Surgical simulation training for escharotomy: A novel course, improving candidate's confidence in a time critical procedure.

BACKGROUND: Circumferential deep burns on the limb lead to a constrictive, tourniquet-like effect causing critical limb ischaemia. The treatment, escharotomy, is a time-critical procedure that sometimes is required before the patient arrives at a burn centre. At present, no practical method of teaching this procedure is incorporated into formal educational courses. METHODS: The feasibility of a comprehensive education package to teach upper limb escharotomy was assessed in a group of plastic and general surgery trainees in Wales. Small group workshops focused on the clinical presentation of patients requiring escharotomy. Participants then executed this on a custom-made high-fidelity simulation upper limb model. The articulated limb has subcutaneous silicone fat which bulges upon decompression and a finger-tip which turns pink indicating satisfactory reperfusion. A before and after five-point Likert scale was used to evaluate changes in participants' self-assessed confidence in the surgical management of escharotomy. Statistical significance between scores was assessed using the Wilcoxon signed-rank test. RESULTS: A total of 34 participants took part. Following completion of the course, general surgery trainees' confidence in executing the procedure increased from a median score of 1.00 "not confident at all" (IQR 1.00-2.00) to 4.00 "fairly confident" (IQR 4.00-5.00, p < 0.01). Plastic surgery trainees' confidence increased from a median score of was 3.00 "somewhat confident" (IQR 1.75-4.00) to 4.00 "fairly confident" (IQR 3.00-4.25, p < 0.01). DISCUSSION: We developed a comprehensive simulator course that has been demonstrated to improve candidate's confidence in performing escharotomy. The next stage in the course development is to confirm the results in a larger cohort. By developing this simulator course we aim to improve emergency burn care education in the UK and globally.

Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)-protocol for an individually randomised parallel-group trial.

BACKGROUND: Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given by paramedics, but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes. We completed a feasibility study of paramedic-provided fascia iliaca compartment block (FICB), testing the intervention, trial methods and data collection. The study (RAPID) demonstrated that a full trial was feasible. In this subsequent study, we aim to test safety, clinical and cost-effectiveness of paramedic-provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment. METHODS: We will conduct a pragmatic multi-centre individually randomised parallel-group trial, with a 1:1 allocation between usual care (control) and FICB (intervention). Hospital clinicians in five sites (paired ambulance services and receiving hospitals) in England and Wales will train 220 paramedics to administer FICB. The primary outcome is change in pain score from pre-randomisation to arrival at the emergency department. One thousand four hundred patients are required to find a clinically important difference between trial arms in the primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). We will use NHS Digital (England) and the SAIL (Secure Anonymised Information Linkage) databank (Wales) to follow up patient outcomes using routine anonymised linked data in an efficient study design, and questionnaires to capture patient-reported outcomes at 1 and 4 months. Secondary outcomes include mortality, length of hospital stay, job cycle time, prehospital medications including morphine, presence of hip fracture, satisfaction, mobility, and NHS costs. We will assess safety by monitoring serious adverse events (SAEs). DISCUSSION: The trial will help to determine whether paramedic administered FICB is a safe, clinically and cost-effective treatment for suspected hip fracture in the pre-hospital setting. Impact will be shown if and when clinical guidelines either recommend or reject the use of FICB in routine practice in this context. TRIAL REGISTRATION: ISRCTN15831813 . Registered on 22 September 2021.

Measuring recovery after open lower limb fractures: combined objective functional tests and global perceived recovery outperform narrower metrics and a standard generic patient reported outcome measure.

BACKGROUND: Open lower limb fractures are serious injuries requiring combined ortho-plastic surgery and have significantly worse outcomes than similar closed fractures. There is little objective published data to determine which functional outcome measures best reflect progress or completeness of physical recovery. Our hypothesis was that objective measures combining strength, mobility and balance would better reflect recovery than isolated parameters (e.g. range of motion ROM) and would compare well to patients' perceived recovery. METHODS: Adult open lower limb fracture patients were reviewed 6 and 12 weeks, 6, 9 and 12 months post-injury. The mechanism, injury pattern, age, gender and treatment were recorded. Isolated parameter objective functional outcome measures (OFOMs) (ROM and MRC strength grade) were compared to combined OFOMs (timed up and go, comfortable gait speed and fast gait speed, Edgren Side Step Test (TUAG, CGS, FGS, ESST) and Single Leg balance. Patient reported outcomes were recorded (Global Perceived Effect (GPE) score and Disability Rating Index (DRI)). Statistical analysis used non-parametric tests (e.g. Spearman correlation) compared each with time since injury. RESULTS: Sixty-eight patients (54 male) with a median age of 45(20-75) years. Of the 19 isolated OFOMs, only knee flexion and ankle plantar flexion ROM and strength improved with time (Spearman correlation p = 0.042, 0.008, 0.032, 0.036 respectively). TUAG, ESST, CGS, FGS and GPE scores showed significant improvement (Spearman correlation p < 0.001). Patients' estimation of recovery paralleled these measures (Spearman correlation p < 0.001) with all but 2 patients achieving the minimum clinical important difference in DRI by 12 months compared to baseline. However, the GPE score had a higher proportion of improving responses than DRI at each time-point. DISCUSSION: Functional recovery is a key determinant in patients returning to work, providing for themselves and their family or resuming independent living for older patients. This study has demonstrated time-related improvements in combined OFOMs measuring mobility, strength, agility and balance paralleling patients' perception of recovery in the 12 months after open lower limb fractures. Over the same time-frame, the simple GPE score compared favourably with the DRI. Such parameters could become part of a defined core outcomes set. Focussing rehabilitation towards these combined OFOMs may help hasten recovery. TRIAL REGISTRATION: South West Wales REC 06/WMW02/10).

A Comparison of Improvised and Commercially Available Point-of-Wounding Tourniquets in Simulated Traumatic Amputation with Catastrophic Hemorrhage.

INTRODUCTION: Catastrophic hemorrhage is the leading cause of preventable trauma deaths in the military and civilian populations. The use of tourniquets by first responders (medical and nonmedically trained) is supported and has the potential to save lives if applied correctly. AIMS: We sought to examine the use of 5 tourniquets: 1 improvised and 4 commercially available tourniquets to investigate the time taken to stop simulated bleeding and to secure the device; evidence of rebleeding when the "blood pressure" was restored and to gain qualitative feedback on their application. MATERIALS AND METHODS: Four commercially available tourniquets (Combat Application Tourniquet [C-A-T], Special Operations Forces Tactical Tourniquet - Wide (SOFTT-W), stretch, wrap, and tuck tourniquet [SWAT-T], and the Tourni-key) and an improvised tourniquet (tie & wooden spoon) were tested on a complex silicone simulation model used to replicate catastrophic hemorrhage from a blast injury with above traumatic knee amputation (SAM 4.1 Trauma Simulation Ltd, UK). To limit the user variability, the same investigator applied each tourniquet and each was tested 3 times. No ethical approval was required to conduct this study. RESULTS: None of the devices took longer than 1 minute to secure. The C-A-T and SOFTT-W were quickest to occlude and secure. Although the Tourni-key took longer statistically, this was unlikely to be a clinically important difference. Compared to the others, the SOFTT-W rebled on 2 out of 3 applications. The improvised tourniquet had an obvious ligature effect because of its narrowness, followed by the Tourni-key. This effect was least evident with the SWAT-T; however, particular care was needed to ensure it was safely secured as it was slippery when wet. CONCLUSIONS: All tourniquets tested were effective and swift to apply. The Tourni-key's antipinch card seems helpful in reducing local pain under the windlass. Reinspection for rebleeding is important and should be routinely performed irrespective of the device. The width of the SWAT-T may be beneficial, thereby, reducing the risk of crush injury.

The development of a novel patient-derived recovery scale for open tibial fractures.

AIMS: The aim of this study was to develop a psychometrically sound measure of recovery for use in patients who have suffered an open tibial fracture. METHODS: An initial pool of 109 items was generated from previous qualitative data relating to recovery following an open tibial fracture. These items were field tested in a cohort of patients recovering from an open tibial fracture. They were asked to comment on the content of the items and structure of the scale. Reduction in the number of items led to a refined scale tested in a larger cohort of patients. Principal components analysis permitted further reduction and the development of a definitive scale. Internal consistency, test-retest reliability, and responsiveness were assessed for the retained items. RESULTS: The initial scale was completed by 35 patients who were recovering from an open tibial fracture. Subjective and objective analysis permitted removal of poorly performing items and the addition of items suggested by patients. The refined scale consisted of 50 Likert scaled items and eight additional items. It was completed on 228 occasions by a different cohort of 204 patients with an open tibial fracture recruited from several UK orthoplastic tertiary referral centres. There were eight underlying components with tangible real-life meaning, which were retained as sub-scales represented by ten Likert scaled and eight non-Likert items. Internal consistency and test-retest reliability were good to excellent. CONCLUSION: The Wales Lower Limb Trauma Recovery (WaLLTR) Scale is the first tool to be developed from patient data with the potential to assess recovery following an open tibial fracture. Cite this article: Bone Joint J 2020;102-B(1):17-25.

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study.

OBJECTIVE: To explore patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury. DESIGN: Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture. SETTING: Patients treated by paramedics in the catchment area of one emergency department in South Wales. PARTICIPANTS: Six patients and one carer of a patient who received fascia iliaca compartment block (FICB). INTERVENTION: FICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB-a local anaesthetic injection directly into the hip region-or usual care-most commonly morphine-using audited scratch cards. OUTCOMES: Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants' consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member. RESULTS: Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury. CONCLUSIONS: This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting. TRIAL REGISTRATION NUMBER: ISRCTN60065373.

Flow Cytometric Analysis of Hematopoietic Populations in Rat Bone Marrow. Impact of Trauma and Hemorrhagic Shock.

Severe injury and hemorrhagic shock (HS) result in multiple changes to hematopoietic differentiation, which contribute to the development of immunosuppression and multiple organ failure (MOF). Understanding the changes that take place during the acute injury phase may help predict which patients will develop MOF and provide potential targets for therapy. Obtaining bone marrow from humans during the acute injury phase is difficult so published data are largely derived from peripheral blood samples, which infer bone marrow changes that reflect the sustained inflammatory response. This preliminary and opportunistic study investigated leucopoietic changes in rat bone marrow 6 h following traumatic injury and HS. Terminally anesthetized male Porton Wistar rats were allocated randomly to receive a sham operation (cannulation with no injury) or femoral fracture and HS. Bone marrow cells were flushed from rat femurs and immunophenotypically stained with specific antibody panels for lymphoid (CD45R, CD127, CD90, and IgM) or myeloid (CD11b, CD45, and RP-1) lineages. Subsequently, cell populations were fluorescence-activated cell sorted for morphological assessment. Stage-specific cell populations were identified using a limited number of antibodies, and leucopoietic changes were determined 6 h following trauma and HS. Myeloid subpopulations could be identified by varying levels CD11b expression, CD45, and RP-1. Trauma and HS resulted in a significant reduction in total CD11b + myeloid cells including both immature (RP-1(-)) and mature (RP-1+) granulocytes. Multiple B-cell lymphoid subsets were identified. The total percentage of CD90+ subsets remained unchanged following trauma and HS, but there was a reduction in the numbers of maturing CD90(-) cells suggesting movement into the periphery. © 2019 The Authors. Cytometry Part A published by Wiley Periodicals, Inc. on behalf of International Society for Advancement of Cytometry.

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

BACKGROUND: In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible. METHODS: Volunteer paramedics used scratchcards to allocate patients with hip fracture at random between FICB and pain relief as usual. Primary outcomes were mortality and quality of life. We also measured adverse events, costs, final diagnosis, length of stay in hospital, pain scores and quality of care and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on the recruitment of paramedics and patients, delivery of FICB, retrieval of outcome data, safety, acceptability, and diagnostic accuracy of hip fracture. RESULTS: We effectively met all progression criteria: we recruited 19 paramedics who randomly allocated 71 patients between trial arms between 28 June 2016 and 31 July 2017; 57 (31 experimental arm, 26 usual care arm, 80% overall) retrospectively consented to follow-up. Just over half (17/31) of experimental participants received FICB; all others had contraindications, including nine taking anticoagulants. Four of the 31 participants assigned FICB and six of the 26 assigned usual care died within 6 months of hospital admission. Serious adverse events were also similar: 3/35 experimental versus 4/36 in usual care. Paramedics' recognition of hip fracture had sensitivity of 49/64 (77%) with a positive predictive value of 46/57 (81%). We received quality of life questionnaires for 30 of 49 patients (61%) at 1 month and 12 of 17 (71%) at 6 months. Patient satisfaction was similar: experimental mean 3.4 (n = 20) versus 3.5 (n = 13) for usual care. CONCLUSIONS: RAPID met all progression criteria within reasonable limits. As equipoise remains, we plan to undertake a fully powered multi-centre trial to test clinical and cost effectiveness of paramedic-administered FICB at the scene of hip fracture. TRIAL REGISTRATION: ISRCTN 60065373 sought 5 November 2015.

Paramedics' experiences of administering fascia iliaca compartment block to patients in South Wales with suspected hip fracture at the scene of injury: results of focus groups.

OBJECTIVES: To explore paramedics' experience of delivering fascia iliaca compartment block (FICB) to patients with suspected hip fracture at the scene of injury. DESIGN: Focus groups within a randomised controlled trial. SETTING: Paramedics based at ambulance stations in the catchment area of one Emergency Department in South Wales, recruited and trained in a feasibility study about an alternative to routine prehospital pain management for patients with suspected hip fracture. PARTICIPANTS: 11 paramedics. INTERVENTION: Paramedic-administered FICB to patients with suspected hip fracture. We randomly allocated eligible patients to FICB, a local anaesthetic injection directly into the hip region-or usual care, most commonly morphine - using audited scratch cards. OUTCOMES: Paramedics' experiences of administering FICB gathered through thematic analysis of interview transcripts by two researchers, one paramedic and one lay member. RESULTS: Respondents believed that FICB was a suitable intervention for paramedics to deliver. It aligned with routine practice and was within people's capabilities. They said it took up to 10 minutes longer than usual care to prepare and deliver, in part due to nervousness and unfamiliarity with a new procedure. They praised the training provided but said they were anxious about causing harm by injecting into the wrong location. Confidence increased after one paramedic team successfully treated a patient for local anaesthetic toxicity. Reported challenges related to the emergency context: patients often waited many hours for ambulance arrival; moving patients exacerbated their pain; family and neighbours were present as paramedics administered treatment. CONCLUSIONS: Paramedics are willing and able to administer FICB to patients with suspected hip fracture before ambulance transport to hospital. Feasibility study findings will inform further research. TRIAL REGISTRATION NUMBER: ISRCTN60065373; Pre results.

The use of personalised patient information leaflets to improve patients' perceived understanding following open fractures.

Open tibial fractures can have devastating long-term effects. In our centre, these patients are followed up in a multidisciplinary Orthoplastic Research Clinic. To improve patient comprehension of information, we have developed personalised information leaflets. This study determines patients' views on these. The leaflet was completed during clinic visits and its role explained. At their next appointment, patients were given anonymised feedback forms, adapted from previously published questionnaires, to complete on their views and use of the leaflet. During the study period, 48 new patients attended clinic; 40 completed questionnaires and were analysed. A majority of patients (39) self-reported improved understanding of their condition, and 11 patients used the information leaflet to improve communication with other healthcare professionals. A majority of patients (34) wished to receive the information leaflet on discharge. The majority of patients in this study felt the leaflet improved their knowledge of their injuries and management.

Trauma assessment and follow up with integration of modern communication devices (TRAFIC). A pilot study.

OBJECTIVES: This pilot study aimed to evaluate the feasibility of prospectively collecting electronic PROMs on patients being assessed as a result of musculoskeletal trauma, using a web-based application (APP), administered onto tablet and desktop computers (TCs or DCs) in the outpatient setting. METHODS: Following local research ethics approval, a web-based APP (TRAFIC) was developed. It consisted of a total of 12 questions (demographic information, employment, and rehabilitation status as well as quality of life (EQ5D)). The APP was viewable on TCs, with DCs being used in review cubicles when necessary with assistance from a medical professional. Eligible patients were invited to use TRAFIC during the 'Lag period'; the time period from the patient 'booking in' to 'being called' for their appointment. An evaluation of the total time spent using the app (APP-time), was recorded as well as the total time spent in the outpatient department (CLINIC-time) for all patients recruited. CLINIC-time was also assessed for a control group of patients not utilising the APP during their outpatient assessment. RESULTS: One hundred patients were recruited for the study n = 50 males, n = 50 females with a mean age of 49.1 (± 17.6 years). All recruited patients completed the questionnaire items with a median APP-time of 5 min (range 2-118 min). The median 'Lag period' was 16 min. (Range 2-166 min), with a median CLINIC-time of 81 min (range 4-428). The CLINIC-time was higher than for the control group (median 67 min (range 18-242) but this was not statistically significant (Mann Whitney U test; p = 0.199). CONCLUSIONS: Electronic PROMs collection in the musculoskeletal trauma outpatient clinic using a web-based APP is feasible, with the APP-time falling well within the 'Lag period', and no significant impact on the total time spent for the appointment.

Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT.

BACKGROUND: The best treatment for fractures of the distal tibia remains controversial. Most of these fractures require surgical fixation, but the outcomes are unpredictable and complications are common. OBJECTIVES: To assess disability, quality of life, complications and resource use in patients treated with intramedullary (IM) nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia. DESIGN: This was a multicentre randomised trial. SETTING: The trial was conducted in 28 UK acute trauma centres from April 2013 to final follow-up in February 2017. PARTICIPANTS: In total, 321 adult patients were recruited. Participants were excluded if they had open fractures, fractures involving the ankle joint, contraindication to nailing or inability to complete questionnaires. INTERVENTIONS: IM nail fixation (n = 161), in which a metal rod is inserted into the hollow centre of the tibia, versus locking plate fixation (n = 160), in which a plate is attached to the surface of the tibia with fixed-angle screws. MAIN OUTCOME MEASURES: The primary outcome measure was the Disability Rating Index (DRI) score, which ranges from 0 points (no disability) to 100 points (complete disability), at 6 months with a minimum clinically important difference of 8 points. The DRI score was also collected at 3 and 12 months. The secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life as measured using EuroQol-5 Dimensions (EQ-5D), complications such as infection, and further surgery. Resource use was collected to inform the health economic evaluation. RESULTS: Participants had a mean age of 45 years (standard deviation 16.2 years), were predominantly male (61%, 197/321) and had experienced traumatic injury after a fall (69%, 223/321). There was no statistically significant difference in DRI score at 6 months [IM nail fixation group, mean 29.8 points, 95% confidence interval (CI) 26.1 to 33.7 points; locking plate group, mean 33.8 points, 95% CI 29.7 to 37.9 points; adjusted difference, 4.0 points, 95% CI -1.0 to 9.0 points; p = 0.11]. There was a statistically significant difference in DRI score at 3 months in favour of IM nail fixation (IM nail fixation group, mean 44.2 points, 95% CI 40.8 to 47.6 points; locking plate group, mean 52.6 points, 95% CI 49.3 to 55.9 points; adjusted difference 8.8 points, 95% CI 4.3 to 13.2 points; p < 0.001), but not at 12 months (IM nail fixation group, mean 23.1 points, 95% CI 18.9 to 27.2 points; locking plate group, 24.0 points, 95% CI 19.7 to 28.3 points; adjusted difference 1.9 points, 95% CI -3.2 to 6.9 points; p = 0.47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS and EQ-5D scores at 3 and 6 months in favour of IM nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (13% in the locking plate group and 9% in the IM nail fixation group). Further surgery was more common in the locking plate group (12% in locking plate group and 8% in IM nail fixation group at 12 months). The economic evaluation showed that IM nail fixation provided a slightly higher quality of life in the 12 months after injury and at lower cost and, therefore, it was cost-effective compared with locking plate fixation. The probability of cost-effectiveness for IM nail fixation exceeded 90%, regardless of the value of the cost-effectiveness threshold. LIMITATIONS: As wound dressings after surgery are clearly visible, it was not possible to blind the patients to their treatment allocation. This evidence does not apply to intra-articular (pilon) fractures of the distal tibia. CONCLUSIONS: Among adults with an acute fracture of the distal tibia who were randomised to IM nail fixation or locking plate fixation, there were similar disability ratings at 6 months. However, recovery across all outcomes was faster in the IM nail fixation group and costs were lower. FUTURE WORK: The potential benefit of IM nail fixation in several other fractures requires investigation. Research is also required into the role of adjuvant treatment and different rehabilitation strategies to accelerate recovery following a fracture of the tibia and other long-bone fractures in the lower limb. The patients in this trial will remain in longer-term follow-up. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99771224 and UKCRN 13761. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 25. See the NIHR Journals Library website for further project information.

Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia: The UK FixDT Randomized Clinical Trial.

Importance: The best treatment for fractures of the distal tibia remains controversial. Most such fractures require surgical fixation but outcomes are unpredictable and complications are common. Objective: To assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation. Design, Setting, and Participants: A multicenter randomized trial recruiting 321 patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia from April 2013 through April 2016 with final follow-up in February 2017. Exclusion criteria included open fractures, fractures involving the ankle joint, contraindication to nailing, or inability to complete questionnaires. Interventions: Intramedullary nail fixation (nail group; n = 161), a metal rod inserted into the hollow center of the tibia, vs locking plate fixation (plate group; n = 160), a plate attached to the surface of the tibia with fixed-angle screws. Main Outcomes and Measures: Disability Rating Index (DRI; score range, 0 [no disability] to 100 [complete disability]) at 6 months was the primary outcome measure, with a minimal clinically important difference of 8 points. DRI measurement was also collected at 3 and 12 months. Secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life, and complications (such as infection and further surgery). Results: Among 321 randomized patients (mean age, 45 years [SD, 16.2]; men, 197 [61%]; had experienced traumatic injury after a fall, 223 [69%]), 258 completed the study. There was no statistically significant difference in the DRI score at 6 months between groups (mean score, 29.8 in the nail group vs 33.8 in the plate group; adjusted difference, 4.0 [95% CI, -1.0 to 9.0], P = .11). There was a statistically significant difference in the DRI score at 3 months in favor of nail fixation (mean score, 44.2 in the nail group and 52.6 in the plate group; adjusted difference, 8.8 [95% CI, 4.3 to 13.2], P < .001), but not at 12 months (mean score, 23.1 in the nail group and 24.0 in the plate group; adjusted difference, 1.9 [95% CI, -3.2 to 6.9], P = .47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS at 3 and 6 months in favor of nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (9% in the nail group vs 13% in the plate group). Further surgery was more common in the plate group at 12 months (8% in nail group vs 12% in plate group). Conclusions and Relevance: Among patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia, neither nail fixation nor locking plate fixation resulted in superior disability status at 6 months. Other factors may need to be considered in deciding the optimal approach. Trial Registration: clinicaltrials.gov Identifier: ISRCTN99771224.

Combat Trousers as Effective Improvised Pelvic Binders A Comparative Cadaveric Study.

BACKGROUND: Improvised explosive devices and landmines can cause pelvic fractures, which, in turn, can produce catastrophic hemorrhage. This cadaveric study compared the intrapelvic pressure changes that occurred with the application of an improvised pelvic binder adapted from the combat trousers worn by British military personnel with the commercially available trauma pelvic orthotic device (TPOD). METHODS: Six unembalmed cadavers (three male, three female) were used to simulate an unstable pelvic fracture with complete disruption of the posterior arch (AO/OTA 61-C1) by dividing the pelvic ring anteriorly and posteriorly. A 3-4cm manometric balloon filled with water was placed in the retropubic space and connected to a 50mL syringe and water manometer via a three-way tap. A baseline pressure of 8cm H2O (average central venous pressure) was set. The combat trouser binder (CTB) and TPOD were applied to each cadaver in a random sequence and the steady intrapelvic pressure changes were recorded. Statistical analysis was performed using the Wilcoxon rank-sum test and a paired t test depending on the normality of the data to determine impact on the intrapelvic pressure of each intervention compared with baseline. RESULTS: The median steady intrapelvic pressure achieved after application of the CTB was 16cm H2O and after application of the TPOD binder was 18cm H2O, both of which were significantly greater than the baseline pressure (ρ < .01 and .036, respectively) but not significantly different from each other (ρ > .05). CONCLUSION: Pelvic injuries are increasingly common in modern theaters of war. The CTB is a novel, rapidly deployable, yet effective, method of pelvic binding adapted from the clothes the casualty is already wearing. This technique may be used in austere environments to tamponade and control intrapelvic hemorrhage.

Intra-pelvic pressure changes after pelvic fracture: A cadaveric study quantifying the effect of a pelvic binder and limb bandaging over a bolster.

INTRODUCTION: Unstable pelvic fractures can be life-threatening due to catastrophic haemorrhage. Non-invasive methods of reducing and stabilising these injuries include pelvic binder application and also lower limb bandaging over a knee-flexion bolster. Both of these methods help close the pelvic ring and should tamponade bleeding. This study aimed to quantify the intra-pelvic pressure changes that occurred with 3 different manoeuvres: lower limb bandaging over a bolster; a Trauma Pelvic Orthotic Device (T-POD) pelvic binder, and a combination of both. METHODS: Following a pilot study with 2 soft embalmed cadavers, a formal study with 6 unembalmed cadavers was performed. For each specimen an unstable pelvic injury was created (OA/OTA 61-C1) by dividing the pelvic ring anteriorly and posteriorly. A 3-4cm manometric water-filled balloon was placed in the retropubic space and connected to a 50ml syringe and water manometer via a 3-way tap. A baseline pressure of 8cmH2O (equating to the average central venous pressure) was used for each cadaver. Steady intra-pelvic pressures (more reliably reflecting the pressures achieved following an intervention) were used in the subsequent statistical analysis, using R statistical language and Rstudio. Paired t-test or Wilcoxon's rank sum test were used (depending on the normality of the dataset) to determine the impact of each intervention on the intra-pelvic pressure. RESULTS: The mean steady intra-pelvic pressures were significantly greater than the baseline pressure for each intervention. The binder and limb bandaging over a bolster alone increased the mean steady pelvic pressures significantly to 24 (SE=5) (p<0.036) and 15.5 (SE=2) (p<0.02)cmH2O respectively. Combining these interventions further increased the mean steady pressure to 31 (SE=7)cmH2O. However, this was not significantly greater than pressures for each of the individual interventions. DISCUSSION: Both lower limb bandaging over a bolster and pelvic binder application significantly increased intra-pelvic pressure above the baseline pressure. This was further increased through combining these interventions, which could be useful clinically to augment haemorrhage control in these fractures. CONCLUSION: Lower-limb bandaging over a bolster, and pelvic binder application, both significantly increased intra-pelvic pressures, and were greatest in combination. These findings support the use of these techniques to facilitate non-surgical haemorrhage control.

Rapid analgesia for prehospital hip disruption (RAPID): protocol for feasibility study of randomised controlled trial.

BACKGROUND: Adequate pain relief at the point of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia iliaca compartment block (FICB) is a procedure routinely undertaken by doctors and nurses in the emergency department for patients with hip fracture but not yet evaluated for use by paramedics at the scene of emergency calls. In this feasibility study, we aim to test whether FICB administered by paramedics at the scene of participants' hip fractures is feasible, safe and acceptable. This will enable us to decide whether to proceed to a fully powered, multi-centre pragmatic randomised trial to evaluate whether the procedure is effective for patients and worthwhile for the NHS. METHODS/DESIGN: In this study, we propose to recruit ten paramedics in an urban area of South Wales. We will train them to carry out FICB when they attend patients with hip fracture. We will randomly allocate eligible patients to FICB or usual care using audited scratch cards. We will follow up participants to assess measurability of key outcomes including quality of life, pain scores, adverse events, length of stay in hospital, acceptability to patients and compliance of paramedics. We will assess whether the findings meet specified feasibility criteria and, if so, plan a full trial. DISCUSSION: This study will enable us to recommend whether to undertake a definitive trial of FICB by paramedics for hip fracture. TRIAL REGISTRATION: ISRCTN60065373.

The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years.

BACKGROUND: Close contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults. OBJECTIVES: We aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences. DESIGN: A pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study. SETTING: Trauma and orthopaedic departments of 24 NHS hospitals. PARTICIPANTS: Adults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded. INTERVENTIONS: CCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern. MAIN OUTCOME MEASURES: Follow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud-Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol. RESULTS: We recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference -0.65 points, 95% confidence interval (CI) -3.98 to 2.68 points; standardised effect size -0.04, 95% CI -0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%); p < 0.001]. Malleolar non-union was lower in the ORIF group [lateral: 0/274 (0%) vs. 8/248 (3%); p = 0.002; medial: 3/274 (1%) vs. 18/248 (7%); p < 0.001]. During the trial, CCC showed modest mean cost savings [NHS mean difference -£644 (95% CI -£1390 to £76); society mean difference -£683 (95% CI -£1851 to £536)]. Estimates showed some imprecision. Incremental quality-adjusted life-years following CCC were no different from ORIF. Over common willingness-to-pay thresholds, the probability that CCC was cost-effective was very high (> 95% from NHS perspective and 85% from societal perspective). Experiences of treatments were similar; both groups endured the impact of fracture, uncertainty regarding future function and the need for further interventions. LIMITATIONS: Assessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon. CONCLUSIONS: CCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months. FUTURE WORK: Longer-term follow-up of trial participants is under way to address concerns over potential later complications or additional procedures and their potential to impact on ankle function. Further study of the patient factors, radiological fracture patterns and outcomes, treatment responses and prognosis would also contribute to understanding the treatment pathway. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04180738. FUNDING: The National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 75. See the NIHR Journals Library website for further project information. This report was developed in association with the National Institute for Health Research Oxford Biomedical Research Unit funding scheme. The pilot phase was funded by the AO Research Foundation.