Cellular therapies for bone repair: current insights.

Mesenchymal stem cells are core to bone homeostasis and repair. They both provide the progenitor cells from which bone cells are formed and regulate the local cytokine environment to create a pro-osteogenic environment. Dysregulation of these cells is often seen in orthopaedic pathology and can be manipulated by the physician treating the patient. This narrative review aims to describe the common applications of cell therapies to bone healing whilst also suggesting the future direction of these techniques.

The outcomes of the management of complex distal tibia and ankle fractures in elderly with tibiotalocalcaneal nail in a minimum 12-month follow-up period.

PURPOSE: To evaluate the clinical outcomes of the use of tibiotalocalcaneal nail for the treatment of complex distal tibia and ankle fractures in elderly people, in a major trauma centre. METHODS: Elderly patients (age > 65) with distal tibia or ankle fractures that underwent stabilization with a tibiotalocalcaneal nail were eligible to participate. Exclusion criteria were patients that died or were lost to follow-up and cases in which the nail was used in a chronic setting, such as malunion and non-union. Main parameters evaluated were fracture union, complications and functional outcomes. The functional outcome was assessed using the Olerud-Molander Ankle Score (OMAS). The minimum follow-up was 12 months. RESULTS: Thirty-two consecutive patients (12 males) with a mean age of 80.2 years (range 66-98) met the inclusion criteria and formed the basis of this study. Fracture union was achieved in 93.8% of the cases at a mean time of 3.9 months (range 2-8). Two patients developed surgical site infections and underwent reoperation before union. The overall complication rate was 25.1%, while the respective reintervention rate was 18.8%. In terms of functional outcomes, the mean OMAS score was 45, ranging from 20 to 70. CONCLUSION: Tibiotalocalcaneal nailing can be considered as an acceptable less invasive option with good functional outcomes for the treatment of complex distal tibia and ankle fractures in frail patients with problematic local soft tissues.

Paediatric open fractures presenting to a level 1 trauma centre: a 10 year epidemiological study.

PURPOSE: The epidemiology of paediatric fractures has been previously described, however there is limited data available on open fractures in this population. The purpose of this study was to investigate trends, mechanism of injury (MOI) and severity of paediatric open fractures and undertake an epidemiological study. METHODS: All children ≤ 16.0 years presenting with open fractures were identified between 01/04/2013 and 01/04/2023. Those with craniofacial, thoracic and distal phalangeal fractures were excluded. Incidence was calculated based on those presenting within the local geographical region. Social deprivation was measured using the Index of Multiple Deprivation (IMD). RESULTS: There were 208 open fractures with a median age of 11.0(q1 7.4-q3 13.4) years, and 153(74.6%) were in males. The MOIs were road traffic collisions 73(35.1%), sports/play 45(21.6%), fall > 2m 29(13.9%), simple fall 25(12.0%), crush 16(7.7%), bites 8(3.8%), assault 6(2.9%), and other 6(2.9%). Nineteen children (9.1%) presented with polytrauma. Gustilo-Anderson grade for long bone fractures were I-61(29.3%), II-24(11.5%), IIIa-36(17.3%), IIIb-30(14.4%) and IIIc-7(3.4%). There were 129 children presenting within the local geographical region providing an annual incidence of 8.0/100,000. Radius and ulna were the most frequently injured 49(38.0%) followed by tibia and fibula 44(34.1%). There were 69(53.5%) children presenting from an IMD quintile 1 with open fractures. CONCLUSION: Paediatric open fractures are commonly seen in the adolescent male and affect those who are from a more socially deprived background. These injuries account for 3.2% of fractures admitted to a MTC. Data suggests children principally sustain open fractures through two distinct injury patterns and ten-year trends suggests that there is a gradual decline in the annual incidence.

Periprosthetic Distal Femoral Fractures Around a Total Knee Arthroplasty: a Meta-analysis Comparing Locking compression Plating and Retrograde Intramedullary Nailing.

Purpose: The number of total knee replacements (TKRs) performed per year has been increasing annually and it is estimated that by 2030 demand would reach 3.48 million procedures per year in the United States Of America. The prevalence of periprosthetic fractures (PPFs) around TKRs has followed this trend with incidences ranging from 0.3% to 3.5%. Distal femoral PPFs are associated with significant morbidity and mortality. When there is sufficient bone stock in the distal femur and a fracture pattern conducive to fixation, locking compression plating (LCP) and retrograde intramedullary nailing (RIMN) are commonly used fixation strategies. Conversely, in situations with loosening and deficient bone stock, a salvage procedure such as a distal femoral replacement is recognized as an alternative. This meta-analysis investigates the rates of non-union, re-operation, infection, and mortality for LCPs and RIMNs when performed for distal femoral PPFs fractures around TKRs. Method: A search was conducted to identify articles relevant to the management of distal femoral PPFs around TKRs in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Articles meeting the inclusion criteria were then assessed for methodological quality using the methodological items for non-randomised studies (MINORS) criteria. Articles were reviewed, and data were compiled into tables for analysis. Results: 10 articles met the inclusion criteria, reporting on 528 PPFs. The overall incidence of complications was: non-union 9.4%, re-operation 12.9%, infection 2.4%, and mortality 5.5%. This meta-analysis found no significant differences between RIMN and LCP in rates of non-union (9.2% vs 9.6%) re-operation (15.1% vs 11.3%), infection (2.1% vs 2.6%), and mortality (6.0% vs 5.2%), respectively. Conclusion: This meta-analysis demonstrated no significant difference in rates of non-union, re-operation, infection, and mortality between RIMN and LCP and both remain valid surgical treatment options.

Allogeneic platelet-rich plasma for knee osteoarthritis in patients with primary immune thrombocytopenia: A randomized clinical trial.

The treatment of painful KOA in adult patients with ITP has not been well studied yet. We conducted a prospective, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of intra-articular allogeneic PRP injections on symptoms and joint structure in patients with KOA and ITP. 80 participants were randomly allocated in a 1:1 ratio to allogeneic PRP group or saline group. The primary outcome was the WOMAC total score at 12 months post-injection. The number of patients in each group who achieved MCID of primary outcome showed a statistically significant difference only at 3-month (27/39 vs. 5/39, p = 0.001) and 6-month (15/39 vs. 3/38, p = 0.032). The difference in WOMAC total score exceeded the MCID only at 3 month (mean difference of -15.1 [95% CI -20.7 to -9.5], p < 0.001). Results suggest that allogeneic PRP was superior to placebo only with respect to symptoms at 3-month of follow-up.

The local and systemic effects of immune function on fracture healing.

The immune system plays an integral role in the regulation of cellular processes responsible for fracture healing. Local and systemic influences on fracture healing correlate in many ways with fracture-related outcomes, including soft tissue healing quality and fracture union rates. Impaired soft tissue healing, restricted perfusion of a fracture site, and infection also in turn affect the immune response to fracture injury. Modern techniques used to investigate the relationship between immune system function and fracture healing include precision medicine, using vast quantities of data to interpret broad patterns of inflammatory response. Early data from the PRECISE trial have demonstrated distinct patterns of inflammatory response in polytrauma patients, which thereby directly and indirectly regulate the fracture healing response. The clearly demonstrated linkage between immune function and fracture healing suggests that modulation of immune function has significant potential as a therapeutic target that can be used to enhance fracture healing.

In Vitro Osteogenesis Study of Shell Nacre Cement with Older and Young Donor Bone Marrow Mesenchymal Stem/Stromal Cells.

Bone void-filling cements are one of the preferred materials for managing irregular bone voids, particularly in the geriatric population who undergo many orthopedic surgeries. However, bone marrow mesenchymal stem/stromal cells (BM-MSCs) of older-age donors often exhibit reduced osteogenic capacity. Hence, it is crucial to evaluate candidate bone substitute materials with BM-MSCs from the geriatric population to determine the true osteogenic potential, thus simulating the clinical situation. With this concept, we investigated the osteogenic potential of shell nacre cement (SNC), a bone void-filling cement based on shell nacre powder and ladder-structured siloxane methacrylate, using older donor BM-MSCs (age > 55 years) and young donor BM-MSCs (age < 30 years). Direct and indirect cytotoxicity studies conducted with human BM-MSCs confirmed the non-cytotoxic nature of SNC. The standard colony-forming unit-fibroblast (CFU-F) assay and population doubling (PD) time assays revealed a significant reduction in the proliferation potential (p < 0.0001, p < 0.05) in older donor BM-MSCs compared to young donor BM-MSCs. Correspondingly, older donor BM-MSCs contained higher proportions of senescent, ß-galactosidase (SA-ß gal)-positive cells (nearly 2-fold, p < 0.001). In contrast, the proliferation capacity of older donor BM-MSCs, measured as the area density of CellTrackerTM green positive cells, was similar to that of young donor BM-MSCs following a 7-day culture on SNC. Furthermore, after 14 days of osteoinduction on SNC, scanning electron microscopy with energy-dispersive spectroscopy (SEM-EDS) showed that the amount of calcium and phosphorus deposited by young and older donor BM-MSCs on SNC was comparable. A similar trend was observed in the expression of the osteogenesis-related genes BMP2, RUNX2, ALP, COL1A1, OMD and SPARC. Overall, the results of this study indicated that SNC would be a promising candidate for managing bone voids in all age groups.

Osteosynthesis, hemiarthroplasty, total hip arthroplasty in hip fractures: All I need to know.

Recent data from the UK's National Hip Fracture Database (NHFD) demonstrate an upward trajectory in the incidence of hip fractures, a trend which is expected to persist. In 2023 alone, the NHFD reported 72,160 cases, underscoring the prevalence of these injuries. These fractures are associated with significant morbidity, mortality, and economic costs. National guidelines for the surgical management of these fractures are established, although the implementation of total hip arthroplasty (THA) as a primary treatment modality varies. This review offers a narrative synthesis of contemporary literature on hip fractures, focusing on epidemiology, classification systems, and treatment options, with a particular emphasis on the outcomes of THA.

Is there genetic susceptibility for atypical femoral fractures?

The mechanisms underlying AFF remain unclear, with hypotheses including bone turnover suppression and morphological variation. Recent studies have suggested a potential genetic susceptibility to AFF. A scoping review was conducted using PubMed to identify studies published since 2016. Twenty-one studies were identified, focusing on histological and genetic analysis of AFF patients and Bisphosphonates users. Biopsies and imaging modalities were used to assess histological and morphometric parameters, while genetic sequencing was performed to identify variants in target genes. Genetic studies identified variants in geranylgeranyl diphosphate synthase 1 (GGPS1) and CYP1A1 genes, which play roles in osteoclast function and drug metabolism, respectively. Functional analysis revealed reduced enzymatic activity in mutant variants of these genes, which could be further inhibited by BP use. Other genes, such as ATRAID, ALPL, and COL1A2, were also associated with AFF. Histomorphometric studies supported the hypothesis of bone turnover suppression in AFF, with alterations in tissue mechanical properties and microarchitecture observed, particularly in cortical bone. The findings suggest a potential genetic susceptibility to AFF, with variants in GGPS1 and CYP1A1 genes affecting osteoblast and osteoclast function. Bone turnover suppression and altered tissue properties contribute to the pathogenesis of AFF.

Unstable pelvic fractures in women: implications on obstetric outcome.

PURPOSE: Obstetric outcomes in women following pelvic injuries requiring surgical fixation is not thoroughly known. We aimed to evaluate if radiographic measurements (RMs) can be used to provide information on delivery methods outcome after these injuries, and to evaluate if metal work removal is required prior to delivery. METHOD: A retrospective study in a level 1 trauma centre of female patients with pelvic fractures treated operatively, aged 16-45 at the time of injury. Participants completed a questionnaire regarding their obstetric history. RM evaluating pelvic symmetry, displacement, and pelvimetry were conducted on postoperative radiographs and CT scans. Patients who gave birth after the injury were divided to two groups according to the delivery method: vaginal delivery (VD) and caesarean section (CS). These two groups RM were compared. RESULTS: Forty-four patients were included, comparison of the RM of patients who delivered by CS (9) and patients who had only VD (11) showed no significant difference between the groups. Two patients underwent a trial of VD who subsequently underwent urgent CS due to prolonged labour, their RM were below the average and their pelvimetry measurements were above the cut-off for CS recommendation. Eleven patients had uncomplicated VD, all had retained sacroiliac screws at the time of delivery and one patient had an anterior pubic plate. CONCLUSION: Postoperative RM did not show an effect on delivery method of women after pelvic fracture fixation. A relatively high number of patients who underwent normal vaginal delivery had retained sacroiliac screws. These findings can form the foundation for larger cohort studies.

Trends of impact factor contributors to the Injury Journal: A bibliometric analysis.

PURPOSE: This study aims to analyse papers concerning journal impact factors published in the Injury-International Journal of the Care of the Injured between 1997 and 2022. Through this analysis, the research offers valuable insights into the publication performance and contributors to the journal impact factor, encompassing papers, authors, institutions, and countries. METHODS: Articles and reviews published in the Injury between 1995 and 2021 were examined using the Science Citation Index Expanded database. The study employed the journal impact factor contributing indicator to compare highly cited and high journal impact factor papers across various aspects, including papers, authors, institutions, and countries. RESULTS: A notable correlation exists between prolific authors, institutions, and countries, alongside those who contribute to high journal impact factors. However, a less distinct connection was observed between highly cited papers/authors and high journal impact factor contributors. The Injury serves as a well-regarded international journal. Notably, editorial members of the journal play a substantial role, serving as model editors and contributing significantly to the journal's success. Out of the Top 25 IF contributing papers with the CN of 34 or more the following themes were noted to dominate: bone healing/tissue regeneration (40 %) of papers, covid-19 pandemic (24 %), polytrauma/coagulopathy (12 %) and infection (8 %). CONCLUSIONS: Utilizing the journal impact factor to assess research performance at the individual, institutional, or national levels appears not to be the most appropriate method. The results show that highly cited authors did not hold the distinction of being the primary contributors to the IF. Analysis revealed a low significant relationship among the primary contributors to the IF, highly cited papers, and the most influential papers in 2022. A more effective indicator could involve considering the total number of citations a publication receives from its year of publication up to the end of the most recent year.

Modern osteosynthesis of periarticular fractures: The role of provisional fixation revisited.

Periarticular fractures are complex injuries affecting the joint articular surface, the subchondral area, the metaphyseal region, the surrounding soft tissue envelope and not infrequently the ligamentous structures. The management of these injuries has evolved over the years, from one stage to two stage procedures thus facilitating soft tissue resuscitation, adequate pre-operative planning and the use of biologics optimizing the conditions for definitive fixation for a successful long-term outcome. Provisional fixation constitutes an essential step in the surgical treatment of these fractures. Herein, the role of provisional fixation as well as strategies on how they should be applied are discussed. The aim is to revisit this important step of provisional fracture fixation since its introduction by Albin Lambotte, in the early 1900's.

Management of metastatic bone disease of the pelvis: current concepts.

PURPOSE: Metastatic disease of the pelvis is frequently associated with severe pain and impaired ambulatory function. Depending on the patient's characteristics, primary tumor, and metastatic pelvic disease, the treatment choice may be varied. This study aims to report on the current management options of metastatic pelvic disease. METHODS: We comprehensively researched multiple databases and evaluated essential studies about current concepts of managing a metastatic bone disease of the pelvis, focusing on specific indications as well as on the result of treatment. RESULTS: Pelvic metastases not in the periacetabular region can be managed with modification of weight-bearing, analgesics, bisphosphonates, chemotherapy and/or radiotherapy. Minimally invasive approaches include radiofrequency ablation, cryoablation, embolization, percutaneous osteoplasty, and percutaneous screw placement. Pathological or impending periacetabular fracture, excessive periacetabular bone defect, radioresistant tumor, and persistent debilitating pain despite non-surgical treatment and/or minimally invasive procedures can be managed with different surgical techniques. Overall, treatment can be divided into nonoperative, minimally invasive, and operative based on specific indications, the expectations of the patient and the lesion. CONCLUSION: Different treatment modalities exist to manage metastatic pelvic bone disease. Decision-making for the most appropriate treatment should be made with a multidisciplinary approach based on a case-by-case basis.

Physiologically engineered porous titanium/brushite scaffolds for critical-size bone defects: A design and manufacturing study.

Repairing critical-size bone defects still represents a critical clinical challenge in the field of trauma surgery. This study focuses on a physiological design and manufacturing of porous composite scaffold (titanium Ti with 10 % mole iron doped brushite DCPD-Fe3+) which can mimic the biomechanical properties of natural cortical bone, specifically for the purpose of repairing critical-size defects. To achieve this, the principle of design of experiments (DOE) was applied for investigating the impact of sintering temperature, mineral ratio, and volume fraction of porosity on the mechanical properties of the fabricated scaffolds. The fabricated scaffolds had open porosity up to 60 %, with pore size approximately between 100 µm and 850 µm. The stiffness of the porous composite scaffolds varied between 3.30 GPa and 20.50 GPa, while the compressive strength ranged from approximately 130 MPa-165 MPa at sintering temperatures equal to or exceeding 1000 °C. Scaffolds with higher porosity and mineral content demonstrated lower stiffness values, resembling natural bone. Numerical simulation was employed by Ansys Workbench to investigate the stress and strain distribution of a critical size defect in mid-shaft femur which was designed to be replaced with the fabricated scaffold. The fabricated scaffolds showed flexible biomechanical behaviour at the bone/scaffold interface, generating lower stress levels and indicating a better match with the femoral shaft stiffness. The experimental and numerical findings demonstrated promising applications for manufacturing a patient-specific bone scaffold for critical and potentially large defects for reducing stress shielding and minimizing non-union risk.

Distraction osteogenesis versus induced membrane technique for infected tibial non-unions with segmental bone loss: a systematic review of the literature and meta-analysis of available studies.

INTRODUCTION: Infected tibial non-unions with associated bone loss can be challenging to manage. At present, the two main methods utilized in the management of these fractures include the Ilizarov technique of Distraction Osteogenesis (DO) using external fixator devices, or alternatively, the Induced Membrane Technique (IMT), devised by Masquelet. As there is a paucity of data directly comparing the outcomes of these techniques, there is no universal agreement on which strategy a surgeon should choose to use. AIMS: This systematic review and meta-analysis aimed to summarize the outcomes of both DO and IMT, in terms of primary outcomes (bone union and infection elimination), and secondary outcomes (complication rates and functional outcomes). METHODS: A PRISMA strategy was used. Medline, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar library databases were interrogated using pre-defined MeSH terms and Boolean operators. Quality of evidence was evaluated using OCEBM and GRADE systems. RESULTS: Thirty-two studies with 1136 subjects met the inclusion criteria. With respect to the primary outcomes of interest, union was observed in 94.6% (DO method) and 88.0% (IMT method); this difference, however, was not significant between the two techniques (p = 0.45). In addition, infection elimination rates were also higher in the Ilizarov DO group when compared to Masquelet (Mq) IMT (93.0% vs 80.4% respectively). Again, no significant difference was observed (p = 0.06). For all secondary outcomes assessed (unplanned re-operations, re-fracture rates amputation rate), no statistically significant differences were documented between the treatment options. CONCLUSION: This study demonstrated that there is no clinical difference in outcomes for patients treated with Ilizarov DO versus Mq IMT techniques. The evidence base at present is relatively sparse and, therefore, we would recommend for further Level I studies to be conducted, to make more meaningful conclusions.

Stabilization of Tibial Fractures at Risk of Complications With the Bactiguard Intramedullary Nail: Early to Medium Results With a Novel Metal-Coated Device.

OBJECTIVES: The purpose of this study was to investigate the safety and early clinical results from the use of a novel, noble metal-coated titanium tibial nail for the definite stabilization of tibial shaft fractures at risk of developing complications. DESIGN: This is a retrospective case series with prospectively collected data. SETTING: Level I Trauma Centre in the United Kingdom. PATIENTS AND INTERVENTION: Thirty-one patients who were managed with the Bactiguard-coated Natural Nail and achieved a minimum of a 12-month follow-up. MAIN OUTCOME MEASUREMENTS: The main outcomes of this study were the incidence of adverse events (related to implant safety), complications (particularly infection), and reinterventions. RESULTS: Thirty-one patients with a mean age of 41.6 years were included in this study. Active heavy smokers or intravenous drug users were 25.8% and 9.7% of them were diabetic. Five fractures were open while 13 had concomitant soft-tissue involvement (Tscherne grade 1 or 2). Twenty-seven patients healed with no further intervention in a mean time of 3.3 months. Three patients developed nonunion and required further intervention. The overall union rate was 96.7%. One patient developed deep infection after union (infection incidence 3.2%). Six patients (6/31; [19.3%]) required reinterventions [2 for the treatment of nonunion, 3 for removal of screws soft-tissue irritation, and 1 for the management of infection). CONCLUSIONS: The management of tibial shaft fractures with a noble metal-coated titanium tibial nail demonstrates encouraging outcomes. Further studies are desirable to gather more evidence in the performance of this innovative implant. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Neglected pelvic fragility fracture managed with unilateral triangular osteosynthesis.

We report on the treatment of a neglected displaced vertical shear pelvic fracture with functional impairment 6 months after injury in a 74-year-old woman with underlying osteoporosis. She was managed with open reduction and internal fixation and grafting of her left SI joint, while the ipsilateral pubic rami fractures were treated conservatively. She achieved union and pain free weight bearing 6 months postoperatively. Appropriate evaluation of the pathology and selection of the appropriate treatment in this elderly patient cohort is essential for a successful outcome. Experienced surgical team and individualized treatment approach are also vital to optimize the result of treatment.

Periprosthetic acetabular fractures as a complication of total hip arthroplasty.

Periprosthetic acetabular fractures are rare but potentially devastating complications of total hip arthroplasty. As the number of total hip arthroplasties performed annually increases, so has the incidence of periprosthetic fractures, with the topic being spotlighted more frequently in the orthopaedic community. There is a particular sparsity of literature regarding periprosthetic acetabular fractures, with periprosthetic femoral fractures after total hip arthroplasty being traditionally far more commonly reported. This article aims to provide an up-to-date review of the epidemiology, risk factors, diagnostic challenges, classifications, and management strategies for periprosthetic acetabular fractures after total hip arthroplasty.

Failure of Fixation in Trochanteric Hip Fractures: Does Nail Design Matter?

OBJECTIVE: The objective of this study was to compare clinical outcomes of patients with trochanteric hip fractures treated with specific different cephalomedullary nail (CMN) designs. METHODS: A scoping review of the English literature was performed. Inclusion criteria were studies comparing perioperative and postoperative outcomes of trochanteric hip fractures fixated by CMNs for one of the following CMN designs: short versus long nails, blade versus screw fixation, dual versus single lag screw fixation, and application of cement augmentation. Inclusion criteria consisted of human comparative clinical trials (randomized and observational). Exclusion criteria included noncomparative studies, studies comparing CMN with non-CMN devices or with arthroplasty, studies with less than 3 months follow-up, studies that did not provide relevant clinical outcome measures, biomechanical, finite element analyses, animal, or in vitro publications. Data regarding reoperations, peri-implant fractures, mechanical failure, nonunion, infection rates, and functional outcomes were reviewed. RESULTS: Twenty-two studies met the inclusion criteria and formed the basis of this study. Failure of fixation rates and reoperation rates for each of the nail designs selected for evaluation is presented, in addition to specific outcome measures relevant to that nail design which was explored: peri-implant fracture-short versus long nails, and specific mechanism of failure-blade versus plate. CONCLUSIONS: Decreased failure of fixation and reoperations rates were found for integrated dual lag screw fixation. Similar fixation failure and reoperation rates were found for the long versus short nails and for blade versus screw fixation. LEVEL OF EVIDENCE: Diagnostic, Level IV.

Endovis Nail versus Dynamic Hip Screw for Unstable Pertrochanteric Fractures: A Feasibility Randomised Control Trial including Patients with Cognitive Impairment.

A prospective, feasibility, randomised study was performed to compare intramedullary versus extramedullary fixation of unstable pertrochanteric fractures and to assess the feasibility of including patients with dementia. From July 2016 to November 2017, 60 consecutive patients with an unstable pertrochanteric (OTA/AO 31-A2) fracture were randomized to either receive a short cephalomedullary nail (Endovis EBA2, Citieffe) or a dynamic hip screw (DHS, Zimmer Biomet). Primary feasibility measures included randomisation, recruitment, and retention rates. Secondary outcomes included peri-operative parameters, patient-reported outcomes and radiographic outcomes. Patients were followed-up at two, four, and twelve weeks. There was no difference in the randomisation rate between patients with and without cognitive impairment. Significantly more patients without cognitive impairment attended the 12-week follow-up. The overall recruitment rate was 0.9 patients per week. Patients treated with the nail had less pain at 2 weeks and less neck collapse, medialisation, and leg shortening at all time points. The rest of secondary outcomes were similar. Patients with dementia can successfully be enrolled in a randomised trial on hip fractures. Patients treated with the Endovis nail had lower levels of pain at two weeks and better radiographic outcomes.