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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. Discussion. The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open 2021;2(3):150–163


Bone & Joint Open
Vol. 4, Issue 3 | Pages 188 - 197
15 Mar 2023
Pearson NA Tutton E Gwilym SE Joeris A Grant R Keene DJ Haywood KL

Aims

To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery.

Methods

We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes.


Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

Aims

A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.

Methods

We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 78 - 78
1 May 2012
Smitham P Molvik H Smith K Attard J Cullen N Singh D Goldberg A
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Introduction. There are approximately 1.2 million patients using orthotics in the UK costing the NHS in excess of £100 million per annum. Despite this, there is little data available to determine efficacy and patient compliance. There have been a few reports on patient satisfaction, which indicate that between 13-50% of patients are dissatisfied with their orthotics. Our aim was to evaluate patient reported satisfaction with orthotics prescribed and to investigate the reasons behind patient dissatisfaction. Methods. Seventy consecutive patients receiving foot orthoses at the Royal National Orthopaedic Hospital were retrospectively asked to complete a questionnaire and to bring their shoes and orthotics to research clinic. The inside width of the shoes and corresponding width of the orthotic were measured. A semi-structured interview was carried out on 10 patients, including those that were satisfied or unsatisfied, using qualitative research methods to identify issues that are important to patients. Results. Forty out of 70 patients (57%) completed the questionnaire either by telephone or in the clinic. There was a statistically significant difference between the width of the orthotics and the inside diameter of the shoes that the orthotic was meant to fit in. Dissatisfaction with the new custom made insoles was reported in 28% of patients. Half of these patients reported that the insoles did not fit with their feet into their shoes, and 30% indicated a preference for cosmetic issues over function. The majority of patients had tried numerous homemade or off the shelf versions prior to attending the orthotic department. Conclusion. There is a high level of patient dissatisfaction with orthotics. This dissatisfaction was due to a disconnection between prescribed foot orthoses and shoes purchased by patients. There is an urgent need to join up these two industries to prevent financial waste and improve the cost-effectiveness of orthotic services