NCT05008029

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Instituto de Ortopedia Infantil Roosevelt · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radius Fracture Distal

Interventions

Type	Name	Description
PROCEDURE	In situ immobilization	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.
PROCEDURE	Reduction under general anesthesia	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.

Timeline

• Start date: 2021-06-15
• Primary completion: 2024-04-15
• Completion: 2024-07-15
• First posted: 2021-08-17
• Last updated: 2024-10-03

Locations

1 site across 1 country: Colombia