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The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 769 - 774
1 Apr 2021
Hoogervorst LA Hart MJ Simpson PM Kimmel LA Oppy A Edwards ER Gabbe BJ

Aims. Complex fractures of the femur and tibia with associated severe soft tissue injury are often devastating for the individual. The aim of this study was to describe the two-year patient-reported outcomes of patients in a civilian population who sustained a complex fracture of the femur or tibia with a Mangled Extremity Severity Score (MESS) of ≥ 7, whereby the score ranges from 2 (lowest severity) to 11 (highest severity). Methods. Patients aged ≥ 16 years with a fractured femur or tibia and a MESS of ≥ 7 were extracted from the Victorian Orthopaedic Trauma Outcomes Registry (January 2007 to December 2018). Cases were grouped into surgical amputation or limb salvage. Descriptive analysis were used to examine return to work rates, three-level EuroQol five-dimension questionnaire (EQ-5D-3L), and Glasgow Outcome Scale-Extended (GOS-E) outcomes at 12 and 24 months post-injury. Results. In all, 111 patients were included: 90 (81%) patients who underwent salvage and 21 (19%) patients with surgical amputation. The mean age of patients was 45.8 years (SD 15.8), 93 (84%) were male, 37 (33%) were involved in motor vehicle collisions, and the mean MESS score was 8.2 (SD 1.4). Two-year outcomes in the cohort were poor: six (7%) patients achieved a GOS-E good recovery, the mean EQ-5D-3L summary score was 0.52 (SD 0.27), and 17 (20%) patients had returned to work. Conclusion. A small proportion of patients with severe lower limb injury (MESS ≥ 7) achieved a good level of function 24 months post-injury. Further follow-up is needed to better understand the long-term trajectory of these patients, including delayed amputation, hospital readmissions, and healthcare utilization. Cite this article: Bone Joint J 2021;103-B(4):769–774


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1735 - 1742
1 Dec 2020
Navarre P Gabbe BJ Griffin XL Russ MK Bucknill AT Edwards E Esser MP

Aims. Acetabular fractures in older adults lead to a high risk of mortality and morbidity. However, only limited data have been published documenting functional outcomes in such patients. The aims of this study were to describe outcomes in patients aged 60 years and older with operatively managed acetabular fractures, and to establish predictors of conversion to total hip arthroplasty (THA). Methods. We conducted a retrospective, registry-based study of 80 patients aged 60 years and older with acetabular fractures treated surgically at The Alfred and Royal Melbourne Hospital. We reviewed charts and radiological investigations and performed patient interviews/examinations and functional outcome scoring. Data were provided by the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR). Survival analysis was used to describe conversion to THA in the group of patients who initially underwent open reduction and internal fixation (ORIF). Multivariate regression analyses were performed to identify factors associated with conversion to THA. Results. Seven patients (8.8%) had died at a median follow-up of 18 months (interquartile range (IQR) 12 to 25), of whom four were in the acute THA group. Eight patients (10%) underwent acute THA. Of the patients who underwent ORIF, 17/72 (23.6%) required conversion to THA at a median of 10.5 months (IQR 4.0 to 32.0) . After controlling for other factors, transport-related cases had an 88% lower rate of conversion to THA (hazard ratio (HR) 0.12, 95% confidence interval (CI) 0.02 to 0.91). Mean standardized Physical Component Summary Score (PCS-12) of the 12-Item Short Form Health Survey (SF-12) was comparable with the general population (age-/sex-matched) by 12 to 24 months. Over half of patients working prior to injury (14/26) returned to work by six months and two-thirds of patients (19/27) by 12 months. Conclusion. Patients over 60 years of age managed operatively for displaced acetabular fractures had a relatively high mortality rate and a high conversion rate to THA in the ORIF group but, overall, patients who survived had mean PCS-12 scores that improved over two years and were comparable with controls. Cite this article: Bone Joint J 2020;102-B(12):1735–1742


Bone & Joint Open
Vol. 4, Issue 6 | Pages 463 - 471
23 Jun 2023
Baldock TE Walshaw T Walker R Wei N Scott S Trompeter AJ Eardley WGP

Aims

This is a multicentre, prospective assessment of a proportion of the overall orthopaedic trauma caseload of the UK. It investigates theatre capacity, cancellations, and time to surgery in a group of hospitals that is representative of the wider population. It identifies barriers to effective practice and will inform system improvements.

Methods

Data capture was by collaborative approach. Patients undergoing procedures from 22 August 2022 and operated on before 31 October 2022 were included. Arm one captured weekly caseload and theatre capacity. Arm two concerned patient and injury demographics, and time to surgery for specific injury groups.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 849 - 857
1 Aug 2024
Hatano M Sasabuchi Y Ishikura H Watanabe H Tanaka T Tanaka S Yasunaga H

Aims

The use of multimodal non-opioid analgesia in hip fractures, specifically acetaminophen combined with non-steroidal anti-inflammatory drugs (NSAIDs), has been increasing. However, the effectiveness and safety of this approach remain unclear. This study aimed to compare postoperative outcomes among patients with hip fractures who preoperatively received either acetaminophen combined with NSAIDs, NSAIDs alone, or acetaminophen alone.

Methods

This nationwide retrospective cohort study used data from the Diagnosis Procedure Combination database. We included patients aged ≥ 18 years who underwent surgery for hip fractures and received acetaminophen combined with NSAIDs (combination group), NSAIDs alone (NSAIDs group), or acetaminophen alone (acetaminophen group) preoperatively, between April 2010 and March 2022. Primary outcomes were in-hospital mortality and complications. Secondary outcomes were opioid use postoperatively; readmission within 90 days, one year, and two years; and total hospitalization costs. We used propensity score overlap weighting models, with the acetaminophen group as the reference group.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 69 - 76
1 Jan 2024
Tucker A Roffey DM Guy P Potter JM Broekhuyse HM Lefaivre KA

Aims

Acetabular fractures are associated with long-term morbidity. Our prospective cohort study sought to understand the recovery trajectory of this injury over five years.

Methods

Eligible patients at a level I trauma centre were recruited into a longitudinal registry of surgical acetabular fractures between June 2004 and August 2019. Patient-reported outcome measures (PROMs), including the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS), were recorded at baseline pre-injury recall and six months, one year, two years, and five years postoperatively. Comparative analyses were performed for elementary and associated fracture patterns. The proportion of patients achieving minimal clinically important difference (MCID) was determined. The rate of, and time to, conversion to total hip arthroplasty (THA) was also established.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 980 - 986
1 Aug 2022
Ikram A Norrish AR Marson BA Craxford S Gladman JRF Ollivere BJ

Aims

We assessed the value of the Clinical Frailty Scale (CFS) in the prediction of adverse outcome after hip fracture.

Methods

Of 1,577 consecutive patients aged > 65 years with a fragility hip fracture admitted to one institution, for whom there were complete data, 1,255 (72%) were studied. Clinicians assigned CFS scores on admission. Audit personnel routinely prospectively completed the Standardised Audit of Hip Fracture in Europe form, including the following outcomes: 30-day survival; in-hospital complications; length of acute hospital stay; and new institutionalization. The relationship between the CFS scores and outcomes was examined graphically and the visual interpretations were tested statistically. The predictive values of the CFS and Nottingham Hip Fracture Score (NHFS) to predict 30-day mortality were compared using receiver operating characteristic area under the curve (AUC) analysis.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 157 - 167
1 Jan 2022
Makaram NS Goudie EB Robinson CM

Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1219 - 1228
14 Sep 2020
Hall AJ Clement ND Farrow L MacLullich AMJ Dall GF Scott CEH Jenkins PJ White TO Duckworth AD

Aims

The primary aim was to assess the independent influence of coronavirus disease (COVID-19) on 30-day mortality for patients with a hip fracture. The secondary aims were to determine whether: 1) there were clinical predictors of COVID-19 status; and 2) whether social lockdown influenced the incidence and epidemiology of hip fractures.

Methods

A national multicentre retrospective study was conducted of all patients presenting to six trauma centres or units with a hip fracture over a 46-day period (23 days pre- and 23 days post-lockdown). Patient demographics, type of residence, place of injury, presentation blood tests, Nottingham Hip Fracture Score, time to surgery, operation, American Society of Anesthesiologists (ASA) grade, anaesthetic, length of stay, COVID-19 status, and 30-day mortality were recorded.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 26 - 32
1 Jan 2020
Parikh S Singh H Devendra A Dheenadhayalan J Sethuraman AS Sabapathy R Rajasekaran S

Aims

Open fractures of the tibia are a heterogeneous group of injuries that can present a number of challenges to the treating surgeon. Consequently, few surgeons can reliably advise patients and relatives about the expected outcomes. The aim of this study was to determine whether these outcomes are predictable by using the Ganga Hospital Score (GHS). This has been shown to be a useful method of scoring open injuries to inform wound management and decide between limb salvage and amputation.

Methods

We collected data on 182 consecutive patients with a type II, IIIA, or IIIB open fracture of the tibia who presented to our hospital between July and December 2016. For the purposes of the study, the patients were jointly treated by experienced consultant orthopaedic and plastic surgeons who determined the type of treatment. Separately, the study team (SP, HS, AD, JD) independently calculated the GHS and prospectively collected data on six outcomes for each patient. These included time to bony union, number of admissions, length of hospital stay, total length of treatment, final functional score, and number of operations. Spearman’s correlation was used to compare GHS with each outcome. Forward stepwise linear regression was used to generate predictive models based on components of the GHS. Five-fold cross-validation was used to prevent models from over-fitting.


The Bone & Joint Journal
Vol. 101-B, Issue 3 | Pages 260 - 265
1 Mar 2019
Lee SH Han SS Yoo BM Kim JW

Aims

The aim of this study was to evaluate the clinical and radiological outcomes of locking plate fixation, with and without an associated fibular strut allograft, for the treatment of displaced proximal humeral fractures in elderly osteoporotic patients.

Patients and Methods

We undertook a retrospective comparison of two methods of fixation, using a locking plate without an associated fibular strut allograft (LP group) and with a fibular allograft (FA group) for the treatment of these fractures. The outcome was assessed for 52 patients in the LP group and 45 in the FA group, with a mean age of 74.3 years (52 to 89), at a mean follow-up of 14.2 months (12 to 19). The clinical results were evaluated using a visual analogue scale (VAS) score for pain, the Constant score, the American Shoulder and Elbow Surgeons (ASES) score, and the range of movement. Radiological results were evaluated using the neck-shaft angle (NSA) and humeral head height (HHH).


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 715 - 723
1 Jun 2019
Jayakumar P Teunis T Williams M Lamb SE Ring D Gwilym S

Aims

The purpose of this study was to identify factors associated with limitations in function, measured by patient-reported outcome measures (PROMs), six to nine months after a proximal humeral fracture, from a range of demographic, injury, psychological, and social variables measured within a week and two to four weeks after injury.

Patients and Methods

We enrolled 177 adult patients who sustained an isolated proximal humeral fracture into the study and invited them to complete PROMs at their initial outpatient visit within one week of injury, between two and four weeks, and between six to nine months after injury. There were 128 women and 49 men; the mean age was 66 years (sd 16; 18 to 95). In all, 173 patients completed the final assessment. Bivariate analysis was performed followed by multivariable regression analysis accounting for multicollinearity using partial R2, correlation matrices, and variable inflation factor.


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 958 - 963
1 Jul 2017
Mamarelis G Key S Snook J Aldam C

Aims

Hip hemiarthroplasty is a standard treatment for intracapsular proximal femoral fractures in the frail elderly. In this study we have explored the implications of early return to theatre, within 30 days, on patient outcome following hip hemiarthroplasty.

Patients and Methods

We retrospectively reviewed the hospital records of all hip hemiarthroplasties performed in our unit between January 2010 and January 2015. Demographic details, medical backround, details of the primary procedure, complications, subsequent procedures requiring return to theatre, re-admissions, discharge destination and death were collected.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 229 - 236
1 Feb 2011
Briffa N Pearce R Hill AM Bircher M

We report the outcome of 161 of 257 surgically fixed acetabular fractures. The operations were undertaken between 1989 and 1998 and the patients were followed for a minimum of ten years. Anthropometric data, fracture pattern, time to surgery, associated injuries, surgical approach, complications and outcome were recorded. Modified Merle D’Aubigné score and Matta radiological scoring systems were used as outcome measures. We observed simple fractures in 108 patients (42%) and associated fractures in 149 (58%).

The result was excellent in 75 patients (47%), good in 41 (25%), fair in 12 (7%) and poor in 33 (20%). Poor prognostic factors included increasing age, delay to surgery, quality of reduction and some fracture patterns. Complications were common in the medium- to long-term and functional outcome was variable. The gold-standard treatment for displaced acetabular fractures remains open reduction and internal fixation performed in dedicated units by specialist surgeons as soon as possible.


Bone & Joint Research
Vol. 2, Issue 8 | Pages 162 - 168
1 Aug 2013
Chia PH Gualano L Seevanayagam S Weinberg L

Objectives

To determine the morbidity and mortality outcomes of patients presenting with a fractured neck of femur in an Australian context. Peri-operative variables related to unfavourable outcomes were identified to allow planning of intervention strategies for improving peri-operative care.

Methods

We performed a retrospective observational study of 185 consecutive adult patients admitted to an Australian metropolitan teaching hospital with fractured neck of femur between 2009 and 2010. The main outcome measures were 30-day and one-year mortality rates, major complications and factors influencing mortality.


The Bone & Joint Journal
Vol. 95-B, Issue 2 | Pages 224 - 229
1 Feb 2013
Bennett PM Sargeant ID Midwinter MJ Penn-Barwell JG

This is a case series of prospectively gathered data characterising the injuries, surgical treatment and outcomes of consecutive British service personnel who underwent a unilateral lower limb amputation following combat injury. Patients with primary, unilateral loss of the lower limb sustained between March 2004 and March 2010 were identified from the United Kingdom Military Trauma Registry. Patients were asked to complete a Short-Form (SF)-36 questionnaire. A total of 48 patients were identified: 21 had a trans-tibial amputation, nine had a knee disarticulation and 18 had an amputation at the trans-femoral level. The median New Injury Severity Score was 24 (mean 27.4 (9 to 75)) and the median number of procedures per residual limb was 4 (mean 5 (2 to 11)). Minimum two-year SF-36 scores were completed by 39 patients (81%) at a mean follow-up of 40 months (25 to 75). The physical component of the SF-36 varied significantly between different levels of amputation (p = 0.01). Mental component scores did not vary between amputation levels (p = 0.114). Pain (p = 0.332), use of prosthesis (p = 0.503), rate of re-admission (p = 0.228) and mobility (p = 0.087) did not vary between amputation levels.

These findings illustrate the significant impact of these injuries and the considerable surgical burden associated with their treatment. Quality of life is improved with a longer residual limb, and these results support surgical attempts to maximise residual limb length.

Cite this article: Bone Joint J 2013;95-B:224–9.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 4 | Pages 544 - 548
1 Apr 2012
Macri F Marques LF Backer RC Santos MJ Belangero WD

There is no absolute method of evaluating healing of a fracture of the tibial shaft. In this study we sought to validate a new clinical method based on the systematic observation of gait, first by assessing the degree of agreement between three independent observers regarding the gait score for a given patient, and secondly by determining how such a score might predict healing of a fracture.

We used a method of evaluating gait to assess 33 patients (29 men and four women, with a mean age of 29 years (15 to 62)) who had sustained an isolated fracture of the tibial shaft and had been treated with a locked intramedullary nail. There were 15 closed and 18 open fractures (three Gustilo and Anderson grade I, seven grade II, seven grade IIIA and one grade IIIB). Assessment was carried out three and six months post-operatively using videos taken with a digital camera. Gait was graded on a scale ranging from 1 (extreme difficulty) to 4 (normal gait). Bivariate analysis included analysis of variance to determine whether the gait score statistically correlated with previously validated and standardised scores of clinical status and radiological evidence of union.

An association was found between the pattern of gait and all the other variables. Improvement in gait was associated with the absence of pain on weight-bearing, reduced tenderness over the fracture, a higher Radiographic Union Scale in Tibial Fractures score, and improved functional status, measured using the Brazilian version of the Short Musculoskeletal Function Assessment questionnaire (all p < 0.001). Although further study is needed, the analysis of gait in this way may prove to be a useful clinical tool.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 729 - 735
1 Jun 2022
Craxford S Marson BA Nightingale J Forward DP Taylor A Ollivere B

Aims. The last decade has seen a marked increase in surgical rib fracture fixation (SRF). The evidence to support this comes largely from retrospective cohorts, and adjusting for the effect of other injuries sustained at the same time is challenging. This study aims to assess the impact of SRF after blunt chest trauma using national prospective registry data, while controlling for other comorbidities and injuries. Methods. A ten-year extract from the Trauma Audit and Research Network formed the study sample. Patients who underwent SRF were compared with those who received supportive care alone. The analysis was performed first for the entire eligible cohort, and then for patients with a serious (thoracic Abbreviated Injury Scale (AIS) ≥ 3) or minor (thoracic AIS < 3) chest injury without significant polytrauma. Multivariable logistic regression was performed to identify predictors of mortality. Kaplan-Meier estimators and multivariable Cox regression were performed to adjust for the effects of concomitant injuries and other comorbidities. Outcomes assessed were 30-day mortality, length of stay (LoS), and need for tracheostomy. Results. A total of 86,838 cases were analyzed. The rate of SRF was 1.2%. SRF significantly reduced risk of mortality (odds ratio (OR) 0.27 (95 confidence interval (CI) 0.128 to 0.273); p < 0.001) and need for tracheostomy (OR 0.22 (95% CI 0.191 to 0.319); p < 0.001) after adjustment for other covariables across the whole cohort. SRF remained protective in patients with a serious chest injury (hazard ratio (HR) 0.24 (95% CI 0.13 to 0.45); p < 0.001). The benefit in more minor chest injury was less clear. Mean LoS for patients who survived was longer in the SRF group (24.29 days (SD 26.54) vs 16.60 days (SD 26.35); p < 0.001). Conclusion. SRF reduces mortality after significant chest trauma associated with both major and minor polytrauma. The rate of fixation in the UK is low and potentially underused as a treatment for severe chest wall injury. Cite this article: Bone Joint J 2022;104-B(6):729–735


The Bone & Joint Journal
Vol. 100-B, Issue 6 | Pages 693 - 702
1 Jun 2018
Jayakumar P Overbeek CL Vranceanu A Williams M Lamb S Ring D Gwilym S

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 assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods. A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to “CATs”, “orthopaedics”, “trauma”, and “anatomical regions”. Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg. istered (PROSPERO: CRD42016053886). Results. A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion. Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures. Cite this article: Bone Joint J 2018;100-B:693–702


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 997 - 1008
1 Aug 2022

Aims

The aim of this study was to describe the management and associated outcomes of patients sustaining a femoral hip periprosthetic fracture (PPF) in the UK population.

Methods

This was a multicentre retrospective cohort study including adult patients who presented to 27 NHS hospitals with 539 new PPFs between 1 January 2018 and 31 December 2018. Data collected included: management strategy (operative and nonoperative), length of stay, discharge destination, and details of post-treatment outcomes (reoperation, readmission, and 30-day and 12-month mortality). Descriptive analysis by fracture type was performed, and predictors of PPF management and outcomes were assessed using mixed-effects logistic regression.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 987 - 996
1 Aug 2022

Aims

The aim of this study was to describe the demographic details of patients who sustain a femoral periprosthetic fracture (PPF), the epidemiology of PPFs, PPF characteristics, and the predictors of PPF types in the UK population.

Methods

This is a multicentre retrospective cohort study including adult patients presenting to hospital with a new PPF between 1 January 2018 and 31 December 2018. Data collected included: patient characteristics, comorbidities, anticoagulant use, social circumstances, level of mobility, fracture characteristics, Unified Classification System (UCS) type, and details of the original implant. Descriptive analysis by fracture location was performed, and predictors of PPF type were assessed using mixed-effects logistic regression models.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1520 - 1525
1 Nov 2017
Haines N Kempton LB Seymour RB Bosse MJ Churchill C Hand K Hsu JR Keil D Kellam J Rozario N Sims S Karunakar MA

Aims. To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. 3. orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. 3. . Cite this article: Bone Joint J 2017;99-B:1520–5


Bone & Joint Open
Vol. 4, Issue 9 | Pages 659 - 667
1 Sep 2023
Nasser AAHH Osman K Chauhan GS Prakash R Handford C Nandra RS Mahmood A

Aims

Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade.

Methods

Using a multicentre collaborative study design, independent of registry data, we identified adults from 29 centres with PPFs around the hip between January 2010 and December 2019. Radiographs were assessed for the Unified Classification System (UCS) grade. Patient and injury characteristics, management, and outcomes were compared between UCS grades. A multinomial logistic regression was performed to estimate relative risk ratios (RRR) of variables on UCS grade.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1201 - 1205
1 Nov 2023
Farrow L Clement ND Mitchell L Sattar M MacLullich AMJ

Aims

Surgery is often delayed in patients who sustain a hip fracture and are treated with a total hip arthroplasty (THA), in order to await appropriate surgical expertise. There are established links between delay and poorer outcomes in all patients with a hip fracture, but there is little information about the impact of delay in the less frail patients who undergo THA. The aim of this study was to investigate the influence of delayed surgery on outcomes in these patients.

Methods

A retrospective cohort study was undertaken using data from the Scottish Hip Fracture Audit between May 2016 and December 2020. Only patients undergoing THA were included, with categorization according to surgical treatment within 36 hours of admission (≤ 36 hours = ‘acute group’ vs > 36 hours = ‘delayed’ group). Those with delays due to being “medically unfit” were excluded. The primary outcome measure was 30-day survival. Costs were estimated in relation to the differences in the lengths of stay.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 795 - 800
1 Jul 2023
Parsons N Achten J Costa ML

Aims

To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial.

Methods

The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded.


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 1013 - 1019
1 Sep 2023
Johansen A Hall AJ Ojeda-Thies C Poacher AT Costa ML

Aims

National hip fracture registries audit similar aspects of care but there is variation in the actual data collected; these differences restrict international comparison, benchmarking, and research. The Fragility Fracture Network (FFN) published a revised minimum common dataset (MCD) in 2022 to improve consistency and interoperability. Our aim was to assess compatibility of existing registries with the MCD.

Methods

We compared 17 hip fracture registries covering 20 countries (Argentina; Australia and New Zealand; China; Denmark; England, Wales, and Northern Ireland; Germany; Holland; Ireland; Japan; Mexico; Norway; Pakistan; the Philippines; Scotland; South Korea; Spain; and Sweden), setting each of these against the 20 core and 12 optional fields of the MCD.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 387 - 393
1 Apr 2024
Dean BJF Riley N Little C Sheehan W Gidwani S Brewster M Dhiman P Costa ML

Aims

There is a lack of published evidence relating to the rate of nonunion seen in occult scaphoid fractures, diagnosed only after MRI. This study reports the rate of delayed union and nonunion in a cohort of patients with MRI-detected acute scaphoid fractures.

Methods

This multicentre cohort study at eight centres in the UK included all patients with an acute scaphoid fracture diagnosed on MRI having presented acutely following wrist trauma with normal radiographs. Data were gathered retrospectively for a minimum of 12 months at each centre. The primary outcome measures were the rate of acute surgery, delayed union, and nonunion.


Bone & Joint Open
Vol. 4, Issue 10 | Pages 728 - 734
1 Oct 2023
Fokkema CB Janssen L Roumen RMH van Dijk WA

Aims

In the Netherlands, general practitioners (GPs) can request radiographs. After a radiologically diagnosed fracture, patients are immediately referred to the emergency department (ED). Since 2020, the Máxima Medical Centre has implemented a new care pathway for minor trauma patients, referring them immediately to the traumatology outpatient clinic (OC) instead of the ED. We investigated whether this altered care pathway leads to a reduction in healthcare consumption and concomitant costs.

Methods

In this retrospective cohort study, patients were included if a radiologist diagnosed a fracture on a radiograph requested by the GP from August to October 2019 (control group) or August to October 2020 (research group), on weekdays between 8.30 am and 4.00 pm. The study compared various outcomes between groups, including the length of the initial hospital visit, frequency of hospital visits and medical procedures, extent of imaging, and healthcare expenses.


Aims

Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance.

Methods

We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs.


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 872 - 879
1 Aug 2023
Ogawa T Onuma R Kristensen MT Yoshii T Fujiwara T Fushimi K Okawa A Jinno T

Aims

The aim of this study was to investigate the association between additional rehabilitation at the weekend, and in-hospital mortality and complications in patients with hip fracture who underwent surgery.

Methods

A retrospective cohort study was conducted in Japan using a nationwide multicentre database from April 2010 to March 2018, including 572,181 patients who had received hip fracture surgery. Propensity score matching was performed to compare patients who received additional weekend rehabilitation at the weekend in addition to rehabilitation on weekdays after the surgery (plus-weekends group), as well as those who did not receive additional rehabilitation at the weekend but did receive weekday rehabilitation (weekdays-only group). After the propensity score matching of 259,168 cases, in-hospital mortality as the primary outcome and systemic and surgical complications as the secondary outcomes were compared between the two groups.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 602 - 611
21 Aug 2023
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims

To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture.

Methods

This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty).


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 953 - 962
1 Aug 2022
Johnson NA Fairhurst C Brealey SD Cook E Stirling E Costa M Divall P Hodgson S Rangan A Dias JJ

Aims

There has been an increasing use of early operative fixation for scaphoid fractures, despite uncertain evidence. We conducted a meta-analysis to evaluate up-to-date evidence from randomized controlled trials (RCTs), comparing the effectiveness of the operative and nonoperative treatment of undisplaced and minimally displaced (≤ 2 mm displacement) scaphoid fractures.

Methods

A systematic review of seven databases was performed from the dates of their inception until the end of March 2021 to identify eligible RCTs. Reference lists of the included studies were screened. No language restrictions were applied. The primary outcome was the patient-reported outcome measure of wrist function at 12 months after injury. A meta-analysis was performed for function, pain, range of motion, grip strength, and union. Complications were reported narratively.


Bone & Joint Open
Vol. 3, Issue 12 | Pages 941 - 952
23 Dec 2022
Shah A Judge A Griffin XL

Aims

Several studies have reported that patients presenting during the evening or weekend have poorer quality healthcare. Our objective was to examine how timely surgery for patients with severe open tibial fracture varies by day and time of presentation and by type of hospital. This cohort study included patients with severe open tibial fractures from the Trauma Audit and Research Network (TARN).

Methods

Provision of prompt surgery (debridement within 12 hours and soft-tissue coverage in 72 hours) was examined, using multivariate logistic regression to derive adjusted risk ratios (RRs). Time was categorized into three eight-hour intervals for each day of the week. The models were adjusted for treatment in a major trauma centre (MTC), sex, age, year of presentation, injury severity score, injury mechanism, and number of operations each patient received.


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 959 - 965
1 Jul 2018
Mackenzie SP Carter TH Jefferies JG Wilby JBJ Hall P Duckworth AD Keating JF White TO

Aims. The Edinburgh Trauma Triage Clinic (TTC) streamlines outpatient care through consultant-led ‘virtual’ triage of referrals and the direct discharge of minor fractures from the Emergency Department. We compared the patient outcomes for simple fractures of the radial head, little finger metacarpal, and fifth metatarsal before and after the implementation of the TTC. Patients and Methods. A total of 628 patients who had sustained these injuries over a one-year period were identified. There were 337 patients in the pre-TTC group and 289 in the post-TTC group. The Disabilities of the Arm, Shoulder and Hand Score (QuickDASH) or Foot and Ankle Disability Index (FADI), EuroQol-5D (EQ-5D), visual analogue scale (VAS) pain score, satisfaction rates, and return to work/sport were assessed six months post-injury. The development of late complications was excluded by an electronic record evaluation at three years post-injury. A cost analysis was performed. Results. Outcomes were as good or better post-TTC, compared with pre-TTC scores. At three years, the pre-TTC group required a total of 496 fracture clinic appointments compared with 61 in the post-TTC group. Mean cost per patient was nearly fourfold less after the commencement of the TTC. Conclusion. Management of minor fractures through the Edinburgh TTC results in clinical outcomes that are comparable with the previous system of routine face-to-face consultation. Outpatient workload for these injures was reduced by 88%. Cite this article: Bone Joint J 2018;100-B:959–65


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 633 - 639
2 May 2022
Costa ML Achten J Parsons NR

Aims

The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial.

Methods

The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded.


Bone & Joint Open
Vol. 3, Issue 4 | Pages 284 - 290
1 Apr 2022
O'Hara NN Carullo J Joshi M Banoub M Claeys KC Sprague S Slobogean GP O'Toole RV

Aims

There is increasing evidence to support the use of topical antibiotics to prevent surgical site infections. Although previous research suggests a minimal nephrotoxic risk with a single dose of vancomycin powder, fracture patients often require multiple procedures and receive additional doses of topical antibiotics. We aimed to determine if cumulative doses of intrawound vancomycin or tobramycin powder for infection prophylaxis increased the risk of drug-induced acute kidney injury (AKI) among fracture patients.

Methods

This cohort study was a secondary analysis of single-centre Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) trial data. We included patients with a surgically treated appendicular fracture. The primary outcome was drug-induced AKI. The odds of AKI per gram of vancomycin or tobramycin powder were calculated using Bayesian regression models, which adjusted for measured confounders and accounted for the interactive effects of vancomycin and tobramycin.


Aims

Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures.

Methods

A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout.


The Bone & Joint Journal
Vol. 99-B, Issue 2 | Pages 255 - 260
1 Feb 2017
Macke C Winkelmann M Mommsen P Probst C Zelle B Krettek C Zeckey C

Aims . To analyse the influence of upper extremity trauma on the long-term outcome of polytraumatised patients. . Patients and Methods. A total of 629 multiply injured patients were included in a follow-up study at least ten years after injury (mean age 26.5 years, standard deviation 12.4). The extent of the patients’ injury was classified using the Injury Severity Score. Outcome was measured using the Hannover Score for Polytrauma Outcome (HASPOC), Short Form (SF)-12, rehabilitation duration, and employment status. Outcomes for patients with and without a fracture of the upper extremity were compared and analysed with regard to specific fracture regions and any additional brachial plexus lesion. Results. In all, 307 multiply-injured patients with and 322 without upper extremity injuries were included in the study. The groups with and without upper limb injuries were similar with respect to demographic data and injury pattern, except for midface trauma. There were no significant differences in the long-term outcome. In patients with brachial plexus lesions there were significantly more who were unemployed, required greater retraining and a worse HASPOC. Conclusion. Injuries to the upper extremities seem to have limited effect on long-term outcome in patients with polytrauma, as long as no injury was caused to the brachial plexus. Cite this article: Bone Joint J 2017;99-B:255–60


Bone & Joint Open
Vol. 2, Issue 11 | Pages 958 - 965
16 Nov 2021
Craxford S Marson BA Nightingale J Ikram A Agrawal Y Deakin D Ollivere B

Aims

Deep surgical site infection (SSI) remains an unsolved problem after hip fracture. Debridement, antibiotic, and implant retention (DAIR) has become a mainstream treatment in elective periprosthetic joint infection; however, evidence for DAIR after infected hip hemiarthroplaty is limited.

Methods

Patients who underwent a hemiarthroplasty between March 2007 and August 2018 were reviewed. Multivariable binary logistic regression was performed to identify and adjust for risk factors for SSI, and to identify factors predicting a successful DAIR at one year.


Aims

Monocyte-lymphocyte ratio (MLR) or neutrophil-lymphocyte ratio (NLR) are useful for diagnosing periprosthetic joint infection (PJI), but their diagnostic values are unclear for screening fixation-related infection (FRI) in patients for whom conversion total hip arthroplasty (THA) is planned after failed internal fixation for femoral neck fracture.

Methods

We retrospectively included 340 patients who underwent conversion THA after internal fixation for femoral neck fracture from January 2008 to September 2020. Those patients constituted two groups: noninfected patients and patients diagnosed with FRI according to the 2013 International Consensus Meeting Criteria. Receiver operating characteristic (ROC) curves were used to determine maximum sensitivity and specificity of these two preoperative ratios. The diagnostic performance of the two ratios combined with preoperative CRP or ESR was also evaluated.


Aims

We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial.

Methods

HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1526 - 1533
1 Sep 2021
Schoeneberg C Pass B Oberkircher L Rascher K Knobe M Neuerburg C Lendemans S Aigner R

Aims

The impact of concomitant injuries in patients with proximal femoral fractures has rarely been studied. To date, the few studies published have been mostly single-centre research focusing on the influence of upper limb fractures. A retrospective cohort analysis was, therefore, conducted to identify the impact and distribution of concomitant injuries in patients with proximal femoral fractures.

Methods

A retrospective, multicentre registry-based study was undertaken. Between 1 January 2016 and 31 December 2019, data for 24,919 patients from 100 hospitals were collected in the Registry for Geriatric Trauma. This information was queried and patient groups with and without concomitant injury were compared using linear and logistic regression models. In addition, we analyzed the influence of the different types of additional injuries.


Bone & Joint Open
Vol. 2, Issue 8 | Pages 646 - 654
16 Aug 2021
Martin JR Saunders PE Phillips M Mitchell SM Mckee MD Schemitsch EH Dehghan N

Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1317 - 1324
1 Jul 2021
Goubar A Martin FC Potter C Jones GD Sackley C Ayis S Sheehan KJ

Aims

The aim of this study to compare 30-day survival and recovery of mobility between patients mobilized early (on the day of, or day after surgery for a hip fracture) and patients mobilized late (two days or more after surgery), and to determine whether the presence of dementia influences the association between the timing of mobilization, 30-day survival, and recovery.

Methods

Analysis of the National Hip Fracture Database and hospital records for 126,897 patients aged ≥ 60 years who underwent surgery for a hip fracture in England and Wales between 2014 and 2016. Using logistic regression, we adjusted for covariates with a propensity score to estimate the association between the timing of mobilization, survival, and recovery of walking ability.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1033 - 1039
1 Jun 2021
Coughlin T Norrish AR Scammell BE Matthews PA Nightingale J Ollivere BJ

Aims

Following cast removal for nonoperatively treated distal radius fractures, rehabilitation facilitated by advice leaflet and advice video were compared to a course of face-to-face therapy.

Methods

Adults with an isolated, nonoperatively treated distal radius fracture were included at six weeks post-cast removal. Participants were randomized to delivery of rehabilitation interventions in one of three ways: an advice leaflet; an advice video; or face-to-face therapy session(s). The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at six weeks post intervention and secondary outcome measures included DASH at one year, DASH work subscale, grip strength, and range of motion at six weeks and one year.


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 902 - 907
1 May 2021
Marson BA Ng JWG Craxford S Chell J Lawniczak D Price KR Ollivere BJ Hunter JB

Aims

The management of completely displaced fractures of the distal radius in children remains controversial. This study evaluates the outcomes of surgical and non-surgical management of ‘off-ended’ fractures in children with at least two years of potential growth remaining.

Methods

A total of 34 boys and 22 girls aged 0 to ten years with a closed, completely displaced metaphyseal distal radial fracture presented between 1 November 2015 and 1 January 2020. After 2018, children aged ten or under were offered treatment in a straight plaster or manipulation under anaesthesia with Kirschner (K-)wire stabilization. Case notes and radiographs were reviewed to evaluate outcomes. In all, 16 underwent treatment in a straight cast and 40 had manipulation under anaesthesia, including 37 stabilized with K-wires.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 264 - 270
1 Feb 2021
Nilsen SM Asheim A Carlsen F Anthun KS Johnsen LG Vatten LJ Bjørngaard JH

Aims

Few studies have investigated potential consequences of strained surgical resources. The aim of this cohort study was to assess whether a high proportion of concurrent acute surgical admissions, tying up hospital surgical capacity, may lead to delayed surgery and affect mortality for hip fracture patients.

Methods

This study investigated time to surgery and 60-day post-admission death of patients 70 years and older admitted for acute hip fracture surgery in Norway between 2008 and 2016. The proportion of hospital capacity being occupied by newly admitted surgical patients was used as the exposure. Hip fracture patients admitted during periods of high proportion of recent admissions were compared with hip fracture patients admitted at the same hospital during the same month, on similar weekdays, and times of the day with fewer admissions.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 271 - 278
1 Feb 2021
Chang JS Ravi B Jenkinson RJ Paterson JM Huang A Pincus D

Aims

Echocardiography is commonly used in hip fracture patients to evaluate perioperative cardiac risk. However, echocardiography that delays surgical repair may be harmful. The objective of this study was to compare surgical wait times, mortality, length of stay (LOS), and healthcare costs for similar hip fracture patients evaluated with and without preoperative echocardiograms.

Methods

A population-based, matched cohort study of all hip fracture patients (aged over 45 years) in Ontario, Canada between 2009 and 2014 was conducted. The primary exposure was preoperative echocardiography (occurring between hospital admission and surgery). Mortality rates, surgical wait times, postoperative LOS, and medical costs (expressed as 2013$ CAN) up to one year postoperatively were assessed after propensity-score matching.


Aims

This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial.

Methods

The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims

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.

Methods

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.