33 research outputs found

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

    Get PDF
    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

    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

    Get PDF
    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

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

    Get PDF
    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

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

    Get PDF
    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

    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

    Get PDF
    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
    corecore