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TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.

ABSTRACT: INTRODUCTION:Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker. METHODS AND ANALYSIS:The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12?months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial. ETHICS AND DISSEMINATION:Ethical approval for the study was given by the South West-Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences. TRIAL REGISTRATION NUMBER:ISRCTN10649958.

SUBMITTER: Barnfield S

PROVIDER: S-EPMC7044852 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.

Barnfield Steven S Ingram Jenny J Halliday Ruth R Griffin Xavier X Greenwood Rosemary R Kandiyali Rebecca R Thompson Julian J Glynn Joel J Beasant Lucy L McArthur John J Bates Peter P Acharya Mehool M

BMJ open 20200210 2

<h4>Introduction</h4>Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displace ...[more]

PMID: 32047021

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Project description:OBJECTIVES:To undertake a systematic review of the evidence base for the effectiveness of surgical fixation of lateral compression (LC-1) fragility fractures of the pelvis compared with non-surgical approaches. SEARCHES:MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and two international trials registers were searched up to January 2017 (MEDLINE to February 2019) for studies of internal or external fixation of fragility fractures of the pelvis. PARTICIPANTS:Patients with lateral compression pelvic fractures, sustained as the result of a low-energy mechanism, defined as a fall from standing height or less. INTERVENTIONS:Surgery using either external or internal fixation devices. Conservative non-surgical treatment was the defined comparator. OUTCOME MEASURES:Outcomes of interest were patient mobility and function, pain, quality of life, fracture union, mortality, hospital length of stay and complications (additional operative procedures, number and type of adverse events and serious adverse events). QUALITY ASSESSMENT AND SYNTHESIS:The Joanna Briggs Institute Checklist for Case Series was used to assess the included studies. Results were presented in a narrative synthesis. RESULTS:Of 3421 records identified, four retrospective case series met the inclusion criteria. Fixation types were not consistent between studies or within studies and most patients had more than one type of pelvic fixation. Where reported, mobility and function improved post-surgery, and a reduction in pain was recorded. Length of hospital stay ranged from 4?days to 54 days for surgical fixation of any type. Reported complications and adverse outcomes included: infections, implant loosening, pneumonia and thrombosis. Use of analgesia was not reported. CONCLUSIONS:There is insufficient evidence to support guidance on the most effective treatment for patients who fail to mobilise after sustaining an LC-1 fragility fracture. TRIAL REGISTRATION NUMBER:CRD42017055872.

Project description:BackgroundThe incidence of osteoporotic pelvic fractures in elderly patient is rising. This brings an increasing burden on health and social care systems as these injuries often lead to prolonged hospital admissions, loss of independence, morbidity and mortality. Some centres now advocate stabilisation of these injuries to reduce pain, facilitate early mobilisation, decrease hospital stay and restore independence. A systematic review of the literature was planned to establish the evidence for this intervention.MethodsA systematic review was performed according to PRISMA guidelines. A clinical librarian performed a search of the following databases: NHS Evidence, TRIP, the Cochrane Database of Systematic Reviews, MEDLINE and EMBASE. Seventeen eligible studies were identified with 766 patients.ResultsThe quality of evidence was poor with no good quality randomised trials. The majority of injuries were minimally displaced. Posterior ring injuries were most often stabilised with percutaneous screws which were sometimes augmented with void filler. A number of techniques were described for stabilisation of the anterior ring although fixation of the anterior ring was frequently not performed. There was consistent evidence from the included studies that operative intervention significantly improved pain. Complications were minimal but there were increased failure rates when a single unaugmented sacroiliac joint screw was used. The limited availability of non-operative comparators made it difficult to draw firm conclusions about the efficacy of surgical over non-surgical management in these patients.ConclusionsOperative management of fragility fractures of the pelvis should be considered for patients failing a brief period of non-operative management, however prospective randomised trials need to be performed to provide improved evidence for this intervention. Surgeons should consider which fixation techniques for fragility fractures of the pelvis are robust enough to allow immediate weightbearing, whilst minimising operative morbidity and post-operative complications. PROSPERO Systematic Review ID: CRD42020171237.

Project description:BACKGROUND:Surgical and non-surgical interventions are the two categories for treatment of vertebral compression fractures (VCFs). However, there is clinical uncertainty over optimal management. This study aimed to examine the safety and effectiveness of surgical management for treatment of VCFs with osteopenia compared with non-surgical treatment. METHODS:We conducted a systematic search through electronic databases from inception to June 2014, with no limits on study data or language. Randomized controlled trials (RCTs) evaluating surgical versus non-surgical interventions for treatment of patients with VCFs due to osteopenia were considered. Primary outcomes were pain and adverse effects. A random-effects model was used to calculate the pooled mean difference (MD) or risk ratios with 95% confidence interval (CI). RESULTS:Sixteen reports (11 studies) met the inclusion criteria, and provided data for the meta-analysis with a total of 1,401 participants. Compared with conservative treatment, surgical treatment was more effective in reducing pain (short-term: MD -2.05, 95% CI -3.55 to -0.56, P=0.007; mid-term: MD -1.70, 95% CI -2.78 to -0.62, P=0.002; long-term: MD -1.24, 95% CI -2.20 to -0.29, P=0.01) and disability on the Roland-Morris Disability score (short-term: MD -4.97, 95% CI -8.71 to -1.23, P=0.009), as well as improving quality of life on the Short-Form 36 Physical Component Summary score (short-term: MD 5.53, 95% CI 1.45 to 9.61, P=0.008) and the Quality of Life Questionnaire of the European Foundation for Osteoporosis score (short-term: MD -5.01, 95% CI -8.11 to -1.91, P=0.002). Indirect comparisons between vertebroplasty and kyphoplasty found no evidence that the treatment effect differed across the two interventions for any outcomes assessed. Compared with the sham procedure, surgical treatment showed no evidence of improvement in pain relief and physical function. Based on these two comparisons, no significant difference between groups was noted in the pooled results for adverse events. CONCLUSION:Compared to conservative treatment, surgical treatment was more effective in decreasing pain in the short,mid and long terms. However, no significant mid- and long-term differences in physical function and quality of life was observed. Little good evidence is available for surgical treatment compared with that for sham procedure. PV and BK are currently used to treat VCFs with osteopenia, with little difference in treatment effects. Evidence of better quality and from a larger sample size is required before a recommendation can be made. SYSTEMATIC REVIEW REGISTRATION:http://www.crd.york.ac.uk/PROSPERO PROSPERO registration number: CRD42013005142.

Project description:OBJECTIVE:To determine research priorities in fragility fractures of the lower limb and pelvis which represent the shared priorities of patients, their friends and families, carers and healthcare professionals. DESIGN/SETTING:A national (UK) research priority setting partnership. PARTICIPANTS:Patients over 60 years of age who have experienced a fragility fracture of the lower limb or pelvis; carers involved in their care (both in and out of hospital); family and friends of patients; healthcare professionals involved in the treatment of these patients including but not limited to surgeons, anaesthetists, paramedics, nurses, general practitioners, physicians, physiotherapists and occupational therapists. METHODS:Using a multiphase methodology in partnership with the James Lind Alliance over 18?months (August 2016-January 2018), a national scoping survey asked respondents to submit their research uncertainties. These were amalgamated into a smaller number of research questions. The existing evidence was searched to ensure that the questions had not been answered. A second national survey asked respondents to prioritise the research questions. A final shortlist of 25 questions was taken to a multistakeholder workshop where a consensus was reached on the top 10 priorities. RESULTS:There were 963 original uncertainties submitted by 365 respondents to the first survey. These original uncertainties were refined into 88 research questions of which 76 were judged to be true uncertainties following a review of the research evidence. Healthcare professionals and other stakeholders (patients, carers, friends and families) were represented equally in the responses. The top 10 represent uncertainties in rehabilitation, pain management, anaesthesia and surgery. CONCLUSIONS:We report the top 10 UK research priorities in patients with fragility fractures of the lower limb and pelvis. The priorities highlight uncertainties in rehabilitation, postoperative physiotherapy, pain, weight-bearing, infection and thromboprophylaxis. The challenge now is to refine and deliver answers to these research priorities.

Dataset Information

TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.

Publications

TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.

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