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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. Conclusion. This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results. Cite this article: Bone Joint Open 2020;1-6:205–213


Bone & Joint Open
Vol. 1, Issue 2 | Pages 3 - 7
5 Feb 2020
Widnall J Capstick T Wijesekera M Messahel S Perry DC

Aims. This study sought to estimate the clinical outcomes and describe the nationwide variation in practice, as part of the feasibility workup for a National Institute for Health and Care Excellence (NICE) recommended randomized clinical trial to determine the optimal treatment of torus fractures of the distal radius in children. Methods. Prospective data collection on torus fractures presenting to our emergency department. Patient consent and study information, including a copy of the Wong-Baker Faces pain score, was issued at the first patient contact. An automated text message service recorded pain scores at days 0, 3, 7, 21, and 42 postinjury. A cross-sectional survey of current accident and emergency practice in the UK was also undertaken to gauge current practice following the publication of NICE guidance. Results. In all, 30 patients with a mean age of 8.9 years were enrolled over a six-week period. Of the 150 potential data points, data was captured in 146, making the data 97.3% complete. Pain scores were recorded at day 0 (mean 6.5 (95% confidence interval (CI) 5.7 to 7.3)), day 3 (4.4 (95% CI 3.5 to 5.2)), day 7 (3.0 (95% CI 2.3 to 3.6)), day 21 (1.2 (95% CI 0.7 to 1.7)) and day 42 (0.4 (95% CI 0.1 to 0.7)). Of the 100 units who participated in the nationwide survey, 38% were unaware of any local or national protocols regarding torus fractures, 41% treated torus fractures with cast immobilization, and over 60% of patients had follow-up arranged, both contradictory to national guidelines. Conclusion. We have demonstrated the severity, recovery trajectory, and variation in pain scores among children with torus fractures. We demonstrate excellent follow-up of patient outcomes using text messages. Despite national guidelines, there is significant variation in practice. This data directly informed the development of an ongoing nationwide randomized clinical trial – the FORearm Fracture Recovery in Children Evaluation (FORCE) study


Bone & Joint Open
Vol. 5, Issue 7 | Pages 581 - 591
12 Jul 2024
Wang W Xiong Z Huang D Li Y Huang Y Guo Y Andreacchio A Canavese F Chen S

Aims

To investigate the risk factors for unsuccessful radial head reduction (RHR) in children with chronic Monteggia fractures (CMFs) treated surgically.

Methods

A total of 209 children (mean age 6.84 years (SD 2.87)), who underwent surgical treatment for CMFs between March 2015 and March 2023 at six institutions, were retrospectively reviewed. Assessed risk factors included age, sex, laterality, dislocation direction and distance, preoperative proximal radial metaphysis width, time from injury to surgery, reduction method, annular ligament reconstruction, radiocapitellar joint fixation, ulnar osteotomy, site of ulnar osteotomy, preoperative and postoperative ulnar angulation, ulnar fixation method, progressive ulnar distraction, and postoperative cast immobilization. Independent-samples t-test, chi-squared test, and logistic regression analysis were used to identify the risk factors associated with unsuccessful RHR.


Bone & Joint Open
Vol. 2, Issue 4 | Pages 255 - 260
15 Apr 2021
Leo DG Russell A Bridgens A Perry DC Eastwood DM Gelfer Y

Aims

This study aims to define a set of core outcomes (COS) to allow consistent reporting in order to compare results and assist in treatment decisions for idiopathic clubfoot.

Methods

A list of outcomes will be obtained in a three-stage process from the literature and from key stakeholders (patients, parents, surgeons, and healthcare professionals). Important outcomes for patients and parents will be collected from a group of children with idiopathic clubfoot and their parents through questionnaires and interviews. The outcomes identified during this process will be combined with the list of outcomes previously obtained from a systematic review, with each outcome assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). This stage will be followed by a two round Delphi survey aimed at key stakeholders in the management of idiopathic clubfoot. The final outcomes list obtained will then be discussed in a consensus meeting of representative key stakeholders.