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Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in Children Aged 7–12 Years: a Study Protocol for a Randomised Controlled Trial

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Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in Children Aged 7–12 Years: a Study Protocol for a Randomised Controlled Trial Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-048248 on 20 August 2021. Downloaded from Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7–12 years: a study protocol for a randomised controlled trial Petra Grahn ,1 Juha- Jaakko Sinikumpu,2 Yrjänä Nietosvaara,1,3 Johanna Syvänen,4 Anne Salonen,5 Matti Ahonen,1 Ilkka Helenius6 To cite: Grahn P, Sinikumpu J- J, ABSTRACT Strengths and limitations of this study Nietosvaara Y, et al. Casting Introduction The forearm is the most common fracture versus flexible intramedullary location in children, with an increasing incidence. nailing in displaced forearm ► First randomised controlled trial (RCT) to examine shaft fractures in children Displaced forearm shaft fractures have traditionally been the treatment and outcome of displaced both bone aged 7–12 years: a study treated with closed reduction and cast immobilisation. forearm paediatric fractures. protocol for a randomised Diaphyseal fractures in children have poor remodelling ► Multicentre RCT with blinded outcome assessors controlled trial. BMJ Open capacity. Malunion can cause permanent cosmetic and recruiters. 2021;11:e048248. doi:10.1136/ and functional disability. Internal fixation with flexible ► Use of several patient- reported outcome measures bmjopen-2020-048248 intramedullary nails has gained increasing popularity, as well as active and passive upper limb range of ► Prepublication history for without evidence of a better outcome compared with motion. this paper is available online. closed reduction and cast immobilisation. ► Bone age to determine remodelling capacity. To view these files, please visit Method and analysis This is a multicentre, randomised ► Patient and treating surgeons not blinded. the journal online (http:// dx. doi. superiority trial comparing closed reduction and cast org/ 10. 1136/ bmjopen- 2020- 048248). immobilisation to flexible intramedullary nails in children aged 7–12 years with >10° of angulation and/or >10 mm INTRODUCTION http://bmjopen.bmj.com/ Received 20 December 2020 of shortening in displaced both bone forearm shaft The incidence of paediatric forearm fractures Accepted 03 August 2021 fractures (AO-paedia tric classification: 22D/2.1–5.2). A is increasing, and almost half of all fractures total of 78 patients with minimum 2 years of expected growth left are randomised in 1:1 ratio to either treatment in the growing skeleton are located in the forearm.1–3 Angular malunion exceeding group. The study has a parallel non- randomised patient 4–6 preference arm. Both treatments are performed under 10° can result in limited forearm rotation. general anaesthesia. In the cast group a long arm cast The remodelling capacity of shaft fractures is applied for 6 weeks. The flexible intramedullary nail in children is poorer and less predictable group is immobilised in a collar and cuff sling for 4 weeks. than in metaphyseal and physeal fractures. on September 25, 2021 by guest. Protected copyright. Data are collected at baseline and at each follow-up until More correction can be expected in chil- 1 year. dren younger than 9 years and in children Primary outcome is (1) PROMIS paediatric upper extremity with fractures close to the distal physes.7 8 and (2) forearm pronation-supina tion range of motion at The reported angular correction rate in the 1-year follow-up. Secondary outcomes are Quick DASH, diaphysis is only 1°–2° per year until the end Paediatric Pain Questionnaire, Cosmetic Visual Analogue of growth, in malrotation probably even Scale, wrist and elbow range of motion as well as any less.9–11 © Author(s) (or their complications and costs of treatment. Active forearm rotation is restored during employer(s)) 2021. Re- use We hypothesise that flexible intramedullary nailing results the first year after the fracture, after which permitted under CC BY-NC. No in a superior outcome. commercial re- use. See rights regardless of remodelling very little change Ethics and dissemination We have received ethical 12 and permissions. Published by can be expected. Minimal total forearm BMJ. board approval (number: 78/1801/2020) and permissions rotation for performing activities of daily to conduct the study from all five participating university For numbered affiliations see living in children and adolescents is consid- hospitals. Informed consent is obtained from the end of article. ered to be 110° (50° of supination, 65° of parent(s). Results will be disseminated in peer- reviewed pronation) and in adults (50°–60° of supi- Correspondence to publications. nation and 40°–50° of pronation).13 14 Loss Dr Petra Grahn; Trial registration number NCT04664517. petra. grahn@ hus. fi of ≤60° goes unnoticed in many patients.15 Grahn P, et al. BMJ Open 2021;11:e048248. doi:10.1136/bmjopen-2020-048248 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-048248 on 20 August 2021. Downloaded from Table 1 Pros and cons of the two treatment modalities Pros Cons Cast treatment Non- invasive Cast complications Cast wedging Loss of reduction Inexpensive Frequent FU visits Joint stiffness FIN treatment Loss of reduction rare Invasive Low need for Implant removal immobilisation Less FU visits Infection Less affected ROM Risk for tendon/nerve injury Modified from Mehlman and Wall.16 FIN, flexible intramedullary nail; FU, follow- up; ROM, range of motion. Good forearm function has been documented in patients with ≤50° of loss in pro- supination.7 9 Non- operative treatment (reduction and casting) is the golden standard in closed paediatric forearm shaft fractures, especially in children younger than 12 years of age.16 There is abundant evidence, that non-operative Figure 1 Eligibility screening, inclusion and exclusion treatment of most forearm fractures gives satisfactory criteria and patient allocation the study. long- term cosmetic and functional outcomes.7 16–19 Completely displaced both bone forearm fractures in older children and adolescents tend to be treated surgi- METHODS AND ANALYSIS cally, although evidence of successful outcome with cast Study design treatment exists.20 21 Failure of reduction after closed This is a multicentre parallel-group superiority treatment is higher in children >10 years of age and with randomised controlled trial (RCT) that complies with the http://bmjopen.bmj.com/ fractures exceeding 15° of angulation.22 23 Standard Protocol Items: Recommendations for Interven- Flexible intramedullary nailing (FIN) has become the tional Trials statement. The trial offers a patient choice most popular method of internal fixation of paediatric arm (figure 1). The study is coordinated by Helsinki forearm shaft fractures. FIN when applied correctly is University Central Hospital, Children’s Hospital unit for minimally invasive surgery, with low complication rates paediatric orthopaedics. Recruitment is done at all five 20 24 compared with open reduction and internal fixation. Finnish university hospitals (Helsinki, Kuopio, Oulu, Reported risk of iatrogenic complications varies between Tampere, Turku). The study is overseen by an external 7 25–30 9% and 31% with local wound infections and tendon monitor provided by HUCH Clinical Research Institute on September 25, 2021 by guest. Protected copyright. injuries being the most common. Surgical management of (Clinical Research Institute HUCH, Helsinki, Finland, paediatric forearm fractures has increased >250% during 31 32 https:// hyksinstituutti. fi/ser vices/ monitoring- services/? the last two decades. The two treatment modalities lang= en). of displaced both bone forearm fractures have different Any changes in study protocol will be uploaded to the benefits (table 1). Level I evidence regarding optimal trial registry. treatment is missing.1 20 Different patient- reported outcome measures have been used, but only few are vali- 33 Patient recruitment dated. The Patient- Reported Outcomes Measurement Information System (PROMIS) Paediatric Item Bank A specialist of either hand surgery, paediatric surgery, V.2.034 - Upper Extremity is validated and has been used paediatric orthopaedics or orthopaedics screens all in prior paediatric upper extremity fracture studies.35 patients fitting the inclusion criteria for eligibility. If The aim of this study is to compare outcome of closed inclusion criteria are met, written consent is asked from reduction and casting under general anaesthesia to the guardian. Patients and parents are given a written internal fixation with FIN in paediatric displaced both informed consent regarding the trial. The patient version bone forearm fractures. We hypothesise, that internal is age adjusted for easier understanding according to the fixation of the fractures with FIN provides better func- Finnish Investigators Network for Pediatric Medicines ( tional outcome than closed reduction and cast treatment www. finpedmed. fi). 2 Grahn P, et al. BMJ Open 2021;11:e048248. doi:10.1136/bmjopen-2020-048248 Open access BMJ Open: first published as 10.1136/bmjopen-2020-048248 on 20 August 2021. Downloaded from method described by Greulich and Pyle38 by an experi- enced paediatric radiologist. Randomisation Included patients receive a temporary long arm cast supporting the fracture. Randomisation is done at treat- ment day 1 with patient under general anaesthesia in the operating theatre with the treating surgeon opening the assigned envelop. Prior to trial recruitment randomisa- tion is performed at the main study for the expected trial population using a computer
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