| 1. |
- Evangelou, Evangelos, et al.
(författare)
-
A meta-analysis of genome-wide association studies identifies novel variants associated with osteoarthritis of the hip
- 2014
-
Ingår i: Annals of the Rheumatic Diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 73:12, s. 2130-2136
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives Osteoarthritis (OA) is the most common form of arthritis with a clear genetic component. To identify novel loci associated with hip OA we performed a meta-analysis of genome-wide association studies (GWAS) on European subjects. Methods We performed a two-stage meta-analysis on more than 78 000 participants. In stage 1, we synthesised data from eight GWAS whereas data from 10 centres were used for 'in silico' or 'de novo' replication. Besides the main analysis, a stratified by sex analysis was performed to detect possible sex-specific signals. Meta-analysis was performed using inverse-variance fixed effects models. A random effects approach was also used. Results We accumulated 11 277 cases of radiographic and symptomatic hip OA. We prioritised eight single nucleotide polymorphism (SNPs) for follow-up in the discovery stage (4349 OA cases); five from the combined analysis, two male specific and one female specific. One locus, at 20q13, represented by rs6094710 (minor allele frequency (MAF) 4%) near the NCOA3 (nuclear receptor coactivator 3) gene, reached genome-wide significance level with p=7.9x10(-9) and OR=1.28 (95% CI 1.18 to 1.39) in the combined analysis of discovery (p= 5.6x10(-8)) and follow-up studies (p=7.3x10(-4)). We showed that this gene is expressed in articular cartilage and its expression was significantly reduced in OA-affected cartilage. Moreover, two loci remained suggestive associated; rs5009270 at 7q31 (MAF 30%, p=9.9x10(-7), OR=1.10) and rs3757837 at 7p13 (MAF 6%, p=2.2x10(-6), OR=1.27 in male specific analysis). Conclusions Novel genetic loci for hip OA were found in this meta-analysis of GWAS.
|
|
| 2. |
- Hoogervorst, Lotje A., et al.
(författare)
-
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review
- 2023
-
Ingår i: International Journal of Health Policy and Management. - : Kerman University of Medical Sciences. - 2322-5939 .- 2322-5939. ; 12:1, s. 1-11
-
Forskningsöversikt (refereegranskat)abstract
- Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformite Europeenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.
|
|
| 3. |
- Leta, Tesfaye H., et al.
(författare)
-
Periprosthetic Joint Infection After Total Knee Arthroplasty With or Without Antibiotic Bone Cement
- 2024
-
Ingår i: JAMA Network Open. - 2574-3805. ; 7:5, s. 2412898-2412898
-
Tidskriftsartikel (refereegranskat)abstract
- Importance: Despite increased use of antibiotic-loaded bone cement (ALBC) in joint arthroplasty over recent decades, current evidence for prophylactic use of ALBC to reduce risk of periprosthetic joint infection (PJI) is insufficient. Objective: To compare the rate of revision attributed to PJI following primary total knee arthroplasty (TKA) using ALBC vs plain bone cement. Design, Setting, and Participants: This international cohort study used data from 14 national or regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, New Zealand, Norway, Romania, Sweden, Switzerland, the Netherlands, the UK, and the US. The study included primary TKAs for osteoarthritis registered from January 1, 2010, to December 31, 2020, and followed-up until December 31, 2021. Data analysis was performed from April to September 2023. Exposure: Primary TKA with ALBC vs plain bone cement. Main Outcomes and Measures: The primary outcome was risk of 1-year revision for PJI. Using a distributed data network analysis method, data were harmonized, and a cumulative revision rate was calculated (1 - Kaplan-Meier), and Cox regression analyses were performed within the 10 registries using both cement types. A meta-analysis was then performed to combine all aggregated data and evaluate the risk of 1-year revision for PJI and all causes. Results: Among 2 168 924 TKAs included, 93% were performed with ALBC. Most TKAs were performed in female patients (59.5%) and patients aged 65 to 74 years (39.9%), fully cemented (92.2%), and in the 2015 to 2020 period (62.5%). All participating registries reported a cumulative 1-year revision rate for PJI of less than 1% following primary TKA with ALBC (range, 0.21%-0.80%) and with plain bone cement (range, 0.23%-0.70%). The meta-analyses based on adjusted Cox regression for 1 917 190 TKAs showed no statistically significant difference at 1 year in risk of revision for PJI (hazard rate ratio, 1.16; 95% CI, 0.89-1.52) or for all causes (hazard rate ratio, 1.12; 95% CI, 0.89-1.40) among TKAs performed with ALBC vs plain bone cement. Conclusions and Relevance: In this study, the risk of revision for PJI was similar between ALBC and plain bone cement following primary TKA. Any additional costs of ALBC and its relative value in reducing revision risk should be considered in the context of the overall health care delivery system.
|
|
| 4. |
- Leta, Tesfaye H., et al.
(författare)
-
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
- 2023
-
Ingår i: Acta Orthopaedica. - 1745-3674 .- 1745-3682. ; 94, s. 416-425
-
Tidskriftsartikel (refereegranskat)abstract
- 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, Den-mark, 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.
|
|
| 5. |
- Nelissen, Rob G H H, et al.
(författare)
-
RSA and registries: the quest for phased introduction of new implants.
- 2011
-
Ingår i: The Journal of bone and joint surgery. American volume. - 1535-1386. ; 93 Suppl 3, s. 62-5
-
Tidskriftsartikel (refereegranskat)abstract
- Although the overall survival of knee and hip prostheses at ten years averages 90%, recent problems with several hip and knee prostheses have illustrated that the orthopaedic community, industry, and regulators can still further improve patient safety. Given the early predictive properties of roentgen stereophotogrammetric analysis (RSA) and the meticulous follow-up of national joint registries, these two methods are ideal tools for such a phased clinical introduction. In this paper, we elaborate on the predictive power of RSA within a two-year follow-up after arthroplasty and its relationship to national joint registries. The association between RSA prosthesis-migration data and registry data is evaluated.The five-year rate of revision of RSA-tested total knee replacements was compared with that of non-RSA-tested total knee replacements. Data were extracted from the published results of the national joint registries of Sweden, Australia, and New Zealand.There was a 22% to 35% reduction in the number of revisions of RSA-tested total knee replacements as compared with non-RSA-tested total knee replacements in the national joint registries. Assuming that the total cost of total knee arthroplasty is $37,000 in the United States, a 22% to 35% reduction in the number of revisions (currently close to 55,000 annually) could lead to an estimated annual savings of over $400 million to the health-care system.The phased clinical introduction of new prostheses with two-year RSA results as a qualitative tool could lead to better patient care and could reduce the costs associated with revision total knee arthroplasty. Follow-up in registries is necessary to substantiate these results and to improve post-market surveillance.
|
|
| 6. |
- van Hamersveld, Koen T., et al.
(författare)
-
Risk Factors for Tibial Component Loosening : A Meta-Analysis of Long-Term Follow-up Radiostereometric Analysis Data
- 2021
-
Ingår i: Journal of Bone and Joint Surgery. American volume. - : NLM. - 0021-9355 .- 1535-1386. ; 103:12, s. 1115-1124
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Radiostereometric analysis (RSA) is a highly accurate tool to detect implant migration and predict loosening following total knee arthroplasty (TKA). However, little is known about the predisposing risk factors for implant migration, nor which migration profile should be considered physiological (i.e., merely part of an implant-settling phase) and which should be considered pathological (i.e., having a high probability for implant loosening). By pooling individual participant data from long-term follow-up RSA studies, we aimed to identify predisposing risk factors for tibial component loosening.METHODS: Individual data were collected for 630 patients from 11 RSA studies. The repeated measurements were analyzed with use of a linear mixed-effects model, determining the effect of age, sex, body mass index, diagnosis, preoperative and postoperative limb alignment, and prosthesis characteristics on tibial component migration over time, taking into account the clustering of patients within studies.RESULTS: High initial migration was found to result in early mechanical loosening in 18 cases (2.9%) and septic loosening in 2 cases (0.3%), whereas stabilization of high initial migration occurred in 17 cases (2.7%). Late loosening occurred in 13 cases (2.1%). All other 580 cases (92.1%) showed early stabilization and remained stable over time. Mixed-effects model analyses showed that for cemented prostheses, sex, diagnosis, and posterior cruciate ligament type had an effect on migration, but these differences were nonsignificant when analyzing migration from 3 months onwards. Uncemented prostheses aligned in varus showed more migration than neutrally and valgus-aligned TKAs (p = 0.031), and this difference increased over time (p < 0.001). Significantly higher migration was observed following uncemented TKA without an osseointegration-promoting surface (p < 0.001).CONCLUSIONS: For cemented prostheses, increased migration during the first 3 postoperative months was observed for female patients, patients with rheumatoid arthritis, and patients who underwent a posterior-stabilized TKA. For uncemented prostheses, both postoperative varus alignment of the lower limb and the absence of an osseointegration-promoting surface significantly increased postoperative tibial component migration.LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.
|
|
| 7. |
- Hasan, Shaho, et al.
(författare)
-
All-polyethylene versus metal-backed posterior stabilized total knee arthroplasty : similar 2-year results of a randomized radiostereometric analysis study
- 2019
-
Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 90:6, s. 590-595
-
Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — The all-polyethylene tibial (APT) component, introduced in the early 1970s, was surpassed by metal-backed tibial (MBT) trays as the first choice for total knee arthroplasty (TKA). With improved polyethylene, the modern APT components can reduce costs, and have shown equivalent results in survivorship and early migration of the cruciate-retaining and cruciate-stabilizing designs. This study compares the 2-year migration of a similarly designed APT-posterior stabilized (PS) and a MBT-PS TKA, using radiostereometric analysis (RSA). Patients and methods — 60 patients were randomized to receive either an APT Triathlon PS or an MBT Triathlon PS TKA (Stryker, NJ, USA). Migration measured by RSA and clinical scores were evaluated at baseline and at 3, 12, and 24 months postoperatively. Repeated measurements were analyzed with a linear mixed model and generalized estimating equations. Results — The mean maximum total point movement (MTPM) at 3, 12, and 24 months was 0.41 mm (95% CI 0.33–0.50), 0.57 mm (0.44–0.70), and 0.56 mm (0.42–0.69) respectively in the MBT group and 0.46 mm (0.36–0.57), 0.61 mm (0.49–0.73), and 0.64 mm (0.50–0.77) in the APT group. 2 MBT and 1 APT implant were considered unstable at the 2-year follow-up. The KSS Knee score and KSS Function across 3, 12, and 24 months were comparable in both groups. Interpretation — For an APT-PS designed component, MTPM measured with RSA is comparable to the MBT-PS component after 2 years of follow-up. No differences in complications or clinical outcomes were found.
|
|
| 8. |
- Hasan, Shaho, et al.
(författare)
-
Late stabilization after initial migration in patients undergoing cemented total knee arthroplasty : a 5-year followup of 2 randomized controlled trials using radiostereometric analysis
- 2022
-
Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3682 .- 1745-3674. ; 93, s. 271-276
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND PURPOSE: In total knee arthroplasty (TKA), metal-backed (MBT) and all-polyethylene (APT) designs have shown comparable implant migration up to 2 years postoperatively using radiostereometric analysis (RSA). However, studies comparing mid-term migration of both designs are lacking. Furthermore, continuously migrating TKAs up to 2 years may continue to migrate or stabilize thereafter. Therefore, we compared 5-year migration of MBT and APT using either cruciate-stabilizing (CS) or posteriorstabilizing (PS) designs and specifically assessed migration profiles of continuously migrating TKAs beyond 2 years. PATIENTS AND METHODS: The present study includes results from 2 randomized trials comparing migration of cemented MBT with APT of either CS (CS study, n = 59) or PS (PS study, n = 56) design. 2 surgeons performed all surgeries. We used a linear mixed model for the analyses. RESULTS: The overall migration between MBT and APT TKAs was similar for either the CS or PS design over a 5-year period. In both studies combined, 9 implants showed continuous migration in the second postoperative year, of which 1 (APT-CS) was revised for instability, 4 (2 MBT-CS, MBT-PS, APT-PS) stabilized, and 4 (2 MBT-CS, APT-CS, MBT-PS) lacked 5-year data. INTERPRETATION: Overall migration was similar between MBT and APT TKAs up to 5 years, for both the CS and PS design. 4 initially migrating TKAs stabilized between 2- and 5-year follow-up, stressing the need for longer-term followup to determine whether second-year continuous migration correctly predicts loosening.
|
|
| 9. |
- Hasan, Shaho, et al.
(författare)
-
The Influence of Postoperative Coronal Alignment on Tibial Migration After Total Knee Arthroplasty in Preoperative Varus and Valgus Knees : A Secondary Analysis of 10 Randomized Controlled Trials Using Radiostereometric Analysis
- 2021
-
Ingår i: The Journal of bone and joint surgery. American volume. - 1535-1386. ; 103:24, s. 2281-2290
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Orthopaedic surgeons aim for mechanical alignment when performing total knee arthroplasty (TKA) as malalignment is associated with loosening. Loosening may be predicted by migration as measured with radiostereometric analysis (RSA), but previous RSA studies on postoperative alignment have shown contradictory results and have been limited to cemented implants and small numbers of patients. Therefore, we performed a secondary analysis of 10 previously published randomized controlled trials (RCTs) to compare migration between postoperative in-range and out-of-range cemented and uncemented TKA implants among patients with a preoperative varus or valgus knee. METHODS: All RCTs involving the use of RSA that had been conducted at 2 centers were included. Alignment was classified, with use of the hip-knee-ankle angle (HKA), as in-range (0° ± 3°) or out-of-range (<-3° or >3°). The fixation methods included cemented, uncemented-coated, and uncemented-uncoated. Migration was measured at 3, 12, and 24 months. A linear mixed model was used, with adjustment for fixation method and clustering of patients within centers. RESULTS: Of 476 TKA implants that had been out-of-range preoperatively, 290 were in-range postoperatively and 186 were out-of-range in either varus (n = 143) or valgus (n = 43) postoperatively. The mean migration at 3, 12, and 24 months was 0.73 mm (95% confidence interval [CI], 0.66 to 0.79 mm), 0.92 mm (95% CI, 0.85 to 1.00 mm), and 0.97 mm (95% CI, 0.90 to 1.05 mm), respectively, for the in-range group and 0.80 mm (95% CI, 0.72 to 0.87 mm), 0.98 (95% CI, 0.90 to 1.07 mm), and 1.04 mm (95% CI, 0.95 to 1.13 mm), respectively, for the out-of-range group (p = 0.07). The fixation method significantly influenced migration, with uncemented-uncoated implants migrating more than cemented and uncemented-coated implants (p < 0.001). CONCLUSIONS: Postoperative alignment did not influence migration of TKAs in the first 2 postoperative years in patients with preoperative varus or valgus alignment of the knee. However, the fixation method significantly influenced migration, with uncemented-uncoated implants showing the greatest migration. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
|
|
| 10. |
- Lewis, Peter L., et al.
(författare)
-
Short-term Revision Risk of Patellofemoral Arthroplasty Is High : An Analysis from Eight Large Arthroplasty Registries
- 2020
-
Ingår i: Clinical Orthopaedics and Related Research. - 0009-921X. ; 478:6, s. 1222-1231
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Patellofemoral arthroplasty (PFA) is one option for the treatment of isolated patellofemoral osteoarthritis, but there are limited data regarding the procedure and results. Because isolated patellofemoral arthritis is relatively uncommon, available case series generally are small, and even within national registries, sample sizes are limited. Combining data from multiple registries may aid in assessing worldwide PFA usage and survivorship. QUESTIONS/PURPOSES: We combined and compared data from multiple large arthroplasty registries worldwide to ask: (1) What proportion of patients undergoing primary knee arthroplasty have PFA? (2) What are the patient and prosthesis characteristics associated with PFA in common practice, as reflected in registries? (3) What is the survivorship free from revision of PFA and what are the reasons for and types of revisions? METHODS: Data were provided by eight registries that are members of the International Society of Arthroplasty Registries (ISAR) who agreed to share aggregate data: Australia, New Zealand, Canada, Sweden, Finland, Norway, the Netherlands, and the United States. De-identified data were obtained for PFA performed from either the beginning of year 2000, or the earliest recorded implantation date after that in each individual registry when PFA data collection commenced, up to December 31, 2016. This included patient demographics, implant use, all-cause revision rate (determined by cumulative percent revision [CPR]), and reasons for and type of revision. RESULTS: During the data collection period, 6784 PFAs were performed in the eight countries. PFAs comprised less than 1% of primary knee replacements in all registries. Patient demographics were comparable in all countries. Patients were generally more likely to be women than men, and the mean age ranged from 50 years to 60 years. All registries showed a high rate of revision for PFA. The 5-year CPR for any reason ranged from 8.0% (95% CI 4.5 to 11.5) in Norway to 18.1% (95% CI 15.5 to 20.7) in the Netherlands. The most common reason for revision across all countries was disease progression (42%, 434 of 1034). Most PFAs (83%, 810 of 980) were revised to a TKA. CONCLUSIONS: The revision risk of PFA in all registries surveyed was more than three times higher than the reported revision risk of TKA at the same times. The survivorship of PFA is similar to that of the no-longer-used procedure of metal-on-metal conventional hip replacement. Although there may be potential functional benefits from PFA, these findings of consistent and alarmingly high rates of revision should create concern, particularly as this procedure is often used in younger patients. LEVEL OF EVIDENCE: Level III, therapeutic study.
|
|
