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The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 5 | Pages 716 - 719
1 Jul 2002
Wilkinson AG Sherlock DA Murray GD

We have reviewed the outcome of 134 hips in 96 children with Graf type-III or type-IV dysplasia of the hip on ultrasound examination. We treated 28 affected hips in 22 children with the Craig splint, 43 hips in 30 children with the Pavlik harness, and 26 hips in 16 children with the von Rosen splint. A total of 37 affected hips in 28 children was not splinted. All children were less than three months of age at referral. Those treated with the von Rosen splint had a significantly better ultrasound appearance at 12 to 20 weeks of age and fewer radiological abnormalities than those not splinted or treated with the Pavlik harness. In the von Rosen group no hip required further treatment with an abduction plaster or operation compared with ten in the Pavlik harness group, three in the Craig splint group and eight in the group without splintage. Our results suggest that the von Rosen splint is more likely to improve the outcome of neonatal dysplasia of the hip and a definitive, large-scale randomised trial is therefore indicated


Aims. The study was undertaken to compare the efficacy of Woodcast splints and plaster-of-Paris casts in maintaining correction following sequential manipulation of idiopathic clubfeet. Methods. In this randomized prospective trial, 23 idiopathic clubfeet were immobilized with plaster-of-Paris casts and 23 clubfeet were immobilized with a splint made of Woodcast that encircled only two-thirds the circumference of the limb. The number of casts or splints needed to obtain full correction, the frequency of cast or splint-related complications, and the time taken for application and removal of the casts and splints were compared. Results. The mean number of casts required to obtain full correction of the deformity (Pirani Score 0) was 4.35 (95% confidence interval (CI) 3.74 to 4.95) when plaster-of-Paris was used and 4.87 (95% CI 4.33 to 5.41) when the Woodcast splint was used (p = 0.190). The time required for application and removal of the Woodcast splint were significantly less than that required for application and removal of plaster-of-Paris casts (p < 0.001). Woodcast splint-related complications were not more frequent than plaster-of-Paris cast related complications. Conclusion. Though Woodcast splints covering two-thirds of the circumference of the lower limbs of infants were effective in maintaining the correction of clubfoot deformity during serial manipulation and casting treatment, the superiority of Woodcasts over plaster-of-Paris could not be established. Cite this article: Bone Joint J 2020;102-B(10):1399–1404


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 991 - 998
1 May 2021
Lyu X Chen T Yang Z Fu G Feng C Zhang T Lu M

Aims. The objective of this study was to evaluate the clinical and radiological outcomes of patients younger than six months of age with developmental dysplasia of the hip (DDH) managed by either a Pavlik harness or Tübingen hip flexion splint. Methods. Records of 251 consecutive infants with a mean age of 89 days (SD 47), diagnosed with DDH between January 2015 and December 2018, were retrospectively reviewed. Inclusion criteria for patients with DDH were: younger than 180 days at the time of diagnosis; ultrasound Graf classification of IIc or greater; treatment by Pavlik harness or Tübingen splint; and no prior treatment history. All patients underwent hip ultrasound every seven days during the first three weeks of treatment and subsequently every three to four weeks until completion of treatment. If no signs of improvement were found after three weeks, the Pavlik harness or Tübingen splint was discontinued. Statistical analysis was performed. Results. The study included 251 patients with Graf grades IIc to IV in 18 males and 233 females with DDH. Mean follow-up time was 22 months (SD 10). A total of 116 hips were graded as Graf IIc (39.1%), nine as grade D (3.0%), 100 as grade III (33.7%), and 72 as grade IV (24.2%). There were 109 patients (128 hips) in the Pavlik group and 142 patients (169 hips) in the Tübingen group (p = 0.227). The Tübingen group showed a 69.8% success rate in Graf III and Graf IV hips while the success rate was significantly lower in the Pavlik group, 53.9% (p = 0.033). For infants older than three months of age, the Tübingen group showed a 71.4% success rate, and the Pavlik group a 54.4% success rate (p = 0.047). Conclusion. The Tübingen splint should be the preferred treatment option for children older than three months, and for those with severe forms of DDH such as Graf grade III and IV, who are younger than six months at time of diagnosis. The Tübingen hip flexion splint is a valid alternative to the Pavlik harness for older infants and those with more severe DDH. Cite this article: Bone Joint J 2021;103-B(5):991–998


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1405 - 1411
3 Oct 2020
Martynov I Klink T Slowik V Stich R Zimmermann P Engel C Lacher M Boehm R

Aims. This exploratory randomized controlled trial (RCT) aimed to determine the splint-related outcomes when using the novel biodegradable wood-composite splint (Woodcast) compared to standard synthetic fibreglass (Dynacast) for the immobilization of undisplaced upper limb fractures in children. Methods. An exploratory RCT was performed at a tertiary paediatric referral hospital between 1 June 2018 and 30 September 2019. The intention-to-treat population consisted of 170 patients (mean age 8.42 years (SD 3.42); Woodcast (WCG), n = 84, 57 male (67.9%); Dynacast (DNG), n = 86, 58 male (67.4%)). Patients with undisplaced upper limb fractures were randomly assigned to WCG or DNG treatment groups. Primary outcome was the stress stability of the splint material, defined as absence of any deformations or fractures within the splint during study period. Secondary outcomes included patient satisfaction and medical staff opinion. Additionally, biomechanical and chemical analysis of the splint samples was carried out. Results. Of the initial 170 patients, 168 (98.8%) completed at least one follow-up, and were included for analysis of the primary endpoint. Both treatment groups were well-matched regarding to age, sex, and type and localization of the fracture. Splint breakage occurred in three patients (3.6%; 95% confidence interval (CI), 0.007% to 0.102%) in the WCG and in three children (3.5%, 95% CI 0.007% to 0.09%) in the DNG (p > 0.99). The incidence of splint-related adverse events did not differ between the WCG (n = 21; 25.0%) and DNG (n = 24; 27.9%; p = 0.720). Under experimental conditions, the maximal tensile strength of Dynacast samples was higher than those deriving from Woodcast (mean 15.37 N/mm² (SD 1.37) vs 10.75 N/mm² (SD 1.20); p = 0.002). Chemical analysis revealed detection of polyisocyanate-prepolymer in Dynacast and polyester in Woodcast samples. Conclusion. Splint-related adverse events appear similar between WCG and DNG treatment groups during the treatment of undisplaced forearm fractures. Cite this article: Bone Joint J 2020;102-B(10):1405–1411


The Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 6 | Pages 1023 - 1028
1 Nov 1999
Williams PR Jones DA Bishay M

Between January 1987 and December 1988 there were 7575 births in the Swansea maternity unit. Of these 823 (10.9%) were considered to be at ‘high risk’ for developmental dysplasia of the hip (DDH). Static ultrasound examination was performed in each case and the results classified on the basis of the method of Graf. A total of 117 type III–IV hips in 83 infants was splinted using the Aberdeen splint. Radiographs of these hips were taken at six and 12 months. Hilgenreiner’s measurements of the acetabular angle were made in all cases and the development of the femoral capital epiphysis was assessed by measuring the epiphyseal area. The effect of splintage on the acetabular angle and the epiphyseal area between the normal and abnormal splinted hips was compared. Radiographs of 16 normal infants (32 normal unsplinted hips) were used as a control group. This cohort has now been followed up for a minimum of nine years. There have been no complications as a result of splintage. The failure rate was 1.7% or 0.25 per 1000 live births. No statistical difference was found when comparing the effect of splintage on the acetabular angle and epiphyseal area between normal and abnormal splinted hips and normal unsplinted hips. Our study has shown that while the Aberdeen splint had a definite but small failure rate, it was safe in that it did not produce avascular necrosis. The current conventional view that a low rate of splintage is always best is therefore brought into question if the Aberdeen splint is chosen for the management of neonatal DDH


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 209 - 214
1 Feb 2023
Aarvold A Perry DC Mavrotas J Theologis T Katchburian M

Aims. A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening. Methods. A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group. Results. A total of 60 statements were graded by 128 clinicians in the first round and 132 in the second round. Consensus was reached on 30 out of 60 statements in the first round and an additional 12 in the seond. This was summarized in a consensus statement and distilled into a flowchart to guide clinical practice. Conclusion. We identified agreement in an area of medicine that has a long history of controversy and varied practice. None of the areas of consensus are based on high-quality evidence. This document is thus a framework to guide clinical practice and on which high-quality clinical trials can be developed. Cite this article: Bone Joint J 2023;105-B(2):209–214


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 623 - 630
1 Jun 2024
Perry DC Dritsaki M Achten J Appelbe D Knight R Widnall J Roland D Messahel S Costa ML Mason J

Aims

The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius.

Methods

A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1767 - 1773
1 Dec 2020
Maikku M Ohtonen P Valkama M Leppilahti J

Aims. We aimed to determine hip-related quality of life and clinical findings following treatment for neonatal hip instability (NHI) compared with age- and sex-matched controls. We hypothesized that NHI would predispose to hip discomfort in long-term follow-up. Methods. We invited those born between 1995 and 2001 who were treated for NHI at our hospital to participate in this population-based study. We included those that had Von Rosen-like splinting treatment started before one month of age. A total of 96 patients treated for NHI (75.6 %) were enrolled. A further 94 age- and sex-matched controls were also recruited. The Copenhagen Hip and Groin Outcome Score (HAGOS) questionnaire was completed separately for both hips, and a physical examination was performed. Results. The mean follow-up was 18.2 years (14.6 to 22.0). The HAGOS scores between groups were similar and met statistical and clinical significance only in the Symptoms subscale (mean difference 3.80, 95% confidence interval (CI) 0.31 to 7.29; p = 0.033). Those patients who had undergone treatment for NHI had a higher frequency of positive flexion-adduction-internal rotation test (odds ratio (OR) 2.6, 95% CI 1.2 to 5.6; p = 0.014), resisted straight leg rise test (OR 4.5, 95% CI 1.4 to 14.9; p = 0.014), and also experienced more pain in the groin during passive end range hip flexion (OR 2.5, 95% CI 1.2 to 5.3; p = 0.015) than controls. Conclusion. NHI predisposes to hip discomfort in clinical tests, but no clinically relevant differences in experience of pain, physical function, and hip-related quality of life could be observed between the treated group and matched controls in 18 years of follow-up. Cite this article: Bone Joint J 2020;102-B(12):1767–1773


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_11 | Pages 13 - 13
1 Feb 2013
Roberts D Jones S Uglow M
Full Access

Aim. To determine if the instigation of Magnetic Resonance Extremity (MRE) scanning in our unit as part of the management of suspected paediatric scaphoid fractures has prevented overuse of splints or casts reduced unnecessary clinic appointments and saved our department financially. Methods. Children with traumatic anatomical snuffbox tenderness and negative radiographs are seen 10 days following injury having been given a Futura® splint. If repeat radiographs are negative with on-going positive clinical findings the child has an MRE scan, which is usually reported the same day. If negative, the splint is removed on that day, but if positive, a cast is applied and the child referred onto paediatric fracture clinic. Results. Over a one-year period, 65 acute injuries were referred for MRE scanning. Fourteen bony injuries (22%) were identified including 10 scaphoid, 1 capitate and 3 distal radius fractures. The delay until MRE scanning averaged 11 days from emergency department and 14 days from outpatient clinic. Of these positive cases, the average time to clinic was 15 days equating to an average of 5 weeks from injury to orthopaedic review. The saving of orthopaedic clinics offsets the cost of the MRE scan by £5000 per annum. Fractures were identified in 22% of patients referred for MRE scanning with normal radiographs. Conclusion. The practice of streamlined MRE scanning for suspected paediatric scaphoid fractures can tailor management more efficiently. It has reduced the length of immobilisation in those normal cases and eradicated the need for continuing orthopaedic clinic review without increasing costs


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 8 | Pages 1173 - 1175
1 Nov 2001
Davidson JS Brown DJ Barnes SN Bruce CE

Torus (buckle) fractures of the distal radius are common in childhood. Based on the results of a postal questionnaire and a prospective, randomised trial, we describe a simple treatment for this injury, which saves both time and money. Over a six-month period, we randomised 201 consecutive patients with this injury to treatment with either a traditional forearm plaster-of-Paris cast or a ‘Futura-type’ wrist splint. All patients were treated for a period of three weeks, followed by clinical and radiological review. There was no difference in outcome between the two groups, and all patients had a good result. Only one patient did not tolerate the splint which was replaced by a cast. The questionnaire showed a marked variation in the way in which these injuries are treated with regard to the method and period of immobilisation, the number of follow-up visits and radiographs taken. We suggest that a ‘Futura-type’ wrist splint can be used to treat these fractures. The patient should be reviewed on the following day to confirm the diagnosis and to give appropriate advice. There is no evidence that further follow-up is required. This simple treatment has major benefits in terms of cost and reduction of the number of attendances


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 198 - 208
1 Feb 2023
Cheok T Smith T Wills K Jennings MP Rawat J Foster B

Aims

We investigated the prevalence of late developmental dysplasia of the hip (DDH), abduction bracing treatment, and surgical procedures performed following the implementation of universal ultrasound screening versus selective ultrasound screening programmes.

Methods

A systematic search of PubMed, Embase, The Cochrane Library, OrthoSearch, and Web of Science from the date of inception of each database until 27 March 2022 was performed. The primary outcome of interest was the prevalence of late detection of DDH, diagnosed after three months. Secondary outcomes of interest were the prevalence of abduction bracing treatment and surgical procedures performed in childhood for dysplasia. Only studies describing the primary outcome of interest were included.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 69 - 77
25 Jan 2024
Achten J Appelbe D Spoors L Peckham N Kandiyali R Mason J Ferguson D Wright J Wilson N Preston J Moscrop A Costa M Perry DC

Aims

The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial.

Methods

Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 2 | Pages 245 - 248
1 Feb 2009
Myers J Hadlow S Lynskey T

Since September 1964, neonates born in New Plymouth have undergone clinical examination for instability of the hip in a structured clinical screening programme. Of the 41 563 babies born during this period, 1639 were diagnosed as having unstable hips and 663 (1.6%) with persisting instability were splinted, five of which failed. Also, three unsplinted hips progressed to congenital dislocation, and there were four late-presenting (walking) cases, giving an overall failure rate of 0.29 per 1000 live births, with an incidence of late-walking congenital dislocation of the hip of 0.1 per 1000 live births. This study confirms that clinical screening for neonatal instability of the hip by experienced orthopaedic examiners significantly reduces the incidence of late-presenting (walking) congenital dislocation of the hip


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_1 | Pages 11 - 11
1 Jan 2014
Talbot CL Paton RW
Full Access

A 15 year prospective, observational cohort study was undertaken to assess selective screening of DDH in males and females referred with risk factors only. Individuals born breech or with evidence of a strong family history for DDH were the ‘risk factors’ studied. All were clinically examined and sonographically screened by one Consultant Paediatric Orthopaedic surgeon. Irreducible hip dislocation rate was the primary outcome measure. From a cohort of 64670 live births, 2,984 neonates/infants, 46.1 per 1000 live births [95% CI 44.6 to 47.8 per 1000 live births] were referred and sonographically screened with ‘pure’ risk factors of breech presentation and/or family history, with clinical stability. 1360 were male, of which 4 were identified as having ‘pathological’ DDH; an incidence of 1 in 333 of those males referred [95 CI 0.001, 0.008]. 1624 were female, of which 45 were identified as having ‘pathological’ DDH; an incidence of 1 in 36 of those females referred [95% CI 0.021, 0.037]. There was a significant difference in the number of female individuals sonographically diagnosed as having ‘pathological’ DDH compared to males (p<0.001). Four individuals were diagnosed with irreducible hip dislocation, 0.06 per 1000 live births [95% CI 0.24, 0.159 per 1000 live births]. All were in females. Additionally, there were 2 female individuals; both with family history of DDH (1. st. cousin splinted and sister splinted, respectively) as a risk factor, referred late. Our study suggests that there is a significant difference between the incidence of female and male individuals diagnosed with ‘pathological’ DDH, in those referred purely with risk factors (breech and family history). These findings question the current screening policy for ultrasound examination of males with risk factors in the absence of clinical instability, and may influence future DDH screening programme policy. Level of evidence: II


The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1327 - 1332
1 Dec 2023
Morris WZ Kak A Mayfield LM Kang MS Jo C Kim HKW

Aims

Abduction bracing is commonly used to treat developmental dysplasia of the hip (DDH) following closed reduction and spica casting, with little evidence to support or refute this practice. The purpose of this study was to determine the efficacy of abduction bracing after closed reduction in improving acetabular index (AI) and reducing secondary surgery for residual hip dysplasia.

Methods

We performed a retrospective review of patients treated with closed reduction for DDH at a single tertiary referral centre. Demographic data were obtained including severity of dislocation based on the International Hip Dysplasia Institute (IHDI) classification, age at reduction, and casting duration. Patients were prescribed no abduction bracing, part-time, or full-time wear post-reduction and casting. AI measurements were obtained immediately upon cast removal and from two- and four-year follow-up radiographs.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 455 - 464
15 Mar 2023
de Joode SGCJ Meijer R Samijo S Heymans MJLF Chen N van Rhijn LW Schotanus MGM

Aims

Multiple secondary surgical procedures of the shoulder, such as soft-tissue releases, tendon transfers, and osteotomies, are described in brachial plexus birth palsy (BPBP) patients. The long-term functional outcomes of these procedures described in the literature are inconclusive. We aimed to analyze the literature looking for a consensus on treatment options.

Methods

A systematic literature search in healthcare databases (PubMed, Embase, the Cochrane library, CINAHL, and Web of Science) was performed from January 2000 to July 2020, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The quality of the included studies was assessed with the Cochrane ROBINS-I risk of bias tool. Relevant trials studying BPBP with at least five years of follow-up and describing functional outcome were included.


The Bone & Joint Journal
Vol. 95-B, Issue 2 | Pages 271 - 278
1 Feb 2013
Singh AK Roshan A Ram S

The Ponseti and French taping methods have reduced the incidence of major surgery in congenital idiopathic clubfoot but incur a significant burden of care, including heel-cord tenotomy. We developed a non-operative regime to reduce treatment intensity without affecting outcome. We treated 402 primary idiopathic clubfeet in patients aged < three months who presented between September 1991 and August 2008. Their Harrold and Walker grades were 6.0% mild, 25.6% moderate and 68.4% severe. All underwent a dynamic outpatient taping regime over five weeks based on Ponseti manipulation, modified Jones strapping and home exercises. Feet with residual equinus (six feet, 1.5%) or relapse within six months (83 feet, 20.9%) underwent one to three additional tapings. Correction was maintained with below-knee splints, exercises and shoes. The clinical outcome at three years of age (385 feet, 95.8% follow-up) showed that taping alone corrected 357 feet (92.7%, ‘good’). Late relapses or failure of taping required limited posterior release in 20 feet (5.2%, ‘fair’) or posteromedial release in eight feet (2.1%, ‘poor’). The long-term (> 10 years) outcomes in 44 feet (23.8% follow-up) were assessed by the Laaveg–Ponseti method as excellent (23 feet, 52.3%), good (17 feet, 38.6%), fair (three feet, 6.8%) or poor (one foot, 2.3%). These compare favourably with published long-term results of the Ponseti or French methods. This dynamic taping regime is a simple non-operative method that delivers improved medium-term and promising long-term results. Cite this article: Bone Joint J 2013;95-B:271–8


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims

The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures.

Methods

A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders.


Bone & Joint Open
Vol. 2, Issue 8 | Pages 594 - 598
3 Aug 2021
Arneill M Cosgrove A Robinson E

Aims

To determine the likelihood of achieving a successful closed reduction (CR) of a dislocated hip in developmental dysplasia of the hip (DDH) after failed Pavlik harness treatment We report the rate of avascular necrosis (AVN) and the need for further surgical procedures.

Methods

Data was obtained from the Northern Ireland DDH database. All children who underwent an attempted closed reduction between 2011 and 2016 were identified. Children with a dislocated hip that failed Pavlik harness treatment were included in the study. Successful closed reduction was defined as a hip that reduced in theatre and remained reduced. Most recent imaging was assessed for the presence of AVN using the Kalamchi and MacEwen classification.


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.