Acta OrthopaedicaPub Date : 2024-12-10DOI: 10.2340/17453674.2024.42183
Anne M C Roerink, Rob G H H Nelissen, Carl Holder, Stephen E Graves, Michael Dunbar, Eric Bohm, Alexander W Grimberg, Arnd Steinbrück, Håvard Dale, Anne Marie Fenstad, Ashley W Blom, Erik Lenguerrand, Christopher Frampton, Tine Willems, Jan Victor, Mireia Espallargues, Jorge Arias-de la Torre, Enrico Ciminello, Marina Torre, Bart G Pijls
{"title":"Sex-based differences in risk of revision for infection after hip, knee, shoulder, and ankle arthroplasty in osteoarthritis patients: a multinational registry study of 4,800,000 implants.","authors":"Anne M C Roerink, Rob G H H Nelissen, Carl Holder, Stephen E Graves, Michael Dunbar, Eric Bohm, Alexander W Grimberg, Arnd Steinbrück, Håvard Dale, Anne Marie Fenstad, Ashley W Blom, Erik Lenguerrand, Christopher Frampton, Tine Willems, Jan Victor, Mireia Espallargues, Jorge Arias-de la Torre, Enrico Ciminello, Marina Torre, Bart G Pijls","doi":"10.2340/17453674.2024.42183","DOIUrl":"10.2340/17453674.2024.42183","url":null,"abstract":"<p><strong>Background and purpose: </strong> We aimed to determine sex differences for periprosthetic joint infections after primary arthroplasty of the hip, knee, ankle, and shoulder in osteoarthritis patients in an international perspective.</p><p><strong>Methods: </strong> This is a multinational combined arthroplasty registry study. Each arthroplasty registry performed Cox-regression analysis of their data and reported the crude and adjusted hazard ratios (HR) with an a priori designed data form. A random-effects model was used to pool these HRs to estimate an overall HR with 95% confidence interval (CI). Adjustment was undertaken for patient age, BMI, ASA grade, type of fixation, and type of implant. 9 arthroplasty registries participated. Patients who received primary total joint arthroplasty for primary osteoarthritis were considered: 2,134,313 hip arthroplasties, 2,658,237 knee arthroplasties, 57,889 shoulder arthroplasties, and 8,445 ankle arthroplasties. We calculated hazard ratios (HR) for the overall risk of complete revision due to infection for each implant type and follow-up.</p><p><strong>Results: </strong>The pooled HR for revision due to infection for men compared with women at 1-year follow-up was 1.60 (95% confidence interval [CI] 1.42-1.80) for hip arthroplasties; 2.06 (CI 1.90-2.46) for knee arthroplasties; 4.51 (CI 2.99-6.80) for shoulder arthroplasties; and 0.87 (CI 0.46-1.62) for ankle arthroplasties. These results remained consistent over time and were identified in both unadjusted and adjusted models.</p><p><strong>Conclusion: </strong> Men have a higher risk of revision due to infection than women after primary hip, knee, and shoulder arthroplasty. No evidence of difference was found for ankle arthroplasty. These elevated relative risks persist in the fully adjusted investigations and over the 10-year postoperative period studied.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"730-736"},"PeriodicalIF":2.5,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11632196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-12-10DOI: 10.2340/17453674.2024.42448
Mark Stegeman, Nathalie Pruijn, Saskia Susan, Petra J C Heesterbeek, Jan Willem K Louwerens
{"title":"Open versus arthroscopic fusion of the subtalar joint: a randomized controlled trial.","authors":"Mark Stegeman, Nathalie Pruijn, Saskia Susan, Petra J C Heesterbeek, Jan Willem K Louwerens","doi":"10.2340/17453674.2024.42448","DOIUrl":"10.2340/17453674.2024.42448","url":null,"abstract":"<p><strong>Background and purpose: </strong> Our primary aim was to compare the early complication rate (< 6 weeks postoperatively) after open or arthroscopic fusion of the subtalar joint. Secondary outcomes included late complications (> 6 weeks postoperatively), function, pain, and patient satisfaction.</p><p><strong>Methods: </strong> In this prospective randomized controlled trial, patients listed for subtalar joint fusion were included and randomized for open or arthroscopic fusion. Complications were assessed at scheduled visits at 2 and 6 weeks, 3, 6, and 12 months postoperatively. Functional scores, pain scores, and patient satisfaction were assessed at 3, 6, and 12 months postoperatively, and PROMS at baseline (preoperatively), 3, 6, and 12 months postoperatively. The scores were compared over time between the groups using Fisher's exact test and linear mixed models.</p><p><strong>Results: </strong> 51 patients were included between 2013 and 2020, of whom 25 were allocated to open and 26 to arthroscopic fusion. 3 early complications (2 sural nerve lesions, 1 infection) occurred in the open fusion group (12%; 95% confidence interval [CI] 3-32) and 3 (2 wound healing problems, 1 screw exchange) in the arthroscopic group (12%; CI 3-31). Late complications included screw removal (n = 5) in the open fusion group versus screw removal (n = 5), non-union (n = 2), bony prominence/calcification removal (n = 1), sural nerve lesion (n = 1), lesion of the calcaneal branch of the tibial nerve (n = 1), complex regional pain syndrome type II (n = 1), and secondary plantar fasciitis (n = 1) in the arthroscopic fusion group. No superiority of arthroscopic over open fusion was found regarding early (P = 1.0) and late complications (P = 0.2), function and pain scores, and patient satisfaction over 12 months Conclusion: Arthroscopic fusion did not result in fewer early complications compared with open fusion. Secondary outcomes did not differ significantly between the approaches.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"723-729"},"PeriodicalIF":2.5,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11632194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-29DOI: 10.2340/17453674.2024.42360
Irene Katharina Sigmund, Antony J R Palmer, Andrew J Hotchen, Martin A McNally, Bernadette C Young, Abtin Alvand, Adrian Taylor, Benjamin John Lee Kendrick
{"title":"The use of antibiotic-loaded calcium sulphate beads in debridement, antibiotics, and implant retention (DAIR) for periprosthetic infections: a retrospective comparative cohort on outcome.","authors":"Irene Katharina Sigmund, Antony J R Palmer, Andrew J Hotchen, Martin A McNally, Bernadette C Young, Abtin Alvand, Adrian Taylor, Benjamin John Lee Kendrick","doi":"10.2340/17453674.2024.42360","DOIUrl":"10.2340/17453674.2024.42360","url":null,"abstract":"<p><strong>Background and purpose: </strong> We aimed to compare the effect of calcium sulphate (CS) beads loaded with antibiotics on infection eradication in debridement, antibiotics, and implant retention (DAIR) of periprosthetic joint infection relative to DAIR without local antibiotics delivery.</p><p><strong>Methods: </strong> 176 patients with hip or knee arthroplasty undergoing DAIR were retrospectively identified and divided into a bead group (n = 102) and a control group (n = 74). Infections were classified as early postoperative, acute hematogenous, and chronic. Logistic regression analyses were performed on the use of CS beads. Revision-free and infection-free survival was estimated using Kaplan-Meier analysis.</p><p><strong>Results: </strong> Reinfection occurred in 36% of the bead group, and 39% of the control group (odds ratio [OR] 0.9, 95% confidence interval [CI] 0.5- 1.6); reoperation rates were 34% and 43% (OR 0.7, CI 0.4-1.3). Kaplan-Meier analysis showed no statistically significant difference between the 2 groups regarding infection-free (HR 1.1, CI 0.7-1.8) and revision-free (HR 1.1, CI 0.7-1.9) survival rates. In acute hematogenous PJIs, reinfection (29% vs 56%, OR 0.3, CI 0.1-1.1) and reoperation rates (25% vs 61%, OR 0.2, CI 0.1-0.8) were reduced when CS beads were used; Kaplan-Meier analysis revealed higher infection-free (HR 0.5, CI 0.2-1.4) and revision-free (HR 0.5, CI 0.2-1.3) survival rates in the bead group but not of statistical significance. Wound drainage was not increased by CS beads use (OR 1.0, CI 0.99-1.01), but hypercalcemia was seen in 9% in the bead group.</p><p><strong>Conclusion: </strong> DAIR with antibiotic-loaded CS beads did not improve outcome in early postoperative and chronic PJIs, but reduced the reoperation rate in acute haematogenous infections with similar results compared with early postoperative PJIs.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"707-714"},"PeriodicalIF":2.5,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605582/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-29DOI: 10.2340/17453674.2024.42488
Ali Yalcinkaya, Ole Rahbek, Maria Tirta, Jette Frost Jepsen, Michael Skovdal Rathleff, Christopher Iobst, Søren Kold
{"title":"Outcomes and outcome measurement instruments in lower-limb lengthening surgery: a scoping review to inform core outcome set development.","authors":"Ali Yalcinkaya, Ole Rahbek, Maria Tirta, Jette Frost Jepsen, Michael Skovdal Rathleff, Christopher Iobst, Søren Kold","doi":"10.2340/17453674.2024.42488","DOIUrl":"10.2340/17453674.2024.42488","url":null,"abstract":"<p><strong>Background and purpose: </strong> The heterogeneous outcomes used in lower-limb lengthening surgery (LLLS) complicate evidence synthesis, weakening systematic reviews and clinical recommendations, and reducing research impact. This scoping review maps the outcomes and outcome measurement instruments (OMIs) used in LLLS.</p><p><strong>Methods: </strong>This pre-registered review systematically identified studies reporting outcomes in adults or children who underwent LLLS. Outcomes and OMIs were extracted verbatim, and experts grouped outcome terms under headings using the COMET taxonomy.</p><p><strong>Results: </strong> The search found 5,308 unique hits, including 149 studies from 2020-2024. They reported 2,939 verbatim outcomes, which were consolidated into 92 outcome headings and 27 subheadings. \"Life impact\" accounted for 13%, while \"Clinical outcomes\" represented 83% of all outcomes. Among the clinical outcomes, \"Musculoskeletal and connective tissue\" was the most reported outcome domain (68% of all outcomes). The most frequently reported outcomes were \"Lengthening,\" \"Bone healing,\" \"Range of motion,\" \"Limb alignment\", and \"Complications.\"</p><p><strong>Conclusion: </strong> Outcomes reported for people undergoing LLLS are heterogeneous and vary widely in the definitions and measurement tools used to collect them. Outcomes likely to be important to patients (life impact outcomes), such as quality of life and measures of physical function, are rarely reported.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"715-722"},"PeriodicalIF":2.5,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-28DOI: 10.2340/17453674.2024.42490
Moritz F Lodde, Christoph Katthagen, Matthias Klimek, Karl Abshagen, Christian Peez, Arian Große-Allermann, Michael J Raschke, Oliver Riesenbeck
{"title":"Angular stable plate fixation provides favorable biomechanical stability in simulated T-shaped acetabular fractures: a biomechanical study.","authors":"Moritz F Lodde, Christoph Katthagen, Matthias Klimek, Karl Abshagen, Christian Peez, Arian Große-Allermann, Michael J Raschke, Oliver Riesenbeck","doi":"10.2340/17453674.2024.42490","DOIUrl":"10.2340/17453674.2024.42490","url":null,"abstract":"<p><strong>Background and purpose: </strong> The treatment of acetabular fractures remains technically demanding. In the case of reduced bone quality or fracture morphology reducing the amount of bone available for fixation, locking plates should provide considerable advantages. The aim of the present study was to compare conventional and locking plate fixation. It was hypothesized that locking plate fixation provides less displacement and higher construct stiffness.</p><p><strong>Methods: </strong> A T-shaped acetabular fracture was simulated in 16 synthetic pelvic models. The fracture was addressed with a biplanar 10-hole 2-column plate buttressing the medial acetabular wall. Optical markers were attached to the fracture sites for motion tracking. Standardization of the acetabulum loading mechanism was performed using a unipolar hemiarthroplasty. The primary outcome measure was displacement at the fracture sites. The secondary outcome measure was the construct stiffness (N/mm).</p><p><strong>Results: </strong> Fracture displacement was less in the group of angular stable implants compared with the group fixed with conventional non-locking implants. Under cyclic loading displacement was less in the group of locking plate fixation. No differences in mean initial axial stiffness were detected between locking plate fixation (407 N/mm) and conventional plating (308 N/mm, ∆ 99 N/mm, 95% confidence interval -48 to 245).</p><p><strong>Conclusion: </strong> We showed that locking plate fixation buttressing the medial acetabular wall achieved less fracture displacement but showed no differences in axial stiffness compared with conventional plating.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"701-706"},"PeriodicalIF":2.5,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142737934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-28DOI: 10.2340/17453674.2024.42414
Madelene Albrektsson, Michael Möller, Mikael Sundfeldt, David Wennergren, Olof Wolf, Carl Bergdahl
{"title":"Patient-reported outcome following an acetabular fracture: an observational study of 385 patients from the Swedish Fracture Register.","authors":"Madelene Albrektsson, Michael Möller, Mikael Sundfeldt, David Wennergren, Olof Wolf, Carl Bergdahl","doi":"10.2340/17453674.2024.42414","DOIUrl":"10.2340/17453674.2024.42414","url":null,"abstract":"<p><strong>Background and purpose: </strong> The primary aim of this study was to assess the patient's self-reported change in health 1 year after sustaining an acetabular fracture. The secondary objective was to examine differences in patient-reported outcomes (PROMs) based on sex, age groups, injury mechanisms, type of fracture, and treatment.</p><p><strong>Methods: </strong> Data was collected from the Swedish Fracture Register (SFR) for patients with acetabular fractures sustained between 2014 and 2021. Patients with additional fractures at the time of injury or during the following 18 months, periprosthetic fractures, or pediatric fractures were excluded. The PROM used was the Short Musculoskeletal Function Assessment (SMFA) wherein the subindices of bother, dysfunction, and mobility were analyzed with a higher score indicating worse outcome. The differences in SMFA and in subindices between the score 1 year after fracture and preinjury (recall) were analyzed.</p><p><strong>Results: </strong> Of the 385 included patients with complete PROMs, there was no significant difference in changes in SMFA score between the sexes. Surgically treated patients had significantly higher scores 1 year post-injury compared with non-surgically treated patients with bother index 18.3 (95% confidence [CI] 14.0-22.6) vs 7.2 (CI 4.7-9.8), dysfunction index 15.8 (CI 12.7-18.9) vs 7.0 (CI 5.0-9.0), and mobility index 21.6 (CI 17.9-25.2) vs 9.2 (CI 6.9-11.5).</p><p><strong>Conclusion: </strong> Most patients sustaining an acetabular fracture experience a decline in their functional abilities 1 year after the injury compared with before the injury. Younger patients with high-energy injuries and complex fracture types, which typically require surgical intervention, experience the most unfavorable outcomes. The large group of non-surgically treated patients reported minimal functional changes, likely attributable to selection bias.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"695-700"},"PeriodicalIF":2.5,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603666/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142737948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-25DOI: 10.2340/17453674.2024.42304
Turid Rognsvåg, Ingrid K Nordmo, Ingvild B Bergvad, Anne M Fenstad, Ove Furnes, Anners Lerdal, Maren F Lindberg, Søren T Skou, Mona Badawy
{"title":"Digital health literacy in Norwegian patients with hip and knee arthroplasty: normative data from a cross-sectional study.","authors":"Turid Rognsvåg, Ingrid K Nordmo, Ingvild B Bergvad, Anne M Fenstad, Ove Furnes, Anners Lerdal, Maren F Lindberg, Søren T Skou, Mona Badawy","doi":"10.2340/17453674.2024.42304","DOIUrl":"10.2340/17453674.2024.42304","url":null,"abstract":"<p><strong>Background and purpose: </strong> As digital health services become increasingly important in osteoarthritis treatment, understanding patients' digital health literacy (eHL) is crucial, including those undergoing total hip and knee arthroplasty (THA/TKA). We primarily aimed to provide eHL norms in a representative group of Norwegian patients, and secondarily to examine the relationships between eHL and health-related quality of life (QoL).</p><p><strong>Methods: </strong> We invited 800 randomly selected THA/TKA patients from the Norwegian Arthroplasty Register to complete a paper-based questionnaire, which included sociodemographic variables. eHL was measured using the eHealth Literacy Questionnaire (eHLQ) with 7 domains: Using technology, Understand, Engage, Control, Motivation, Access, and Needs, scored from 1 (strongly disagree) to 4 (strongly agree). The EuroQol EQ-5D-5L measured health-related QoL. We used multivariable regression to examine relationships between eHL domains and health-related QoL controlling for sociodemographic variables.</p><p><strong>Results: </strong> Respondents' (N = 383, 48%) mean age was 70 years (SD 9.0) and 246 (64%) were female. Mean eHLQ and the proportion of patients with low eHL (≤ 2.5) were Technology 2.7 (34%), Understanding 3.0 (14%), Engage 2.7 (28%), Control 3.2 (7.7%), Motivation 2.8 (35%), Access 2.8 (33%), and Needs 2.6 (46%). Low eHL correlated with older age and low education, but not with sex or type of surgery. Regression analyses showed that lower scores on the domains Technology, Engage, Control, Access, and Needs were associated with poorer QoL after adjusting for sociodemographic factors.</p><p><strong>Conclusion: </strong> About one-third of THA/TKA patients have low eHL, and low eHL was associated with poor QoL.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"677-684"},"PeriodicalIF":2.5,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11587163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142708925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-25DOI: 10.2340/17453674.2024.42449
Maartje Belt, Katrijn Smulders, B Willem Schreurs, Gerjon Hannink
{"title":"Clinical prediction models for patients undergoing total hip arthroplasty: an external validation based on a systematic review and the Dutch Arthroplasty Register.","authors":"Maartje Belt, Katrijn Smulders, B Willem Schreurs, Gerjon Hannink","doi":"10.2340/17453674.2024.42449","DOIUrl":"10.2340/17453674.2024.42449","url":null,"abstract":"<p><strong>Background and purpose: </strong> External validation is a crucial step after prediction model development. Despite increasing interest in prediction models, external validation is frequently overlooked. We aimed to evaluate whether joint registries can be utilized for external validation of prediction models, and whether published prediction models are valid for the Dutch population with a total hip arthroplasty.</p><p><strong>Methods: </strong> We identified prediction models developed in patients undergoing arthroplasty through a systematic literature search. Model variables were evaluated for availability in the Dutch Arthroplasty Registry (LROI). We assessed the model performance in terms of calibration and discrimination (area under the curve [AUC]). Furthermore, the models were updated and evaluated through intercept recalibration and logistic recalibration.</p><p><strong>Results: </strong> After assessing 54 papers, 19 were excluded for not describing a prediction model (n = 16) or focusing on non-TJA populations (n = 3), leaving 35 papers describing 44 prediction models. 90% (40/44) of the prediction models used outcomes or predictors missing in the LROI, such as diabetes, opioid use, and depression. 4 models could be externally validated on LROI data. The models' discrimination ranged between poor and acceptable and was similar to that in the development cohort. The calibration of the models was insufficient. The model performance improved slightly after updating.</p><p><strong>Conclusion: </strong> External validation of the 4 models resulted in suboptimal predictive performance in the Dutch population, highlighting the importance of external validation studies.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"685-694"},"PeriodicalIF":2.5,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11587164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142708920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-25DOI: 10.2340/17453674.2024.42361
Lotje A Hoogervorst, Yijun Ren, Tom Melvin, Ashley A Stratton-Powell, Anne Lübbeke, Robert E Geertsma, Alan G Fraser, Rob G H H Nelissen, Enrico G Caiani, Perla J Marang-van de Mheen
{"title":"Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.","authors":"Lotje A Hoogervorst, Yijun Ren, Tom Melvin, Ashley A Stratton-Powell, Anne Lübbeke, Robert E Geertsma, Alan G Fraser, Rob G H H Nelissen, Enrico G Caiani, Perla J Marang-van de Mheen","doi":"10.2340/17453674.2024.42361","DOIUrl":"10.2340/17453674.2024.42361","url":null,"abstract":"<p><strong>Background and purpose: </strong> Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as \"outlier.\" We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants.</p><p><strong>Methods: </strong> The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined according to the Medical Device Regulation (MDR) as \"a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.\" Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports.</p><p><strong>Results: </strong> 787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with \"Manufacturing/Packaging/Shipping\" problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA outliers with safety notices.</p><p><strong>Conclusion: </strong> 55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"667-676"},"PeriodicalIF":2.5,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11587162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142708932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acta OrthopaedicaPub Date : 2024-11-20DOI: 10.2340/17453674.2024.42113
Ragnhild Loven Kirkeboe, Jan Erik Madsen, Lars Nordsletten, John Clarke-Jenssen
{"title":"Acute treatment of elderly patients with acetabular fractures by open reduction, internal fixation, and total hip arthroplasty: a 1-10-year follow-up of 48 patients.","authors":"Ragnhild Loven Kirkeboe, Jan Erik Madsen, Lars Nordsletten, John Clarke-Jenssen","doi":"10.2340/17453674.2024.42113","DOIUrl":"10.2340/17453674.2024.42113","url":null,"abstract":"<p><strong>Background and purpose: </strong> Acetabular fractures in osteoporotic bone are associated with substantial joint impaction and comminution, previously shown to be prognostic for a poor result. A combined procedure of open reduction, internal fixation (ORIF), and total hip arthroplasty (THA) can be a good option, allowing for immediate weightbearing as tolerated. We report short- to medium-term outcome and complications of the results of patients treated with this combined procedure.</p><p><strong>Methods: </strong> 48 cases treated with ORIF and acute THA from 2000 to 2019 were identified from our local pelvic fracture registry, from which follow-up data was extracted. Descriptive statistics were used and Kaplan-Meier survival curves were calculated. Primary outcome was HHS at 1 year. Secondary outcomes were implant survival, complications requiring surgery, and mortality at 3 months.</p><p><strong>Results: </strong> There were 37 men and 11 women treated in the study period. Mean age was 68 (37-87) years. 6 patients died within 3 months of surgery, leaving 42 cases available for follow-up. Mean follow-up (FU) was 2.8 (1-16) years. The most common mechanism of injury was fall from standing height (n = 36). Medical comorbidities were common. Mean Harris Hip Score (HHS) was 83 (51-100) at 1-year follow-up. There were 7 reoperations: 6 for postoperative infection and 1 closed reduction of implant dislocation. 38 had their implant intact at latest FU. At the latest FU, 28 patients were ambulatory without a walking aid.</p><p><strong>Conclusion: </strong> Our results indicate that ORIF and acute THA can be performed with good functional results in patients with unreconstructable displaced acetabular fractures, but with a significant risk of infection and revision.</p>","PeriodicalId":6916,"journal":{"name":"Acta Orthopaedica","volume":"95 ","pages":"661-666"},"PeriodicalIF":2.5,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}