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Purpose Does patients revised for unexplained pain after mUKA present the same PROM and satisfaction scores 1–3 years after revision as patients revised for aseptic loosening?”. Methods 104 patients undergoing revision of mUKA's for the indications unexplained pain and aseptic loosening were included in the period January 1, 2018 to December 31, 2020. from the Danish Knee Arthroplasty Register. 52 patients were revised for unexplained pain and 52 for aseptic loosening. Patient demographics did not differ between the two groups. PROMs [Oxford Knee Score (OKS), EQ-5D-5L, Forgotten Joint Score (FJS)] and questions about satisfaction with the surgery were sent to digitally secured mailboxes. Pearson’s Chi-square test and Wilcoxon Rank Sum test were used to test for statistical differences between groups. Results The median OKS 1–3 years after revision was 26 (IQR 22) for unexplained pain vs 34 (IQR 12) for aseptic loosening, p  = 0.033. The median EQ-5D-5L Index after revision was 0.7 (IQR 0.6) for unexplained vs 0.8 (IQR 0.1) for aseptic loosening, p  = 0.014. The median FJS after revision was 48 (IQR 10) for unexplained pain vs 52 (IQR 14) for aseptic loosening, p  = 0.1. The mean satisfaction with the surgery on a 0–100 scale (100 = not satisfied; 0 = very satisfied) was 55 (IQR 60) for unexplained pain vs 50 (IQR 67) for aseptic loosening, p  = 0.087, and patients revised for unexplained pain were less likely to find their knee problem importantly improved ( p  = 0.032). Conclusion Patients undergoing revision of mUKAs for unexplained pain presented poor postoperative PROM scores, and PROM scores were worse compared to those of patients revised for aseptic loosening. Patients revised for unexplained pain were less likely to find their knee problem importantly improved. This study support the evidence against revisions for unexplained pain. Level of evidence Level III.

Background Osteoarthritis (OA) is a joint disease with a high worldwide prevalence, often leading to replacement surgery. However, despite the high success rate of replacement surgery, some patients fail to experience the intended benefits. Given the importance of patient involvement, this trial aims to assess the effect of shared decision-making (SDM) on decisional quality for patients with severe OA. Specifically, it investigates whether an in-consult patient decision aid (PtDA) enhances decisional quality, involvement, and health outcomes for patients with severe hip or knee OA. Methods This protocol outlines a pragmatic two-armed multicentre cluster-randomised controlled trial (C-RCT), chosen for its ability to assess the combined effect of shared decision-making (SDM) and a newly developed in-consult patient decision aid (PtDA) in routine clinical practice. The PtDA is a tool designed to help patients make informed decisions during the consultation by providing personalised treatment options, benefits, and risks. The C-RCT design is particularly well-suited to this context, as it effectively minimises contamination and bias across treatment groups. A total of 19 orthopaedic surgeons will be randomised 1:1, stratified by centre, to either continue standard consultations without the PtDA or implement SDM using the PtDA. The trial will recruit 615 patients with severe hip or knee OA. Outcomes will be measured at one week, three months, and 12 months post treatment start. The primary outcome, decisional quality, will be assessed using the Hip/Knee OA Decision Quality Instrument, focusing on patients being well-informed and receiving their preferred treatment. The secondary outcomes include patient involvement in the decision-making process and consultation durations. The tertiary outcomes include patients’ satisfaction, regret and health-related outcomes. The primary outcome will be analysed using a multilevel mixed-effects logistic regression with surgeons as random effects reporting odds ratios with 95% confidence intervals. Discussion This study aims to contribute insights into the use of SDM facilitated by a PtDA and its impact on improving decisional quality for future patients with hip or knee OA. Trial registration www.ClinicalTrials.gov (NCT05972525), Data of registration: 06.08.2023.

Background Navigating the various surgical and non-surgical options for treating osteoarthritis (OA) presents a significant challenge for patients. Determining the optimal treatment involves carefully weighing each option’s benefits, risks, and consequences. What constitutes the “best treatment”—whether surgical or non-surgical—is often subjective and shaped by individual circumstances and personal preferences. While shared decision-making, supported by in-consult patient decision aids, has proven valuable in helping patients and clinicians clarify values and choose the most suitable treatment, its integration into orthopaedic consultations remains limited. This study aims to identify the key decision-making factors relevant to patients and surgeons in the context of hip or knee OA. Methods This qualitative exploratory study involved 15 field observations guided by the five-item Observing Patient Involvement instrument and two focus group discussions (FGs) with patients ( n  = 14) and their relatives ( n  = 4) and two (FGs) with orthopaedic surgeons ( n  = 12). The data were analysed using thematic analysis. Results Field observations revealed variations in consultation practices, particularly in duration, information sharing, and patient-surgeon dynamics. FGs identified six main themes influencing treatment decisions. Patient-derived themes emphasized the critical role of the patient-surgeon relationship in building confidence, the importance of weighing treatment options, and the long decision-making process that often led patients to delay their appointment with the surgeon until they felt surgery was their only option. Surgeon-derived themes highlighted the need for more standardised information, scepticism about the shared decision-making approach, and concerns that patients with predefined treatment decisions might hinder the shared decision-making process. Conclusions This study underscores the complexity of decision-making for patients with severe hip or knee OA, highlighting factors such as symptom severity and trust in healthcare providers. Its findings suggest a need for a more standardised approach to information delivery and the implementation of shared decision-making to improve patient satisfaction with joint replacement outcomes. Introducing in-consult patient decision aids earlier in the decision-making process could help prepare and inform patients.

Background Distal femoral resection knee arthroplasty may be a viable option for several indications other than bone tumors. Resection knee arthroplasty appears to be becoming more common, but patients requiring this type of surgery are often elderly and with high comorbidity. The aim of this study was to report in-hospital complications, readmissions, reoperations, and mortality after distal femoral resection knee arthroplasty for non-tumor indications. Methods We retrospectively identified a consecutive cohort of 45 knees (45 patients) treated with distal femoral resection knee arthroplasty in a single institution between 2012 and 2021. Indications for surgery were failure of osteosynthesis (8), primary fracture treatment (2), periprosthetic fracture (22), and revision arthroplasty with severe bone loss (13). A major reoperation was defined as a major component exchange procedure or amputation. Mean follow-up was 3.9 years. Results The mean age was 71.3 years (SD 12.3), and 64.4% were female; 8.9% were ASA I, 40% ASA II, and 51% ASA III. Median length of stay was 7 days (range 3–19) with no major in-hospital complications, but 55.6% ( n  = 25) required blood transfusion. The 90-day readmission rate was 17.8% ( n  = 8), of which 50% was prosthesis-related. Four patients (8.9%) underwent major reoperation due to infection ( n  = 2), mechanical failure ( n  = 1), or periprosthetic fracture ( n  = 1). The mortality rate was 0% ≤ 90 days and 2.2% ≤1 year. Conclusions Distal femoral resection knee arthroplasty in this fragile patient population appears to be a viable and safe option considering that it is a limp salvage procedure most cases.

Background Evidence on how to improve daily physical activity (PA) levels following total knee arthroplasty (TKA) or medial uni-compartmental knee arthroplasty (mUKA) by motivational feedback is lacking. Moreover, it is unknown whether a focus on increased PA after discharge from the hospital improves rehabilitation, physical function, and quality of life. The aim of this randomized controlled trial (RCT) nested in a prospective cohort is (a) to investigate whether PA, physical function, and quality of life following knee replacement can be increased using an activity monitoring device including motivational feedback via a patient app in comparison with activity monitoring without feedback (care-as-usual), and (b) to investigate the potential predictive value of PA level prior to knee replacement for the length of stay, return to work, and quality of life. Methods The study is designed as a multicenter, parallel-group, superiority RCT with balanced randomization (1:1) and blinded outcome assessments. One hundred and fifty patients scheduled for knee replacement (TKA or mUKA) will be recruited through Odense University Hospital, Denmark, Vejle Hospital, Denmark and Herlev/Gentofte Sygehus, Denmark. Patients will be randomized to either 12 weeks of activity monitoring and motivational feedback via a patient app by gamification or 'care-as-usual,' including activity monitoring without motivational feedback. The primary outcome is the between-group change score from baseline to 12-week follow-up of cumulative daily accelerometer counts, which is a valid proxy for average objectively assessed daily PA. Discussion Improving PA through motivational feedback following knee replacement surgery might improve post-surgical function, health-related quality of life, and participation in everyday life. Trial registration ClinicalTrials.gov, ID: NCT06005623. Registered on 2023–08-22. Trial status Recruiting.

To evaluate the validity of diagnosis codes for Major Osteoporotic Fracture (MOF) in the Danish National Patient Registry (NPR) and secondly to evaluate whether the fracture was incident/acute using register-based definitions including date criteria and procedural codes. We identified a random sample of 2400 records with a diagnosis code for a MOF in the NPR with dates in the year of 2018. Diagnoses were coded with the 10th revision of the International Classification of Diseases (ICD-10). The sample included 2375 unique fracture patients from the Region of Southern Denmark. Medical records were retrieved for the study population and reviewed by an algorithmic search function and medical doctors to verify the MOF diagnoses. Register-based definitions of incident/acute MOF was evaluated in NPR data by applying date criteria and procedural codes. The PPV for MOF diagnoses overall was 0.99 (95% CI: 0.98;0.99) and PPV=0.99 for the four individual fracture sites, respectively. Further, analyses of incident/acute fractures applying date criteria, procedural codes and using patients' first contact in the NPR resulted in PPV=0.88 (95% CI: 0.84;0.91) for hip fractures, PPV=0.78 (95% CI: 0.74;0.83) for humerus fractures, PPV=0.78 (95% CI: 0.73;0.83) for clinical vertebral fractures and PPV=0.87 (95% CI: 0.83;0.90) for wrist fractures. ICD-10 coded MOF diagnoses are valid in the NPR. Furthermore, a set of register-based criteria can be applied to qualify if the MOF fracture was incident/acute. Thus, the NPR is a valuable and reliable data source for epidemiological research on osteoporotic fractures.

Background Lower extremity amputation patients represent a frail group with extensive comorbidity. Transfemoral amputation is a high-risk procedure with 37–50% risk of mortality in the first year. Substantial blood loss during surgery increases the risk of anemic complications and death for these already weakened patients. The use of tourniquet during surgery may reduce blood loss, the need for blood transfusions, the related complications as well as the length of the surgery. However the use of tourniquet may be related to impaired wound healing and hence the use should be investigated in a randomized controlled trial. The primary aim of this study is to investigate the total blood loss and secondary to investigate differences in complications after transfemoral amputation between patients operated with or without tourniquet. Methods The total blood loss is calculated using Nadlers approach. Based on data from a pilot series, the sample size was calculated to 124, allocated 1:1 in two groups of 62 participants to ensure detection of at least 200 mL difference in the total blood loss. The primary outcome is the total blood loss. Secondary outcomes are blood transfusions, duration of surgery, length of hospital stay and risk of complications within 90 days (re-admissions, re-operations and mortality). Explorative outcomes are 1 year mortality and re-operation risk. Further explorative outcomes are postoperative quality of life (questionnaire EQ-5D-5L) and evaluation of number of prosthesis users including evaluation of prosthesis-specific function measured 3, 6, and 12 months postoperatively. Discussion The possibility to enhance patient safety is highly relevant and this trial will provide data for evidence based recommendations of best practice in amputation surgery. Trial registration The trial is registered on ClinicalTrials.gov with ID: NCT05550623. Initial release: 13/09 2022.

Patients who undergo major lower extremity amputation (MLEA) have the highest postoperative mortality among orthopedic patient groups. The comorbidity profile for MLEA patients is often extensive and associated with elevated postoperative mortality. This study primarily aimed to investigate the increased short- and long-term mortality following first and subsequent major lower extremity amputation. Secondarily, to examine the mediation role of post-amputation complications. With data from the Danish National Patient Registry, 11,695 first-time MLEAs in patients aged ≥50 years were identified between January 1, 2010, and December 31, 2021, along with 58,466 unamputated persons matched 1:5 by year of birth, sex, and region of residence. Mediators were identified through diagnosis codes (ICD-10) present in 6 months following MLEA. The increased mortality following MLEA was highest in the month following MLEA, hazard ratio (HR) 38.7 (95% confidence interval (CI) 30.5-48.9) in women and HR 55.7 (CI 44.3-70.2) in men compared to a matched unamputated cohort. Subsequent amputation resulted in an increased mortality the month after a subsequent amputation (overall HR 3.2 (CI 2.8-3.7) in women and HR 3.2 (CI 2.8-3.6) in men) and almost normalized after the first year. The proportion of the mortality risk that potentially could be reduced by preventing sepsis was 16% (CI 11.7-20.3) for women and 17% (CI 13.4-20.4) for men. For pneumonia, it was 10.5% (CI 7.1-13.9) in women and 14.9% (11.6-18.2) in men. We observed an increased mortality in the month following MLEA, which remained elevated for years compared to the matched unamputated cohort. A subsequent amputation results in increased mortality in the following year, but declined and normalized after the first year. Sepsis and pneumonia arising after the amputation appeared to be important factors that contributed to the increased postoperative mortality.

Background Distal femoral resection knee arthroplasty is a limb salvage procedure. The impact of distal femoral resection arthroplasty on patient function and health status is unknown. The aim of this study was to report knee function, quality of life, knee pain, and living conditions after distal femoral resection knee arthroplasty for non-tumor indications. Methods Of 52 patients (52 knees) undergoing distal femoral resection knee arthroplasty in a single institution between 2012 and 2021, 22 were excluded as 3 patients had ≤90 days follow-up, 6 had died, and 13 declined or were unable to participate for unrelated reasons. Thus, 30 patients were included and interviewed by telephone in March 2021 (mean follow-up 3.5 years after surgery). Patient completed the Oxford Knee Score (0–48, 48 best), EQ-5D-5L, and the Copenhagen Knee ROM, and information on pain and living conditions was obtained. Results The mean age was 67.9 years (SD 13.6), and 21 (70%) were female. Mean total Oxford Knee Score was 29.9 (SD 10.5), mean Copenhagen Knee ROM flexion was 116° (SD 21.6), and mean extension was − 2° (SD10.1). Mobility aids were used by 18 (60%) patients, i.e. a cane (30%), walker (26.7%) or wheelchair (3.3%). Mean EQ-5D index score was 0.70 (SD 0.22) and mean EQ-5D VAS score was 55.4 (SD 23.9). Nine (30%) patients used paracetamol or NSAID and 2 (6.7%) used opioids for knee pain. Mean VAS knee pain score was 1.30 (SD 2.2) at rest and 2.8 (SD 3.1) when walking. Most (90%) patients lived in their own home, with only 3 patients in nursing homes. Two-thirds (66.7%) required no home care, 5 (16.6%) received home care 1–2 times over 2 weeks, and 5 (16.6%) every day. Conclusion Distal femoral resection knee arthroplasty appears to be a viable treatment option for non-tumor indications. Acceptable patient outcomes were achieved in terms of functional status and quality of life, especially considering treatment alternatives such as femoral amputation.

The interplay between osteoblasts and osteoclasts (OCs) is a highly regulated and coordinated process essential for maintaining bone skeletal integrity and health. Disruption of this balance marks the onset of various bone disorders, such as osteoporosis. In our previous study, we demonstrated that non-coding RNAs (ncRNAs) were able to regulate OC behaviour. Specifically, the long ncRNA DLEU1 and the small ncRNA miR-16 independently control OCs multinuclearity, fusion and resorption. Herein, we investigate whether OCs modulated with ncRNAs impact the behaviour of osteoblast lineage cells (OBs) in a biomimetic co-culture system. Communication between OB and OC comprises numerous molecules and processes, including the secretion of coupling factors, release of matrix-derived signals during bone resorption, and exposure of previously occluded proteins within the bone resorption cavities. Firstly, we explored how ncRNAs influence the composition of the secretome and the remodelling of resorption cavities left by the ncRNA-engineered-OCs on OBs responses. In our OC/OB co-culture system, conducted in the absence of FBS and exogenous RANKL, we observed changes in the levels of secreted factors 72 h after DLEU1 levels were decreased in mature OCs (siDLEU1-OC condition), specifically in RANKL, leptin, osteocalcin, MMP7, MMP8, TIMP1 and TIMP2. Meanwhile, leptin and MMP8 levels were increased in the OC/OB co-culture when miR-16 was overexpressed in OCs (miR-16-OC condition). The results also show that OBs co-cultured with siDLEU1-OCs exhibited impaired migratory capacity and increased ALP levels, while OBs co-cultured with miR-16-OCs displayed a tendency towards decreased elongation. On bone slices, OBs persisted for a longer duration in the trenches created by siDLEU1-OCs. Besides altering OBs behaviour, silencing of DLEU1 reduced the area of each individual trench cavity, while miR-16 overexpression significantly hindered the total eroded surface and inhibited trench formation in the OC/OB co-culture system. Overall, these findings identify DLEU1 and miR-16 as key regulators in the interplay between human primary OBs and OCs, highlighting the potential of targeting ncRNAs in OCs to modulate their paracrine and matrix-mediated effects on OBs.