Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius

Study Overview
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Brief Summary
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Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary. The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.

Detailed Description
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The participant will be recruited in one center. If participants and their parents accept to participate in this study, treatments will be randomly allocated using the Big Stick Design technique with a maximum tolerated imbalance of 2. The sequence will be generated by a research assistant who is completely independent of the study, does not know the purpose of the study and the interventions. Each of the random numbers will be stored in an opaque envelope sealed externally with the order in which they should be opened. Patient registration and follow-up information will be stored in REDCap®. Clinical and radiographic outcomes will be evaluated.

Official Title
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Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.

Conditions
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Radius Fracture Distal

Intervention / Treatment
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* Procedure: Reduction under general anesthesia
* Procedure: In situ immobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 5 years to 10 years Unilateral metaphyseal distal radius fracture Fracture shortening of 0 to 10mm or angulation of 10 ° to 20 ° in the oblique plane. (AO 23-M 2-3 or 23r-M 2-3) Admission in the first 14 days after the fracture Exclusion Criteria: Polytrauma: Injury Severity Score (ISS)> 16 Associated fracture in the same limb. Neuromuscular pathology (e.g., cerebral palsy, spinal muscular atrophy, Duchenne disease) Open fractures. History of fractures, septic arthritis, or osteomyelitis in the same limb. Neurological or vascular injury in the fractured upper limb. Known alteration of bone metabolism (e.g., osteogenesis imperfecta, rickets, osteopetrosis, skeletal dysplasias, lysosomal storage diseases). Congenital longitudinal deficiency.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In situ immobilization<br>Immobilization without reducing the radius fracture and above-elbow casting. | Procedure: In situ immobilization<br>* Immobilization with an above-elbow cast. A 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow supervised by a pediatric orthopedic surgeon will perform the procedure without reduction, sedation, or anesthesia. Analgesia will be administered with paracetamol at doses of 10-15 mg/kg/dose or tramadol 0.5-1mg/kg/dose. Supposing immobilization is not satisfactory, or the patient or family member does not authorize the procedure to be carried out by staff in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon.<br>|
| Active Comparator: Reduction under general anesthesia<br>Radius closed reduction under general anesthesia and above-elbow casting. Percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block if needed. | Procedure: Reduction under general anesthesia<br>* The participants will receive paracetamol at 10-15 mg/kg/dose or tramadol 0.5-1 mg/kg/dose for pain control until the time of surgery. Under general anesthesia, radius closed reduction, and above-elbow casting will be performed. After the reduction maneuvers, the radius reduction is satisfactory if the translation in the coronal and sagittal planes of less than 50% and angulation in the same planes is less than 10 °. If the radius does not remain reduced, it is unstable. Unstable fractures require percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block. The procedures will be carried out by a 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow under the supervision of a child orthopedist. Suppose reduction is not satisfactory or the patient or parent doesn´t authorize the procedure performed by personnel in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb function | Assess upper extremity function with PROMIS Physical Function, Upper Extremity subdomain. The investigators will apply the parent-proxy version between 5 and 7 years old and the pediatric version between 8 and 10. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrist range of motion | Wrist passive degrees of flexion and extension measured with a goniometer aligned with the forearm axis and the second metacarpal. Pronation and supination. The investigators will ask the patient to hold a pencil vertically with the ulnar edge of the forearm on the table and the elbow flexed 90 °. The wrist is rotated medially or laterally, respectively. One arm of the goniometer is placed on the table and the other is aligned with the pencil, the degrees obtained must be subtracted from 90 °. | 3 and 6 months | 
| Ulnar variance | The investigators will consider the ulnar variance as the distance between the most distal aspect of the metaphysis of the radius and the ulna according to the Hafner distal-distal method (DIDI). | 9 months | 
| Deformity | Angulation in the oblique plane | 2 weeks, 3 months and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radius fracture, children, conservative treatment, distal radius