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

NCT05008029 | Terminated DMC

• 1 other identifier: 2021012101
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fracture Distal

Keywords

radius fracture; children; conservative treatment; distal radius

Outcome Measures

Primary Outcomes (1)

• Upper limb function

  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.

  6 months

Secondary Outcomes (3)

• Wrist range of motion

  3 and 6 months

• Ulnar variance

  9 months

• Deformity

  2 weeks, 3 months and 9 months

Other Outcomes (5)

• Number of patients with anesthetic complications

  During and immediately after the intervention

• Presence of a pressure ulcer (NPUAP scale)

  2 and 6 weeks

• Patients's pain control

  2 and 6 weeks

Study Arms (2)

In situ immobilization

EXPERIMENTAL

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

Procedure: In situ immobilization

Reduction under general anesthesia

ACTIVE COMPARATOR

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.

Procedure: Reduction under general anesthesia

Interventions

In situ immobilization 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.

In situ immobilization

Reduction under general anesthesia 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.

Reduction under general anesthesia

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Ortopedia Infantil Roosevelt: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Instituto Roosevelt

Bogota, Cundinamarca, 110321, Colombia

Location

Related Publications (2)

• 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.

  PMID: 33709769 BACKGROUND

• 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.

  PMID: 35436224 DERIVED

MeSH Terms

Conditions

Wrist Fractures; Radius Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Forearm Injuries

Study Officials

• Maria F Garcia, MD

  Instituto Roosevelt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will analyze the database without knowing which treatment arm each participant was allocated. He does not work in the center where the study will be carried out, nor does he contact the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: August 17, 2021
• Study Start: June 15, 2021
• Primary Completion: April 15, 2024
• Study Completion: July 15, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: On permission request

Locations

CO (1)