Clinical trial NCT05008029: Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius
Official title: Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radius Fracture Distal
Keywords: radius fracture
children
conservative treatment
distal radius
Lead sponsor: Instituto de Ortopedia Infantil Roosevelt
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
First posted: 2021-08-17
Enrollment: 59
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper limb function
timeFrame: 6 months
Secondary outcomes:
measure: Wrist range of motion
timeFrame: 3 and 6 months
measure: Ulnar variance
timeFrame: 9 months
measure: Deformity
timeFrame: 2 weeks, 3 months and 9 months
Other outcomes:
measure: Number of patients with anesthetic complications
timeFrame: During and immediately after the intervention
measure: Presence of a pressure ulcer (NPUAP scale)
timeFrame: 2 and 6 weeks
measure: Patients's pain control
timeFrame: 2 and 6 weeks
measure: Number of patients with pin tract infection (Dahl scale)
timeFrame: 2 and 6 weeks
measure: Number of patients with reintervention
timeFrame: 0 to 9 months
Locations:
city: Bogota
country: Colombia
facility: Instituto Roosevelt
state: Cundinamarca
Study officials:
affiliation: Instituto Roosevelt
name: Maria F Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marson BA, Ng JWG, Craxford S, Chell J, Lawniczak D, Price KR, Ollivere BJ, Hunter JB. Treatment of completely displaced distal radial fractures with a straight plaster or manipulation under anaesthesia. Bone Joint J. 2021 May;103-B(5):902-907. doi: 10.1302/0301-620X.103B.BJJ-2020-1740.R1. Epub 2021 Mar 12.
citation: Garcia-Rueda MF, Bohorquez-Penaranda AP, Gil-Laverde JFA, Aguilar-Sierra FJ, Mendoza-Pulido C. Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial. JMIR Res Protoc. 2022 Apr 14;11(4):e34576. doi: 10.2196/34576.