Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius
- Conditions
- Radius Fracture Distal
- Registration Number
- NCT05008029
- Lead Sponsor
- Instituto de Ortopedia Infantil Roosevelt
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Upper limb function 6 months 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.
- Secondary Outcome Measures
Name Time Method Deformity 2 weeks, 3 months and 9 months Angulation in the oblique plane
Wrist range of motion 3 and 6 months 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 °.Ulnar variance 9 months 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).
Trial Locations
- Locations (1)
Instituto Roosevelt
🇨🇴Bogota, Cundinamarca, Colombia
Instituto Roosevelt🇨🇴Bogota, Cundinamarca, Colombia