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

NCT ID: NCT05008029

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2024-07-15

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.

Conditions

Radius Fracture Distal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

In situ immobilization

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

Group Type: EXPERIMENTAL

In situ immobilization

Intervention Type: PROCEDURE

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.

Reduction under general anesthesia

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.

Group Type: ACTIVE_COMPARATOR

Reduction under general anesthesia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Javeriana

OTHER

Sponsor Role: collaborator

Instituto de Ortopedia Infantil Roosevelt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria F Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Roosevelt

Locations

Instituto Roosevelt

Bogota, Cundinamarca, Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 33709769 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35436224 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021012101

Identifier Type: -

Identifier Source: org_study_id