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Bone & Joint Open
Vol. 4, Issue 11 | Pages 889 - 898
23 Nov 2023
Clement ND Fraser E Gilmour A Doonan J MacLean A Jones BG Blyth MJG

Aims. To perform an incremental cost-utility analysis and assess the impact of differential costs and case volume on the cost-effectiveness of robotic arm-assisted unicompartmental knee arthroplasty (rUKA) compared to manual (mUKA). Methods. This was a five-year follow-up study of patients who were randomized to rUKA (n = 64) or mUKA (n = 65). Patients completed the EuroQol five-dimension questionnaire (EQ-5D) preoperatively, and at three months and one, two, and five years postoperatively, which was used to calculate quality-adjusted life years (QALYs) gained. Costs for the primary and additional surgery and healthcare costs were calculated. Results. rUKA was associated with a relative 0.012 QALY gain at five years, which was associated with an incremental cost per QALY of £13,078 for a unit undertaking 400 cases per year. A cost per QALY of less than £20,000 was achieved when ≥ 300 cases were performed per year. However, on removal of the cost for a revision for presumed infection (mUKA group, n = 1) the cost per QALY was greater than £38,000, which was in part due to the increased intraoperative consumable costs associated with rUKA (£626 per patient). When the absolute cost difference (operative and revision costs) was less than £240, a cost per QALY of less than £20,000 was achieved. On removing the cost of the revision for infection, rUKA was cost-neutral when more than 900 cases per year were undertaken and when the consumable costs were zero. Conclusion. rUKA was a cost-effective intervention with an incremental cost per QALY of £13,078 at five years, however when removing the revision for presumed infection, which was arguably a random event, this was no longer the case. The absolute cost difference had to be less than £240 to be cost-effective, which could be achieved by reducing the perioperative costs of rUKA or if there were increased revision costs associated with mUKA with longer follow-up. Cite this article: Bone Jt Open 2023;4(11):889–898


Bone & Joint Open
Vol. 3, Issue 11 | Pages 898 - 906
15 Nov 2022
Dakin H Rombach I Dritsaki M Gray A Ball C Lamb SE Nanchahal J

Aims. To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective. Methods. We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded. Results. The within-trial economic evaluation found that adalimumab plus standard care cost £503,410 per quality-adjusted life year (QALY) gained versus standard care alone over a 12-month time horizon. The model-based extrapolation suggested that, over a lifetime, repeated courses of adalimumab could cost £14,593 (95% confidence interval £7,534 to £42,698) per QALY gained versus standard care alone. If the NHS was willing to pay £20,000/QALY gained, there is a 77% probability that adalimumab with retreatment is the best value for money. Conclusion. Repeated courses of adalimumab are likely to be a cost-effective treatment for progressive early-stage DD. The value of perfect parameter information that would eliminate all uncertainty around the parameters estimated in RIDD and the duration of quiescence was estimated to be £105 per patient or £272 million for all 2,584,411 prevalent cases in the UK. Cite this article: Bone Jt Open 2022;3(11):898–906


Bone & Joint Open
Vol. 3, Issue 6 | Pages 455 - 462
6 Jun 2022
Nwankwo H Mason J Costa ML Parsons N Redmond A Parsons H Haque A Kearney RS

Aims. To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. Methods. A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically. Results. The incremental cost and QALYs of using brace over a 12-month period were £46.73 (95% confidence interval (CI) £-9 to £147) and 0.0141 (95% CI -0.005 to 0.033), respectively. The cost per QALY gained was £3,318. The probability of brace being cost-effective at a £30,000 per QALY willingness-to-pay threshold was 88%. The results remained robust to a range of sensitivity analyses. Conclusion. This within-trial economic evaluation found that it is probable that using a removable brace provides good value to the NHS when compared to cast, in the management of adults with ankle fracture. Cite this article: Bone Jt Open 2022;3(6):455–462


Bone & Joint Open
Vol. 5, Issue 3 | Pages 218 - 226
15 Mar 2024
Voigt JD Potter BK Souza J Forsberg J Melton D Hsu JR Wilke B

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


Bone & Joint Open
Vol. 3, Issue 12 | Pages 977 - 990
23 Dec 2022
Latijnhouwers D Pedersen A Kristiansen E Cannegieter S Schreurs BW van den Hout W Nelissen R Gademan M

Aims. This study aimed to investigate the estimated change in primary and revision arthroplasty rate in the Netherlands and Denmark for hips, knees, and shoulders during the COVID-19 pandemic in 2020 (COVID-period). Additional points of focus included the comparison of patient characteristics and hospital type (2019 vs COVID-period), and the estimated loss of quality-adjusted life years (QALYs) and impact on waiting lists. Methods. All hip, knee, and shoulder arthroplasties (2014 to 2020) from the Dutch Arthroplasty Register, and hip and knee arthroplasties from the Danish Hip and Knee Arthroplasty Registries, were included. The expected number of arthroplasties per month in 2020 was estimated using Poisson regression, taking into account changes in age and sex distribution of the general Dutch/Danish population over time, calculating observed/expected (O/E) ratios. Country-specific proportions of patient characteristics and hospital type were calculated per indication category (osteoarthritis/other elective/acute). Waiting list outcomes including QALYs were estimated by modelling virtual waiting lists including 0%, 5% and 10% extra capacity. Results. During COVID-period, fewer arthroplasties were performed than expected (Netherlands: 20%; Denmark: 5%), with the lowest O/E in April. In the Netherlands, more acute indications were prioritized, resulting in more American Society of Anesthesiologists grade III to IV patients receiving surgery. In both countries, no other patient prioritization was present. Relatively more arthroplasties were performed in private hospitals. There were no clinically relevant differences in revision arthroplasties between pre-COVID and COVID-period. Estimated total health loss depending on extra capacity ranged from: 19,800 to 29,400 QALYs (Netherlands): 1,700 to 2,400 QALYs (Denmark). With no extra capacity it will take > 30 years to deplete the waiting lists. Conclusion. The COVID-19 pandemic had an enormous negative effect on arthroplasty rates, but more in the Netherlands than Denmark. In the Netherlands, hip and shoulder patients with acute indications were prioritized. Private hospitals filled in part of the capacity gap. QALY loss due to postponed arthroplasty surgeries is considerable. Cite this article: Bone Jt Open 2022;3(12):977–990


Bone & Joint Open
Vol. 3, Issue 7 | Pages 566 - 572
18 Jul 2022
Oliver WM Molyneux SG White TO Clement ND Duckworth AD

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


Bone & Joint Open
Vol. 2, Issue 8 | Pages 685 - 695
2 Aug 2021
Corbacho B Brealey S Keding A Richardson G Torgerson D Hewitt C McDaid C Rangan A

Aims. A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. Methods. A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods. Results. ACR was £1,734 more costly than ESP ((95% confidence intervals (CIs) £1,529 to £1,938)) and £1,457 more costly than MUA (95% CI £1,283 to £1,632). MUA was £276 (95% CI £66 to £487) more expensive than ESP. Overall, ACR had worse QALYs compared with MUA (-0.0293; 95% CI -0.0616 to 0.0030) and MUA had better QALYs compared with ESP (0.0396; 95% CI -0.0008 to 0.0800). At a £20,000 per QALY willingness-to-pay threshold, MUA had the highest probability of being cost-effective (0.8632) then ESP (0.1366) and ACR (0.0002). The results were robust to sensitivity analyses. Conclusion. While ESP was less costly, MUA was the most cost-effective option. ACR was not cost-effective. Cite this article: Bone Jt Open 2021;2(8):685–695


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1027 - 1034
1 Dec 2021
Hassellund S Zolic-Karlsson Z Williksen JH Husby T Madsen JE Frihagen F

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


Bone & Joint Open
Vol. 5, Issue 7 | Pages 550 - 559
5 Jul 2024
Ronaldson SJ Cook E Mitchell A Fairhurst CM Reed M Martin BC Torgerson DJ

Aims

To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS).

Methods

A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 138 - 145
1 Mar 2023
Clark JO Razii N Lee SWJ Grant SJ Davison MJ Bailey O

Aims

The COVID-19 pandemic has caused unprecedented disruption to elective orthopaedic services. The primary objective of this study was to examine changes in functional scores in patients awaiting total hip arthroplasty (THA), total knee arthroplasty (TKA), and unicompartmental knee arthroplasty (UKA). Secondary objectives were to investigate differences between these groups and identify those in a health state ‘worse than death’ (WTD).

Methods

In this prospective cohort study, preoperative Oxford hip and knee scores (OHS/OKS) were recorded for patients added to a waiting list for THA, TKA, or UKA, during the initial eight months of the COVID-19 pandemic, and repeated at 14 months into the pandemic (mean interval nine months (SD 2.84)). EuroQoL five-dimension five-level health questionnaire (EQ-5D-5L) index scores were also calculated at this point in time, with a negative score representing a state WTD. OHS/OKS were analyzed over time and in relation to the EQ-5D-5L.


Aims

The tibial component of total knee arthroplasty can either be an all-polyethylene (AP) implant or a metal-backed (MB) implant. This study aims to compare the five-year functional outcomes of AP tibial components to MB components in patients aged over 70 years. Secondary aims are to compare quality of life, implant survivorship, and cost-effectiveness.

Methods

A group of 130 patients who had received an AP tibial component were matched for demographic factors of age, BMI, American Society of Anesthesiologists (ASA) grade, sex, and preoperative Knee Society Score (KSS) to create a comparison group of 130 patients who received a MB tibial component. Functional outcome was assessed prospectively by KSS, quality of life by 12-Item Short-Form Health Survey questionnaire (SF-12), and range of motion (ROM), and implant survivorships were compared. The SF six-dimension (6D) was used to calculate the incremental cost effectiveness ratio (ICER) for AP compared to MB tibial components using quality-adjusted life year methodology.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 920 - 928
21 Oct 2024
Bell KR Oliver WM White TO Molyneux SG Graham C Clement ND Duckworth AD

Aims

The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups.

Methods

A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178).


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims

Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures.

Methods

The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


Bone & Joint Open
Vol. 5, Issue 6 | Pages 499 - 513
20 Jun 2024
Keene DJ Achten J Forde C Png ME Grant R Draper K Appelbe D Tutton E Peckham N Dutton SJ Lamb SE Costa ML

Aims

Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Methods

This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 184 - 201
7 Mar 2024
Achten J Marques EMR Pinedo-Villanueva R Whitehouse MR Eardley WGP Costa ML Kearney RS Keene DJ Griffin XL

Aims

Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care.

Methods

This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 120 - 128
1 Mar 2023
Franco H Saxby N Corlew DS Perry DC Pigeolet M

Aims

Within healthcare, several measures are used to quantify and compare the severity of health conditions. Two common measures are disability weight (DW), a context-independent value representing severity of a health state, and utility weight (UW), a context-dependent measure of health-related quality of life. Neither of these measures have previously been determined for developmental dysplasia of the hip (DDH). The aim of this study is to determine the DW and country-specific UWs for DDH.

Methods

A survey was created using three different methods to estimate the DW: a preference ranking exercise, time trade-off exercise, and visual analogue scale (VAS). Participants were fully licensed orthopaedic surgeons who were contacted through national and international orthopaedic organizations. A global DW was calculated using a random effects model through an inverse-variance approach. A UW was calculated for each country as one minus the country-specific DW composed of the time trade-off exercise and VAS.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 69 - 77
25 Jan 2024
Achten J Appelbe D Spoors L Peckham N Kandiyali R Mason J Ferguson D Wright J Wilson N Preston J Moscrop A Costa M Perry DC

Aims

The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial.

Methods

Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.


Bone & Joint Open
Vol. 3, Issue 11 | Pages 913 - 920
18 Nov 2022
Dean BJF Berridge A Berkowitz Y Little C Sheehan W Riley N Costa M Sellon E

Aims

The evidence demonstrating the superiority of early MRI has led to increased use of MRI in clinical pathways for acute wrist trauma. The aim of this study was to describe the radiological characteristics and the inter-observer reliability of a new MRI based classification system for scaphoid injuries in a consecutive series of patients.

Methods

We identified 80 consecutive patients with acute scaphoid injuries at one centre who had presented within four weeks of injury. The radiographs and MRI scans were assessed by four observers, two radiologists, and two hand surgeons, using both pre-existing classifications and a new MRI based classification tool, the Oxford Scaphoid MRI Assessment Rating Tool (OxSMART). The OxSMART was used to categorize scaphoid injuries into three grades: contusion (grade 1); unicortical fracture (grade 2); and complete bicortical fracture (grade 3).


Bone & Joint Open
Vol. 4, Issue 5 | Pages 338 - 356
10 May 2023
Belt M Robben B Smolders JMH Schreurs BW Hannink G Smulders K

Aims

To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration.

Methods

We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map.


Bone & Joint Open
Vol. 5, Issue 6 | Pages 464 - 478
3 Jun 2024
Boon A Barnett E Culliford L Evans R Frost J Hansen-Kaku Z Hollingworth W Johnson E Judge A Marques EMR Metcalfe A Navvuga P Petrie MJ Pike K Wylde V Whitehouse MR Blom AW Matharu GS

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Methods

The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.


Bone & Joint Open
Vol. 3, Issue 7 | Pages 573 - 581
1 Jul 2022
Clement ND Afzal I Peacock CJH MacDonald D Macpherson GJ Patton JT Asopa V Sochart DH Kader DF

Aims

The aims of this study were to assess mapping models to predict the three-level version of EuroQoL five-dimension utility index (EQ-5D-3L) from the Oxford Knee Score (OKS) and validate these before and after total knee arthroplasty (TKA).

Methods

A retrospective cohort of 5,857 patients was used to create the prediction models, and a second cohort of 721 patients from a different centre was used to validate the models, all of whom underwent TKA. Patient characteristics, BMI, OKS, and EQ-5D-3L were collected preoperatively and one year postoperatively. Generalized linear regression was used to formulate the prediction models.


Bone & Joint Open
Vol. 3, Issue 3 | Pages 196 - 204
4 Mar 2022
Walker RW Whitehouse SL Howell JR Hubble MJW Timperley AJ Wilson MJ Kassam AM

Aims

The aim of this study was to assess medium-term improvements following total hip arthroplasty (THA), and to evaluate what effect different preoperative Oxford Hip Score (OHS) thresholds for treatment may have on patients’ access to THA and outcomes.

Methods

Patients undergoing primary THA at our institution with an OHS both preoperatively and at least four years postoperatively were included. Rationing thresholds were explored to identify possible deprivation of OHS improvement.


Bone & Joint Open
Vol. 3, Issue 5 | Pages 398 - 403
9 May 2022
Png ME Petrou S Knight R Masters J Achten J Costa ML

Aims

This study aims to estimate economic outcomes associated with 30-day deep surgical site infection (SSI) from closed surgical wounds in patients with lower limb fractures following major trauma.

Methods

Data from the Wound Healing in Surgery for Trauma (WHiST) trial, which collected outcomes from 1,547 adult participants using self-completed questionnaires over a six-month period following major trauma, was used as the basis of this empirical investigation. Associations between deep SSI and NHS and personal social services (PSS) costs (£, 2017 to 2018 prices), and between deep SSI and quality-adjusted life years (QALYs), were estimated using descriptive and multivariable analyses. Sensitivity analyses assessed the impact of uncertainty surrounding components of the economic analyses.


Bone & Joint Open
Vol. 3, Issue 7 | Pages 536 - 542
11 Jul 2022
Karayiannis PN Agus A Bryce L Hill JC Beverland D

Aims

Tranexamic acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomized control trial (RCT) aimed to assess if an additional 24 hours of TXA postoperatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date, this trial included high-risk patients. This paper presents the results of a cost analysis undertaken alongside this RCT.

Methods

TRAC-24 was a prospective RCT on patients undergoing TKA and THA. Three groups were included: Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour postoperative oral regime, Group 2 received only the perioperative dose, and Group 3 did not receive TXA. Cost analysis was performed out to day 90.


Bone & Joint Open
Vol. 2, Issue 3 | Pages 150 - 163
1 Mar 2021
Flett L Adamson J Barron E Brealey S Corbacho B Costa ML Gedney G Giotakis N Hewitt C Hugill-Jones J Hukins D Keding A McDaid C Mitchell A Northgraves M O'Carroll G Parker A Scantlebury A Stobbart L Torgerson D Turner E Welch C Sharma H

Aims

A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

Methods

A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.


Aims

Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.

Methods

DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.


Bone & Joint Open
Vol. 1, Issue 3 | Pages 13 - 18
1 Mar 2020
Png ME Fernandez MA Achten J Parsons N McGibbon A Gould J Griffin X Costa ML

Aim

This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial.

Methods

A within-trial cost-utility analysis (CUA) will be conducted at four months postinjury from a health system (National Health Service and personal social services) perspective. Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months. Sensitivity analysis will be conducted to assess the robustness of the results.


Aims

Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization.

Methods

FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.