articulations. Alumina ceramics and AMC were compared. In terms of factors potentially associated with revision, patient factors (age, sex, and diagnosis), type of articulation (CoP or CoC), femoral head size, and femoral head/neck length were evaluated with Cox regression models to evaluate any association with ceramic fracture and a Poisson regression to compare alumina and AMC head fractures. To evaluate subsequent revisions, hips that were revised for ceramic fracture were evaluated for any further revisions; Kaplan-Meier survivorship free of further revisions was calculated, and revision causes were identified. RESULTS: Survivorship free from revision for ceramic fracture was 99.9% (95% CI 99.9 to 99.9) for CoP bearings, and 99.8% (95% CI 99.6 to 100) for CoC bearings at 10 years, with 7467 and 1884 hips at risk in the two groups, respectively. The hazard ratio for ceramic head fracture was 3.6 (95% CI 1.7 to 7.6) for CoC compared with CoP. The risk of fracture was greater for alumina ceramics than for AMC heads (adjusted HR 14.1 [95% CI 4.2 to 47.0]; p < 0.001). Factors that were associated with revision for fracture of a ceramic head were male sex (HR 5.2 [95% CI 2.6 to 10.4]; p < 0.001), a CoC articulation compared with CoP (HR 3.6 [95% CI 1.7 to 7.6]; p = 0.001), a 28-mm femoral head compared with a 32-mm head (HR 2.7 [95% CI 1.1 to 6.4]; p = 0.02), and short head/neck length compared with a medium head/neck length (HR 2.5 [95% CI 1.1 to 5.3]; p = 0.03). Five of 50 patients undergoing revision for ceramic fracture underwent further revisions, resulting in a 5-year survivorship free from re-revision of 86% (95% CI 74.4 to 98.0). The reasons for re-revision were infection (n = 2), another ceramic head fracture (n = 2), and cup loosening (n = 1). CONCLUSIONS: Fracture of a ceramic THA bearing is rare and seems to affect about one in 1000 patients who receive such a bearing. To minimize the risk of this complication, surgeons should avoid small femoral heads (< 32 mm) and the shortest head/neck lengths. Surgeons should also know that the risk is increased in CoC articulations and in males. Bearings made of AMC appear to be at lower risk than those made from alumina ceramics. However, the long-term clinical wear performance of AMC bearings has not been extensively studied and should be studied further. LEVEL OF EVIDENCE: Level III, therapeutic study.

Is there a weekend effect after hip fracture surgery? A study of 74,410 hip fractures reported to the Norwegian Hip Fracture Register.

Background and purpose - The term "weekend effect" describes differences in outcomes between patients treated at weekends compared with weekdays. We investigated whether there is a weekend effect for the risk of reoperation and mortality after hip fracture surgery at Norwegian hospitals.Patients and methods - We included data from 76,410 hip fractures in patients 60 years and older reported to the Norwegian Hip Fracture Register (NHFR) between 2005 and 2017. Cox survival analyses with adjustments for age, sex, ASA class, type of fracture, operating method, and waiting time from fracture to surgery were used to calculate the risk of reoperation and death after surgeries performed at weekends compared with surgeries performed on weekdays.Results - The mean age for all patients was 82 years, and 71% were female. 73% of fractures occurred on weekdays (Monday to Friday) and 27% during weekends (Saturday and Sunday). 71% of fractures were operated on a weekday and 29% at a weekend. Slightly increased mortality was observed during the 2 first months after weekend admission with hip fracture (HR 1.08; 95% CI 1.03-1.14). This did not continue in subsequent months, but the initial effect of weekend presentation was still apparent at 1-year follow-up. Further, there was no difference in mortality between patients who were operated at a weekend and patients operated on a weekday. Neither were there any differences in the risk of reoperation between weekday and weekend when comparing day of fracture or day of surgery.Interpretation - Patients who suffered a hip fracture during a weekend had slightly increased mortality in the first 2 months postoperatively. Whether the surgery was done on weekdays or at weekends did not affect mortality or the risk of reoperation.