Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.
Phase: NA
Conditions: Radius Fracture Distal
Sponsor: Instituto de Ortopedia Infantil Roosevelt

 
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Casting without Reduction versus Closed Reduction with or without Fixation in the Treatment 
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of Distal Radius Fractures in Children: A Study Protocol for a Randomized Non-Inferiority Trial 
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Background 
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Fractures are prevalent in the pediatric population. It is estimated that one in three children will 
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sustain at least one fracture before adulthood, of which distal metaphyseal radius fractures are 
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the most frequent[1, 2]. Current treatments include in situ cast immobilization, or reduction 
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with or without fixation with K-wires, decided upon angulation and displacement. Traditionally, 
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specific deformity limits are tolerated, given the child's age and gender, however, these limits 
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lack supportive evidence. Further, treatment agreement, even between experienced pediatric 
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orthopedic surgeons, is minimal[3]. 
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Distal radius fractures have a remarkable remodeling potential. The remodeling rate is higher 
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when the angulation is more severe, and it progressively decreases as the alignment 
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approaches to normal[4]. Observational designs have shown that fractures up to 29 degrees of 
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angulation and 19 mm of shortening immobilized in situ regain complete alignment about a 
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year after injury[5]. Even shorter times to proper alignment are reported in younger children[5]. 
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Additionally, Crawford et al. describe a series of children treated with cast immobilization 
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without restoring the length of the radius, achieving neutral ulnar variance at follow-up[6]. 
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Furthermore, when alignment is lost, typical radius morphology is present within three years 
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even when the fracture is immobilized without any attempt to regain alignment[7]. Hence, 
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casting without reduction is considered a suitable treatment. 
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Some specialized centers reserve distal radius corrective osteotomy solely for fracture 
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malunion in children approaching the end of growth or with associated physeal arrest. It is also 
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the treatment of choice for children with congenital dysplastic conditions of the bone[8]. 
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Functional evaluation 
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Upper extremity functionality refers to reaching, grasping, and manipulating objects with the 
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intention to perform daily life activities[9]. Most of the instruments that assess upper extremity 
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functionality in the pediatric population are specific to patients with longitudinal deficiencies, 
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amputations, or neurodevelopmental disorders. Specific instruments for adults have also been 
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published, however, several items refer to tasks that a 5-year-old child might not be able to 
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properly execute. 
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The physical functioning domain of the PROMIS scales is available for assessing functionality of 
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children without disabilities since 2011[10]. It is a precise and easy-to-administer outcome 
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measurement instrument in children with orthopedic conditions. Children aged 8 years 
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onwards are able to, effortlessly, answer the questionnaire by themselves. A parent-proxy 
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version is available for younger children. The upper extremity functionality is a subdomain of 
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the physical functioning domain. It comprises 29 Liker-type questions with five categories that 
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enquire about the difficulty of carrying out activities during the past week. 
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The trial's primary goal is to establish whether upper extremity’s functionality of children who 
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sustained a distal metaphyseal fracture of the radius and were treated with in situ cast 
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immobilization, is not worse than the functionality of children treated with closed reduction 
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and cast immobilization, with or without fixation, measured at 6 months with the PROMIS 
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scale. Secondarily, range of motion (ROM), alignment, complications and further treatments 
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will also be compared. Results may contribute to not only strengthening the evidence of secure 
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shortening and angulation boundaries, aiding the clinician with evidence-based decision, but 
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risks and costs may also be questioned, when encountering these kinds of fractures. 
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Methods 
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Study design and procedures 
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This is a randomized non-inferiority trial that will take place at Instituto Roosevelt in Bogota– 
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Colombia, a single institution that focuses on providing treatment for children with orthopedic 
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and neuromuscular conditions. Two accepted treatments for metaphyseal distal radius 
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fractures will be compared: cast immobilization without reduction as the experimental 
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intervention, and closed reduction and immobilization with or without percutaneous fixation as 
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the control intervention. Acutely, conventional oral analgesics will be routinely provided, 
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afterwards, the principal researcher will invite children and parents to enter into the trial upon 
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confirming admission criteria. Informed consent, along with informed assent, will be signed. 
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Inclusion criteria 
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Children between 5 to 10 years of age with a proven acute (i.e., within 14 days after injury) 
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metaphyseal fracture of the distal radius (23-M 2-3 or 23r-M 2-3 according to the AO pediatric 
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classification) will be regarded as eligible for the trial. Fracture shortening and angulation must 
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range from 0 to 10 mm and 10 to 20 degrees in the oblique plane, respectively.  
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Exclusion criteria 
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 Polytrauma (Injury Severity Score ≥ 16) 
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 A concomitant fracture in the same limb 
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 Pathologic/open fracture 
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 Neuromuscular/metabolic bone diseases 
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 Concomitant neurologic/vascular lesions 
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 Longitudinal limb deficiency 
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 Previous infection/fracture in the fractured radius 
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Randomization 
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Randomization will be performed centrally by the Instituto Roosevelt Medical Research 
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Department. Therefore, allocation will be concealed to the orthopedic surgeons. The Big Stick 
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Design (BSD) with a maximum tolerated imbalance of 2 will be the methodology for 
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randomization. The BSD has a very low probability of correctly guessing the allocation of the 
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next child compared to other designs[11]. The R and RStudio statistical software, specifically the 
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randomizeR package version 4.1, will be used[12].  
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Interventions 
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Patients will be allocated in a 1:1 ratio to either the experimental or control group. In the 
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former, fractures will be immobilized without reduction. In the latter, fractures will be reduced 
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and immobilized. Provided instability, K-wires will be used. Instability is considered when, after 
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reduction, alignment is lost: a new displacement or angulation larger than 50% and 10 degrees, 
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respectively. General anesthesia will be mandatory exclusively for the control group. Discharge 
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within two hours is the standard practice for both procedures. Plain radiographs will be 
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obtained immediately after the intervention, at two weeks, three-, and nine-months during 
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follow-up. Casts and K-wires will be removed at 6 weeks. 
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Endpoints and follow up 
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Children will be evaluated at about two and six weeks, three, six, and nine months after 
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randomization. The primary endpoint is the upper extremity function assessed with the 
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PROMIS Pediatric Physical Function v2.0 at six months. Parents will serve as proxies of children 
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<8 years with the proper format of the scale. From 8 years of age onwards, children will 
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personally answer the questionnaire. 
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The secondary outcomes are the ROM, ulnar variance, and fracture alignment in the sagittal 
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and coronal planes. Plain radiographs of the wrist at two weeks, three and nine months and a 
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standard goniometer will be used. Additionally, general anesthesia-related adverse effects, 
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pressure ulcers according to the National Pressure Ulcer Advisory Panel, the number of days of 
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required oral analgesics and Dahl classification of pin tract infections will also be registered[13]. 
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Further treatments such as radius osteotomy due to deformity, pseudoarthrosis cure, and 
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remanipulation will also be recorded. Figure 1 depicts the flow of the study. 
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Power analysis and sample calculation  
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In a personal communication, Dr. Calfee provided PROMIS range scores (36 to 39), variability 
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(SD=10) and the minimally clinical important difference (MCID; 3 to 5) in children who have 
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sustained an upper extremity fracture[14]. Therefore, assuming a non-inferiority threshold of 5, 
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the trial requires a sample of 126 children (63 per group) to demonstrate no meaningful 
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difference in the primary outcome (one-tailed α=0.05, β=0.2). The sample will be inflated to 
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152 (20%) due to the anticipation of loss to follow-up. 
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Data management 
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Participant's information will be recorded in the REDCap software. Registries will be password-
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protected with access granted just to the principal researcher and the study conductor. Data 
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will be kept at the Instituto Roosevelt Medical Research Department. After completing the 
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study, data will be preserved for two years, then all non-anonymized documents will be 
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discarded. 
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Statistical analysis 
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Customary descriptive statistics will be used whether the variables are continuous or 
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categorical. The intention-to-treat principle will be followed in this trial. Authors of the scale in 
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the Northwestern University will standardize PROMIS scores once data gathering is completed, 
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afterwards, the primary outcome will be evaluated with a t-test. The non-inferiority threshold 
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will be compared to the lower bound of the 95% confidence interval of the mean difference. 
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Secondary outcomes measured with continuous variables (i.e., ROM, ulnar variance, fracture 
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alignment and number of days with oral analgesia) will be compared with the t-test or Mann-
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Whitney's U conforming to the distribution of the variables. Categorical outcomes will be 
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compared with the Fisher's exact test (i.e., anesthesia-related adverse effects, pressure ulcers, 
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pin tract infections, radius osteotomies, pseudoarthrosis, and remanipulations). Early 
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termination of the trial is unlikely; therefore, interim analyses are not considered: given the 
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proposed design, neither superiority nor futility of the experimental treatment is expected. 
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Schedule 
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Recruitment commenced in June 2021. The principal researcher personally interviews parents 
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and children and the trial’s general characteristics are completely explained. Benefits, such as a 
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close follow-up (e.g., radiographs, pain, functionality) are also explained. Authors expect an 
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average of ten patients monthly, therefore, recruitment and analysis should be complete by 
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June 2023. 
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O? 
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Declarations 
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Both, Instituto Roosevelt and Pontificia Universidad Javeriana Ethics Committees, evaluated 
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and accepted trial’s protocol, research manual, consent and assent forms, and information 
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brochures (approval No. 2021012101-002 and FM-CIE-0416-21, respectively). The datasets used 
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and/or analyzed during the current trial will be available from the corresponding author upon 
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reasonable request. Authors declare no competing interests. No funding to declare. 
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Acknowledgments: None. Authors’ contributions: MGR: conception and design, data 
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acquisition, analysis and interpretation, drafting of the manuscript and approval of the final 
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version. CMP: critically revised the manuscript, drafting of the manuscript and approval of the 
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final version 
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Discussion 
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This is the protocol of the first randomized trial that intends to compare functional outcomes of 
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non-reduced versus reduced distal radius fractures in children. To authors knowledge, medical 
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literature lacks experimental designs that take into account shortening and angulation in this 
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age group. 
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The principal strength of this trial is the objective evaluation of functional outcomes with a 
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scale constructed with modern measurement theory which is appropriate for the pediatric 
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population, including previously healthy children who sustained a fracture of the wrist. In 
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addition to functional recovery, anatomical parameters, as well as complications due to 
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treatment will also be recorded. 
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The limitations of this trial are the lack of blindness for obvious reasons, and generalizability. 
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Children will be recruited and treated in a specialized center. In most of authors’ country 
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institutions that deal with fractures in children a pediatric orthopedic surgeon is not available. 
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The allocation will be open-labeled for patients, parents, and medical staff, this scenario may 
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affect participants’ feelings of well-being. However, results analyses will be blinded. 
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References 
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