Aims. Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Methods. Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated. Results. For treatment-naïve patients, the lifetime ICER for OPRA was $279/quality-adjusted life-year (QALY). For treatment-refractory patients the ICER was $273/QALY. In sensitivity analysis, the variable thresholds that would affect a change in the course of treatment based on cost (from socket to OPRA), included the following for the treatment-naïve group: yearly replacement components for socket > $8,511; cost yearly replacement parts OPRA < $1,758; and for treatment-refractory group: yearly replacement component for socket of > $12,467. Conclusion. The use of the OPRA prosthesis in physically active transfemoral amputees should be considered as a cost-effective alternative in both treatment-naïve and treatment-refractory socket prosthesis patients. Disease-specific quality of life assessments such as Q-TFA are more sensitive when evaluating cost-effectiveness. Cite this article: Bone Jt Open 2024;5(3):218–226

Aims. The aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb. Patients and Methods. An economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation. Results. The base case analysis produced an incremental cost-effectiveness ratio of £267 910 per QALY gained, reflecting higher costs on average (£678; 95% confidence interval (CI) -£1082 to £2438) and only marginally higher QALYS (0.002; 95% CI -0.054 to 0.059) in the NPWT group. The probability that NPWT is cost-effective in this patient population did not exceed 27% regardless of the value of the cost-effectiveness threshold. This result remained robust to several sensitivity and subgroup analyses. Conclusion. This trial-based economic evaluation suggests that NPWT is unlikely to be a cost-effective strategy for improving outcomes in adult patients with severe open fractures of the lower limb. Cite this article: Bone Joint J 2019;101-B:1392–1401

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. . There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively. . NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture. Cite this article: Bone Joint J 2015;97-B:1264–70

Aims

Occult (clinical) injuries represent 15% of all scaphoid fractures, posing significant challenges to the clinician. MRI has been suggested as the gold standard for diagnosis, but remains expensive, time-consuming, and is in high demand. Conventional management with immobilization and serial radiography typically results in multiple follow-up attendances to clinic, radiation exposure, and delays return to work. Suboptimal management can result in significant disability and, frequently, litigation.

Aims. To compare the cost-effectiveness of high-dose, dual-antibiotic cement versus single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults. Methods. Using data from a multicentre randomized controlled trial (World Hip Trauma Evaluation 8 (WHiTE-8)) in the UK, a within-trial economic evaluation was conducted. Resource usage was measured over 120 days post randomization, and cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY), gained from the UK NHS and personal social services (PSS) perspective in the base-case analysis. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. The base-case analysis showed that high-dose, dual-antibiotic cement had a significantly higher mean cost (£224 (95% confidence interval (CI) -408 to 855)) and almost the same QALYs (0.001 (95% CI -0.002 to 0.003)) relative to single-antibiotic cement from the UK NHS and PSS perspective. The probability of the high-dose, dual-antibiotic cement being cost-effective was less than 0.3 at alternative cost-effectiveness thresholds, and its net monetary benefit was negative. This finding remained robust in the sensitivity analyses. Conclusion. This study shows that high-dose, dual-antibiotic cement is unlikely to be cost-effective compared to single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults. Cite this article: Bone Joint J 2023;105-B(10):1070–1077

Aims. The primary aim was to estimate the cost-effectiveness of routine operative fixation for all patients with humeral shaft fractures. The secondary aim was to estimate the health economic implications of using a Radiographic Union Score for HUmeral fractures (RUSHU) of < 8 to facilitate selective fixation for patients at risk of nonunion. Methods. From 2008 to 2017, 215 patients (mean age 57 yrs (17 to 18), 61% female (n = 130/215)) with a nonoperatively managed humeral diaphyseal fracture were retrospectively identified. Union was achieved in 77% (n = 165/215) after initial nonoperative management, with 23% (n = 50/215) uniting after surgery for nonunion. The EuroQol five-dimension three-level health index (EQ-5D-3L) was obtained via postal survey. Multiple regression was used to determine the independent influence of patient, injury, and management factors upon the EQ-5D-3L. An incremental cost-effectiveness ratio (ICER) of < £20,000 per quality-adjusted life-year (QALY) gained was considered cost-effective. Results. At a mean of 5.4 yrs (1.2 to 11.0), the mean EQ-5D-3L was 0.736 (95% confidence interval (CI) 0.697 to 0.775). Adjusted analysis demonstrated the EQ-5D-3L was inferior among patients who united after nonunion surgery (β = 0.103; p = 0.032). Offering routine fixation to all patients to reduce the rate of nonunion would be associated with increased treatment costs of £1,542/patient, but would confer a potential EQ-5D-3L benefit of 0.120/patient over the study period. The ICER of routine fixation was £12,850/QALY gained. Selective fixation based on a RUSHU < 8 at six weeks post-injury would be associated with reduced treatment costs (£415/patient), and would confer a potential EQ-5D-3L benefit of 0.335 per ‘at-risk patient’. Conclusion. Routine fixation for patients with humeral shaft fractures to reduce the rate of nonunion observed after nonoperative management appears to be a cost-effective intervention at five years post-injury. Selective fixation for patients at risk of nonunion based on their RUSHU may confer even greater cost-effectiveness, given the potential savings and improvement in health-related quality of life. Cite this article: Bone Jt Open 2022;3(7):566–572

Aim. The aim of this study was to compare the cost-effectiveness of intramedullary nail fixation and ‘locking’ plate fixation in the treatment of extra-articular fractures of the distal tibia. Patients and Methods. An economic evaluation was conducted from the perspective of the United Kingdom National Health Service (NHS) and personal social services (PSS), based on evidence from the Fixation of Distal Tibia Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients were available for analysis. Costs were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality adjusted life year (QALY) gained, and net monetary benefit. Sensitivity analyses were conducted to test the robustness of cost-effectiveness estimates. Results. Mean NHS and PSS costs were significantly lower for patients treated with an intramedullary nail than for those treated with a locking plate (-£970, 95% confidence interval (CI) -1685 to -256; p = 0.05). There was a small increase in QALYs gained in the nail fixation group (0.01, 95% CI -0.03 to 0.06; p = 0.52). The probability of cost-effectiveness for nail fixation exceeded 90% at cost-effectiveness thresholds as low as £15 000 per additional QALY. The cost-effectiveness results remained robust to several sensitivity analyses. Conclusion. This trial-based economic evaluation suggests that nail fixation is a cost-effective alternative to locking plate fixation. Cite this article: Bone Joint J 2018;100-B:624–33

Aims. To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs. Methods. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. The incremental cost of standard dressing versus iNPWT over six months was £2,037 (95% confidence interval (CI) £349 to £3,724). There was an insignificant increment in QALYs gained in the iNPWT group (0.005, 95% CI -0.018 to 0.028). The probability of iNPWT being cost-effective at £20,000 per QALY was 1.9%. The results remained robust in the sensitivity analysis. Conclusion. The within-trial economic evaluation suggests that iNPWT is unlikely to be a cost-effective alternative to standard dressing in adults with closed surgical wounds to their lower limbs. Cite this article: Bone Joint J 2020;102-B(8):1072–1081

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. Conclusion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72–78

Aims. Patients with A1 and A2 trochanteric hip fractures represent a substantial proportion of trauma caseload, and national guidelines recommend that sliding hip screws (SHS) should be used for these injuries. Despite this, intramedullary nails (IMNs) are routinely implanted in many hospitals, at extra cost and with unproven patient outcome benefit. We have used data from the National Hip Fracture Database (NHFD) to examine the use of SHS and IMN for A1 and A2 hip fractures at a national level, and to define the cost implications of management decisions that run counter to national guidelines. Methods. We used the NHFD to identify all operations for fixation of trochanteric fractures in England and Wales between 1 January 2021 and 31 December 2021. A uniform price band from each of three hip fracture implant manufacturers was used to set cost implications alongside variation in implant use. Results. We identified 18,156 A1 and A2 trochanteric hip fractures in 162 centres. Of these, 13,483 (74.3%) underwent SHS fixation, 2,352 (13.0%) were managed with short IMN, and 2,321 (12.8%) were managed with long IMN. Total cost of IMN added up to £1.89 million in 2021, and the clinical justification for this is unclear since rates of IMN use varied from 0% to 97% in different centres. Conclusion. Most trochanteric hip fractures are managed with SHS, in keeping with national guidelines. There is considerable variance between hospitals for implant choice, despite the lack of evidence for clinical benefit and cost-effectiveness of more expensive nailing systems. This suggests either a lack of awareness of national guidelines or a choice not to follow them. We encourage provider units to reassess their practice if outwith the national norm. Funding bodies should examine implant use closely in this population to prevent resource waste at a time of considerable health austerity. Cite this article: Bone Jt Open 2022;3(10):741–745

Aims. The purpose was to compare operative treatment with a volar plate and nonoperative treatment of displaced distal radius fractures in patients aged 65 years and over in a cost-effectiveness analysis. Methods. A cost-utility analysis was performed alongside a randomized controlled trial. A total of 50 patients were randomized to each group. We prospectively collected data on resource use during the first year post-fracture, and estimated costs of initial treatment, further operations, physiotherapy, home nursing, and production loss. Health-related quality of life was based on the Euro-QoL five-dimension, five-level (EQ-5D-5L) utility index, and quality-adjusted life-years (QALYs) were calculated. Results. The mean QALYs were 0.05 higher in the operative group during the first 12 months (p = 0.260). The healthcare provider costs were €1,533 higher per patient in the operative group: €3,589 in the operative group and 2,056 in the nonoperative group. With a suggested willingness to pay of €27,500 per QALY there was a 45% chance for operative treatment to be cost-effective. For both groups, the main costs were related to the primary treatment. The primary surgery was the main driver of the difference between the groups. The costs related to loss of production were high in both groups, despite high rates of retirement. Retirement rate was unevenly distributed between the groups and was not included in the analysis. Conclusion. Surgical treatment was not cost-effective in patients aged 65 years and older compared to nonoperative treatment of displaced distal radius fractures in a healthcare perspective. Costs related to loss of production might change this in the future if the retirement age increases. Level of evidence: II. Cite this article: Bone Jt Open 2021;2(12):1027–1034

Aims. The primary aim of this study was to establish the cost-effectiveness of the early fixation of displaced midshaft clavicle fractures. Patients and Methods. A cost analysis was conducted within a randomized controlled trial comparing conservative management (n = 92) versus early plate fixation (n = 86) of displaced midshaft clavicular fractures. The incremental cost-effectiveness ratio (ICER) was used to express the cost per quality-adjusted life-year (QALY). The Six-Dimension Short-Form Health Survey (SF-6D) score was used as the preference-based health index to calculate the cost per QALY at 12 months after the injury. Results. The mean 12-month SF-6D was 0.9522 (95% confidence interval (CI) 0.9355 to 0.9689) following conservative management and 0.9607 (95% CI 0.9447 to 0.9767) following fixation, giving an advantage for fixation of 0.0085, which was not statistically significant (p = 0.46). The mean cost per patient was £1322.69 for conservative management and £5405.32 for early fixation. This gave an ICER of £480 309.41 per QALY. For a threshold of £20 000 per QALY, the benefit of fixation would need to be present for 24 years to be cost-effective compared with conservative treatment. Linear regression analysis identified nonunion as the only factor to adversely influence the SF-6D at 12 months (p < 0.001). Conclusion. Routine plate fixation of displaced midshaft clavicular fractures is not cost-effective. Nonunion following conservative management has an increased morbidity with comparable expense to early fixation. This may suggest that a targeted approach of fixation in patients who are at higher risk of nonunion would be more cost-effective than the routine fixation of all displaced fractures. Cite this article: Bone Joint J 2019;101-B:995–1001

Aims. The aim of this study was to compare the cost-effectiveness of treatment with an osseointegrated percutaneous (OI-) prosthesis and a socket-suspended (S-) prosthesis for patients with a transfemoral amputation. Patients and Methods. A Markov model was developed to estimate the medical costs and changes in quality-adjusted life-years (QALYs) attributable to treatment of unilateral transfemoral amputation over a projected period of 20 years from a healthcare perspective. Data were collected alongside a prospective clinical study of 51 patients followed for two years. Results. OI-prostheses had an incremental cost per QALY gained of €83 374 compared with S-prostheses. The clinical improvement seen with OI-prostheses was reflected in QALYs gained. Results were most sensitive to the utility value for both treatment arms. The impact of an annual decline in utility values of 1%, 2%, and 3%, for patients with S-prostheses resulted in a cost per QALY gained of €37 020, €24 662, and €18 952, respectively, over 20 years. Conclusion. From a healthcare perspective, treatment with an OI-prosthesis results in improved quality of life at a relatively high cost compared with that for S-prosthesis. When patients treated with S-prostheses had a decline in quality of life over time, the cost per QALY gained by OI-prosthesis treatment was considerably reduced. Cite this article: Bone Joint J 2018;100-B:527–34

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.

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.

Aims

The aim of this study was to investigate the rate of revision for distal femoral arthroplasty (DFA) performed as a primary procedure for native knee fractures using data from the Australian Orthopaedic Association National Joint Arthroplasty Registry (AOANJRR).

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.

Aims. The fundamental concept of open reduction and internal fixation (ORIF) of ankle fractures has not changed appreciably since the 1960s and, whilst widely used, is associated with complications including wound dehiscence and infection, prominent hardware and failure. Closed reduction and intramedullary fixation (CRIF) using a fibular nail, wires or screws is biomechanically stronger, requires minimal incisions, and has low-profile hardware. We hypothesised that fibular nailing in the elderly would have similar functional outcomes to standard fixation, with a reduced rate of wound and hardware problems. Patients and Methods. A total of 100 patients (25 men, 75 women) over the age of 65 years with unstable ankle fractures were randomised to undergo standard ORIF or fibular nailing (11 men and 39 women in the ORIF group, 14 men and 36 women in the fibular nail group). The mean age was 74 years (65 to 93) and all patients had at least one medical comorbidity. Complications, patient related outcome measures and cost-effectiveness were assessed over 12 months. Results. Significantly fewer wound infections occurred in the fibular nail group (p = 0.002). At one year, there was no evidence of difference in mean functional scores (Olerud and Molander Scores 63; 30 to 85, versus 61; 10 to 35, p = 0.61) or scar satisfaction. The overall cost of treatment in the fibular nail group was £91 less than in the ORIF group despite the higher initial cost of the implant. Conclusion. We conclude that the fibular nail allows accurate reduction and secure fixation of ankle fractures, with a significantly lower rate of soft-tissue complications, and is more cost-effective than ORIF. Cite this article: Bone Joint J 2016;98-B:1248–52

Aims

This study evaluated variation in the surgical treatment of stable (A1) and unstable (A2) trochanteric hip fractures among an international group of orthopaedic surgeons, and determined the influence of patient, fracture, and surgeon characteristics on choice of implant (intramedullary nailing (IMN) versus sliding hip screw (SHS)).

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.

Aims

Infection after surgery increases treatment costs and is associated with increased mortality. Hip fracture patients have historically had high rates of methicillin-resistant Staphylococcus aureus (MRSA) colonization and surgical site infection (SSI). This paper reports the impact of routine MRSA screening and the “cleanyourhands” campaign on rates of MRSA SSI and patient outcome.

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Bone health assessment and the prescription of medication for secondary fracture prevention have become an integral part of the acute management of patients with hip fracture. However, there is little evidence regarding compliance with prescription guidelines and subsequent adherence to medication in this patient group.

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It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT.

Aims

Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment.

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The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis.

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This study explores data quality in operation type and fracture classification recorded as part of a large research study and a national audit with an independent review.

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This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial.

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The aim of this study was to estimate economic outcomes associated with deep surgical site infection (SSI) in patients with an open fracture of the lower limb.

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The aim of this paper is to review the evidence relating to the anatomy of the proximal femur, the geometry of the fracture and the characteristics of implants and methods of fixation of intertrochanteric fractures of the hip.

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A pragmatic multicentre randomised controlled trial (PROFHER) was conducted in United Kingdom National Health Service (NHS) hospitals to evaluate the clinical effectiveness and cost effectiveness of surgery compared with non-surgical treatment for displaced fractures of the proximal humerus involving the surgical neck in adults.

Aims

The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up.

Aims

Our aim, using English Hospital Episode Statistics data before during and after the Distal Radius Acute Fracture Fixation Trial (DRAFFT), was to assess whether the results of the trial affected clinical practice.

Objectives

A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults.

Background

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.

Fractures of the proximal femur are one of the greatest challenges facing the medical community, constituting a heavy socioeconomic burden worldwide. Controversy exists regarding the optimal treatment for independent patients with displaced intracapsular fractures of the proximal femur. The recognised alternatives are hemiarthroplasty and total hip replacement. At present there is no established standard of care, with both types of arthroplasty being used in many centres. The principal advantages of total hip replacement are a functional benefit over hemiarthroplasty and a reduced risk of revision surgery. The principal criticism is the increased risk of dislocation. We believe that an alternative acetabular component may reduce the risk of dislocation but still provide the functional benefit of total hip replacement in these patients. We therefore propose to investigate the dislocation risk of a dual-mobility acetabular component compared with standard polyethylene component in total hip replacement for independent patients with displaced intracapsular fractures of the proximal femur within the framework of the larger WHiTE (Warwick Hip Trauma Evaluation) Comprehensive Cohort Study.

Cite this article: Bone Joint Res 2013;2:210–13.

United Kingdom National Institute for Health and Clinical Excellence guidelines recommend the use of total hip replacement (THR) for displaced intracapsular fractures of the femoral neck in cognitively intact patients, who were independently mobile prior to the injury. This study aimed to analyse the risk factors associated with revision of the implant and mortality following THR, and to quantify risk. National Joint Registry data recording a THR performed for acute fracture of the femoral neck between 2003 and 2010 were analysed. Cox proportional hazards models were used to investigate the extent to which risk of revision was related to specific covariates. Multivariable logistic regression was used to analyse factors affecting peri-operative mortality (< 90 days). A total of 4323 procedures were studied. There were 80 patients who had undergone revision surgery at the time of censoring (five-year revision rate 3.25%, 95% confidence interval 2.44 to 4.07) and 137 patients (3.2%) patients died within 90 days. After adjusting for patient and surgeon characteristics, an increased risk of revision was associated with the use of cementless prostheses compared with cemented (hazard ratio (HR) 1.33, p = 0.021). Revision was independent of bearing surface and head size. The risk of mortality within 90 days was significantly increased with higher American Society of Anesthesiologists (ASA) grade (grade 3: odds ratio (OR) 4.04, p < 0.001; grade 4/5: OR 20.26, p < 0.001; both compared with grades 1/2) and older age (≥ 75 years: OR 1.65, p = 0.025), but reduced over the study period (9% relative risk reduction per year).

THR is a good option in patients aged < 75 years and with ASA 1/2. Cementation of the femoral component does not adversely affect peri-operative mortality but improves survival of the implant in the mid-term when compared with cementless femoral components. There are no benefits of using head sizes > 28 mm or bearings other than metal-on-polyethylene. More research is required to determine the benefits of THR over hemiarthroplasty in older patients and those with ASA grades > 2.

The aim of this study was to analyse the functional outcome after a displaced intracapsular fracture of the femoral neck in active patients aged over 70 years without osteoarthritis or rheumatoid arthritis of the hip, randomised to receive either a hemiarthroplasty or a total hip replacement (THR). We studied 252 patients of whom 47 (19%) were men, with a mean age of 81.1 years (70.2 to 95.6). They were randomly allocated to be treated with either a cemented hemiarthroplasty (137 patients) or cemented THR (115 patients). At one- and five-year follow-up no differences were observed in the modified Harris hip score, revision rate of the prosthesis, local and general complications, or mortality. The intra-operative blood loss was lower in the hemiarthroplasty group (7% > 500 ml) than in the THR group (26% > 500 ml) and the duration of surgery was longer in the THR group (28% > 1.5 hours versus 12% > 1.5 hours). There were no dislocations of any bipolar hemiarthroplasty and eight dislocations of a THR during follow-up.

Because of a higher intra-operative blood loss (p < 0.001), an increased duration of the operation (p < 0.001) and a higher number of early and late dislocations (p = 0.002), we do not recommend THR as the treatment of choice in patients aged ≥ 70 years with a fracture of the femoral neck in the absence of advanced radiological osteoarthritis or rheumatoid arthritis of the hip.

Low-energy fractures of the proximal humerus indicate osteoporosis and it is important to direct treatment to this group of patients who are at high risk of further fracture. Data were prospectively collected from 79 patients (11 men, 68 women) with a mean age of 69 years (55 to 86) with fractures of the proximal humerus in order to determine if current guidelines on the measurement of the bone mineral density at the hip and lumbar spine were adequate to stratify the risk and to guide the treatment of osteoporosis. Bone mineral density measurements were made by dual-energy x-ray absorptiometry at the proximal femur, lumbar spine (L2-4) and contralateral distal radius, and the T-scores were generated for comparison. Data were also collected on the use of steroids, smoking, the use of alcohol, hand dominance and comorbidity.

The mean T-score for the distal radius was −2.97 (sd 1.56) compared with −1.61 (sd 1.62) for the lumbar spine and −1.78 (sd 1.33) for the femur. There was a significant difference between the mean lumbar and radial T scores (1.36 (1.03 to 1.68); p < 0.001) and between the mean femoral and radial T-scores (1.18 (0.92 to 1.44); p < 0.001). The inclusion of all three sites in the determination of the T-score increased the sensitivity to 66% compared with that of 46% when only the proximal femur and lumbar spine were used. This difference between measurements in the upper limb compared with the axial skeleton and lower limb suggests that basing risk assessment and treatment on only the bone mineral density taken at the hip or lumbar spine may misrepresent the extent of osteoporosis in the upper limb and the subsequent risk of fracture at this site.

The assessment of osteoporosis must include measurement of the bone mineral density at the distal radius to avoid underestimation of osteoporosis in the upper limb.

In a series of 450 patients over 70 years of age with displaced fractures of the femoral neck sustained between 1995 and 1997 treatment was randomised either to internal fixation or replacement. Depending on age and level of activity the latter was either a total hip replacement or a hemiarthroplasty. Patients who were confused or bed-ridden were excluded, as were those with rheumatoid arthritis. At ten years there were 99 failures (45.6%) after internal fixation compared with 17 (8.8%) after replacement. The rate of mortality was high at 75% at ten years, and was the same in both groups at all times. Patient-reported pain and function were similar in both groups at five and ten years. Those with successfully healed fractures had more hip pain and reduction of mobility at four months compared with patients with an uncomplicated replacement, and they never attained a better outcome than the latter patients regarding pain or function.

Primary replacement gave reliable long-term results in patients with a displaced fracture of the femoral neck.

The extended lateral L-shaped approach for the treatment of displaced intra-articular fractures of the calcaneum may be complicated by wound infection, haematoma, dehiscence and injury to the sural nerve. In an effort to reduce the risk of problems with wound healing a technique was developed that combined open reduction and fixation of the joint fragments and of the anterior process with percutaneous reduction and screw fixation of the tuberosity. A group of 24 patients with unilateral isolated closed Sanders type II and III fractures was treated using this technique and compared to a similar group of 26 patients managed by the extended approach and lateral plating. The operation was significantly shorter (p < 0.001) in the first group, but more minor secondary procedures and removal of heel screws were necessary. There were no wound complications in this group, whereas four minor complications occurred in the second group. The accuracy and maintenance of reduction, and ultimate function were equivalent.