Aims. Supracondylar fractures are the most frequently occurring paediatric fractures about the elbow and may be associated with a neurovascular injury. The British Orthopaedic Association Standards for Trauma 11 (BOAST 11) guidelines describe best practice for supracondylar fracture management. This study aimed to assess whether emergency departments in the United Kingdom adhere to BOAST 11 standard 1: a documented assessment, performed on presentation, must include the status of the radial pulse, digital capillary refill time, and the individual function of the radial, median (including the anterior interosseous), and ulnar nerves. . Materials and Methods. Stage 1: We conducted a multicentre, retrospective audit of adherence to BOAST 11 standard 1. Data were collected from eight hospitals in the United Kingdom. A total of 433 children with Gartland type 2 or 3 supracondylar fractures were eligible for inclusion. A centrally created data collection sheet was used to guide objective analysis of whether BOAST 11 standard 1 was adhered to. Stage 2: We created a quality improvement proforma for use in emergency departments. This was piloted in one of the hospitals used in the primary audit and was re-audited using equivalent methodology. In all, 102 patients presenting between January 2016 and July 2017 were eligible for inclusion in the re-audit. Results. Stage 1: Of 433 patient notes audited, adherence to BOAST 11 standard 1 was between 201 (46%) and 232 (54%) for the motor and sensory function of the individual nerves specified, 318 (73%) for radial pulse, and 247 (57%) for digital capillary refill time. Stage 2: Of 102 patient notes audited, adherence to BOAST 11 standard 1 improved to between 72 (71%) and 80 (78%) for motor and sensory function of the nerves, to 84 (82%) for radial pulse, and to 82 (80%) for digital capillary refill time. Of the 102 case notes reviewed in stage 2, only 44 (43%) used the quality improvement proforma; when the proforma was used, adherence improved to between 40 (91%) and 43 (98%) throughout. Conclusion. Adherence to BOAST 11 standard 1 is poor in hospitals across the country. This is concerning as neurovascular deficit may be an indication for emergent surgery, and missed neurovascular injury can cause long-term, or even permanent, functional impairment. We present a simple proforma that improves adherence to this standard, can easily be implemented into emergency departments, and may improve patient safety. Cite this article: Bone Joint J 2018;100-B:346–51

Aims. The purpose of this study was to determine the weightbearing practice of operatively managed fragility fractures in the setting of publically funded health services in the UK and Ireland. Methods. The Fragility Fracture Postoperative Mobilisation (FFPOM) multicentre audit included all patients aged 60 years and older undergoing surgery for a fragility fracture of the lower limb between 1 January 2019 and 30 June 2019, and 1 February 2021 and 14 March 2021. Fractures arising from high-energy transfer trauma, patients with multiple injuries, and those associated with metastatic deposits or infection were excluded. We analyzed this patient cohort to determine adherence to the British Orthopaedic Association Standard, “all surgery in the frail patient should be performed to allow full weight-bearing for activities required for daily living”. Results. A total of 19,557 patients (mean age 82 years (SD 9), 16,241 having a hip fracture) were included. Overall, 16,614 patients (85.0%) were instructed to perform weightbearing where required for daily living immediately postoperatively (15,543 (95.7%) hip fracture and 1,071 (32.3%) non-hip fracture patients). The median length of stay was 12.2 days (interquartile range (IQR) 7.9 to 20.0) (12.6 days (IQR 8.2 to 20.4) for hip fracture and 10.3 days (IQR 5.5 to 18.7) for non-hip fracture patients). Conclusion. Non-hip fracture patients experienced more postoperative weightbearing restrictions, although they had a shorter hospital stay. Patients sustaining fractures of the shaft and distal femur had a longer median length of stay than demographically similar patients who received hip fracture surgery. We have shown a significant disparity in weightbearing restrictions placed on patients with fragility fractures, despite the publication of a national guideline. Surgeons intentionally restrict postoperative weightbearing in the majority of non-hip fractures, yet are content with unrestricted weightbearing following operations for hip fractures. Cite this article: Bone Joint J 2022;104-B(8):972–979

Aims. The mid-term results of kinematic alignment (KA) for total knee arthroplasty (TKA) using image derived instrumentation (IDI) have not been reported in detail, and questions remain regarding ligamentous stability and revisions. This paper aims to address the following: 1) what is the distribution of alignment of KA TKAs using IDI; 2) is a TKA alignment category associated with increased risk of failure or poor patient outcomes; 3) does extending limb alignment lead to changes in soft-tissue laxity; and 4) what is the five-year survivorship and outcomes of KA TKA using IDI?. Methods. A prospective, multicentre, trial enrolled 100 patients undergoing KA TKA using IDI, with follow-up to five years. Alignment measures were conducted pre- and postoperatively to assess constitutional alignment and final implant position. Patient-reported outcome measures (PROMs) of pain and function were also included. The Australian Orthopaedic Association National Joint Arthroplasty Registry was used to assess survivorship. Results. The postoperative HKA distribution varied from 9° varus to 11° valgus. All PROMs showed statistical improvements at one year (p < 0.001), with further improvements at five years for Knee Osteoarthritis Outcome Score symptoms (p = 0.041) and Forgotten Joint Score (p = 0.011). Correlation analysis showed no difference (p = 0.610) between the hip-knee-ankle and joint line congruence angle at one and five years. Sub-group analysis showed no difference in PROMs for patients placed within 3° of neutral compared to those placed > 3°. There were no revisions for tibial loosening; however, there were reports of a higher incidence of poor patella tracking and patellofemoral stiffness. Conclusion. PROMs were not impacted by postoperative alignment category. Ligamentous stability was maintained at five years with joint line obliquity. There were no revisions for tibial loosening despite a significant portion of tibiae placed in varus; however, KA executed with IDI resulted in a higher than anticipated rate of patella complications. Cite this article: Bone Jt Open 2022;3(8):656–665

The global COVID-19 pandemic has resulted in 71 million confirmed global cases and 1.6 million deaths. Hip fractures are a major global health burden with 70 000 admissions per annum in the UK. This multicentre UK study aimed to assess the impact of perioperative COVID-19 status on 30-day and 120-day mortality after a hip fracture. A prospective multicentre study of 10 hospitals in South England comprising eight DGHs and two MTCs treating c.8% of the annual incidence of hip fractures in England was performed. All fragility hip fractures presenting between 1. st. March to 30. th. April 2020 were eligible for inclusion. COVID-19 infection was diagnosed after a positive PCR swab. Expected 30-day mortality was calculated using the Nottingham Hip Fracture Score (NHFS), with non COVID-19 30-day mortality compared against the same study period in 2019. 746 patients were included in this study with 87 (12%) testing positive for COVID-19. Crude 30-day mortality for COVID-19 positive hip fractures was 35% compared to 6% for COVID-19 negative patients, with COVID-19 positive 30-mortality rates being significantly higher than expected based on NHFS alone (RR 3.0, 95% CI 1.57–5.75, p<0.001). There was no significant difference between expected NHFS and actual 2019 and COVID-19 negative hip fracture rates (p>0.05). Overall 120-day mortality was significantly higher for COVID-19 positive (46%) compared to COVID-19 negative (15%) hip fractures (p<0.001). However, mortality rates from 31–120 days were not significantly different despite COVID-19 status (p=0.107). COVID-19 results in significant increases in both 30 and 120-day mortality, above the expected mortality rates when confounding comorbidities are accounted for by the NHFS. However, COVID-19 positive patients who survive beyond 30-days have comparable mortality rates up to 120-days when compared to COVID-19 negative patients. Efforts should therefore be made to mitigate known risks for 30-day mortality such as time to theatre, to improve 30-day mortality rates in COVID-19 positive patients thus increasing the likelihood of long-term survival

Abstract. Objectives. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus NWB and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures. The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection, displacement of osteosynthesis, the full arc of ankle motion, RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the IWB group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021 with a similar result at three months. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a PE, both were randomised to NWB. Length of hospital stay was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusion. In this large multicentre RCT, we investigated WB following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome

Aims. Intraoperative pressure sensors allow surgeons to quantify soft-tissue balance during total knee arthroplasty (TKA). The aim of this study was to determine whether using sensors to achieve soft-tissue balance was more effective than manual balancing in improving outcomes in TKA. Methods. A multicentre randomized trial compared the outcomes of sensor balancing (SB) with manual balancing (MB) in 250 patients (285 TKAs). The primary outcome measure was the mean difference in the four Knee injury and Osteoarthritis Outcome Score subscales (ΔKOOS. 4. ) in the two groups, comparing the preoperative and two-year scores. Secondary outcomes included intraoperative balance data, additional patient-reported outcome measures (PROMs), and functional measures. Results. There was no significant difference in ΔKOOS. 4. between the two groups at two years (mean difference 0.4 points (95% confidence interval (CI) -4.6 to 5.4); p = 0.869), and multiple regression found that SB was not associated with a significant ΔKOOS. 4. (0.2-point increase (95% CI -5.1 to 4.6); p = 0.924). There were no significant differences between groups in other PROMs. Six-minute walking distance was significantly increased in the SB group (mean difference 29 metres; p = 0.015). Four-times as many TKAs were unbalanced in the MB group (36.8% MB vs 9.4% SB; p < 0.001). Irrespective of group assignment, no differences were found in any PROM when increasing ICPD thresholds defined balance. Conclusion. Despite improved quantitative soft-tissue balance, the use of sensors intraoperatively did not differentially improve the clinical or functional outcomes two years after TKA. These results question whether a more precisely balanced TKA that is guided by sensor data, and often achieved by more balancing interventions, will ultimately have a significant effect on clinical outcomes. Cite this article: Bone Joint J 2022;104-B(5):604–612

Introduction and Objective. Lower limb fractures are amongst the most common surgically managed orthopaedic injuries, with open reduction and internal fixation (ORIF) as the conventional method of treatment of the fibula. In recent years, dedicated intramedullary implants have emerged for fibula fixation in tandem with the move towards minimally invasive surgery in high-risk patients. This is the largest multicentre review to date with the aim of establishing the clinical outcomes following intramedullary nail (IMN) fixation of the fibula and to identify the absolute indication for fibula IMN fixation. Materials and Methods. A retrospective study of adult patients in all UK hospitals, who underwent fibula nail fixation between 01/01/2018 and 31/10/2020 was performed. Primary outcome measures included time to union, infection rate, other post-operative complications associated with the fixation and length of hospital stay. The secondary outcome measure was to identify the indication for fibula nailing. Data tabulation was performed using Microsoft Excel and analysis was performed using SPSS Version 23 (SPSS Statistics). Results. 2 Major Trauma Centres (MTCs) and 9 Trauma Units (TUs) were eligible for inclusion. 102 patients were included and 91% were classified as ankle fractures of 68% (n=69) were Weber B, 24% (n=24) Weber C and 8% (n=9) were either distal tibial fractures with an associated fibula fracture or pilon fractures. The mean age was 64 years of which 45 were male patients and 57 were female. The average BMI was 30.03kg/m. 2. and 44% of patients were ASA 3. 74% of patients had poor pre-op skin condition including swelling and open wounds. The calculated infection rate for fibula nail was 4.9% and metal-work complication rate was 4.9%. The average time to union was 13 weeks and length of inpatient stay was 15 days (SD +/− 12 days). Conclusions. MEFNO has demonstrated that fibula nail is an ideal implant in patients who have a physiologically higher risk of surgery, poor skin condition and a complex fracture pattern. The time to union, complication and infection risks are lower than that reported in literature for ankle ORIFs

Aims. This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Methods. This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals. Discussion. A multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article: Bone Jt Open 2021;2(11):909–920

Aims. Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. Methods. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. Discussion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England – Cambridge Central Research Ethics Committee. Publication is anticipated to occur in 2024. Cite this article: Bone Jt Open 2024;5(4):343–349

Aims. This study reports the ten-year wear rates, incidence of osteolysis, clinical outcomes, and complications of a multicentre randomized controlled trial comparing oxidized zirconium (OxZr) versus cobalt-chrome (CoCr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Methods. Patients undergoing primary THA were recruited from four institutions and prospectively allocated to the following treatment groups: Group A, CoCr femoral head with XLPE liner; Group B, OxZr femoral head with XLPE liner; and Group C, OxZr femoral head with UHMWPE liner. All study patients and assessors recording outcomes were blinded to the treatment groups. The outcomes of 262 study patients were analyzed at ten years’ follow-up. Results. Patients in Group C were associated with increased mean liner wear rates compared to patients in Group A (0.133 mm/yr (SD 0.21) vs 0.031 mm/yr (SD 0.07), respectively; p < 0.001) and Group B (0.133 mm/yr (SD 0.21) vs 0.022 mm/yr (SD 0.05), respectively; p < 0.001) at ten years’ follow-up. Patients in Group C were also associated with increased risk of osteolysis and aseptic loosening requiring revision surgery, compared with patients in Group A (7/133 vs 0/133, respectively; p = 0.007) and Group B (7/133 vs 0/135, respectively; p = 0.007). There was a non-statistically significant trend towards increased mean liner wear rates in Group A compared with Group B (0.031 mm/yr (SD 0.07) vs 0.022 mm/yr (SD 0.05), respectively; p = 0.128). All three groups were statistically comparable preoperatively and at ten years’ follow-up when measuring normalized Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.410), 36-Item Short Form Health Survey (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p = 0.451). Conclusion. The use of UHMWPE was associated with progressively increased annual liner wear rates after THA compared to XLPE. At ten years’ follow-up, the group receiving UHMWPE demonstrated an increased incidence of osteolysis and aseptic loosening requiring revision surgery compared to XLPE. Femoral heads composed of OxZr were associated with trend towards reduced wear rates compared to CoCr, but this did not reach statistical significance and did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two femoral head components. Cite this article: Bone Joint J 2022;104-B(7):833–843

Aims. Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance. Methods. We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs. Results. Overall, 139 ankle fractures were fixed by 28 postgraduate year three to five trainee surgeons (mean age 29.4 years; 71% males) during ten months' follow-up. Under the intention-to-treat principle, a technically superior fixation was performed by the cadaveric-trained group compared to the standard-trained group, as measured on the first postoperative radiograph against predefined acceptability thresholds. The cadaveric-trained group used a lower intraoperative dose of radiation than the standard-trained group (mean difference 0.011 Gym. 2. , 95% confidence interval 0.003 to 0.019; p = 0.009). There was no difference in procedure time. Conclusion. Trainees randomized to cadaveric training performed better ankle fracture fixations and irradiated patients less during surgery compared to standard-trained trainees. This effect, which was previously unknown, is likely to be a consequence of the intervention. Further study is required. Cite this article: Bone Jt Open 2023;4(8):594–601

Introduction and Objective. Ankle fractures are common and affect young adults as well as the elderly. An unstable ankle fracture treatment typically involves surgical fixation, immobilisation, and modified weight-bearing for six weeks. Non-weight bearing (NWB) cast immobilisation periods were used to protect the soft tissue envelope and osteosynthesis. This can have implications on patient function and may reduce independence, mobility and return to work. Newer trends in earlier mobilisation compete with traditional NWB doctrine, and weak consensus exists as to the best postoperative strategy. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Materials and Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury). The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the immediate weight-bearing group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a pulmonary embolism; both were randomised to NWB. Length of hospital stay (LOS) was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusions. There is a paucity of quality evidence supporting the postoperative management regimes used most commonly in clinical practice. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. In this large multicentre, randomised controlled trial, we investigated immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome. Once anatomical reduction and stable internal fixation is achieved, we recommend IWB in all types of ankle fractures in a compliant patient

Aims. The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. Methods. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Results. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. Conclusion. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture. Cite this article: Bone Joint J 2023;105-B(4):382–388

Aims. To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture. Methods. This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty). Results. Eight female (29%) and 20 male trainees (71%), mean age 29.4 years, performed 317 DHS operations and 243 hemiarthroplasties during ten months of follow-up. Primary analysis was a random effect model with surgeon-level fixed effects of patient condition, patient age, and surgeon experience, with a random intercept for surgeon. Under the intention-to-treat principle, for hemiarthroplasty there was better implant position in favour of cadaveric training, measured by leg length discrepancy ≤ 10 mm (odds ratio (OR) 4.08 (95% confidence interval (CI) 1.17 to 14.22); p = 0.027). There were significantly fewer postoperative blood transfusions required in patients undergoing hemiarthroplasty by cadaveric-trained compared to standard-trained surgeons (OR 6.00 (95% CI 1.83 to 19.69); p = 0.003). For DHS, there was no significant between-group difference in implant position as measured by tip-apex distance ≤ 25 mm (OR 6.47 (95% CI 0.97 to 43.05); p = 0.053). No between-group differences were observed for any secondary clinical outcomes. Conclusion. Trainees randomized to additional cadaveric training performed hip fracture fixation with better implant positioning and fewer postoperative blood transfusions in hemiarthroplasty. This effect, which was previously unknown, may be a consequence of the intervention. Further study is required. Cite this article: Bone Jt Open 2023;4(8):602–611

Aim. Early fracture-related infections (FRIs) are a common entity in hospitals treating trauma patients. It is important to be aware of the consequences of FRI in order to be able to counsel patients about the expected course of their disease. Therefore, the aims of this study were to evaluate the recurrence rate, to establish the number of secondary surgical procedures needed to gain control of the initial infection, and to identify predictors for recurrence in patients with early FRI. Method. A retrospective multicentre cohort study was conducted in two level 1 trauma centres. All patients between January 1st 2015 to July 1st 2020 with confirmed FRI with an onset of <6 weeks after initial fracture fixation were included. Recorded data included patient demographics, trauma mechanism, clinical and laboratory findings, surgical procedure, microbiology, and follow-up. Univariate and multivariate logistic regression analyses were performed to assess predictors for recurrent FRI. Results. A total of 166 patients were included in this study with a median age of 54.0 years (IQR 33.0–64.0). The cohort consisted of a majority of males (66.3%). Recurrence of FRI at one year follow-up was 11.4% and the overall recurrence rate within a median follow-up time of 24.0 months (IQR 15.4–36.9) was 18.1%. A total of 49.4% of patients needed at least one secondary procedure in order to treat the ongoing FRI, of whom 12.6% required at least three additional procedures. Predictors for recurrent FRI were use of an intramedullary nail during index operation (OR 4.343 (95% CI 1.448–13.028), p=0.009), need for at least one additional washout and debridement (OR 1.908 (95% CI 1.102–3.305), p=0.021), and a decrease in Injury Severity Score (ISS) (inverted OR 1.058 (95% CI 1.002–1.118), p=0.042). Conclusions. An FRI recurrence rate of 18.1% and need for at least one additional surgical procedure to gain control of the initial infection of 49.4% were seen in our cohort. Predictors for recurrent FRI were respectively the use of an intramedullary nail during index operation, need for secondary procedures, and a decrease in ISS. Results of this study can be used for preoperative counselling of early FRI patients

Objectives. Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. Methods. The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1

Aims. It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting. Methods. In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure. Results. The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur. Conclusion. Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups. Cite this article: Bone Joint J 2024;106-B(7):696–704

This large UK multicentre study evaluates clinical outcomes and identifies factors associated with local complication following PFR for non-oncological conditions. 132 patients across four UK centres underwent PFR from 01/08/2004-28/03/2023 with median follow-up of 1.9 (Q10.5-Q34.2) years. 75 (56.8%) patients were female and the mean age was 74.0 (SD 11.7) years. 103 (78%) patients had Charleston Comorbidity Index ≥3. ASA class was III or IV in 66.6%. Indications were infected revision (39, 29.5%), periprosthetic fracture (36, 27.3%), acute trauma (30, 22.7%), aseptic revision (17, 12.9%), failed trauma (nine, 6.8%) and complex primary arthroplasty (one, 0.8%). The primary outcome was the local complication rate. Secondary outcomes were systemic complications, reoperation and mortality rates. Comparisons were made with t-tests and Chi2 tests to investigate patient and surgical factors associated with local complication. Statistical significance was p<0.05. There were 37(28.0%) local complications. These were 18 (13.6%) dislocations, eight (6.1%) prosthetic joint infections, four (3.0%) haematomas, three (2.3%) superficial infections, one (0.8%) wound dehiscence, one (0.8%) sciatic nerve palsy and one (0.8%) femoral perforation. Dislocation mostly occurred in conventional articulations (12, 9.1%) followed by dual-mobility cups (three, 2.3%), constrained cups (two, 1.5%) and hemiarthroplasty (one, 0.8%). Median time to local complication was 30 (Q14-Q3 133) days. Seven (5.3%) patients developed a systemic complication. Thirty-three (25.0%) patients underwent reoperation. Thirty-day and one-year mortality rates were 3.8% and 12.1%, respectively. Longer surgical waiting times (7.9 \[SD 16.9) versus 2.6 \[SD 4.4\] days, p<0.001) and longer operating times (212.5 \[SD 71.8\] versus 189.4 \[SD 59.3\] mins, p=0.0450) were associated with local complication. Due to its high complication rate, PFR should be a salvage option when performed for non-oncological indications. Conventional articulations should be avoided. PFR should be delivered in a timely manner and ideally as dual-consultant cases to reduce operating time

Aims. The advent of trabecular metal (TM) augments has revolutionized the management of severe bone defects during acetabular reconstruction. The purpose of this study was to evaluate patients undergoing revision total hip arthroplasty (THA) with the use of TM augments for reconstruction of Paprosky IIIA and IIIB defects. Patients and Methods. A retrospective study was conducted at four centres between August 2008 and January 2015. Patients treated with TM augments and TM shell for a Paprosky grade IIIA or IIIB defect, in the absence of pelvic discontinuity, and who underwent revision hip arthroplasty with the use of TM augments were included in the study. A total of 41 patients with minimum follow-up of two years were included and evaluated using intention-to-treat analysis. Results. There were 36 (87.8%) patients with a Paprosky IIIA defect and five (12.2%) patients with a Paprosky IIIB defect. The mean age was 56.7 years (28 to 94). There were 21 (51.2%) women and 20 (48.8%) men. The mean follow-up was 39.4 months (12 to 96). One (2%) patient died after eight years. No failures were noted in the series. The mean survivorship was 100% at the time of latest follow-up. Conclusion. The results of this multicentre study showed encouraging short- and mid-term results for the use of TM augments in the management of Paprosky grade IIIA and IIIB defects. Cite this article: Bone Joint J 2018;100-B:903–8

Aims. During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. Methods. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group. Conclusion. The trial findings will provide evidence about the clinical and cost-effectiveness of always patellar resurfacing compared to selective patellar resurfacing. This will inform future NICE guidelines on primary TKR and the role of selective patellar resurfacing. Cite this article: Bone Jt Open 2024;5(6):464–478

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified

Aims. There is no level I evidence dealing with the optimal period of immobilization for patients with a displaced distal radial fracture following closed reduction. A shorter period might lead to a better functional outcome due to less stiffness and pain. The aim of this study was to investigate whether this period could be safely reduced from six to four weeks. Methods. This multicentre randomized controlled trial (RCT) included adult patients with a displaced distal radial fracture, who were randomized to be treated with immobilization in a cast for four or six weeks following closed reduction. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after follow-up at one year. Secondary outcomes were the abbreviated version of the Disability of Arm, Shoulder and Hand (QuickDASH) score after one year, the functional outcome at six weeks, 12 weeks, and six months, range of motion (ROM), the level of pain after removal of the cast, and complications. Results. A total of 100 patients (15 male, 85 female) were randomized, with 49 being treated with four weeks of immobilization in a cast. A total of 93 completed follow-up. The mean PRWE score after one year was 6.9 (SD 8.3) in the four-week group compared with 11.6 (SD 14.3) in the six-week group. However, this difference of -4.7 (95% confidence interval -9.29 to 0.14) was not clinically relevant as the minimal clinically important difference of 11.5 was not reached. There was no significant difference in the ROM, radiological outcome, level of pain, or complications. Conclusion. In adult patients with a displaced and adequately reduced distal radial fracture, immobilization in a cast for four weeks is safe, and the results are similar to those after a period of immobilization of six weeks. Cite this article: Bone Joint J 2023;105-B(9):993–999

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. Virtual fracture clinics (VFCs) are advocated by recent British Orthopaedic Association Standards for Trauma and Orthopaedics (BOASTs) to efficiently manage injuries during the COVID-19 pandemic. The primary aim of this national study is to assess the impact of these standards on patient satisfaction and clinical outcome amid the pandemic. The secondary aims are to determine the impact of the pandemic on the demographic details of injuries presenting to the VFC, and to compare outcomes and satisfaction when the BOAST guidelines were first introduced with a subsequent period when local practice would be familiar with these guidelines. Methods. This is a national cross-sectional cohort study comprising centres with VFC services across the UK. All consecutive adult patients assessed in VFC in a two-week period pre-lockdown (6 May 2019 to 19 May 2019) and in the same two-week period at the peak of the first lockdown (4 May 2020 to 17 May 2020), and a randomly selected sample during the ‘second wave’ (October 2020) will be eligible for the study. Data comprising local VFC practice, patient and injury characteristics, unplanned re-attendances, and complications will be collected by local investigators for all time periods. A telephone questionnaire will be used to determine patient satisfaction and patient-reported outcomes for patients who were discharged following VFC assessment without face-to-face consultation. Ethics and dissemination. The study results will identify changes in case-mix and numbers of patients managed through VFCs and whether this is safe and associated with patient satisfaction. These data will provide key information for future expert-led consensus on management of trauma injuries through the VFC. The protocol will be disseminated through conferences and peer-reviewed publication. This protocol has been reviewed by the South East Scotland Research Ethics Service and is classified as a multicentre audit. Cite this article: Bone Jt Open 2021;2(3):211–215

This study reports the ten-year polyethylene liner wear rates, incidence of osteolysis, clinical outcomes and complications of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. Blinded observers recorded predefined outcomes in 262 study patients at regular intervals for ten years following THA. At ten years follow-up, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C were associated with increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non-significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up when measuring normalised Western Ontario and McMaster Universities Osteoarthritis Index(p=0.410), short-form-36 (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p=0.451). The use of UHMWPE was associated with progressively increased annual liner wear rates after THA. At ten years follow-up, this translated to UHMWPE leading to an increased incidence of osteolysis and aseptic loosening requiring revision THA, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups

Background. There remains a paucity of clinical studies on the effects of coronavirus on perioperative outcomes, with no existing trials reporting on risk factors associated with increased risk of postoperative mortality in these patients. The objectives of this study were to assess perioperative complications and identify risk factors for increased mortality in patients with coronavirus undergoing surgery. Methods. This multicentre cohort study included 340 coronavirus negative patients versus 82 coronavirus positive patients undergoing surgical treatment for neck of femur fractures across nine NHS hospitals within Greater London, United Kingdom. Predefined study outcomes relating to patient demographics, fracture configuration, operative treatment, perioperative complications and mortality were recorded by observers using a standardised data collection proforma. Univariate and multivariate analysis were used to identify risk factors associated with increased risk of mortality. Findings. Coronavirus positive patients had increased risk of postoperative complications (89.0% vs 35.0%, p<0.001), higher rates of admission to high dependency and intensive care units (61.0% vs 18.2%, p<0.001), and increased length of hospital stay (13.8 ± 4.6 days vs 6.7 ± 2.5 days, p<0.001) compared to coronavirus negative patients. Postoperative complications in coronavirus positive patients included respiratory infections (13.4%), thromboembolic disease (13.4%), acute kidney injury (12.2%), and multi-organ dysfunction (12.2%). Coronavirus positive patients had increased risk of postoperative mortality (30.5% vs 10.3%, p<0.001) compared to coronavirus negative patients, with positive smoking status (Hazard ratio: 15.4 (95% CI: 4.55–52.2, p<0.001) and greater than three comorbidities (Hazard ratio: 13.5 (95% CI: 2.82–66.0, p<0.001) associated with increased risk of mortality. Interpretation. Surgery in coronavirus positive patients was associated with increased length of hospital stay, more admissions to the critical care unit, higher risk of perioperative complications and increased mortality compared to coronavirus negative patients. Multivariate analysis revealed that smoking and multiple pre-existing comorbidities were associated with increased risk of postoperative mortality

Aims. Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA. The purpose of this multicentre randomized clinical trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. Patients and Methods. From six-centres, 233 revision TKAs were randomized to one of four regimens: 1 g of intravenous (IV) TXA given prior to the skin incision, a double-dose regimen of 1 g IV TXA given both prior to skin incision and at time of wound closure, a combination of 1 g IV TXA given prior to skin incision and 1 g of intraoperative topical TXA, or three doses of 1950 mg oral TXA given two hours preoperatively, six hours postoperatively, and on the morning of postoperative day one. Randomization was performed based on the type of revision procedure to ensure equivalent distribution among groups. Power analysis determined that 40 patients per group were necessary to identify a 1 g/dl difference in the reduction of haemoglobin postoperatively between groups with an alpha of 0.05 and power of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence. Results. In total, one patient withdrew, five did not undergo surgery, 16 were screening failures, and 25 did not receive the assigned treatment, leaving 186 patients for analysis. There was no significant difference in haemoglobin reduction among treatments (2.8 g/dl for single-dose IV TXA, 2.6 g/dl for double-dose IV TXA, 2.6 g/dl for combined IV/topical TXA, 2.9 g/dl for oral TXA; p = 0.38). Similarly, calculated blood loss (p = 0.65) and transfusion rates (p = 0.95) were not significantly different between groups. Equivalence testing assuming a 1 g/dl difference in haemoglobin change as clinically relevant showed that all possible pairings were statistically equivalent. Conclusion. Despite the higher risk of blood loss in revision TKA, all TXA regimens tested had equivalent blood-sparing properties. Surgeons should consider using the lowest effective dose and least costly TXA regimen in revision TKA. Cite this article: Bone Joint J 2019;101-B(Supple 7):10–16

This study reports the ten-year outcomes of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. The outcomes of 262 study patients were analysed at ten years follow-up. At ten years, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C had increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non- significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up from a clinical score perspective. The use of UHMWPE was associated with progressively increased annual liner wear rates. At ten years follow-up, this translated to an increased incidence of osteolysis and aseptic loosening requiring revision, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups

Short-stem total hip arthroplasty (THA) has primarily been recommended for young and active patients, mainly due to its bone preserving philosophy. Elderly patients, however, may also benefit of a minimally invasive technique due to the short and curved implant design. The purpose of this study was to compare the clinical and radiological outcomes as well as perioperative complications of a calcar-guided short stem between a young (75 years) population. Data were collected in a total of 5 centers, and 400 short stems were included as part of a prospective multicentre observational study between 2010 and 2014 with a mean follow-up of 49.2 months. Clinical and radiological outcomes were assessed in both groups. Secondary outcomes such as perioperative complications, rates and reasons for stem revision were also investigated. No differences were found for the mean visual analogue scale (VAS) values of rest pain, load pain, and satisfaction. Harris Hip Score (HHS) was found to be slightly better in the young group. Comparing both groups, no statistically significant differences ere found in the radiological parameters that were assessed (stress-shielding, cortical hypertrophy, radiolucency, osteolysis). Aseptic loosening was the main cause of implant failure in younger patients whereas in elderly patients, postoperative periprosthetic fractures due to accidental fall was found to be the main cause for stem revision. These short-term results are encouraging towards the use of a cementless short stem in the geriatric population. According to our findings, advanced age and potentially reduced bone quality should not necessarily be considered as contra-indications for calcar-guided short-stem THA but careful and reasonable selection of the patients is mandatory. Longer follow up is necessary in order to draw safer conclusions

This international multicentre retrospective cohort study aimed to assess: 1) prevalence of COVID-19 in hip fracture patients, 2) effect on mortality, and 3) clinical factors associated mortality among COVID-19-positive patients. A collaboration among 112 centres in 14 nations collected data on all patients with a hip fracture between 1st March-31st May 2020. Patient, injury and surgical factors were recorded, and outcome measures included admission duration, COVID-19 and 30-day mortality status. There were 7090 patients and 651 (9.2%) were COVID-19-positive. COVID-19 was independently associated with male sex (p=0.001), residential care (p<0.001), inpatient fall (p=0.003), cancer (p=0.009), ASA grade 4–5 (p=0.008; p<0.001), and longer admission (p<0.001). Patients with COVID-19 had a significantly lower chance of 30-day survival versus those without (72.7% versus 92.6%, p<0.001), and COVID-19 was independently associated with increased 30-day mortality risk (p<0.001). Increasing age (p=0.028), male sex (p<0.001), renal (p=0.017) and pulmonary disease (p=0·039) were independently associated with higher 30-day mortality risk in patients with COVID-19 when adjusting for confounders. The prevalence of COVID-19 in hip fracture patients was 9% and was independently associated with a three-fold increased 30-day mortality risk. Clinical factors associated with mortality among COVID-19-positive hip fracture patients were identified for the first time. This is the largest study, and the only global cohort, reporting on the effect of COVID-19 in hip fracture patients. The findings provide a benchmark against which to determine vaccine efficacy in this vulnerable population and are especially important in the context of incomplete vaccination programmes and the emergence of vaccine-resistant strains

In a prospective multicentre study we investigated variations in pain management used by knee arthroplasty surgeons in order to compare the differences in pain levels among patients undergoing total knee replacements (TKR), and to compare the effectiveness of pain management protocols. The protocols, peri-operative levels of pain and patient satisfaction were investigated in 424 patients who underwent TKR in 14 hospitals. The protocols were highly variable and peri-operative pain levels varied substantially, particularly during the first two post-operative days. Differences in levels of pain were greatest during the night after TKR, when visual analogue scores ranged from 16.9 to 94.3 points. Of the methods of managing pain, the combined use of peri-articular infiltration and nerve blocks provided better pain relief than other methods during the first two post-operative days. Patients managed with peri-articular injection plus nerve block, and epidural analgesia were more likely to have higher satisfaction at two weeks after TKR. This study highlights the need to establish a consistent pain management strategy after TKR

The aims were: (1) assess the influence of COVID-19 on mortality in hip fracture; (2) identify predictors of COVID-19 status, and (3) investigate whether social lockdown influenced the epidemiology of hip fracture. A multicentre retrospective study was conducted of all patients presenting to six hospitals with hip fracture over a 46-day period (23 days pre-/post-lockdown). Demographics, residence, place of injury, presentation blood tests, Nottingham Hip Fracture Score, time to surgery, operation, ASA grade, anaesthetic, length of stay, COVID-19 status, and 30-day mortality were recorded. Of 317 patients with hip fracture 27 (8.5%) had a positive COVID-19 test; only 7 (26%) had symptoms on admission. COVID-19-positive patients had significantly lower 30-day survival compared to those without COVID-19 (67% versus 92%, p<0.001). COVID-19 was independently associated with increased 30-day mortality adjusting for: (1) age, sex, residence (HR 2.93, p=0.008); (2) Nottingham Hip Fracture Score (HR 3.52, p=0.001), and (3) ASA (HR 3.45, p=0.004). Platelet count predicted subsequent COVID-19 status; a value <217 ×109/L was 68% specific and sensitive (95% CI 58 to 77, p=0.002). A similar number of patients presented with hip fracture pre-lockdown (n=160) and post-lockdown (n=157); there was no significant difference in demographics, place of injury, Nottingham Hip Fracture Score, time to surgery, ASA, or management. COVID-19 was independently associated with an increased 30-day mortality in hip fracture. Most patients with COVID-19 lacked suggestive symptoms at presentation. Platelet count was an indicator of risk of COVID-19 infection. These findings have urgent implications for the delivery of hip fracture services

Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Our secondary objectives were to compare disease-specific quality of life and patient reported outcomes as measured by the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Constant score between groups.

Patients undergoing arthroscopic rotator cuff repair at three sites were randomized to receive either bone channeling augmentation or standard repair. Healing rates were determined by ultrasound at 6 and 24 months post operatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12 and 24 months post operatively.

One hundred sixty-eight patients were recruited and randomized between 2013 to 2018. Statistically significant improvements occurred in both groups from pre-operative to all time points in all clinical outcome scores (p < 0 .0001). Intention to treat analysis revealed no statistical differences in healing rates between the two interventions at 24 months post-operative. No differences were observed in WORC, ASES or Constant scores at any time-point.

This trial did not demonstrate superiority of intra-operative bone channeling in rotator cuff repair surgery at 24 months post-operative. Healing rates and patient-reported function and quality of life measures were similar between groups.

The magnetically controlled growing rod (MCGR) system allows growth maintenance without the risk of anaesthesia, implant and wound complications associated with repeated surgeries. This is a medium-term report of the complications of MCGR from a multicentre study. Twenty-six patients from 6 spine institutes that are part of a multicentre study with prospectively collected data of minimum 24 months follow-up were assessed. Pre-operative, immediate post-operative and most recent spine radiographs were reviewed to measure the Cobb angle and the rod lengthening distance. The causes and any associated risk factors for re-operations were examined. Eleven patients required re-operation within the follow-up period, with a mean time to re-operation of 17 months after the initial surgery. Five were due to failure of rod distractions; 3 were due to failure of proximal foundation implants; 2 were due to rod breakage; and one case of superficial wound infection with failure of proximal fixation. Proximal junctional kyphosis occurred in 5 patients. Three had proximal anchor dislodgement and all five constructs were revised. This is the largest series with the longest follow-up to date. Our series show that the perception that using MCGR may reduce the frequency of re-operations may not be entirely true. This is the first report to examine the need for re-operation after MCGR implantation, and highlights the inherent risks of any surgical treatment in this group of patients despite the advantages of this new implant. Longer-term studies and comparisons with traditional growing rods are required

Aims

Base of thumb osteoarthritis (BTOA) is a common age-related disease which has a significant negative impact upon quality of life. Our aim was to assess current UK practice in secondary care with regard to the nature of non-surgical treatments, the surgical procedures most commonly performed, and factors influencing the surgical decision-making process.

Aims

The aim of this study was to explore risk factors for complications associated with dural tear (DT), including the types of DT, and the intra- and postoperative management of DT.

Aims

The aim of this study was to compare open reduction and internal fixation (ORIF) with revision surgery for the surgical management of Unified Classification System (UCS) type B periprosthetic femoral fractures around cemented polished taper-slip femoral components following primary total hip arthroplasty (THA).

Abstract Background

The treatment of bone and joint infections (BJI) involving multi-drug resistant bacteria remains a challenge. MDR Staphylococcus epidermidis (MDRSE) clones, resistant to methicillin, clindamycin, levofloxacin, rifampicin and even linezolid, have been reported worldwide. The interest of delafloxacin (DFX), theoretically active on MRSA, remains to be evaluated with respect to MDRSE.

Background

Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.

Aim

Prosthetic joint infection (PJI) due to Candida spp. is a severe complication of arthroplasty but is little reported. This study describes Candida PJI epidemiology, management, and outcome.

Introduction

AlloStem/Cellular Bone Allograft and autologous bone graft are accepted methods for managing hindfoot degenerative arthritis. The purpose was to evaluate outcomes of AlloStem and autograft in subtalar arthrodesis and compare overall fusion rates.

Introduction

Pain after trauma has received relatively little research attention compared with surgical techniques and functional outcomes, but is important to patients. We aimed to describe nerve dysfunction and pain characteristics using tibial fractures as a model. We hypothesized that early nerve dysfunction was associated with neuropathic and chronic pain.

Aims

Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA).

Aims

The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption.

Abstract

The results of a prospective multicentre study of the Herbert differential pitch bone screw used to treat 50 scaphoid fractures and non-unions are presented. All fresh fractures and four of the five fracture-dislocations united, an overall union rate of 92%. Although the technique is demanding, the Herbert screw can achieve excellent results in the management of scaphoid fractures

Background

Ankle fractures associated with diabetes experience more complications following standard Open-Reduction-Internal-Fixation (ORIF) than those without diabetes. Augmented fixation strategies namely extended ORIF and hind-foot-nail (HFN) may offer better results, and early weightbearing in this group. The aim of this study was to define the population of patients with diabetes undergoing primary fixation for ankle fractures. Secondarily, to assess the utilisation of standard and augmented strategies and the effect of these choices on surgical outcomes including early post-operative weight bearing and surgical complications.

The COVID-19 pandemic presented a significant impact on orthopaedic surgical operating. This multi-centre study aimed to ascertain what factors contributed to delays to theatre in patients with shoulder and elbow trauma.

A retrospective cohort study of 621 upper limb (shoulder and elbow) trauma patients between 16/03/2020 and 16/09/2021 (18-months) was extracted from trauma lists in NHS Tayside, Highland and Grampian and Picture Archiving and Communication Systems (PACS).

Median patient age =51 years (range 2-98), 298 (48%) were male and 323 (52%) female. The commonest operation was olecranon open reduction internal fixation (ORIF) 106/621 cases (17.1%), followed by distal humerus ORIF − 63/621 (10.1%). Median time to surgery was 2 days (range 0-263). 281/621 (45.2%) of patients underwent surgical intervention within 0-1 days and 555/621 patients (89.9%) had an operation within 14 days of sustaining their injury. 66/621 (10.6%) patients waited >14 days for surgery. There were 325/621 (52.3%) patients with documented evidence of delay to surgery; of these 55.6% (181/325) were due to amendable causes. 66/325 (20.3%) of these patients suffered complications; the most common being post-operative stiffness in 48.6% of cases (n=32/66).

To our knowledge, this is the first study to specifically explore effect of COVID-19 pandemic on upper limb trauma patients. We suggest delays to theatre may have contributed to higher rates of post-operative stiffness and require more physiotherapy during the rehabilitation phase. In future pandemic planning, we propose dedicated upper-limb trauma lists to prevent delays to theatre and optimise patients’ post-operative outcomes.

Aims

The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.

Aim

We aimed to assess the incidence and the outcome of Gram-negative prosthetic-joint infections (PJI) in 3 international tertiary hospital.

A number of classification systems exist for posterior malleolus fractures of the ankle. The reliability of these classification systems remains unclear. The primary aim of this study was to evaluate the reliability of three commonly utilised fracture classification systems of the posterior malleolus.

60 patients across 2 hospitals sustaining an unstable ankle fracture with a posterior malleolus fragment were identified. All patients underwent radiographs and computed tomography of their injured ankle. 9 surgeons including pre-ST3 level, ST3-8 level, and consultant level applied the Haraguchi, Rammelt, and Mason & Molloy classifications to these patients, at two timepoints, at least 4 weeks apart. The order was randomised between assessments. Inter-rater reliability was assessed using Fleiss’ kappa and 95% confidence intervals (CI). Intra-rater reliability was assessed using Cohen's Kappa and standard error (SE).

Inter-rater reliability (Fleiss’ Kappa) was calculated for the Haraguchi classification as 0.522 (95% CI 0.490 – 0.553), for the Rammelt classification as 0.626 (95% CI 0.600 – 0.652), and the Mason & Molloy classification as 0.541 (95% CI 0.514 – 0.569). Intra-rater reliability (Cohen's Kappa) was 0.764 (SE 0.034) for the Haraguchi, 0.763 (SE 0.031) for the Rammelt, 0.688 (SE 0.035) for the Mason & Molloy classification.

This study reports the inter-rater and intra-rater reliability for three classification systems for posterior malleolus fractures. Based on definitions by Landis & Koch (1977), inter-rater reliability was rated as ‘moderate’ for the Haraguchi and Mason & Molloy classifications; and ‘substantial’ for the Rammelt classification. Similarly, the intra-rater reliability was rated as ‘substantial’ for all three classifications.

Metacarpal fractures represent up to 33% of all hand fractures; of which the majority can be treated non-operatively. Previous research has shown excellent putcomes with non-operative treatment yet surgical stabilisation is recommended to avoid malrotation and symptomatic shortening. It is unknown whether operative is superior to non-operative treatment in oblique or spiral metacarpal shaft fractures.

The aim of the study was to compare non-operative treatment of mobilisation with open surgical stabilisation.

42 adults (≥ 18 years) with a single displaced oblique or spiral metacarpal shaft fractures were randomly assigned in a 1:1 pattern to either non-operative treatment with free mobilisation or operative treatment with open reduction and fixation with lag screws in a prospective study. The primary outcome measure was grip-strength in the injured hand in comparison to the uninjured hand at 1-year follow-up. The Disabilities of the Arm, Shoulder and Hand Score, ranges of motion, metacarpal shortening, complications, time off work, patient satisfaction and costs were secondary outcomes.

All 42 patients attended final follow-up after 1 year. The mean grip strength in the non-operative group was 104% (range 73–250%) of the contralateral hand and 96% (range 58–121%) in the operatively treated patients. Mean metacarpal shortening was 5.0 (range 0–9) mm in the non-operative group and 0.6 (range 0–7) mm in the operative group. There were five minor complications and three revision operations, all in the operative group.

The costs for non-operative treatment were estimated at 1,347 USD compared to 3,834USD for operative treatment; sick leave was significantly longer in the operative group (35 days, range 0–147) than in the non-operative group (12 days, range 0–62) (p=0.008).

When treated with immediate free mobilization single, patients with displaced spiral or oblique metacarpal shaft fractures have outcomes that are comparable to those after operative treatment, despite some metacarpal shortening. Complication rates, costs and sick leave are higher with operative treatment. Early mobilisation of spiral or long oblique single metacarpal fractures is the preferred treatment.

Trial registration number: ClinicalTrials.gov NCT03067454

Objective: To assess the safety and efficacy of a novel Artificial Cervical Disc. Design: Compare the Bryan prosthesis to Anterior Cervical Discectomy and Fusion (ACDF), by using the pre-defined objective performance criteria (OPC) derived from a literature meta-analysis of ACDF in which a success rate of 73% was established. The Null hypothesis is that the success rate for the Bryan prosthesis is greater or equal to the OPC (Objective Performance Criteria) of 85%. Secondary Objectives studied included the range of motion after implantation; adverse events from implantation onwards; maintenance of the disc space height; amount of subsidence. Radiology was assessed by an independent radiologist. Improvement in the quality of life for the patient (SF-36) was also recorded at six weeks, six months and one year. Data was collected by an independent research practitioner. Subjects: Multicentre study seven European centres: 107 patients Male 51, Female 66. Age ranged from 27 to 71. Mean age was 42 years with a clinical diagnosis of cervical radiculopathy or myelopathy, and single level disc disease on MRI. Outcome Measures: Odom Criteria, SF-36, radiological range of movement. Results: The Bryan Cervical Disc was associated with a clinical success according to Odom’s criteria of 87%. Radiological success occurred in 97%. SF-36 analysis revealed a statistically significant improvement in all domains. Conclusion: The Bryan Disc has been successfully implanted in 107 patients with good clinical results and at one-year follow-up there is radiological evidence of preserved motion

There is an increasing incidence of revision for periprosthetic joint infection. The addition of vancomycin to beta-lactam antimicrobial prophylaxis in joint arthroplasty may reduce surgical site infections, however, the efficacy and safety have not been established.

This was a multicenter, double-blind, superiority, placebo-controlled trial. We randomized 4239 adult patients undergoing joint arthroplasty surgery to receive 1.5g vancomycin or normal saline placebo, in addition to standard cefazolin antimicrobial prophylaxis. The primary outcome was surgical site infection at 90-days from index surgery. Perioperative carriage of Staphylococcus species was also assessed.

In the 4113 patients included in the modified intention-to-treat population, surgical site infections occurred in 72/2069 (3.5%) in the placebo group and 91/2044 (4. 5%) in the vancomycin group (risk ratio 1.28; 95% confidence interval 0.94 to 1.73; p value 0.11). No difference was observed between the two groups for primary hip arthroplasty procedures. A higher proportion of infections occurred in knee arthroplasty patients in the vancomycin group (63/1109 [4.7%]) compared with the placebo group (42/1124 [3.7%]; risk ratio 1.52; 95% confidence interval 1.04 to 2.23; p value 0.031). Hypersensitivity reactions occurred in 11 (0.5%) patients in the placebo group and 24 (1.2%) in the vancomycin group (risk ratio 2.20; 95% confidence interval 1.08, 4.49) and acute kidney injury in 74 (3.7%) patients in the placebo group and 42 (2.1%) in the vancomycin group (risk ratio 0.57; 95% confidence interval 0.39, 0.83). Perioperative Staphylococcus aureus carriage was detected in 1089/3748 (29.1%) of patients.

This is the first randomized controlled trial examining the addition of a glycopeptide antimicrobial to standard beta-lactam surgical antimicrobial prophylaxis in joint arthroplasty. The addition of vancomycin to standard cefazolin prophylaxis was not superior to placebo for the prevention of surgical site infections in hip and knee arthroplasty surgery.

To evaluate the efficacy of VEPTR in preventing further progression of scoliosis without impeding spinal growth in the treatment of children with progressive early onset scoliosis (EOS) without rib abnormalities. Prospective, multi-center, observational cohort study on patients with EOS treated with VEPTR with 2-year follow up. Data were analysed based on measurements done pre-implant, immediate post-op and at 2-yr f/u. Sixty-three patients met inclusion: 35 males and 28 females. Mean age at time of implantation was 6.1±2.4 yrs. Etiologies included congenital (n=6), neuromuscular (n=36), syndromic (n=4), and idiopathic (n=17). Mean follow up was 2.2±0.4 yrs. Scoliosis (72o±18o) decreased after implant surgery (47o±17o) followed by slight increase at 2-yr f/u (57o±18o), p<0.0001. At 2-yr f/u, VEPTR was effective in treating EOS without rib abnormalities with 86% of patients having an improvement in scoliosis and 94% of patients having an increased spinal height as compared to pre-operatively. VEPTR provided greater than 100% of expected age-matched spine growth and the instrumented spinal segment continued to grow during distraction phase. This large prospective, multicentre study demonstrated the ability of VEPTER to effectively treat EOS without rib abnormalities. Goals of preventing further scoliosis progression and of maintaining normal spine growth were achieved

Aims. The aim of this study was to determine if a three-month course of microorganism-directed oral antibiotics reduces the rate of failure due to further infection following two-stage revision for chronic prosthetic joint infection (PJI) of the hip and knee. Methods. A total of 185 patients undergoing a two-stage revision in seven different centres were prospectively enrolled. Of these patients, 93 were randomized to receive microorganism-directed oral antibiotics for three months following reimplantation; 88 were randomized to receive no antibiotics, and four were withdrawn before randomization. Of the 181 randomized patients, 28 were lost to follow-up, six died before two years follow-up, and five with culture negative infections were excluded. The remaining 142 patients were followed for a mean of 3.3 years (2.0 to 7.6) with failure due to a further infection as the primary endpoint. Patients who were treated with antibiotics were also assessed for their adherence to the medication regime and for side effects to antibiotics. Results. Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012). Five patients (6.9%) in the treatment group experienced adverse effects related to the administered antibiotics severe enough to warrant discontinuation. Conclusion. This multicentre randomized controlled trial showed that a three-month course of microorganism-directed, oral antibiotics significantly reduced the rate of failure due to further infection following a two-stage revision of total hip or knee arthroplasty for chronic PJI. Cite this article: Bone Joint J 2020;102-B(6 Supple A):3–9

Clinical success of prostheses in joint arthroplasty is ultimately determined by survivorship and patient satisfaction. The purpose of this study was to compare (non-inferiority) a new morphometric designed stem for total hip arthroplasty (THA) against an established comparator.

A prospective randomised multi-centre study of 144 primary cementless THA performed by nine experienced orthopaedic surgeons was completed (70 received a fully coated collarless tapered stem and 74 received a morphometric designed proximally coated tapered stem). PROMs and blood serum markers were assessed preoperatively and at intervals up to 2-years postoperatively. In addition, measures of femoral stem fit, fill and subsidence at 2-years post-operatively were measured from radiographs by three observers, with an intra-class correlation coefficient of 0.918. A mixed effects model was employed to compare the two prosthesis over the study period. A p-value <0.05 was considered statistically significant.

Demographics, Dorr types and blood serum markers were similar between groups. Both stems demonstrated a significant improvement in PROMs between the pre- and post-operative measurements, with no difference at any timepoint (p > 0.05). The fully coated tapered collarless femoral stem had a non-significantly higher intra-operative femoral fracture rate (5.8% vs 1.4%, p = 0.24), with all patients treated with cable fixation and partial weight bearing. The mean subsidence at 2-years was 2.5mm +/- 2.3mm for the morphometric stem and 2.4mm +/- 1.8mm for the fully coated tapered collarless femoral stem (p = 0.879). There was one outlier in each group with increased subsidence (fully coated tapered collarless femoral stem 6.9mm, morphometric wedge stem 7.4mm), with both patients reporting thigh pain at 2 years.

When compared with an established stem, the newer designed morphometric wedge stem performed well with comparable radiological and PROM outcomes at 2 year follow up. Continued follow-up is required for long term benchmarking.

Aim

Bone and joint infections (BJIs) are serious infections requiring early optimized antimicrobial therapy. BJIs can be polymicrobial or caused by fastidious bacteria, and the patient may have received antibiotics prior to sampling, which may decrease the sensitivity of culture-based diagnosis. Furthermore, culture-based diagnosis can take up to 14 days. Molecular approaches can be useful to overcome these concerns. The BioFire® system performs syndromic multiplex PCR in 1 hour, with only a few minutes of sample preparation. The BioFire® Joint Infection (JI) panel (BF-JI), recently FDA-cleared, detects both Gram-positive (n=15) and Gram-negative bacteria (n=14), Candida, and eight antibiotic resistance genes directly from synovial fluids. The aim of this study was to evaluate its performance in acute JIs in real-life conditions.

Clinical success of prostheses in joint arthroplasty is ultimately determined by survivorship and patient satisfaction. The purpose of this study was to compare (non-inferiority) a new morphometric designed stem for total hip arthroplasty (THA) against an established comparator.

A prospective randomised multi-centre study of 144 primary cementless THA performed by nine experienced orthopaedic surgeons was completed (70 received a fully coated collarless tapered stem and 70 received a morphometric designed proximally coated tapered stem). PROMs and blood serum markers were assessed preoperatively and at intervals up to 2-years postoperatively. In addition, measures of femoral stem fit, fill and subsidence at 2-years post-operatively were measured from radiographs by three observers, with an intra-class correlation coefficient of 0.918. A mixed effects model was employed to compare the two prostheses over the study period. A p-value <0.05 was considered statistically significant.

Demographics and Dorr types were similar between groups. Both stems demonstrated a significant improvement in PROMs between the pre- and post-operative measurements, with no difference at any timepoint (p > 0.05). The fully coated tapered collarless femoral stem had a non-significantly higher intra-operative femoral fracture rate (5.8% vs 1.4%, p = 0.24), with all patients treated with cable fixation and partial weight bearing. The mean subsidence at 2-years was 2.5mm +/- 2.3mm for the morphometric stem and 2.4mm +/- 1.8mm for the fully coated tapered collarless femoral stem (p = 0.879). There was one outlier in each group with increased subsidence (fully coated tapered collarless femoral stem 6.9mm, morphometric wedge stem 7.4mm), with both patients reporting thigh pain at 2 years.

When compared with an established stem, the newer designed morphometric wedge stem performed well with comparable radiological and PROM outcomes at 2 year follow up. Continued follow-up is required for long term benchmarking.

Total Knee Arthroplasty (TKA) is an effective surgery performed for knee osteoarthritis. Despite this success up to 20% of patients are less than fully satisfied. Rotating platform (RP) bearings have demonstrated significant reduction in rates of wear in laboratory studies but thus far have failed to demonstrate a clinical difference compared to fixed bearing (FB) arthroplasty in patients. This may be due to studies limited by small sample size and single centre design. Additionally, no studies have utilised modern patient-reported outcome measures (PROMs) such as PKIP to investigate differences between these bearings.

A non-randomised, prospective, multi-centre study was conducted across centres in Australia, United Kingdom and the United States from November 2012 to May 2015. Knee prosthesis included were the RP and FB models of the PFC Sigma Knee (Depuy, Synthes) and the ATTUNE Knee (Depuy, Synthes). Data was collected on pre-arthroplasty interventions, demographics and PROMs. PROMs included were the KOOS, OKS, EQ53DL and PKIP. Participants were followed-up for 2 years.

A total of 1,718 patients were recruited across 27 centres. 959 participants underwent a FB TKA, 759 participants underwent a RP TKA. No significant difference was found between RP and FB in change from baseline at 2 years across any parameter in all PROMs investigated at 2 years. Body Mass Index pre-operatively was the biggest indicator of change from baseline at 2 years.

Our data demonstrates similar improvements in the short-term in both RP and TKA across all PROMs. Patients reported similar scores in satisfaction, confidence, mobility and stability in the PKIP PROM for both RP and FB groups. We have not found any evidence to suggest that RP TKA is disadvantageous at 2 years, and this is reassuring for any surgeon looking to utilise this bearing type in practice.

Our data does not demonstrate a clinical advantage in RP TKA over FB TKA at 2 years in any PROM.

Abstract

Introduction. Trabecular Titanium™ is a highly porous biomaterial with a regular hexagonal cell structure, which has shown excellent mechanical properties. Several in vitro studies reported promising data on its osteoinductive and osteoconductive properties. Furthermore, it has demonstrated in vivo to enhance bone in-growth. Aim of this multicentre prospective study was to assess Trabecular Titanium™ osseointegration by measuring change in bone mineral density (BMD) around a cementless DELTA-TT cup with dual-emission X-ray absorptiometry (DXA). Methods. 89 patients (91 hips) underwent primary THA with DELTA-TT cups (Lima Corporate) between 2009 and 2010. There were 46 (52%) men and 43 (48%) women, with a median (IQR) age of 67 (57–70) years and a median (IQR) BMI of 26 (24–29) kg/m. 2. Right side and left side were affected in 44 (48%) and 47 (52%) cases, respectively. Underlying pathology was primary osteoarthritis in 80 (88%) cases, osteonecrosis in 5 (6%), post-traumatic osteoarthritis in 3 (3%), developmental dysplasia of the hip in 2 (2%) and oligoarthritis in 1 (1%). BMD was determined by DXA using DeLee and Charnley 3 Regions of Interest (ROI) at 7 days, 3, 6, 12 and 24 months. Clinical evaluation (Harris Hip Score, HHS), patient health status survey (SF-36) and radiographic assessment were performed preoperatively and at the same time-points. Data were analyzed using non-parametric tests (Mann-Whitney, Wilcoxon signed-rank) and a p < 0.05 as threshold for statistical significance. Results. Excellent results were observed in terms of pain relief and functional recovery. Median (IQR) HHS improved from 48 (39–62) before surgery, to 99 (96–100) at 24 months, with a statistical significant increase of 96% (p < 0.05, Wilcoxon signed-rank). Median (IQR) SF-36 improved from 49 (37–62) preoperatively to 86 (79–92) at 24 months, with a statistical significant increase of 95% (p < 0.05, Wilcoxon signed-rank), indicating a considerable improvement in patients' quality of life. After an initial decrease of BMD values from baseline at 7 days (median [IQR] ROI I: 1.44 [1.21–1.67]; ROI II: 1.23 [0.99–1.49]; ROI III: 1.11 [0.85–1.48] g/cm. 2. ) to 6 months (ROI I: 1.27 [1.08–1.52]; ROI II: 1.14 [0.89–1.37]; ROI III: 1.05 [0.73–1.35] g/cm. 2. ), BMD slightly increased in ROI I, the most loaded area, and stabilized in ROI III. BMD in ROI II increased after 12 months and stabilized at 24 months (ROI I: 1.30 [1.11–1.55]; ROI II: 1.12 [0.96–1.36]; ROI III: 1.04 [0.80–1.25] g/cm. 2. ). Radiographic analysis showed evident signs of bone remodeling and osseointegration, with presence of supero-lateral and infero-medial bone buttress and of radial trabeculae perpendicular to the cup surface in ROI I/II. No radiolucent lines, loosening or osteolysis were observed. All cups were stable and no revision was carried out. Conclusion. BMD patterns and radiographic evaluation showed signs of an effective osseointegration around DELTA-TT cups at 24 months. Although clinical outcomes, functional recovery and stability are very satisfactory, longer follow-ups are necessary to assess survivorship

Purpose. Controversy exists regarding the optimal technique of subscapularis mobilization during shoulder arthroplasty. The purpose of this multicentre randomized double-blind study was to compare the functional outcomes and healing rates of the lesser tuberosity osteotomy (LTO) to the subscapularis tenotomy (ST). Method. Patients undergoing shoulder arthroplasty were randomized to receive either a LTO or ST. The primary outcome was to compare subscapularis strength, as measured by an electronic hand-held dynamometer at 12 months. Secondary outcomes included range of motion, WOOS, Constant and ASES scores. A sample size calculation determined that 80 patients provided 80% power with a 50% effect size to detect a significant difference between groups. Results. Baseline demographic data did not differ between groups including age (p=0.69), sex (p=0.77), affected side (p=0.59) and arthroplasty type (hemiarthroplasty or total, p=0.77). Strength comparison between groups revealed no statistical differences at any time interval (p=0.744, baseline, p=0.449, 3 month, p=0.203, 6 months, 12 months, p=0.45). Statistically significant improvements occurred in both groups from baseline to 12 month time points in all clinical outcome scores (p<0.0001). Conclusion. No statistically significant differences in primary or secondary outcomes were identified between the LTO and ST. This trial does not demonstrate any clear advantage of one subscapularis mobilization technique over the other

Introduction:. Tuberosity healing is strongly correlated with functional results in all series of three- and four-part fractures of the proximal humerus treated by hemiarthroplasty. We formed a working group to improve position of the implant and fixation of the tuberosities on an implant specifically intended for traumatology. Material and Methods:. An anatomic study on 11 cadavers and a prospective multicentre clinical study of 32 cases were performed to validate extrapolable original solutions at the patient scale: placement of the stem at a height indicated in relation to the insertion of the clavicular bundle of the pectoralis major, locking of the stem, placement (based on bone quality) of a variable volume metaphyseal frame (offset modular system® OMS®), avoiding medialisation of the tuberosities, and fixation of the tuberosities using strong looped sutures, brightly coloured so that they can be located more easily. Evaluation by Dash score and Constant score was correlated with positioning of the tuberosities using radiographs. Results:. The clinical study enabled a distance of the top of the head to pectoralis major of 5.5 cm +/− 5 mm to be determined, confirming the results of the anatomic study and data from the literature. The distal double-locking ancillary device and the suturing technique for the tuberosities using looped sutures was judged to be effective by all of the surgeons. 23 patients (5 males, 9 CT4 and 8 CT3) with an mean age 69,6 (33–90) were operated on by 3 senior surgeons and reviewed at a mean follow-up of 17,3 months (6–24). All patients were seen again at 3 months and 6 months and the average motion at last follow was abduction of 90,7° (140–40), active anterior elevation of 113,25° (160–60), and external rotation of 43,2°(55–30). One complication was noted: inadequate position of a locking screw. In the 17 patients operated without oms® 50% had adequate initial positioning of the tuberosities and 10% secondary displacement. In comparison the 6 patients operated with the oms® 100% had adequate initial positioning of the tuberosities and no secondary displacement occurred. Discussion:. The series from Sofcot, Boileau, and more recently Reuther yielded results of 40 to 66% malposition or nonunion of the tuberosities. The initial clinical results from our series are encouraging and demonstrate that using a variable volume metaphyseal frame in synthesis of the tuberosities with control of the height of the implant is reliable. This multicentre study should be extended by a more long-term analysis

Aim

The diagnosis of periprosthetic joint infection (PJI) remains a clinical dilemma, since presentations of PJI usually greatly overlap with aseptic failure (AF). The aim of this study is to evaluate the values of plasma fibrinogen, individually or in combination with CRP, ESR and WBC, for distinguishing PJI from AF.

Aim

In the context of total knee arthroplasty (TKA), trauma with perigenicular fracture fixation or oncological surgical treatment, soft tissue defects can expose critical structures such as the extensor apparatus, the knee joint, bone or implants. This work compares soft tissue reconstruction (STR) between a classical pedicled gastrocnemius (GC) muscle flap and a pedicled chimeric sural artery perforator (SAP) musculocutaneous GC flap in complex orthoplastic scenarios.

The aim of this study was to identify the effect of COVID-19 lockdown on the rates, types, mechanisms and mortality of musculoskeletal trauma across Scotland.

Data for all musculoskeletal trauma requiring operative treatment was collected prospectively from five orthopaedic units across Scotland during the initial lockdown period (23/03/2020-28/05/2020). This was compared with data for the same timeframe in 2018 and 2019. Data collected included all cases requiring surgery, injury type, mechanism of injury, and inpatient mortality.

1315 patients received operative treatment in 2020 compared to 1791 in 2019 and 1719 in 2018. The numbers of all injury types decreased, but the relative frequency of hip fractures increased(36.3% 2020 vs 30.2% 2019, p<0.0001 & 30.7% 2018, p<0.0001). Significant increases were seen in proportion of DIY-related injuries(3.1% 2020 vs 1.7% 2019, p=0.01 & 1.6% 2018, p<0.01) and injuries caused by falls(65.6% 2020 vs 62.6% 2019, p=0.08 & 61.9% 2018, p=0.05). Significant decreases were seen in proportion of RTCs(2.6% 2020 vs 5.4% 2019, p<0.0001 & 4.2% 2018, p=0.02) and occupational injuries(1.8% 2020 vs 3.0% 2019, p=0.03 & 2.3% 2018, p=0.01). A significant increase in proportion of self-harm injuries was seen(1.7% 2020 vs 1.1% 2019, p=0.19 & 0.5% 2018, p<0.0001). Mortality of trauma patients was significantly higher in 2020 (4.9%), than in 2019 (3.2%, p=0.02) and 2018 (2.6%, p<0.0001).

In conclusion, lockdown has resulted in a marked reduction of musculoskeletal trauma requiring surgery in Scotland. There have been major changes in types and mechanisms of injury, and mortality of trauma patients has risen significantly.

Aims

The UK government declared a national lockdown on 23 March 2020 to reduce transmission of COVID-19. This study aims to identify the effect of lockdown on the rates, types, mechanisms, and mortality of musculoskeletal trauma across Scotland.

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Abstract

The gold standard treatment of hip dysplasia is a peri-acetabular osteotomy (PAO). Labral tears are seen in the majority of patients presenting with hip dysplasia and diagnosed using Magnetic Resonance Imaging (MRI). The goal was to (1) evaluate utility/value of MRI in patients undergoing hip arthroscopy at time of PAO, and (2) determine whether MRI findings of labral pathology can predict outcome.

A prospective randomized controlled trial was conducted at tertiary institutions, comparing patients with hip dysplasia treated with isolated PAO versus PAO with adjunct hip arthroscopy. This study was a subgroup analysis on 74 patients allocated to PAO and adjunct hip arthroscopy (age 26±8 years; 89.2% females). All patients underwent radiographic and MRI assessment using a 1.5-Tesla with or 3-Tesla MRI without arthrography to detect labral or cartilage pathology. Clinical outcome was assessed using international Hip Outcome Tool-33 (iHOT).

74% of patients (55/74) were pre-operatively diagnosed with a labral tear on MRI. Among these, 41 underwent labral treatment (74%); whilst among those without a labral tear on MRI, 42% underwent labral treatment (8/19). MRI had a high sensitivity (84%), but a low specificity (56%) for labral pathology (p=0.053). There was no difference in pre-operative (31.3±16.0 vs. 37.3±14.9; p=0.123) and post-operative iHOT (77.7±22.2 vs. 75.2±23.5; p=0.676) between patients with and without labral pathology on MRI.

Value of MRI in the diagnostic work-up of a patient with hip dysplasia is limited. MRI had a high sensitivity (84%), but low specificity (44%) to identify labral pathology in patients with hip dysplasia. Consequently, standard clinical MRI had little value as a predictor of outcome with no differences in PROM scores between patients with and without a labral tear on MRI. Treatment of labral pathology in patients with hip dysplasia remains controversial. The results of this subgroup analysis of a prospective, multi-centre RCT do not show improved outcome among patients with dysplasia treated with labral repair.

Introduction

Hindfoot intramedullary nail fixation (HFN) or fibula pro-tibial screw fixation (PTS) are surgical options for ankle fractures in patients with multiple co-morbidities; we compared their outcomes.

Introduction

Dislocated hip hemiarthroplasties (HA) are associated with a 45% revision rate and 40% mortality rate.

Implant selection for HA operations vary with no universally accepted implant choice. The WHiTE3 trial suggested older designs such as the Thompson has equitable outcomes to more modern and expensive implants such as the Exeter V40+Unitrax.

Our multi-centre consecutive series of NOFs patients treated with HA assesses the impact of surgical and patient factors on dislocation risk.

Aim

The purpose of this study is to analyze the demographic and microbiological variables of acute ankle infections posterior to ankle osteosynthesis and to determine the different characteristics of patients withE. cloacae infection.

Aim

Rifampin is considered as the antibiotic corner stone in the treatment of acute staphylococcal periprosthetic joint infections (PJI). However, if, when, and how to use rifampin has been questioned. We evaluated the outcome of patients treated with and without rifampin, and analysed the influence of timing, dose and co-antibiotic.

The objective of this present study is to conduct a comparative analysis of the kinematic data derived for all subjects having a TKA who were analysed over the past eight years at our laboratory. Femorotibial contact positions for 705 subjects having either a fixed bearing PCR or PS TKA or mobile bearing TKA were analysed in three-dimensions using video fluoroscopy. During a deep knee bend, all PS TKA types subjects experienced a medial pivot motion, averaging −3.8 of lateral condyle posterior femoral rollback (PFR), respectively. Subjects having a fixed bearing PCR TKA experienced only −0.7 mm of lateral condyle PFR and an anterior slide of 1.6 mm for the medial condyle. Twenty-nine percent of the PCR TKA analysed had a lateral pivot and 71% experienced a medial pivot. Subjects having a mobile bearing TKA experienced −2.8 mm of lateral condyle PFR and 0.4 mm of medial condyle anterior slide. Fifty-one percent of the moble bearing implants experienced a medial pivot and 43% experienced a lateral pivot. During gait, PS and PCR fixed bearing TKA types experienced similar kinematic patterns. Subjects having a mobile bearing TKA experienced minimal motion, probably due to the mobile bearing TKA having greater sagittal conformity and had the lowest standard deviation. There was great variability in the data comparing various TKA designs. Subjects in this multicentre analysis predominantly experienced a medial pivot motion, although certain TKA designs did demonstrate a lateral pivot motion

The primary treatment goal for patients with femoroacetabular impingement syndrome, a common hip condition in athletes, is to improve pain and function. In selected patients, in the short term following intervention, arthroscopic hip surgery is superior to a pragmatic NHS- type physiotherapy programme. Here, we report the three-year follow-up results from the FemoroAcetabular Impingement Trial (FAIT), comparing arthroscopic hip surgery with physiotherapy in the management of patients with femoroacetabular impingement (FAI) syndrome.

Two-group parallel, assessor-blinded, pragmatic randomised controlled study across seven NHS England sites. 222 participants aged 18 to 60 years with FAI syndrome confirmed clinically and radiologically were randomised (1:1) to receive arthroscopic hip surgery (n = 112) or physiotherapy and activity modification (n = 110). We previously reported on the hip outcome score at eight months. The primary outcome measure of this study was minimum Joint Space Width (mJSW) on Anteroposterior Radiograph at 38 months post randomisation. Secondary outcome measures included the Hip Outcome Score and Scoring Hip Osteoarthritis with MRI (SHOMRI) score.

Minimum Joint Space Width data were available for 101 participants (45%) at 38 months post randomisation. Hip outcome score and MRI data were available for 77% and 62% of participants respectively. mJSW was higher in the arthroscopy group (mean (SD) 3.34mm (1.01)) compared to the physiotherapy group (2.99mm (1.33)) at 38 months, p=0.017, however this did not exceed the minimally clinically important difference of 0.48mm. SHOMRI score was significantly lower in the arthroscopy group (mean (SD) 9.22 (11.43)) compared to the physiotherapy group (22.76 (15.26)), p-value <0.001. Hip outcome score was higher in the arthroscopy group (mean (SD) 84.2 (17.4)) compared with the physiotherapy group (74.2 (21.9)), p-value < 0.001).

Patients with FAI syndrome treated surgically may experience slowing of osteoarthritisprogression and superior pain and function compared with patients treated non- operatively.

This study aimed to identify the success rate of debridement, antibiotics and implant retention (DAIR) for prosthetic joint infection (PJI) in a large prospective cohort of patients undergoing total knee arthroplasty (TKA). The ability for different PJI classification systems to predict DAIR success was assessed.

A prospective, multicenter study of PJIs occurring between July 2014 and December 2017 in 27 hospitals across Australia and New Zealand was performed. First time PJIs following primary TKA that were managed with DAIR were analyzed. DAIR success was defined as the patient being alive with documented absence of clinical or microbiological evidence of infection and no ongoing antibiotics for the index joint at 2-year follow-up. Multivariate analysis was performed for multiple PJI classification systems to assess their ability to predict DAIR success using their respective definitions of “early” PJI (Coventry ≤1 month, International Consensus Meeting ≤90 days or Auckland <1 year), or as hematogenous versus chronic PJI (Tsukayama).

189 PJIs were managed with DAIR, with an overall success rate of 45% (85/189). Early PJIs had a higher rate of DAIR success when analyzed according to the Coventry system (adjusted odds ratio = 3.85, p = 0.008), the ICM system (adjusted odds ratio = 3.08, p = 0.005) and the Auckland system (adjusted odds ratio = 2.60, p = 0.01). DAIR success was lower in both hematogenous (adjusted odds ratio = 0.36, p = 0.034) and chronic PJIs (adjusted odds ratio = 0.14, p = 0.003) occurring more than one year since the primary TKA.

DAIR success is highest when performed in infections occurring within one year of the primary TKA. Late infections had a high DAIR failure rate irrespective of their classification as hematogenous or chronic. Time since primary is a useful predictor of DAIR success.

Introduction:. 20 cases of bone defect have been treated by the induced membrane technique avoiding allograft, microsurgery and amputation. Material and Methods:. 9 cases of long bone defect (humerus and forearm) and 11 cases of bone defect at the hand have been included in this multicentre prospective study (3 centers). The aetiology in 11 cases was trauma, 7 cases were septic nonunions and 2 cases followed tumors. In the hand the bone loss was at least one phalanx, and for long bones the mean defect was 5 cm (3–11). All cases were treated by the induced membrane technique which consists in stable fixation, flap if necessary and in filling the void created by the bone defect by a cement spacer (PMMA). This technique needs a second stage procedure at the 2. nd. month where the cement is removed and the void is filled by cancellous bone. The key point of this induced membrane technique is to respect the foreign body membrane which appeared around the cement spacer and which creates a biologic chamber for the second procedure. Bone union was evaluated prospectively in each case by a surgeon not involved in the treatment, by X-ray and CT scan. Failure was defined as a nonunion at 1 year, or an uncontrolled sepsis at 1 month. Results:. 3 cases failed to achieve bone union, 2 in the hand and 1 in a long bone. No septic complications occurred and all septic cases healed. In 14 cases bone union was achieved with a delay of 5 months (1, 5–12). 2 biopsies allowed us to prove that osteoid tissue was created by the technique. At hand level all fingers have included. At shoulder and elbow level, function reached 75% of motion of the contralateral side. Discussion:. Masquelet first reported 35 cases of large bone defect of tibia nonunion treated by the induced membrane technique which allow filling a bone defect with cancellous bone alone. The cement spacer induces a foreign body membrane (neo periosteum) which constitute a biological chamber. Animal models showed the properties of the membrane: secretion of growths factors (VEGF, TGFbéta1, BMP2) and osteoinductive activitie of the cells. Conclusion:. This technique is useful in emergency or in septic condition where a bone defect cannot be solved by shortening. The technique avoids the use of microsurgery and the limit is the quantity of available cancellous bone

Aim

To analyse the prevalence of culture negative periprosthetic joint infections (PJI) when adequate culture techniques are applied, and to evaluate the outcome of patients who were treated with antibiotics for a culture negative PJI versus those in whom treatment was withheld.

Aim

Despite the availability of numerous tests, the diagnosis of periprosthetic infection (PJI) continues to be complex. Although several studies have suggested that coagulation-related markers, such as D-dimer and fibrinogen, may be promising tools in the diagnosis of prosthetic infections, their role is still controversial. The aim of this study is to evaluate the diagnostic accuracy of serum D-dimer and fibrinogen in patients with painful total knee replacement.

First Metatarsophalangeal joint fusion has been successfully used to treat Hallux rigidus. We have attempted to evaluate commonly used methods of fixation and joint preparation. To the best of our knowledge, this is the single largest comparative study on first MTPJ fusion. We aimed to evaluate the radiological union and revision rates. We included 409 consecutive MTPJ fusions performed in 385 patients. We collected demographic, comorbidities and complication data. We evaluated the radiographs for the status of the union. Logistic regression was used to calculate the Odds ratio (OR) of non-union for the collected variables. Our union rate was 91.4% (34/409). 29.4% of our non-unions were symptomatic (10/34). Hallux valgus showed a statistically significant relation to non-union (Odds ratio 9.33, p-value 0.017). Other potential contributing factors like sex (OR1.9, p-value 0.44), diabetes (OR 0, p-value 0.99), steroid use (OR 2.07, p-value 0.44), inflammatory arthritis (OR 0, p-value 0.99) and smoking (OR 2.69, p-value 0.34) did not attain statistical significance. Further, the methods of fixation like solid screws (OR 0, p-value 0.99), plate (OR 3.6, p-value 0.187) or cannulated screws (OR 0.09, p-value 0.06) showed no correlation with non-union. We compared two techniques of joint preparation and found no significant difference in union rates (Chi-Square 1.0426, p-value 0.30). Our crude cost comparison showed the average saving to the trust per year could be 33,442.50£ by choosing screws over plate. Only Hallux Valgus had a statistically significant relation to non-union. Solid screw could be economically the most viable option and a valid alternative.

Background

In fixation of the fibula in ankle fractures, AO advocate using a lag screw and one-third tubular neutralisation plate for simple patterns. Where a lag screw cannot be placed, bridging fixation is required. A local pilot service evaluation previously identified variance in use of locking plates in all patterns with significant cost implications. The FAIR study aimed to evaluate current practice and implant use across the United Kingdom (UK) and review outcomes and complication rates between different fibula fixation methods.

We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing

The optimal choice of irrigating solution or irrigating pressure in the initial management of open fracture wounds remains controversial. FLOW compared the effect of castile soap versus normal saline, and low versus high pressure pulsatile lavage on one year re-operation rates in patients with open fracture wounds. We conducted a multicentre, blinded, two-by-two factorial, pilot randomised trial of 111 patients with open fracture wounds receiving either castile soap solution or normal saline and either high or low pressure pulsatile lavage. The primary outcome, re-operation within one year, included infections, wound healing problems, and nonunions. Secondary outcomes included all operative and non-operative infections, wound healing problems, nonunion and functional outcomes. We followed the intention to treat principle. Eighty-nine patients (80.2%) completed the 12-month follow-up. As anticipated in this small-sample-size pilot study, results were compatible with substantial benefit and substantial harm. The hazard ratio (HR) for re-operation with castile soap was 0.77 (95% Confidence Interval (CI) 0.35 to 1.69, p=0.52). With low pressure lavage, the hazard ratio for the risk of re-operation was 0.56, 95% CI 0.25 to 1.27, p=0.17. Secondary outcomes showed a significant relative risk reduction for nonunion of 63% in favour of castile soap (p=0.036), and a trend for a relative risk reduction for nonunion of 44% in favour of low pressure lavage (p=0.22). Functional outcome scores showed no significant differences at any time point between groups. The FLOW pilot randomised controlled trial demonstrated the possibility that the use of low pressure may decrease the re-operation rate for infection, wound healing problems, or nonunion. Our findings provide compelling rationale for continued investigation in a pivotal FLOW trial of 2280 patients

In March 2020, the World Health Organisation declared the COVID-19 outbreak a pandemic. Multiple new guidelines were proposed and existing models of social, domestic and hospital care altered. Most healthcare systems were largely unprepared for this and this pandemic has tested their adaptability. This study is aimed at assessing the impact of covid-19 on the demographics, presentation and clinical management of patients with proximal femoral (hip) fractures.

This retrospective multi-centre cohort study compared all patients admitted with hip fractures, between 1^st March and 30th May 2019 (Group PC: Pre-Covid) with hip fracture patients admitted over the same time period during the pandemic in 2020 (Group C: Covid). The data was obtained from the hospitals' local and National Hip Fracture Databases. Mortality data was checked with the Office for National Statistics (ONS). Primary outcomes were time to theatre, in-patient length of stay and 30-day mortality.

580 patients were included (304 PC, 276 C). Patient Charlson comorbidity index and Nottingham Hip Fracture scores were broadly similar across the two cohorts. There was a significant reduction in percentage of total hip replacements in Group C (11% to 5%, p=0.006). There was an increase in conservative management in group C (1% to 5%, p=0.002). The time to theatre was significantly delayed in Group C (43.7 hours C versus 34.6 hours PC, p<0.001). Overall length of hospital stay was similar in both groups (16.6 days PC versus 15 days C, p=0.089). 30-day mortality rate in Group C was 9.8% compared to 8.2% in Group PC (p=0.431), but for covid (+) patients it was significantly higher at 38.2% versus 5.8% in covid (−) patients (p<0.001).

This is one of the largest multi-centre comparative cohort study in the literature to date, examining the impact of the covid-19 pandemic on the management of hip fracture patients. Whilst mortality rates were similar in both groups, covid patients were almost seven times more likely to die, reflecting the seriousness of the covid-19 infection and its sequelae in such elderly, vulnerable patients.

Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts.

Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion.

Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure.

The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease.

This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming.

Background: The aim of introduction of navigation in knee arthroplasty was to further contribute to precision of endoprosthetic alignment. Methods and material: A multicentre comparative study was conducted including 821 patients. The SEARCH knee system was used throughout the series. 555 TKA’s were implanted with the use of a navigation system (OrthoPilot) and 266 cases were operated using manual instrumentation. Alignment was radiographically evaluated at the three months follow-up with respect to mechanical axis and femoral and tibial axes using one-leg stance x-rays and standardized lateral radiographs. Results: The summarized results of the series are shown in the table below. The chi-square test was applied for the statistical analysis. Conclusions: Endoprosthetic alignment using the navigation system was superior to manual implantation technique on the average with respect to all parameters. Results were more consistent on the tibial side. The navigation system proved to be reliable. The overall results justify the further use and development of navigation tools in knee arthroplasty

Objective:. To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. Design:. A multicentre two arm patient and assessor double blind RCT. Setting:. Four UK centres (Edinburgh, Belfast, Liverpool, Bristol). Participants:. 62 skeletally mature adults undergoing distraction osteogenesis of 2.5–10cm at the proximal tibia. Patients with metabolic bone disorders were excluded. Interventions:. A metaphysial corticotomy was created and an Ilizarov frame applied. After 7 days, distraction was performed (0.75mm/day). After 1cm of distraction, an ‘ultrasound’ device was used for 20 minutes/day. Patients were randomised to either an active or a placebo (control) ultrasound device. Main outcome measures:. Primary outcome measure: time ready for removal of frame for both intension to treat (ITT) and per protocol (PP). Secondary outcomes: covariates affecting time to frame removal, return to weight bearing (>50% body weight), and compliance with device usage. Results:. 90% patients were managed as PP. There was no difference in time to frame removal for ITT (difference . in favour of control. group- 5.0days/cm, 95% CI −8.2 to18.21; p=0.23) or PP (difference . in favour of control. group-10.1days/cm, 95% CI −3.2 to 23.4; p=0.054). Smoking was the only covariate to increase frame removal time (hazard ratio 0.46, 95% CI 0.22 to 0.96; p=0.04). There was no difference in weight bearing between the two groups, after adjusting for distraction length, for the ITT cohort (p>0.5). The compliance was 78.8% & 81.6% in the PP group and 70.0 & 72.3% in the ITT group for active & control devices respectively. Conclusions:. Contrary to the existing literature, including NICE guidelines, this trial found no difference in bone healing between those who underwent low intensity pulsed ultrasound and those who did not. The trial was sufficiently powerful to demonstrate that smoking had a significantly deleterious effect on bone healing; approximately doubling the healing time

Aims

To assess the variation in pre-fracture quality of life (QoL) within the UK hip fracture population, and quantify the nature and strength of associations between QoL and other routinely collected patient characteristics and treatment choices.

Purpose. Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy. Method. Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p < 0.05). Results. At 2-years post-operatively, mean WOSI scores were not statistically different between the groups (p=0.61): ETAC = 74 (SD = 24; 95% CI = 64 84); Open ICS = 77 (SD = 20; 95% CI = 68 86). There was no difference between groups for mean ASES scores (p=0.34): ETAC = 81 (SD = 20; 95% CI = 73 90); Open ICS = 87 (SD = 18; 95% CI = 79 95), mean Constant scores (p = 0.35): ETAC = 83 (SD = 7; 95% CI = 80 86); Open ICS = 85 (SD = 11; 95% CI = 80 − 90), and recurrent instability (p = 0.41): ETAC = 2; Open ICS = 4. Mean surgical time was 23 minutes for ETAC and 59 minutes for Open ICS (p = 0.00). Three subjects (1 ETAC, 2 Open ICS) had stiff shoulders; however, no major complications were observed. Conclusion. Patient outcomes improved from baseline to all follow-up periods. There was no difference between the ETAC and Open ICS groups in quality of life, functional outcomes, and recurrent instability at 2 years post-operatively

Purpose. Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair. The purpose of this multicentre randomized double-blind controlled study was to compare the functional outcomes and healing rates of double-row suture techniques with single row repair. Method. Patients undergoing arthroscopic rotator cuff repair were randomized to receive either a double row (DR) or single row (SR) repair. The primary objective was to compare the WORC score at 24 months. Secondary objectives included anatomical outcomes by MRI or ultrasound, the Constant, and ASES scores. A sample size calculation determined that 84 patients provided 80% power with a 50% effect size to detect a statistical difference between groups. Results. Baseline demographic data did not differ between groups including age (p=0.4), sex (p=0.71), affected side (p=0.33) and cuff tear size (p=0.95). WORC outcome comparison between groups revealed that no statistical differences were detected at any time points (p=0.9, baseline; p=0.15, 3 months; p=0.41, 6 months; p=0.46, 12 months, p=0.42, 24 months). Statistically significant improvements occurred in both groups from baseline to all time points in all clinical outcome scores (p<0.0001). Conclusion. No statistically significant differences in primary or secondary outcomes were identified between DR and SR techniques. Given the added time to complete the procedures and the added cost of additional implants, this trial does not provide justification for use of the more complex repair technique

Periprosthetic femur fracture (PPF) are heterogeneous, complex, and thought to be increasingly prevalent. The aims were to evaluate PPF prevalence, casemix, management, and outcomes.

This nationwide study included all PPF patients aged >50 years from 16 Scottish hospitals in 2019. Variables included: demographics; implant and fracture factors; management factors, and outcomes.

There were 332 patients, mean age 79.5 years, and 220/332 (66.3%) were female. One-third (37.3%) were ASA1-2 and two-thirds (62.3%) were ASA3+, 91.0% were from home/sheltered housing, and median Clinical Frailty Score was 4.0 (IQR 3.0). Acute medical issues featured in 87/332 (26.2%) and 19/332 (5.7%) had associated injuries. There were 251/332 (75.6%) associated with a proximal femoral implant, of which 232/251 (92.4%) were arthroplasty devices (194/251 [77.3%] total hip, 35/251 [13.9%] hemiarthroplasty, 3/251 [1.2%] resurfacing). There were 81/332 (24.4%) associated with a distal femoral implant (76/81 [93.8%] were total knee arthroplasties). In 38/332 (11.4%) there were implants proximally and distally. Most patients (268/332; 80.7%) were treated surgically, with 174/268 (64.9%) requiring fixation only and 104/268 (38.8%) requiring an arthroplasty or combined solution. Median time to theatre was longer for arthroplasty versus fixation procedures (120 vs 46 hours), and those requiring inter-hospital transfer waited longer (94 vs 48 hours).

Barriers to investigating PPF include varied classification, coding challenges, and limitations of existing registries. This is the first study to examine a national PPF cohort and presents important data to guide service design and research. Additional findings relating to fracture patterns, implant types, surgeon skill-mix, and outcomes are reported herein.

Aim. Paediatric fractures are common but those occurring in non-ambulant children are associated with higher rates of Non Accidental Injury (NAI). There is little published on the mechanisms of injury associated with accidental fracture in young children. This study explores the aetiology of long bone fractures in non-ambulant children. Methods. This retrospective multicentre study looked at children aged ≤18 months presenting to three hospitals over 3 years (2009 to 2011). Information was gathered on age, gender, fracture type, injury mechanism, final diagnosis, treatment and details of screening for NAI. Results. 147 children were identified who were ≤18 months old (mean 12 months). There were 32 femoral, 37 tibial, 43 forearm, 17 humeral, 16 clavicular and 3 fibular fractures. We identified 6 confirmed cases of NAI and 7 pathological fractures (osteopenia of prematurity or osteogenesis imperfecta). 5/64 children aged ≤12 months old had NAI compared with 1/83 in those aged >12 months. All 7 pathological fractures occurred in the ≤12 months group. NAI or pathological fracture was more likely in ≤12 months group compared to those >12 months (p=0.0002) Of the 12 children with no clear mechanism of injury, 5 had NAI and 3 had pathological fractures. In 39/147 children NAI was considered in the documentation and 29 had a paediatric review. Falls from beds and change mats were more common in ≤12 months group, as well as transverse femoral fractures; caused when those carrying the child slipped downstairs and applied a sudden bending force to the held leg. In those >12 months falls from chairs, down steps, in playgrounds or on trampolines were more common. 12/147 fractures were caused directly by other children (6 in each group). Conclusion. Our study identified causes of accidental long-bone fracture in non-ambulant children. In cases where there is no clear mechanism of injury, NAI must be carefully excluded

Purpose of the study: The Natural Knee (NK) SystemTM for cementless þxation, has been developed by A. Hofmann in the USA since 1988: aim of this study was to provide early results of this implant prospectively performed by a multicentre group of European surgeons. Material and Methods: Over a 2.6year period, 287 NKñs were implanted in 283 patients by 8 orthopaedic teams in 4 european countries. Mean age and body mass index was 69 years (35–91) and 29 (16–41), repectively. Diagnosis was primary arthrosis (87%), rheumatoid (9%) and post-traumatic arthritis (4%), with previous in 30%. Approach was sub-vastus in 58% and medial-patellar in 42%. Posterior cruciate ligament (PCL) was preserved in 94% of knees and patella was resurfaced in 56%: Cemented/ cementless þxation ratios were; femur, 14/86%; tibia, 24/76%; patella (160 resurfaced), 43/57%. 75.3% of knees were all cementfree. Lateral release was performed in 20% of knees. Regularly monitored clinical and radiographic follow-up data were prospectively collected with use of a FDA-Approved form with computer centralization for statistical analysis. Results: 275 knees (96% of index cohort) were clinically reviewed at 60 month average follow-up (range, 26–95 months). Radiographically (268 knees), aseptic loosening has been observed in 2 cementless TKAñs (0.7%). At 7 years, survivorship of the index group of 287 NKñs with reoperation for any cause (7 knees) and revision for aseptic loosening (2 knees) as end points was 95.7% and 97.65%, respectively. Conclusion: In non-originators orthopaedists hands, the Natural Knee system TM has provided thus far general satisfying early results as normally expected in primary TKR with such modern modular prosthesis

Prolonged length of stay (LOS) is a significant contributor to the variation in surgical health care costs and resource utilization after elective spine surgery. The primary goal of this study was to identify patient, surgical and institutional variables that influence LOS. The secondary objective is to examine variability in institutional practices among participating centers.

This is a retrospective study of a prospectively multicentric followed cohort of patients enrolled in the CSORN between January 2015 and October 2020. A logistic regression model and bootstrapping method was used. A survey was sent to participating centers to assessed institutional level interventions in place to decrease LOS. Centers with LOS shorter than the median were compared to centers with LOS longer than the median.

A total of 3734 patients were included (979 discectomies, 1102 laminectomies, 1653 fusions). The median LOS for discectomy, laminectomy and fusion were respectively 0.0 day (IQR 1.0), 1.0 day (IQR 2.0) and 4.0 days (IQR 2.0). Laminectomy group had the largest variability (SD=4.4, Range 0-133 days). For discectomy, predictors of LOS longer than 0 days were having less leg pain, higher ODI, symptoms duration over 2 years, open procedure, and AE (p< 0.05). Predictors of longer LOS than median of 1 day for laminectomy were increasing age, living alone, higher ODI, open procedures, longer operative time, and AEs (p< 0.05). For posterior instrumented fusion, predictors of longer LOS than median of 4 days were older age, living alone, more comorbidities, less back pain, higher ODI, using narcotics, longer operative time, open procedures, and AEs (p< 0.05). Ten centers (53%) had either ERAS or a standardized protocol aimed at reducing LOS.

In this study stratifying individual patient and institutional level factors across Canada, several independent predictors were identified to enhance the understanding of LOS variability in common elective lumbar spine surgery. The current study provides an updated detailed analysis of the ongoing Canadian efforts in the implementation of multimodal ERAS care pathways. Future studies should explore multivariate analysis in institutional factors and the influence of preoperative patient education on LOS.

Cemented total hip replacement (THR) provides excellent outcomes and is cost-effective. Polished taper-slip (PTS) stems demonstrate successful results and have overtaken traditional composite-beam (CB) stems. Recent reports indicate they are associated with a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to CB stems. This study evaluates risk factors influencing fracture characteristics around PTS and CB cemented stems.

Data were collected for 584 PFF patients admitted to eight UK centres from 25/05/2006-01/03/2020. Radiographs were assessed for Unified Classification System (UCS) grade and Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) type. Statistical comparisons investigated relationships by age, gender, and stem fixation philosophy (PTS versus CB). The effect of multiple variables was estimated using multinomial logistic regression to estimate odds ratios (OR) with 95% confidence intervals (CI).

Median (IQR) age was 79.1 (72.0–86.0) years, 312 (53.6%) patients were female, and 495 (85.1%) stems were PTS. The commonest UCS grade was type B1 (278, 47.6%). The commonest AO/OTA type was spiral (352, 60.3%). Metaphyseal-split fractures occurred only with PTS stems with an incidence of 10.1%. Male gender was associated with a five-fold reduction in odds of a type C fracture (OR 0.22, 95% CI 0.12 to 0.41, p<0.001) compared to a type B fracture. CB stems were associated with significantly increased odds of transverse fracture (OR 9.51, 95% CI 3.72 to 24.34, p <0.001) and wedge fracture (OR 3.72, 95% CI 1.16 to 11.95, p <0.05) compared to PTS stems.

This is the largest study investigating PFF characteristics around cemented stems. The commonest fracture types are B1 and spiral fractures. PTS stems are exclusively associated with metaphyseal-split fractures, but their incidence is low. Males have lower odds of UCS grade C fractures compared to females. CB stems had higher odds of bending type fractures (transverse and wedge) compared to PTS stems. Biomechanical testing is needed for validation and investigation of modifiable factors which may reduce the risk of unstable fracture patterns requiring complex revision surgery over internal fixation.

Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair. No previous comparative trials have reported on the long-term follow-up of single and double row fixation in arthroscopic cuff repair. The purpose of this study was to compare the long-term functional outcomes of single-row and double-row suture techniques for repair of the rotator cuff 10-years post-operatively.

Ninety patients undergoing arthroscopic rotator cuff repair were randomized to receive either single-row or double-row repair. The primary objective was to compare the Western Ontario Rotator Cuff Index (WORC) score 10-years post-operatively. Secondary objectives included comparison of the Constant, and American Shoulder and Elbow Surgeons (ASES) scores and supraspinatus strength between groups. Out of 90 patients originally randomized, 57 returned for the long-term 10-year follow-up.

Baseline demographic data did not differ between groups. The WORC score was not significantly different between groups at long-term follow-up (p=0.13). No statistical differences were observed between groups for the Constant (p=0.51), ASES (p=0.48) scores, or strength scores (p=0.93). A significant improvement was observed between pre-operative and the final 10-year follow-up. There were no differences observed in all outcomes between two and 10-years post-operatively.

No statistically significant differences in functional or quality of life outcomes were identified between single-row and double-row fixation techniques at long-term follow-up.

Purpose: A ceramic head coupled to a metal liner is a proposed new alternate bearing in THA. The authors participated in an FDA approved multicentre prospective, randomized, blinded clinical trial comparing ceramic-on-metal (CoM) to metal-on-metal (MoM) in patients receiving a THA. Method: 390 patients received the same acetabular component and metal insert. 194 patients received a delta ceramic head (CoM) and 196 received a metal head (MoM). Metal ions were evaluated in 72 patients (36-CoM, 36-MoM). Harris Hip scores, radiographs, and metal ion levels (cobalt, chromium and titanium in serum, erythrocytes and urine) were evaluated pre-operatively and at three, 12 and 24 months. Results: No patients were lost to follow-up. There were no differences between groups’ baseline demographics and clinical scores. At two years there were no differences in Harris Hip scores, radiographs, adverse events or postoperative complications. Both groups had overall very low median metal ion profiles with no statistically significant differences. 24 month MoM vs CoM; Serum cobalt ( g/L), mean: 1.2(+/−0.5) vs 1.1(+/−0.3), median: 0.66(range: 0.2–5.6) vs 1.0 (range: 0.3–2.7); Serum chromium ( g/L), mean: 1.1(+/−0.5) vs 1.4(+/−0.4), median: 0.86(range: 0.3–6.9) vs 1.2(range: 0.3–4.9). Urine cobalt and urine chromium ( g/day) demonstrated similar trends to serum ion levels. Conclusion: While CoM is a new bearing surface in North America and not currently FDA or HPB approved, it has been in clinical use globally since 2006. Results of this non-inferiority RCT demonstrated no clinical outcome, metal ion, radiographic or adverse event differences between CoM and MoM cohorts

Background. Vertebral body compression fractures (VCFs) impair quality of life (QOL) and increase patient morbidity and mortality. The international, multicentre, randomised, controlled Fracture Reduction Evaluation (FREE) trial was initiated to compare effectiveness and safety of Balloon kyphoplasty (BKP) to non-surgical management (NSM) for the treatment of acute painful VCFs. We describe the primary endpoint of the ongoing 2-year study. Methods. Patients with 1-3 non-traumatic VCFs (< 3 months old) were randomised to either BKP or NSM. The primary endpoint was the change in QOL as measured by the SF-36 Health Survey Physical Component Summary (PCS) at one month, and device/procedure-related safety. Secondary endpoints included SF-36 subscales, the EQ-5D, self-reported back pain and function using the Roland Morris Disability Questionnaire (RMDQ). All patients were given osteoporosis medical therapy. Results. Among the BKP (N=149) and NSM (N=151) cohorts, mean patient age was 73 years and 77% were female. Most patients had VCFs due to primary osteoporosis; 8 patients due to corticosteroid-induced osteoporosis, and 4 had cancer-related fractures. Thirty-nine BKP (26%) and 36 NSM (24%) patients had >1 VCF treated. At one month follow-up, the mean improvement in the PCS was in favour of BKP over NSM (p<0.0001). All physical component SF-36 subscales and the total EQ-5D score were significantly improved for BKP compared to NSM. Mean improvements in back pain at 7 days and 1 month were significantly greater for BKP compared to NSM (p<0.0001 at both time points). The improvement in RMDQ for BKP over NSM was also significant (p<0.0001). There was one soft tissue haematoma and urinary tract infection, with no bone cement-related serious adverse events. Conclusions. Compared to non-surgical management, balloon kyphoplasty demonstrated superior short-term pain, function and quality of life outcomes with no difference in serious adverse events for the treatment of acute, painful vertebral compression fractures. (Clinical trials.gov number, NCT00211211)