Aims. The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy. Methods. Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions. Results. A total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period. Conclusion. Our study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented. Cite this article: Bone Jt Open 2024;5(7):534–542

Aims. Implantation of ultra-purified alginate (UPAL) gel is safe and effective in animal osteochondral defect models. This study aimed to examine the applicability of UPAL gel implantation to acellular therapy in humans with cartilage injury. Methods. A total of 12 patients (12 knees) with symptomatic, post-traumatic, full-thickness cartilage lesions (1.0 to 4.0 cm. 2. ) were included in this study. UPAL gel was implanted into chondral defects after performing bone marrow stimulation technique, and assessed for up to three years postoperatively. The primary outcomes were the feasibility and safety of the procedure. The secondary outcomes were self-assessed clinical scores, arthroscopic scores, tissue biopsies, and MRI-based estimations. Results. No obvious adverse events related to UPAL gel implantation were observed. Self-assessed clinical scores, including pain, symptoms, activities of daily living, sports activity, and quality of life, were improved significantly at three years after surgery. Defect filling was confirmed using second-look arthroscopy at 72 weeks. Significantly improved MRI scores were observed from 12 to 144 weeks postoperatively. Histological examination of biopsy specimens obtained at 72 weeks after implantation revealed an extracellular matrix rich in glycosaminoglycan and type II collagen in the reparative tissue. Histological assessment yielded a mean overall International Cartilage Regeneration & Joint Preservation Society II score of 69.1 points (SD 10.4; 50 to 80). Conclusion. This study provides evidence supporting the safety of acellular UPAL gel implantation in facilitating cartilage repair. Despite being a single-arm study, it demonstrated the efficacy of UPAL gel implantation, suggesting it is an easy-to-use, one-step method of cartilage tissue repair circumventing the need to harvest donor cells. Cite this article: Bone Joint J 2023;105-B(8):880–887

Aims. Restarting planned surgery during the COVID-19 pandemic is a clinical and societal priority, but it is unknown whether it can be done safely and include high-risk or complex cases. We developed a Surgical Prioritization and Allocation Guide (SPAG). Here, we validate its effectiveness and safety in COVID-free sites. Methods. A multidisciplinary surgical prioritization committee developed the SPAG, incorporating procedural urgency, shared decision-making, patient safety, and biopsychosocial factors; and applied it to 1,142 adult patients awaiting orthopaedic surgery. Patients were stratified into four priority groups and underwent surgery at three COVID-free sites, including one with access to a high dependency unit (HDU) or intensive care unit (ICU) and specialist resources. Safety was assessed by the number of patients requiring inpatient postoperative HDU/ICU admission, contracting COVID-19 within 14 days postoperatively, and mortality within 30 days postoperatively. Results. A total of 1,142 patients were included, 47 declined surgery, and 110 were deemed high-risk or requiring specialist resources. In the ten-week study period, 28 high-risk patients underwent surgery, during which 68% (13/19) of Priority 2 (P. 2. , surgery within one month) patients underwent surgery, and 15% (3/20) of P. 3. (< three months) and 16% (11/71) of P. 4. (> three months) groups. Of the 1,032 low-risk patients, 322 patients underwent surgery. Overall, 21 P. 3. and P. 4. patients were expedited to ‘Urgent’ based on biopsychosocial factors identified by the SPAG. During the study period, 91% (19/21) of the Urgent group, 52% (49/95) of P. 2. , 36% (70/196) of P. 3. , and 26% (184/720) of P. 4. underwent surgery. No patients died or were admitted to HDU/ICU, or contracted COVID-19. Conclusion. Our widely generalizable model enabled the restart of planned surgery during the COVID-19 pandemic, without compromising patient safety or excluding high-risk or complex cases. Patients classified as Urgent or P. 2. were most likely to undergo surgery, including those deemed high-risk. This model, which includes assessment of biopsychosocial factors alongside disease severity, can assist in equitably prioritizing the substantial list of patients now awaiting planned orthopaedic surgery worldwide. Cite this article: Bone Jt Open 2021;2(2):134–140

The February 2024 Hip & Pelvis Roundup. 360. looks at: Trial of vancomycin and cefazolin as surgical prophylaxis in arthroplasty; Is preoperative posterior femoral neck tilt a risk factor for fixation failure? Cemented versus uncemented hemiarthroplasty for displaced intracapsular fractures of the hip; Periprosthetic fractures in larger hydroxyapatite-coated stems: are collared stems a better alternative for total hip arthroplasty?; Postoperative periprosthetic fracture following hip arthroplasty with a polished taper slip versus composite beam stem; Is oral tranexamic acid as good as intravenous?; Stem design and the risk of early periprosthetic femur fractures following THA in elderly patients; Does powered femoral broaching compromise patient safety in total hip arthroplasty?

The August 2024 Children’s orthopaedics Roundup. 360. looks at: Antibiotic prophylaxis and infection rates in paediatric supracondylar humerus fractures; Clinical consensus recommendations for the non-surgical treatment of children with Perthes’ disease in the UK; Health-related quality of life in idiopathic toe walkers: a multicentre prospective cross-sectional study; Children with spinal dysraphism: a systematic review of reported outcomes; No delay in age of crawling, standing, or walking with Pavlik harness treatment: a prospective cohort study; No value found with routine early postoperative radiographs after implant removal in paediatric patients; What do we know about the natural history of spastic hip dysplasia and pain in total-involvement cerebral palsy?; Evaluating the efficacy and safety of preoperative gallows traction for hip open reduction in infants

Aims. This study aimed to assess the risk of acute kidney injury (AKI) associated with combined intravenous (IV) and topical antibiotic therapy in patients undergoing treatment for periprosthetic joint infections (PJIs) following total knee arthroplasty (TKA), utilizing the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for classification. Methods. We conducted a retrospective analysis of 162 knees (162 patients) that received treatment for PJI post-TKA with combined IV and topical antibiotic infusions at a single academic hospital from 1 January 2010 to 31 December 2022. The incidence of AKI was evaluated using the KDIGO criteria, focussing on the identification of significant predictors and the temporal pattern of AKI development. Results. AKI was identified in 9.26% (15/162) of the cohort, predominantly presenting as stage 1 AKI, which was transient in nature and resolved prior to discharge. The analysis highlighted moderate anaemia and lower baseline serum creatinine levels as significant predictors for the development of AKI. Notably, the study found no instances of severe complications such as wound dehiscence, skin erosion, or the need for haemodialysis following treatment. Conclusion. The findings suggest that the combined use of IV and topical antibiotic therapy in the management of PJIs post-TKA is associated with a low incidence of primarily transient stage 1 AKI. This indicates a potentially favourable renal safety profile, advocating for further research to confirm these outcomes and potentially influence treatment protocols in PJI management. Cite this article: Bone Joint Res 2024;13(10):525–534

Aims. In the UK, the agricultural, military, and construction sectors have stringent rules about the use of hearing protection due to the risk of noise-induced hearing loss. Orthopaedic staff may also be at risk due to the use of power tools. The UK Health and Safety Executive (HSE) have clear standards as to what are deemed acceptable occupational levels of noise on A-weighted and C-weighted scales. The aims of this review were to assess the current evidence on the testing of exposure to noise in orthopaedic operating theatres to see if it exceeds these regulations. Methods. A search of PubMed and EMBASE databases was conducted using PRISMA guidelines. The review was registered prospectively in PROSPERO. Studies which assessed the exposure to noise for orthopaedic staff in operating theatres were included. Data about the exposure to noise were extracted from these studies and compared with the A-weighted and C-weighted acceptable levels described in the HSE regulations. Results. A total of 15 studies were deemed eligible. These included a total of 386 orthopaedic operations and the use of 64 orthopaedic instruments. A total of 294 operations (76%) and 45 instruments (70%) exceeded the regulations on an A-weighted scale, and 22% (10 of 46) of operations exceeded the maximum C-weighted peak acceptable level of noise. Noise-induced hearing loss was reported in 28 of 55 orthopaedic staff members (50.9%). Conclusion. Safe levels of noise can be exceeded in orthopaedic operations, and when using orthopaedic instruments. Employers have clear policies about exposure to noise in the workplace but have yet to identify orthopaedic theatres as a potential at-risk area. Orthopaedic staff need education, monitoring, and protection, while employers should consider regular assessments of staff in orthopaedic theatres and offer methods to prevent noise-induced hearing loss. Cite this article: Bone Joint J 2023;105-B(6):602–609

Aims. Although low-intensity pulsed ultrasound (LIPUS) combined with disinfectants has been shown to effectively eliminate portions of biofilm in vitro, its efficacy in vivo remains uncertain. Our objective was to assess the antibiofilm potential and safety of LIPUS combined with 0.35% povidone-iodine (PI) in a rat debridement, antibiotics, and implant retention (DAIR) model of periprosthetic joint infection (PJI). Methods. A total of 56 male Sprague-Dawley rats were established in acute PJI models by intra-articular injection of bacteria. The rats were divided into four groups: a Control group, a 0.35% PI group, a LIPUS and saline group, and a LIPUS and 0.35% PI group. All rats underwent DAIR, except for Control, which underwent a sham procedure. General status, serum biochemical markers, weightbearing analysis, radiographs, micro-CT analysis, scanning electron microscopy of the prostheses, microbiological analysis, macroscope, and histopathology evaluation were performed 14 days after DAIR. Results. The group with LIPUS and 0.35% PI exhibited decreased levels of serum biochemical markers, improved weightbearing scores, reduced reactive bone changes, absence of viable bacteria, and decreased inflammation compared to the Control group. Despite the greater antibiofilm activity observed in the PI group compared to the LIPUS and saline group, none of the monotherapies were successful in preventing reactive bone changes or eliminating the infection. Conclusion. In the rat model of PJI treated with DAIR, LIPUS combined with 0.35% PI demonstrated stronger antibiofilm potential than monotherapy, without impairing any local soft-tissue. Cite this article: Bone Joint Res 2024;13(7):332–341

The April 2024 Foot & Ankle Roundup. 360. looks at: Safety of arthroscopy combined with radial extracorporeal shockwave therapy for osteochondritis of the talus; Bipolar allograft transplantation of the ankle; Identifying risk factors for osteonecrosis after talar fracture; Balancing act: immediate versus delayed weightbearing in ankle fracture recovery; Levelling the field: proximal supination osteotomy’s efficacy in severe and super-severe hallux valgus; Restoring balance: how adjusting the tibiotalar joint line influences movement after ankle surgery

The August 2024 Shoulder & Elbow Roundup. 360. looks at: Comparing augmented and nonaugmented locking-plate fixation for proximal humeral fractures in the elderly; Elevated five-year mortality following shoulder arthroplasty for fracture; Total intravenous anaesthesia with propofol reduces discharge times compared with inhaled general anaesthesia in shoulder arthroscopy: a randomized controlled trial; The influence of obesity on outcomes following arthroscopic rotator cuff repair; Humeral component version has no effect on outcomes following reverse total shoulder arthroplasty: a prospective, double-blinded, randomized controlled trial; What is a meaningful improvement after total shoulder arthroplasty by implant type, preoperative diagnosis, and sex?; The safety of corticosteroid injection prior to shoulder arthroplasty: a systematic review; Mortality and subsequent fractures of patients with olecranon fractures compared to other upper limb osteoporotic fractures

The February 2023 Oncology Roundup. 360. looks at: Is the number of national database research studies in musculoskeletal sarcoma increasing, and are these studies reliable?; Re-excision after unplanned excision of soft-tissue sarcoma is associated with high morbidity; Adjuvant radiation in atypical lipomatous tumours; The oncological outcomes of isolated limb perfusion and neoadjuvant radiotherapy in soft-tissue sarcoma patients - a nationwide multicentre study; Can low-grade chondrosarcoma be treated with intralesional curettage and cryotherapy?; Efficacy and safety of carbon ion radiotherapy for bone sarcomas: a systematic review and meta-analysis; Doxorubicin-polymeric meshes prevent local recurrence after sarcoma resection while avoiding cardiotoxicity; How important are skip lesions in Ewing’s sarcoma?; Improving outcomes for amputees: the health-related quality of life and cost utility analysis of osseointegration prosthetics in transfemoral amputees

Aims. Total knee arthroplasty (TKA) with a highly congruent condylar-stabilized (CS) articulation may be advantageous due to increased stability versus cruciate-retaining (CR) designs, while mitigating the limitations of a posterior-stabilized construct. The aim was to assess ten-year implant survival and functional outcomes of a cemented single-radius TKA with a CS insert, performed without posterior cruciate ligament sacrifice. Methods. This retrospective cohort study included consecutive patients undergoing TKA at a specialist centre in the UK between November 2010 and December 2012. Data were collected using a bespoke electronic database and cross-referenced with national arthroplasty audit data, with variables including: preoperative characteristics, intraoperative factors, complications, and mortality status. Patient-reported outcome measures (PROMs) were collected by a specialist research team at ten years post-surgery. There were 536 TKAs, of which 308/536 (57.5%) were in female patients. The mean age was 69.0 years (95% CI 45.0 to 88.0), the mean BMI was 32.2 kg/m. 2. (95% CI 18.9 to 50.2), and 387/536 (72.2%) survived to ten years. There were four revisions (0.7%): two deep infections (requiring debridement and implant retention), one aseptic loosening, and one haemosiderosis. Results. Kaplan-Meier analysis demonstrated no difference in implant survival according to sex, age, or obesity status. Ten-year PROMs were available for 196/387 (50.6%) surviving patients and were excellent: mean Oxford Knee Score 34.4 (95% CI 32.7 to 36.1); mean Forgotten Joint Score (FJS) 51.2 (95% CI 16.1 to 86.3); mean EuroQol five-dimension five-level questionnaire score 69.9 (95% CI 46.8 to 93.0); 141/196 (71.9%) achieved the 22-point FJS patient-acceptable symptom state (PASS); and 156/196 (79.6%) were “very satisfied or satisfied”. Conclusion. This is the only large study reporting ten-year implant survival and functional outcomes of TKA using a cemented single-radius design and with a CS tibial bearing construct. The findings of excellent implant survival, safety, and functional outcomes indicate that this combination is a safe and effective option in routine TKA. Further investigation of this single-radius design TKA with CS tibial bearings with well-matched patient study groups will allow further insight into the performance of these implants. Cite this article: Bone Joint J 2024;106-B(8):808–816

Aims. Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. Methods. A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014). Discussion. Randomized controlled trials are needed to evaluate alternative nonoperative treatment options for Weber B/SER4a ankle fractures, as current clinical guidelines are based on biomechanical reasoning. The findings will be shared through publication in peer-reviewed journals and presentations at conferences. Cite this article: Bone Jt Open 2023;4(9):713–719

Aims. The aim of this study was to investigate the safety and efficacy of 3D-printed modular prostheses in patients who underwent joint-sparing limb salvage surgery (JSLSS) for malignant femoral diaphyseal bone tumours. Methods. We retrospectively reviewed 17 patients (13 males and four females) with femoral diaphyseal tumours who underwent JSLSS in our hospital. Results. In all, 17 patients with locally aggressive bone tumours (Enneking stage IIB) located in the femoral shaft underwent JSLSS and reconstruction with 3D-printed modular prostheses between January 2020 and June 2022. The median surgical time was 153 minutes (interquartile range (IQR) 117 to 248), and the median estimated blood loss was 200ml (IQR 125 to 400). Osteosarcoma was the most common pathological type (n = 12; 70.6%). The mean osteotomy length was 197.53 mm (SD 12.34), and the median follow-up was 25 months (IQR 19 to 38). Two patients experienced local recurrence and three developed distant metastases. Postoperative complications included wound infection in one patient and screw loosening in another, both of which were treated successfully with revision surgery. The median Musculoskeletal Tumor Society score at the final follow-up was 28 (IQR 27 to 28). Conclusion. The 3D-printed modular prosthesis is a reliable and feasible reconstruction option for patients with malignant femoral diaphyseal tumours. It helps to improve the limb salvage rate, restore limb function, and achieve better short-term effectiveness. Cite this article: Bone Jt Open 2024;5(4):317–323

Aims. Open reduction in developmental dysplasia of the hip (DDH) is regularly performed despite screening programmes, due to failure of treatment or late presentation. A protocol for open reduction of DDH has been refined through collaboration between surgical, anaesthetic, and nursing teams to allow same day discharge. The objective of this study was to determine the safety and feasibility of performing open reduction of DDH as a day case. Methods. A prospectively collected departmental database was visited. All consecutive surgical cases of DDH between June 2015 and March 2020 were collected. Closed reductions, bilateral cases, cases requiring corrective osteotomy, and children with comorbidities were excluded. Data collected included demographics, safety outcome measures (blood loss, complications, readmission, reduction confirmation), and feasibility for discharge according to the Face Legs Activity Cry Consolidability (FLACC) pain scale. A satisfaction questionnaire was filled by the carers. Descriptive statistics were used for analysis. Results. Out of 168 consecutive DDH cases, 16 patients fit the inclusion criteria (age range 10 to 26 months, 13 female). Intraoperative blood loss ranged from "minimal" to 120 ml, and there were no complications or readmissions. The FLACC score was 0 for all patients. The carers satisfaction questionnaire expressed high satisfaction from the experience with adequate information and support provided. Conclusion. Open reduction in DDH, without corrective osteotomy, is safe and feasible to be managed as a day case procedure. It requires a clear treatment pathway, analgesia, sufficient counselling, and communication with carers. It is even more important during the COVID-19 pandemic when reduced length of hospital stay is likely to be safer for both patient and their parents. Cite this article: Bone Joint Open 2021;2(4):271–277

Aims. Computer-assisted 3D preoperative planning software has the potential to improve postoperative stability in total hip arthroplasty (THA). Commonly, preoperative protocols simulate two functional positions (standing and relaxed sitting) but do not consider other common positions that may increase postoperative impingement and possible dislocation. This study investigates the feasibility of simulating commonly encountered positions, and positions with an increased risk of impingement, to lower postoperative impingement risk in a CT-based 3D model. Methods. A robotic arm-assisted arthroplasty planning platform was used to investigate 11 patient positions. Data from 43 primary THAs were used for simulation. Sacral slope was retrieved from patient preoperative imaging, while angles of hip flexion/extension, hip external/internal rotation, and hip abduction/adduction for tested positions were derived from literature or estimated with a biomechanical model. The hip was placed in the described positions, and if impingement was detected by the software, inspection of the impingement type was performed. Results. In flexion, an overall impingement rate of 2.3% was detected for flexed-seated, squatting, forward-bending, and criss-cross-sitting positions, and 4.7% for the ankle-over-knee position. In extension, most hips (60.5%) were found to impinge at or prior to 50° of external rotation (pivoting). Many of these impingement events were due to a prominent ischium. The mean maximum external rotation prior to impingement was 45.9° (15° to 80°) and 57.9° (20° to 90°) prior to prosthetic impingement. No impingement was found in standing, sitting, crossing ankles, seiza, and downward dog. Conclusion. This study demonstrated that positions of daily living tested in a CT-based 3D model show high rates of impingement. Simulating additional positions through 3D modelling is a low-cost method of potentially improving outcomes without compromising patient safety. By incorporating CT-based 3D modelling of positions of daily living into routine preoperative protocols for THA, there is the potential to lower the risk of postoperative impingement events. Cite this article: Bone Jt Open 2023;4(6):416–423

Aims. Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design. Methods. Patients with end-stage osteoarthritis were enrolled in a prospective cohort at a single centre. The cohort consisted of 11 females and 11 males with mean age of 70.6 years (SD 3.5) and BMI of 31.0 kg/m. 2. (SD 5.7). Implant fixation was evaluated using RSA as well as Western Ontario and McMaster Universities Osteoarthritis Index, Harris Hip Score, Oxford Hip Score, Hip disability and Osteoarthritis Outcome Score, 38-item Short Form survey, and EuroQol five-dimension health questionnaire scores at two-year follow-up. At least one acetabular screw was used in all cases. RSA markers were inserted into the innominate bone and proximal femur with imaging at six weeks (baseline) and six, 12, and 24 months. Independent-samples t-tests were used to compare to published thresholds. Results. Mean acetabular subsidence from baseline to 24 months was 0.087 mm (SD 0.152), below the critical threshold of 0.2 mm (p = 0.005). Mean femoral subsidence from baseline to 24 months was -0.002 mm (SD 0.194), below the published reference of 0.5 mm (p < 0.001). There was significant improvement in patient-reported outcome measures at 24 months with good to excellent results. Conclusion. RSA analysis demonstrates excellent fixation with a predicted low risk of revision at ten years of this novel reverse total hip system. Clinical outcomes were consistent with safe and effective hip replacement prostheses. Cite this article: Bone Jt Open 2023;4(5):385–392

Aims. This study aims to determine difference in annual rate of early-onset (≤ 90 days) deep surgical site infection (SSI) following primary total knee arthroplasty (TKA) for osteoarthritis, and to identify risk factors that may be associated with infection. Methods. This is a retrospective population-based cohort study using prospectively collected patient-level data between 1 January 2013 and 1 March 2020. The diagnosis of deep SSI was defined as per the Centers for Disease Control/National Healthcare Safety Network criteria. The Mann-Kendall Trend test was used to detect monotonic trends in annual rates of early-onset deep SSI over time. Multiple logistic regression was used to analyze the effect of different patient, surgical, and healthcare setting factors on the risk of developing a deep SSI within 90 days from surgery for patients with complete data. We also report 90-day mortality. Results. A total of 39,038 patients underwent primary TKA for osteoarthritis during the study period. Of these, 275 patients developed a deep SSI within 90 days of surgery, representing a cumulative incidence of 0.7%. The annual infection rate did not significantly decrease over the seven-year study period (p = 0.162). Overall, 13,885 (35.5%) cases were excluded from the risk analysis due to missing data. Risk factors associated with early-onset deep SSI included male sex, American Society of Anesthesiologists grade ≥ 3, blood transfusion, acute length of stay, and surgeon volume < 30 TKAs/year. Early-onset deep SSI was not associated with increased 90-day mortality. Conclusion. This study establishes a reliable baseline infection rate for early-onset deep SSI after TKA for osteoarthritis using robust Infection Prevention and Control surveillance data, and identifies several potentially modifiable risk factors. Cite this article: Bone Joint J 2023;105-B(9):971–976

Aims. The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. Methods. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 10. 6. PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%. Conclusion. The HIPGEN study assesses the efficacy, safety, and tolerability of intramuscular PLX-PAD administration for the treatment of muscle injury following arthroplasty for hip fracture. It is the first phase III study to investigate the effect of an allogeneic cell therapy on improved mobilization after hip fracture, an aspect which is in sore need of addressing for the improvement in standard of care treatment for patients with FNF. Cite this article: Bone Jt Open 2022;3(4):340–347

Aims. Several short- and mid-term studies have shown minimal liner wear of highly cross-linked polyethylene (HXLPE) in total hip arthroplasty (THA), but the safety of using thinner HXLPE liners to maximize femoral head size remains uncertain. The objective of this study was to analyze clinical survival and radiological wear rates of patients with HXLPE liners, a 36 mm femoral head, and a small acetabular component with a minimum of ten years’ follow-up. Methods. We retrospectively identified 55 patients who underwent primary THA performed at a single centre, using HXLPE liners with 36 mm cobalt-chrome heads in acetabular components with an outer diameter of 52 mm or smaller. Patient demographic details, implant details, death, and all-cause revisions were recorded. Cox regression and Kaplan-Meier survival was used to determine all-cause and liner-specific revision. Of these 55 patients, 22 had a minimum radiological follow-up of seven years and were assessed radiologically for linear and volumetric wear. Results. Overall survival rate for all-cause revision was 94.5% (95% confidence interval (CI) 81.7% to 97.2%) at a mean follow-up of 12.8 years (10.9 to 18.7). Three patients were revised, none for liner wear, fracture, or dissociation. A total of 22 patients were included in the radiological analysis (mean follow-up 9.9 years (7.5 to 13.7)). Mean linear liner wear was 0.085 mm (95% CI -0.086 to 0.257) and the volumetric wear rate was 11.097 mm. 3. /year (95% CI -6.5 to 28.7). Conclusion. Using HXLPE liners with 36 mm heads in 52 mm acetabular components or smaller is safe, with excellent survival and low rates of linear and volumetric wear at medium-term follow-up. Patients did not require revision surgery for liner complications such as fracture, dissociation, or wear. Our results suggest that the advantages of using larger heads outweigh the potential risks of using thin HXLPE liners. Cite this article: Bone Joint J 2023;105-B(1):29–34