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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. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

Aims

This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme.

Methods

A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed.


Bone & Joint Open
Vol. 4, Issue 12 | Pages 957 - 963
18 Dec 2023
van den Heuvel S Penning D Sanders F van Veen R Sosef N van Dijkman B Schepers T

Aims

The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS).

Methods

All patients included in the ‘ROutine vs on DEmand removal Of the syndesmotic screw’ (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups.


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.


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1611 - 1618
1 Oct 2021
Kavarthapu V Budair B

Aims

In our unit, we adopt a two-stage surgical reconstruction approach using internal fixation for the management of infected Charcot foot deformity. We evaluate our experience with this functional limb salvage method.

Methods

We conducted a retrospective analysis of prospectively collected data of all patients with infected Charcot foot deformity who underwent two-stage reconstruction with internal fixation between July 2011 and November 2019, with a minimum of 12 months’ follow-up.


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 945 - 951
1 Jul 2016
Clement ND MacDonald D Dall GF Ahmed I Duckworth AD Shalaby HS McKinley J

Aims

To examine the mid-term outcome and cost utility of the BioPro metallic hemiarthroplasty for the treatment of hallux rigidius.

Patients and Methods

We reviewed 97 consecutive BioPro metallic hemiarthroplasties performed in 80 patients for end-stage hallux rigidus, with a minimum follow-up of five years. There were 19 men and 61 women; their mean age was 55 years (22 to 74). No patient was lost to follow-up.


The Bone & Joint Journal
Vol. 99-B, Issue 2 | Pages 225 - 230
1 Feb 2017
Olsen LL Møller AM Brorson S Hasselager RB Sort R

Aims

Lifestyle risk factors are thought to increase the risk of infection after acute orthopaedic surgery but the evidence is scarce. We aimed to investigate whether smoking, obesity and alcohol overuse are risk factors for the development of infections after surgery for a fracture of the ankle.

Patients and Methods

We retrospectively reviewed all patients who underwent internal fixation of a fracture of the ankle between 2008 and 2013. The primary outcome was the rate of deep infection and the secondary outcome was any surgical site infection (SSI). Associations with the risk factors and possible confounding variables were analysed univariably and multivariably with backwards elimination.


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 290 - 294
1 Mar 2013
MacLeod K Lingham A Chatha H Lewis J Parkes A Grange S Smitham PJ

Clinicians are often asked by patients, “When can I drive again?” after lower limb injury or surgery. This question is difficult to answer in the absence of any guidelines. This review aims to collate the currently available evidence and discuss the factors that influence the decision to allow a patient to return to driving. Medline, Web of Science, Scopus, and EMBASE were searched using the following terms: ‘brake reaction time’, ‘brake response time’, ‘braking force’, ‘brake pedal force’, ‘resume driving’, ‘rate of application of force’, ‘driving after injury’, ‘joint replacement and driving’, and ‘fracture and driving’. Of the relevant literature identified, most studies used the brake reaction time and total brake time as the outcome measures. Varying recovery periods were proposed based on the type and severity of injury or surgery. Surveys of the Driver and Vehicle Licensing Agency, the Police, insurance companies in the United Kingdom and Orthopaedic Surgeons offered a variety of opinions.

There is currently insufficient evidence for any authoritative body to determine fitness to drive. The lack of guidance could result in patients being withheld from driving for longer than is necessary, or returning to driving while still unsafe.

Cite this article: Bone Joint J 2013;95-B:290–4.


The Bone & Joint Journal
Vol. 95-B, Issue 8 | Pages 1083 - 1087
1 Aug 2013
Shaikh N Vaughan P Varty K Coll AP Robinson AHN

Limited forefoot amputation in diabetic patients with osteomyelitis is frequently required. We retrospectively reviewed diabetic patients with osteomyelitis, an unhealed ulcer and blood pressure in the toe of > 45 mmHg who underwent limited amputation of the foot with primary wound closure. Between 2006 and 2012, 74 consecutive patients with a mean age of 67 years (29 to 93), and a median follow-up of 31 months, were included. All the wounds healed primarily at a median of 37 days (13 to 210; mean 48). At a median of 6 months (1.5 to 18; mean 353 days), 23 patients (31%) suffered a further ulceration. Of these, 12 patients (16% of the total) required a further amputation.

We conclude that primary wound closure following limited amputation of the foot in patients with diabetes is a safe and effective technique when associated with appropriate antibiotic treatment.

Cite this article: Bone Joint J 2013;95-B:1083–7.