SGEM#372: Use the FORCE for Buckle Wrist Fractures in Children

Date: July 22nd, 2022 Reference: Perry et al. Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK. The Lancet 2022 Guest Skeptic: Dr. Tessa Davis is a Paediatric Emergency Consultant at the Royal London Hospital, Senior Lecturer at Queen Mary University of London, Co-founder of Don’t Forget The Bubbles (DFTB). Tessa also has a weekly newsletter with tips to help you level up your use of everyday technology and to optimise your writing and to reach the audience you want. Case: Jack is nine years old, and he presents to emergency department (ED) with an arm injury. Today he was running at school, and he fell over onto his outstretched arm. His right arm is neurovascularly intact, with no swelling or deformity. He has bony tenderness at the distal radius. The X-ray shows a buckle fracture of his right distal radius. Background: We covered buckle fractures way back in Season#1 of the SGEM on SGEM#19. In that episode from ten years ago we made the distinction between a buckle fracture and greenstick fractures. Buckle fractures (also called torus fractures) are defined as a compression of the bony cortex on one side with the opposite cortex remains intact. In contrast, a greenstick fractures the opposite cortex is not intact. Buckles of the distal radius are the most common fracture seen in children and very commonly present to the ED [1-2]. Despite being a common injury they are often managed differently. Some clinicians apply casts, some a splint, some have orthopedic follow up, some have no follow up [3]. This practice variation is not new. A survey done almost 20 years ago in Canada demonstrated the variability of managing buckle fractures by Pediatric orthopedic surgeons and pediatric emergency physicians [4]. An RCT published 12 years ago reported that a soft bandage wrapping treatment for four weeks was not statistically different for discomfort, function or fracture displacement compared a below elbow back slab cast for one week followed by circumferential cast for three weeks despite some more pain in the first week with the soft bandage [5]. Yet here we are ten years later doing an SGEM episode on whether it is ok to put a soft bandage on these pediatric patients with a distal radius buckle fracture. It is a great example of how knowledge translation can take years or even decades for clinically relevant information to reach the patients’ bedside due to leaks in the EM knowledge translation pipeline [6-7]. Clinical Question: What is the appropriate management of torus fractures in children? Reference: Perry et al. Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK. The Lancet 2022 Population: Children between 4 and 15 years of age with a distal radius torus fracture that had been confirmed by x-ray. Exclusions: Other fractures, although a concomitant ulnar fracture did not lead to exclusion. Injury over 36 hours old, any cortical disruption seen on x-ray, and any reasons that meant follow-up would not be possible, such as a language barrier, lack of internet access or developmental delay. Intervention: Rigid immobiisation Comparison: Tensor (crepe) bandage Outcome: Primary Outcome: Pain on day three measured using the Wong-Baker FACES Pain Rating Scale [8]. Participants also recorded their pain score on day one, seven and weeks three and six. Secondary Outcomes: Measured a variety of other outcomes at the same time points, unless otherwise specified: Functional recovery using the PROMIS (Patient Report Outcomes Measurement System)Upper Extremity Score – a patient or parent-reported measure of physical function of the upper limbs. Health-related quality of life outcomes, using a EuroQol EQ-5DYa standardised questionnaire, suitable for children, which asks about quality of life, including activities of daily living and pain. Analgesia use and type taken (measured on days 1, 3 and 7) Days of school absence Health care resource use i.e. a new splint (measured at weeks 3 and 6), return to hospital Treatment satisfaction measured using a 7-item Likert scale determined on day 1 and week 6 Complications Trial: The FORCE study was a multi-centered, randomized, non-blinded, equivalence trial conducted at 23 Emergency Departments across the UK. Authors’ Conclusions: “This trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Yes The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. Yes Financial conflicts of interest. This trial was funded by the UK National Institute for Health and Care Research. It is stated in the manuscript that “The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.” Results: They screened 1,513 patients between January 2019 and July 2020 for inclusion in this trial. The researchers randomized 965 children, 61% were boys, and a mean age of 10 years. More than half of those who declined to participate in the FORCE trial said they preferred rigid immobilisation, while only 1% indicated a preference for the soft bandage. Of the 458 (94%) participants in the “offer of a bandage” group chose for it to be applied in the ED. Of the 451 (95%) participants in the rigid immobilisation group were given a removable splint. The remaining 5% in this group were treated with either a plaster cast (back slab or circumferential) or a soft cast. We did mention crossover in the quality check list. A total of 57 children (11%) changed from bandage to rigid immobilisation while only 1 patient changed in the other direction. Key Result: A soft bandage was equivalent to rigid immobilization in children with a distal radius torus fracture. Primary Outcome: Pain on day three measured using the Wong-Baker FACES Pain Rating Scale. There was no statistically significant difference in pain scores with the mITT 3.21 (bandage) vs 3.13 (rigid) with effect size -10 (95% CI; -0.37 to 0.17) They dichotomized into aged 4-7 years and aged 8-15 years and the results were equivalent for the total population and the two subgroups with both the ITT analysis and the PP analysis Secondary Outcomes: There was no statistical difference between the two groups in terms of secondary outcomes either (including PROMIS scores and EQ-5DY-3L utility scores). Parents in the rigid immobilisation group were more satisfied on Day 1 but there was no difference by 6 weeks. Because the number of complications reported was very low no formal statistical comparison were made. There were no cases of worsening deformities. There was no difference in complication rate in either group. Both treatment options led to a similar number of missed school days – around one and a half. There was a (small) difference in analgesia use though. 83% of the bandage group had painkillers, compared to 78% in the rigid immobilisation group on the first day, though there was no significant difference down the track. 1. Something for Coming: Families did not like having no treatment provided. The trial was originally set up to compare rigid immobilisation with no treatment and discharge. A family focus group, carried out by the researchers, suggested that the offer of no treatment at all was unacceptable, and so the study was changed to compare rigid immobilisation with the offer of a soft bandage. 2. Equivalence Trials: We don’t often see trials designed to check for equivalence. The most common design is a superiority trial. The more conservative way to analyze superiority trials is with an ITT analysis. In contrast, non-inferiority trials it is better to conduct a PP analysis. Our friend Dr. Justin Morgenstern from First10EM has tweeted his thoughts about non-inferiority trials citing an article that says non-inferiority trials are unethical [9]. The FORCE trial did both types of analyses (ITT and PP) and demonstrated equivalence. 3. Clinician Variability: Not everyone diagnoses a torus fracture in the same way. We know the technical definition but what you would call a torus fracture might not be the same as me. Defining the line between a buckle of the cortex and a break is tricky. It's open to interpretation - some people have a broader net than others. 4. Don’t Just Do Something Stand There: This is a very important philosophy in medicine that I learned from Dr. Jerry Hoffman. It was explained very well in an article called “Don’t just do something, stand there! The value and art of deliberate clinical inertia” [10]. Clinicians have a desire to usually do something, and this is called intervention bias [11]. More care is not always better care. The use of a soft bandage to treat a distal radius buckle fracture in children is an excellent example.