Ian Pallister

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).

BACKGROUNDOpen lower limb fractures are serious, potentially life-changing injuriesrequiring 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, agility and balance would better reflect recovery than isolated parameters (e.g. range of motion) and would compare well to patients’ perceived recovery.METHODSAdultopen lower limb fracture patients were followed-up at 6 and 12 weeks, 6, 9 and 12 months post-injury. The mechanism,injurypattern, age, gender and treatment were recorded. Isolated parameter objective functional outcome measures (OFOMs)(range of movement and MRC strength grade) were compared to combined OFOMs(timed up and go (TUAG), comfortable and fast gait speed (CGS and FGS), Edgren Side Step Test(ESST) and Single Leg balance. Patient reported outcomes were recorded (Global Perceived Effect (GPE) scoreand Disability Rating Index (DRI)). RESULTS68 patients (54 male) with a medianage of 45 years (range 20-75). Neither range of movement,strength nor Single Leg balance consistently improved with time. TUAG, ESST, CGS, FGS and GPE scoresshowed consistent improvement, with TUAG and FGS showing highest proportion of improving results at each time-point. Patients’ estimation of recovery paralleled these measures with all but 2 patients achieving the minimum clinical important difference in DRI by 12 months compared to baseline. However, the GPE score compared favourably withthe DRI having a higher proportion of improving responses at each time-point. DISCUSSIONFunctional 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 measuringmobility, 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 registrationSouth West Wales REC 06/WMW02/10)

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. 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. 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. 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. ISRCTN 60065373 sought 5 November 2015.

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 inHealth Technology Assessment; Vol. 22, No. 25. See the NIHR Journals Library website for further project information.

The development of the Management of Surgical Emergencies (MSE) course was supported by the Department for International Development with the International Federation of Surgical Colleges, Association of Surgeons of Great Britain and Ireland, and College of Surgeons of East, Central and Southern Africa.2 Following an initial pilot course, the need for integration of compartment syndrome education was identified by one of the authors (YN). In Africa, although a huge proportion of the clinical workload is obstetrics and general surgery, a surgeon is expected to deal with all conditions requiring surgery.

INTRODUCTION: Adequate pain relief at the scene 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 immobilize and long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia Iliaca Compartment Block (FICB) is a procedure routinely undertaken by clinicians in emergency departments for hip fracture patients, but use by paramedics at the scene of emergency calls, is not yet evaluated (1). METHODS: We undertook a randomized controlled feasibility trial using novel audited scratchcard randomization to allocate eligible patients to FICB or usual care. Paramedics are recruited and trained to assess patients for hip fracture and carry out FICB. We will follow up patients to assess accuracy of paramedic diagnosis, acceptability to patients and paramedics, compliance of paramedics and also measures of pain, side effects, time in hospital and quality of life in order to plan a full trial if appropriate. The primary outcome measure is health related quality of life, measured using Short Form (SF)-12 at 1 and 6 months. Interviews and focus groups will be used to understand acceptability of FICB to patients and paramedics. This study was funded by Health and Care Research Wales (1003). RESULTS: We have developed: • paramedic pathway to assess patients for hip fracture and FICB • paramedic training package, delivered by Consultant Anaesthetist • randomization scratchcards. To date we have recruited nineteen paramedics; ten are fully trained and recruiting patients, the remainder are being trained. Fifty-four patients have been randomized and thirty-five have consented to follow-up. Thirteen 1-month and five 6-month follow-up questionnaires have been received. CONCLUSIONS: This study will enable us to recommend whether to undertake a definitive multi-centre randomized controlled trial of FICB by paramedics for hip fracture to determine if the procedure is effective for patients and worthwhile for the National Health Service.

Military Medicine is AMSUS’ monthly peer-reviewed journal, with articles including scientific papers, case reports, and editorials. Its objective is to promote awareness of federal medicine by providing a forum for responsible discussion of common ideas and problems relevant to federal healthcare.

This randomized clinical trial compares the effects of a below-knee cast vs surgery on ankle symptoms and functional outcomes at 6 months among older adults wit

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 inHealth 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.