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The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 38 - 45
1 Jan 2024
Leal J Mirza B Davies L Fletcher H Stokes J Cook JA Price A Beard DJ

Aims. The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness. Methods. A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation. Results. At 18 months, patients in the surgical reconstruction arm reported higher QALYs (0.052 (95% confidence interval (CI) -0.012 to 0.117); p = 0.177) and higher NHS costs (£1,017 (95% CI 557 to 1,476); p < 0.001) compared to rehabilitation. This resulted in an ICER of £19,346 per QALY with the probability of surgical reconstruction being cost-effective of 51% and 72% at a willingness-to-pay threshold of £20,000 and £30,000 per QALY, respectively. Conclusion. Surgical reconstruction as a management strategy for patients with long-standing ACL injury is more effective, but more expensive, at 18 months compared to rehabilitation management. In the UK setting, surgical reconstruction is cost-effective. Cite this article: Bone Joint J 2024;106-B(1):38–45


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


The Bone & Joint Journal
Vol. 101-B, Issue 1 | Pages 55 - 62
1 Jan 2019
Rombach I Merritt N Shirkey BA Rees JL Cook JA Cooper C Carr AJ Beard DJ Gray AM

Aims

The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness.

Patients and Methods

The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping.


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. Results. Compared to participants without deep SSI, those with deep SSI had higher mean adjusted total NHS and PSS costs (adjusted mean difference £1,577 (95% confidence interval (CI) -951 to 4,105); p = 0.222), and lower mean adjusted QALYs (adjusted mean difference -0.015 (95% CI -0.032 to 0.002); p = 0.092) over six months post-injury, but this difference was not statistically significant. The results were robust to the sensitivity analyses performed. Conclusion. This study found worse economic outcomes during the first six months post-injury in participants who experience deep SSI following orthopaedic surgery for major trauma to the lower limb. However, the increase in cost associated with deep SSI was less than previously reported in the orthopaedic trauma literature. Cite this article: Bone Jt Open 2022;3(5):398–403


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


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1648 - 1655
1 Dec 2016
Murphy J Gray A Cooper C Cooper D Ramsay C Carr A

Aims. A trial-based comparison of the use of resources, costs and quality of life outcomes of arthroscopic and open surgical management for rotator cuff tears in the United Kingdom NHS was performed using data from the United Kingdom Rotator Cuff Study (UKUFF) randomised controlled trial. Patients and Methods. Using data from 273 patients, healthcare-related use of resources, costs and quality-adjusted life years (QALYs) were estimated at 12 months and 24 months after surgery on an intention-to-treat basis with adjustment for covariates. Uncertainty about the incremental cost-effectiveness ratio for arthroscopic versus open management at 24 months of follow-up was incorporated using bootstrapping. Multiple imputation methods were used to deal with missing data. Results. There were no significant differences between the arthroscopic and open groups in terms of total mean use and cost of resources or QALYs at any time post-operatively. Open management dominated arthroscopic management in 59.8% of bootstrapped cost and effect differences. The probability that arthroscopic management was cost-effective compared with open management at a willingness-to-pay threshold of £20 000 per QALY gained was 20.9%. Conclusion. There was no significant overall difference in the use or cost of resources or quality of life between arthroscopic and open management in the trial. There was uncertainty about which strategy was most cost-effective. Cite this article: Bone Joint J 2016;98-B:1648–55


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1177 - 1183
1 Nov 2023
van der Graaff SJA Reijman M Meuffels DE Koopmanschap MA

Aims

The aim of this study was to evaluate the cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy plus optional delayed arthroscopic partial meniscectomy in young patients aged under 45 years with traumatic meniscal tears.

Methods

We conducted a multicentre, open-labelled, randomized controlled trial in patients aged 18 to 45 years, with a recent onset, traumatic, MRI-verified, isolated meniscal tear without knee osteoarthritis. Patients were randomized to arthroscopic partial meniscectomy or standardized physical therapy with an optional delayed arthroscopic partial meniscectomy after three months of follow-up. We performed a cost-utility analysis on the randomization groups to compare both treatments over a 24-month follow-up period. Cost utility was calculated as incremental costs per quality-adjusted life year (QALY) gained of arthroscopic partial meniscectomy compared to physical therapy. Calculations were performed from a healthcare system perspective and a societal perspective.


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 Research
Vol. 12, Issue 1 | Pages 72 - 79
18 Jan 2023
Welling MM Warbroek K Khurshid C van Oosterom MN Rietbergen DDD de Boer MGJ Nelissen RGHH van Leeuwen FWB Pijls BG Buckle T

Aims

Arthroplasty surgery of the knee and hip is performed in two to three million patients annually. Periprosthetic joint infections occur in 4% of these patients. Debridement, antibiotics, and implant retention (DAIR) surgery aimed at cleaning the infected prosthesis often fails, subsequently requiring invasive revision of the complete prosthetic reconstruction. Infection-specific imaging may help to guide DAIR. In this study, we evaluated a bacteria-specific hybrid tracer (99mTc-UBI29-41-Cy5) and its ability to visualize the bacterial load on femoral implants using clinical-grade image guidance methods.

Methods

99mTc-UBI29-41-Cy5 specificity for Stapylococcus aureus was assessed in vitro using fluorescence confocal imaging. Topical administration was used to highlight the location of S. aureus cultured on femoral prostheses using fluorescence imaging and freehand single photon emission CT (fhSPECT) scans. Gamma counting and fhSPECT were used to quantify the bacterial load and monitor cleaning with chlorhexidine. Microbiological culturing helped to relate the imaging findings with the number of (remaining) bacteria.


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. 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.


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. 4, Issue 10 | Pages 782 - 790
18 Oct 2023
Hamilton DF Gaston P Macpherson GJ Simpson P Clement ND

Aims

The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component.

Methods

A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m2, or THA performed for pain relief in those with severely restricted mobility.


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.


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. 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. 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.


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. 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.


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.


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 6 | Pages 272 - 280
19 Jun 2020
King D Emara AK Ng MK Evans PJ Estes K Spindler KP Mroz T Patterson BM Krebs VE Pinney S Piuzzi NS Schaffer JL

Virtual encounters have experienced an exponential rise amid the current COVID-19 crisis. This abrupt change, seen in response to unprecedented medical and environmental challenges, has been forced upon the orthopaedic community. However, such changes to adopting virtual care and technology were already in the evolution forecast, albeit in an unpredictable timetable impeded by regulatory and financial barriers. This adoption is not meant to replace, but rather augment established, traditional models of care while ensuring patient/provider safety, especially during the pandemic. While our department, like those of other institutions, has performed virtual care for several years, it represented a small fraction of daily care. The pandemic required an accelerated and comprehensive approach to the new reality. Contemporary literature has already shown equivalent safety and patient satisfaction, as well as superior efficiency and reduced expenses with musculoskeletal virtual care (MSKVC) versus traditional models. Nevertheless, current literature detailing operational models of MSKVC is scarce. The current review describes our pre-pandemic MSKVC model and the shift to a MSKVC pandemic workflow that enumerates the conceptual workflow organization (patient triage, from timely care provision based on symptom acuity/severity to a continuum that includes future follow-up). Furthermore, specific setup requirements (both resource/personnel requirements such as hardware, software, and network connectivity requirements, and patient/provider characteristics respectively), and professional expectations are outlined. MSKVC has already become a pivotal element of musculoskeletal care, due to COVID-19, and these changes are confidently here to stay. Readiness to adapt and evolve will be required of individual musculoskeletal clinical teams as well as organizations, as established paradigms evolve.

Cite this article: Bone Joint Open 2020;1-6:272–280.


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 832 - 837
1 Jul 2019
Shim J Hamilton DF

Aims

Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools.

Patients and Methods

We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s d). External responsiveness was assessed by correlating change scores of the EQ-5D and PROMIS-10, with the minimal clinically important difference (MCID) of the OKS. Receiver operating characteristic (ROC) curves were used to assess the ability of change scores to discriminate between improved and non-improved patients.


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.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 155 - 160
1 May 2014
Carr AJ Rees JL Ramsay CR Fitzpatrick R Gray A Moser J Dawson J Bruhn H Cooper CD Beard DJ Campbell MK

This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery.

Cite this article: Bone Joint Res 2014;3:155–60.