To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.Aims
Methods
Understanding of open fracture management is skewed due to reliance on small-number lower limb, specialist unit reports and large, unfocused registry data collections. To address this, we carried out the Open Fracture Patient Evaluation Nationwide (OPEN) study, and report the demographic details and the initial steps of care for patients admitted with open fractures in the UK. Any patient admitted to hospital with an open fracture between 1 June 2021 and 30 September 2021 was included, excluding phalanges and isolated hand injuries. Institutional information governance approval was obtained at the lead site and all data entered using Research Electronic Data Capture. Demographic details, injury, fracture classification, and patient dispersal were detailed.Aims
Methods
The Open-Fracture Patient Evaluation Nationwide (OPEN) study was performed to provide clarity in open fracture management previously skewed by small, specialist centre studies and large, unfocused registry investigations. We report the current management metrics of open fractures across the UK. Patients admitted to hospital with an open fracture (excluding phalanges or isolated hand injuries) between 1 June 2021 and 30 September 2021 were included. Institutional information governance approval was obtained at the lead site and all data entered using Research Electronic Data Capture software. All domains of the British Orthopaedic Association Standard for Open Fracture Management were recorded.Aims
Method
Open reduction and plate fixation (ORPF) for displaced proximal humerus fractures can achieve reliably good long-term outcomes. However, a minority of patients have persistent pain and stiffness after surgery and may benefit from open arthrolysis, subacromial decompression, and removal of metalwork (ADROM). The long-term results of ADROM remain unknown; we aimed to assess outcomes of patients undergoing this procedure for stiffness following ORPF, and assess predictors of poor outcome. Between 1998 and 2018, 424 consecutive patients were treated with primary ORPF for proximal humerus fracture. ADROM was offered to symptomatic patients with a healed fracture at six months postoperatively. Patients were followed up retrospectively with demographic data, fracture characteristics, and complications recorded. Active range of motion (aROM), Oxford Shoulder Score (OSS), and EuroQol five-dimension three-level questionnaire (EQ-5D-3L) were recorded preoperatively and postoperatively.Aims
Methods
The aims of this network meta-analysis (NMA) were to examine nonunion rates and functional outcomes following various operative and nonoperative treatments for displaced mid-shaft clavicle fractures. Initial search strategy incorporated MEDLINE, PubMed, Embase, and the Cochrane Library for relevant randomized controlled trials (RCTs). Four treatment arms were created: nonoperative (NO); intramedullary nailing (IMN); reconstruction plating (RP); and compression/pre-contoured plating (CP). A Bayesian NMA was conducted to compare all treatment options for outcomes of nonunion, malunion, and function using the Disabilities of the Arm Shoulder and Hand (DASH) and Constant-Murley Shoulder Outcome scores.Aims
Methods
Minimally invasive fixation of pelvic fragility fractures is recommended to reduce pain and allow early mobilization. The purpose of this study was to evaluate the outcome of two different stabilization techniques in bilateral fragility fractures of the sacrum (BFFS). A non-randomized, prospective study was carried out in a level 1 trauma centre. BFFS in 61 patients (mean age 80 years (SD 10); four male, 57 female) were treated surgically with bisegmental transsacral stablization (BTS; n = 41) versus spinopelvic fixation (SP; n = 20). Postoperative full weightbearing was allowed. The outcome was evaluated at two timepoints: discharge from inpatient treatment (TP1; Fitbit tracking, Zebris stance analysis), and ≥ six months (TP2; Fitbit tracking, Zebris analysis, based on modified Oswestry Disability Index (ODI), Majeed Score (MS), and the 12-Item Short Form Survey 12 (SF-12). Fracture healing was assessed by CT. The primary outcome parameter of functional recovery was the per-day step count; the secondary parameter was the subjective outcome assessed by questionnaires.Aims
Methods
Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.Aims
Methods
No randomized comparative study has compared the extensile lateral approach (ELA) and sinus tarsi approach (STA) for Sanders type 2 calcaneal fractures. This randomized comparative study was conducted to confirm whether the STA was prone to fewer wound complications than the ELA. Between August 2013 and August 2018, 64 patients with Sanders type 2 calcaneus fractures were randomly assigned to receive surgical treatment by the ELA (32 patients) and STA (32 patients). The primary outcome was development of wound complications. The secondary outcomes were postoperative complications, pain scored of a visual analogue scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) score, 36-item Short Form health survey, operative duration, subtalar joint range of motion (ROM), Böhler’s angle and calcaneal width, and posterior facet reduction.Aims
Methods
A lack of supporting clinical studies have been published to determine the ideal length of intramedullary nail in fixation of trochanteric fractures of the hip. Nevertheless, there has been a trend to use shorter intramedullary nails for the internal fixation of trochanteric hip fractures. Our aim was to determine if the length of nail affected the outcome. We randomized 229 patients with a trochanteric hip fracture between two implants: a ‘standard’ nail of 220 mm and a shorter nail of 175 mm, which had decreased proximal angulation (4° vs 7°) and a reduced diameter at the level of the lesser trochanter. Patients were followed up for one year by a nurse blinded to the type of implant used to determine if there were differences in mobility and pain with two nail designs. Pain was assessed on a scale of 1 (none) to 8 (severe and constant) and mobility on a scale of 1 (full mobility) to 9 (immobile).Aims
Methods
Aims. Outcome measures quantifying aspects of health in a precise,
efficient, and user-friendly manner are in demand. Computer adaptive
tests (CATs) may overcome the limitations of established fixed scales
and be more adept at measuring outcomes in trauma. The primary objective
of this review was to gain a comprehensive understanding of the
psychometric properties of CATs compared with fixed-length scales
in the
This study aimed to compare the change in health-related quality
of life of patients receiving a traditional cemented monoblock Thompson
hemiarthroplasty compared with a modern cemented modular polished-taper
stemmed hemiarthroplasty for displaced intracapsular hip fractures. This was a pragmatic, multicentre, multisurgeon, two-arm, parallel
group, randomized standard-of-care controlled trial. It was embedded
within the WHiTE Comprehensive Cohort Study. The sample size was
964 patients. The setting was five National Health Service Trauma
Hospitals in England. A total of 964 patients over 60 years of age who
required hemiarthroplasty of the hip between February 2015 and March
2016 were included. A standardized measure of health outcome, the
EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and
at four months following the operation.Aims
Patients and Methods
Flail chest from a blunt injury to the thorax is associated with
significant morbidity and mortality. Its management globally is
predominantly non-operative; however, there are an increasing number
of centres which undertake surgical stabilisation. The aim of this
meta-analysis was to compare the efficacy of this approach with
that of non-operative management. A systematic search of the literature was carried out to identify
randomised controlled trials (RCTs) which compared the clinical
outcome of patients with a traumatic flail chest treated by surgical
stabilisation of any kind with that of non-operative management.Aims
Patients and Methods
We wished to assess the feasibility of a future randomised controlled
trial of parathyroid hormone (PTH) supplements to aid healing of
trochanteric fractures of the hip, by an open label prospective
feasibility and pilot study with a nested qualitative sub study.
This aimed to inform the design of a future powered study comparing
the functional recovery after trochanteric hip fracture in patients
undergoing standard care, We undertook a pilot study comparing the functional recovery
after trochanteric hip fracture in patients 60 years or older, admitted
with a trochanteric hip fracture, and potentially eligible to be
randomised to either standard care or the administration of subcutaneous
PTH for six weeks. Our desired outcomes were functional testing
and measures to assess the feasibility and acceptability of the
study.Aims
Patients and Methods
The aim of this study was to inform a definitive trial which
could determine the clinical effectiveness of the X-Bolt Dynamic
Hip Plating System compared with the sliding hip screw for patients
with complex pertrochanteric fragility fractures of the femur. This was a single centre, participant blinded, randomised, standard-of-care
controlled pilot trial. Patients aged 60 years and over with AO/ASIF
A2 and A3 type femoral pertrochanteric fractures were eligible.Aims
Patients and Methods
Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies.Objectives
Methods
Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.Background
Design
Current studies on the additional benefit of using computed tomography
(CT) in order to evaluate the surgeons’ agreement on treatment plans
for fracture are inconsistent. This inconsistency can be explained
by a methodological phenomenon called ‘spectrum bias’, defined as
the bias inherent when investigators choose a population lacking
therapeutic uncertainty for evaluation. The aim of the study is
to determine the influence of spectrum bias on the intra-observer
agreement of treatment plans for fractures of the distal radius. Four surgeons evaluated 51 patients with displaced fractures
of the distal radius at four time points: T1 and T2: conventional
radiographs; T3 and T4: radiographs and additional CT scan (radiograph
and CT). Choice of treatment plan (operative or non-operative) and
therapeutic certainty (five-point scale: very uncertain to very
certain) were rated. To determine the influence of spectrum bias,
the intra-observer agreement was analysed, using Kappa statistics,
for each degree of therapeutic certainty. Objectives
Methods
To study the measurement properties of a joint specific patient
reported outcome measure, a measure of capability and a general
health-related quality of life (HRQOL) tool in a large cohort of
patients with a hip fracture. Responsiveness and associations between the Oxford Hip Score
(a hip specific measure: OHS), ICEpop CAPability (a measure of capability
in older people: ICECAP-O) and EuroQol EQ-5D (general health-related
quality of life measure: EQ-5D) were assessed using data available
from two large prospective studies. The three outcome measures were assessed
concurrently at a number of fixed follow-up time-points in a consecutive
sequence of patients, allowing direct assessment of change from
baseline, inter-measure associations and validity using a range
of statistical methods.Objectives
Methods
We performed a systematic review of the literature
to evaluate the use and interpretation of generic and disease-specific
functional outcome instruments in the reporting of outcome after
the surgical treatment of disruptions of the pelvic ring. A total
of 28 papers met our inclusion criteria, with eight reporting only
generic outcome instruments, 13 reporting only pelvis-specific outcome
instruments, and six reporting both. The Short-Form 36 (SF-36) was
by far the most commonly used generic outcome instrument, used in
12 papers, with widely variable reporting of scores. The pelvis-specific
outcome instruments were used in 19 studies; the Majeed score in
ten, Iowa pelvic score in six, Hannover pelvic score in two and
the Orlando pelvic score in one. Four sets of authors, all testing construct
validity based on correlation with the SF-36, performed psychometric
testing of three pelvis-specific instruments (Majeed, IPS and Orlando
scores). No testing of responsiveness, content validity, criterion
validity, internal consistency or reproducibility was performed. The existing literature in this area is inadequate to inform
surgeons or patients in a meaningful way about the functional outcomes
of these fractures after fixation.
We treated 47 patients with a mean age of 57 years (22 to 88) who had a proximal humeral fracture in which there was a severe varus deformity, using a standard operative protocol of anatomical reduction, fixation with a locking plate and supplementation by structural allografts in unstable fractures. The functional and radiological outcomes were reviewed. At two years after operation the median Constant score was 86 points and the median Disabilities of the Arm, Shoulder and Hand score 17 points. Seven of the patients underwent further surgery, two for failure of fixation, three for dysfunction of the rotator cuff, and two for shoulder stiffness. The two cases of failure of fixation were attributable to violation of the operative protocol. In the 46 patients who retained their humeral head, all the fractures healed within the first year, with no sign of collapse or narrowing of the joint space. Longer follow-up will be required to confirm whether these initially satisfactory results are maintained.
