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Aim: To identify, define and achieve consensus on perioperative patient safety indicators within a Swedish context.

Design: A modified Delphi method.

Methods: A purposeful sample of 22 experts, all experienced operating room nurse specialists, was recruited for this study. A questionnaire was constructed incorporating statements derived from a preceding study. The experts were asked to rate the importance of each statement concerning patient safety during the perioperative phase. The data collection occurred through an online survey platform between November 2022 and April 2023. The CREDES checklist guided the reporting of this study.

Results: The three-round Delphi study resulted in consensus on 73 statements out of 103, encompassing 74% process indicators and 26% structure indicators. Key areas of consensus included the use of the Surgical Safety Checklist and optimizing the operating room environment.

Conclusion: Consensus was reached on perioperative safety indicators, underscoring the intricate challenges involved in ensuring patient safety in the operating room. It emphasizes the important integration of both structure and process indicators for comprehensive safety assessment during surgical procedures. Recognizing the difficulty in measuring factors like teamwork and communication, essential for patient safety, the study offers practical guidance. It underlines a balanced approach and specific consensus areas applicable in clinical practice to enhance perioperative patient safety.

Implications for the profession and patient care:This study provides concrete practice guidance and establishes a structured framework for evaluating perioperative care processes. It emphasizes the critical role of professionals having the necessary skills and being present during surgical procedures. Additionally, the study underscores the paramount importance of effective communication and teamwork within the operating room team, substantively contributing to overall patient safety enhancement.

Impact: The study focused on addressing the challenge of ensuring patient safety in operating rooms, acknowledging the persistent complications related to surgery despite global efforts to eliminate avoidable harm in healthcare. Consensus was reached on 73 crucial indicators for perioperative patient safety, emphasizing a balanced approach integrating both process and structure indicators for a comprehensive assessment of safety during surgical procedures. The study has a broad impact on professionals and healthcare systems, providing concrete guidance for practice and offering a structured process for evaluating perioperative care.

Reporting Method: The study is reported informed by 'Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations derived from a methodological systematic review'.

Patient or Public Contribution: No patient or public contribution.

BACKGROUND: Patient safety is fundamental when providing care in the operating room. Still, adverse events and errors are a challenge for patient safety worldwide. To avoid preventable patient harm, organisations need a positive safety culture, the measurable component of which is known as the safety climate. To best improve the safety climate the current attitudes to safety must first be understood.

AIM: To explore operating room nurses' safety attitudes and their views on how to improve patient safety in operating rooms.

ETHOD: A cross-sectional study using the Swedish-translated version of the Safety Attitudes Questionnaire, Operating Room version. Data were collected using an online survey platform.

RESULTS: 358 operating room nurses completed the questionnaire. The results show that the older age group rated their working conditions and management support as better than the younger age groups. The older age group also rated their stress recognition as lower compared with the younger age groups. The same pattern was seen in terms of work experience, with more-experienced respondents showing a higher mean score for the factor working conditions and a lower mean score for the factor stress recognition as compared with their less-experienced colleagues. When comparing hospital types, county hospital employees had higher factor scores for safety climate, job satisfaction and working conditions than university hospital employees. The respondents' most recurring recommendations for improving patient safety were 'Having better and clearer communication' followed by 'Having enough time to do things the way they should be done'.

CONCLUSION: More focus on safety with increasing age and experience was observed in this cohort. Need for improvements is reported for patient safety in operating rooms, mainly when it comes to communication and workload. To improve and develop patient safety in the operating room, the organisational safety climate needs to be actively managed and developed. One step in actively managing the safety climate may be efforts to retain experienced operating room nurses.

Background: Uncemented trabecular metal (TM) monoblock tibial components in total knee arthroplasty (TKA) have shown excellent clinical results for up to 10 years. However, these studies were performed in highly specialized units, with few surgeons and often excluding knees with secondary osteoarthritis (OA), severe malalignments and previous surgery. The purpose of this study was to investigate implant survivorship and clinical and radiological outcome of the uncemented TM high-flex posterior stabilized (PS) monoblock tibial component in routine clinical practice.

Methods: A retrospective study of 339 knees (282 patients) operated with the implant in routine clinical practice at two hospitals on patients aged 60 years or younger between 2007 and 2015. The operations were performed by 12 surgeons and there were no specific contraindications for use of the implant. Follow up ended in 2020. The status of the implant of deceased patients at death and those not attending follow up was checked with the Swedish Knee Arthroplasty Register. Clinical follow up consisted of clinical investigation, PROMs, and knee X-ray.

Results: Follow up was mean (range) 8.5 (5–13.8) years, and the 8-year survival rate was 0.98 (standard error 0.007). Five patients five knees) were deceased, five knees were revised (none due to aseptic loosening), and 16 patients did not attend the clinical follow up. Forty-four percent of the knees had secondary OA and 45% had had previous operations. 93% were satisfied or very satisfied with the operation and forgotten joint score (FJS) was median (interquartile range) 81 (44–94). Radiographic analysis revealed bone in close contact with the tibial tray and pegs in most cases, and in only 2% of the knees were potential radiolucent lines found.

Conclusion: The results indicate that this uncemented implant performs excellently in routine clinical practice and also in younger patients with secondary OA or previous knee operations.

Background: We analysed the long-term revision rate, clinical outcomes and metal ion concentrations in blood over time in patients who had undergone metal-on-metal Articular Surface Replacement (ASR) hip arthroplasty. Methods: A total of 38 patients (43 hips) were included: 24 patients (28 hips) underwent large-head total hip arthroplasty (XL THA), and 14 patients (15 hips) underwent hip resurfacing arthroplasty (HRA). The median follow-up time was 11 (range 7-12) years. Results: None of 15 HRA implants were revised. Nine of 28 XL THA implants (32%) in 8 patients were revised. The Co ion levels significantly increased in the XL THA group (p=0.009) over a median time period of 84 (25-97) months. Conclusion: The levels of Co ions in blood were higher in the patients who had undergone XL THA and increased significantly over time.

BACKGROUND AND PURPOSE: The aim of this prospective, randomised and controlled study was to evaluate the wear and fixation properties of a new cemented highly cross-linked all-polyethylene (HXLPE) cup in comparison with a conventional cemented ultra-high molecular weight polyethylene (ConvPE) cup using radiostereometric analysis (RSA).

PATIENTS AND METHODS: A total of 58 patients (58 hips) with primary osteoarthritis (OA) were enrolled in a randomised controlled trial to receive either a ConvPE cup (control) or HXLPE cup (intervention) with identical geometry. The subjects were randomised in a 1:1 ratio. The primary endpoint was proximal wear measured as femoral head penetration into the cup, secondary outcomes were 3D-wear and annual proximal wear from 1 to 5 years. Cup fixation was measured as movement of the cup in relation to the acetabular bone with proximal migration being the primary outcome measure, 3D-migration and change in inclination as secondary outcomes. The patients were followed for 5 years with RSA performed postoperatively, at 3, 12, 24, and 60 months.

RESULTS: The HXLPE displayed a lower median proximal femoral head penetration compared to ConvPE, with a median difference at 2 years of -0.07 mm (95% CI, -0.10 to -0.04 mm), and -0.19 mm (95% CI, -0.27 to -0.15 mm) at 5 years. Annual proximal wear between 1 and 5 years was 0.03 mm/year for HXLPE and 0.06 mm/year for ConvPE (mean difference 0.05 mm, [95% CI, 0.03-0.07 mm]). Proximal migration, 3D migration and change in inclination was numerically slightly higher for HXLPE, albeit not statistically significant.

CONCLUSIONS: Compared to ConvPE, the HXLPE cup displayed significantly lower polyethylene wear. Cup migration was not statistically significant different.

CLINICALTRIALS.GOV IDENTIFIER: NCT04322799.

BACKGROUND: Avoidable complications for surgical patients still occur despite efforts to improve patient safety processes in operating rooms. Analysis of experiences of operating room nurses can contribute to better understanding of perioperative processes and flow, and why avoidable complications still occur.

AIM: To explore aspects of patient safety practice during joint replacement surgery through assessment of operating room nurse experiences.

METHOD: A qualitative design using semistructured interviews with 21 operating room nurses currently involved in joint replacement surgery in Sweden. Inductive qualitative content analysis was used.

RESULTS: The operating room nurses described experiences with patient safety hazards on an organisational, team and individual level. Uncertainties concerning a reliable plan for the procedure and functional reporting, as well as documentation practices, were identified as important. Teamwork and collaboration were described as crucial at the team level, including being respected as valuable, having shared goals and common expectations. On the individual level, professional knowledge, skills and experience were needed to make corrective steps.

CONCLUSION: The conditions to support patient safety, or limit complication risk, during joint replacement surgery continue to be at times inconsistent, and require steady performance attention. Operating room nurses make adjustments to help solve problems as they arise, where there are obvious risks for patient complications. The organisational patient safety management process still seems to allow deviation from established practice standards at times, and relies on individual-based corrective measures at the 'bedside' at times for good results.

Background: Total hip arthroplasty (THA) for developmental dysplasia of the hip (DDH) is a complex procedure due to associated anatomical abnormalities. We studied the extent to which preoperative digital templating is reliable when performing cementless THA in patients with DDH.

Methods: We templated and compared the pre- and postoperative sizes of the acetabular and femoral components and the center of rotation (COR), and analysed the postoperative cup coverage, leg length discrepancy (LLD), and stem alignment in 50 patients (56 hips) with DDH treated with THA.

Results: The implant size exactly matched the template size in 42.9% of cases for the acetabular component and in 38.2% of cases for the femoral component, whereas the templated ±1 size was used in 80.4 and 81.8% of cases for the acetabular and femoral components, respectively. There were no statistically significant differences between templated and used component sizes among different DDH severity levels (acetabular cup: p = 0.30 under the Crowe classification and p = 0.94 under the Hartofilakidis classification; femoral stem: p = 0.98 and p = 0.74, respectively). There were no statistically significant differences between the planned and postoperative COR (p = 0.14 horizontally and p = 0.52 vertically). The median postoperative LLD was 7 (range 0–37) mm.

Conclusion: Digital preoperative templating is reliable in the planning of cementless THA in patients with DDH.

Background and purpose - Preoperative posterior tilt of the femoral head as seen on lateral radiographs has been reported to affect the risk of fixation failure in cases of minimally displaced femoral neck fractures (Garden I-II). We investigated radiological risk factors of treatment failure.

Patients and methods - We included 417 patients (68% women, median age: 78 years (50-108) with a minimally displaced femoral neck fracture (Garden I-II) treated with internal fixation in a retrospective cohort study. The patients were followed for 3.4 years (2-14). Data on age, sex, housing, cognitive impairment, implant angulation, pre- and postoperative tilt, hip complications, and reoperations were recorded. The risk of fixation failure was assessed using Cox proportional hazards regression analysis.

Results - The overall reoperation rate was 17%, and the rate of treatment failure (fixation failure, nonunion, avascular necrosis, or posttraumatic osteoarthritis) was 13%. Cox proportional hazard analysis revealed an increased risk of treatment failure with a preoperative posterior tilt of at least 20° and a preoperative anterior tilt greater than 10°. A failure occurred in 13 of the 65 patients with a posterior tilt of at least 20° and in 5 of the 9 patients with an anterior tilt greater than 10°.

Interpretation - A preoperative posterior tilt of 20° and an anterior tilt greater than 10° in cases of Garden I and II femoral neck fractures increase the risk of fixation failure necessitating additional surgery. In this group of patients, there is a need for future interventional studies regarding the feasibility of primary hip arthroplasty.

Background: Artificial hip joint replacement has undergone tremendous development in the past 100 years. In the beginning, complications, such as infection and early loosening, were the rule rather than the exception. Today, complications of any sort are rare during the first decade after the operation. Artificial hip joint replacement has been chosen as the "Operation of the Century" and has dramatically improved the quality of life of millions of patients. Unfortunately, in the long-term, prosthesis loosening due to pathological bone resorption (osteolysis) around the prosthesis is still common. Traditionally, the prosthesis is anchored in the bone with bone cement (Plexiglas). However, since this cementation method was suspected to cause late loosening, alternative methods, such as the implantation of so-called uncemented prostheses, have been developed and are being increasingly applied. Because the early movement of a prosthesis (migration) increases the risk of loosening, uncemented cups are often augmented with additional screws. The mechanisms regulating the early and late loosening of uncemented cups are not fully established. Wear particles from the artificial joint and intermittent fluid pressure on the bone appear to accelerate or even cause bone loss and can eventually lead to loosening of the prosthesis. Therefore, screw holes in the uncemented cup have been suspected to be a risk factor.

Aims: We have studied whether the additional augmentation of modern uncemented cups with screws, pegs or hydroxyapatite increases the long-term stability, affects the wear rate, influences the development of osteolysis, or has any impact on the risk of cup revision. Furthermore, we investigated whether computed tomography (CT), which is needed to detect osteolysis around the prosthesis, could also be used in the follow-up of migration studies without losing significant precision compared to radiostereometry (RSA), which is the gold standard for these measurements.

Patients and Methods: In studies I-III, we evaluated 48 hips (45 patients) randomized to receive cups with or without augmentation. As part of the 14-year follow-up with conventional radiographs of the pelvis, two pairs of stereo radiographs and a CT scan were obtained. Migration and wear were measured by RSA. The volume and type of osteolysis were determined on CT. Furthermore, we calculated the precision and limit of agreement of RSA and CT to compare these two modalities as tools for migration measurements.

In study IV, we compared the risk of cup revision between 10,371 uncemented cups with and 12,354 without screw holes, using data from the Swedish Hip Arthroplasty Register.

Results: Study I: Cup stability was equally good regardless of cup augmentation. The mean wear rate of the cup liner was high, at 0.21 mm/year, with no significant difference between the groups.

Study II: The limit of agreement between CT and RSA was 1.15°, 1.51°, and 0.70° for rotation and 0.46, 0.43, and 0.52 mm for translation. These results were within the described normal 99% confidence limits for precision in RSA: 0.3° to 2° for rotation and 0.15 to 0.6 mm for translation.

Study III: Osteolysis of some degree was visible in all 48 hips on CT. We found three different types of osteolytic lesions: type 1A, absent trabecular bone and a sclerotic border around the lesion; type 1B, absent trabecular bone and no sclerotic border; and type 2, reduced radiodensity and reduced trabecular number. Cups with screw holes were surrounded with larger osteolytic lesions, and osteolysis around these cups was more likely to be a type 1A lesion.

Study IV: Cups without screw holes showed a decreased risk of cup revision (implant exchange or removal) due to any reason at both 2 years (adjusted hazard ratio, HR: 0.6, confidence interval, CI: 0.5-0.8) and 10 years (HR: 0.7, CI: 0.5- 0.9). However, for aseptic loosening, there was no significant difference between cups with and without screw holes, with an implant survival rate of 99.9% (CI: 99.8-99.9) at 2 years and 99.1% (CI: 98.6-99.7) at 10 years.

Conclusion: Uncemented cups augmented with screws, pegs, or hydroxyapatite do not have improved long-term stability compared with cups with press-fit only. Unsealed screw holes in uncemented cups appear to be a risk factor for the development of larger osteolytic lesions. CT showed three different types of osteolytic lesions. The risk of aseptic loosening for modern uncemented cup designs is very low, and cups without additional augmentation do not have an increased revision rate. In contrast, the risk of cup revision for any reason was higher for cups with screw holes. CT can be used for migration studies for the longitudinal evaluation of patients with tantalum markers with precision comparable to that of RSA.