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

Instituto de Ortopedia Infantil Roosevelt

Status: Terminated

Conditions: Radius Fracture Distal

Treatments: Procedure: Reduction under general anesthesia; Procedure: In situ immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT05008029

2021012101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

In situ immobilization

Experimental group

Description:

Immobilization without reducing the radius fracture and above-elbow casting.

Treatment:

Procedure: In situ immobilization

Reduction under general anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Reduction under general anesthesia