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Comparison of Supination/Flexion Maneuver to Hyperpronation Maneuver

NCT05828641 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-03-28

No results posted yet for this study

Summary

This study is designed as a randomized controlled study. The investigators aim to compare the success of supination-flexion and hyperpronation maneuvers in the treatment of preschool children presenting to the emergency department with radial head subluxation.

All children aged 0-6 years, who are diagnosed with radial head subluxation secondary to traction of the forearm, had no evidence of direct trauma to the arm or fracture in the arm (no deformity, swelling, ecchymosis), had no history of musculoskeletal disease, and are approved to participate in the study by their legal guardians, will be included in the study. Patients who are considered to have radial head subluxation initially but had an X-ray performed by the physician and had a fracture in the arm will be excluded from the study.

In the study, patients will be randomized and assigned to two treatment groups: the supination-flexion group and the hyperpronation group. In the supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint. In the hyperpronation group, the forearm will be pronated with the child's palm facing down. In both groups, maneuvers will be performed by 3 emergency medicine specialists with at least 2 years of experience.

First-attempt failure is determined as the primary outcome of the study. Failure in the second attempt, ultimate failure, recurrence, patient satisfaction during the procedure, pain intensity (assessed by the Face, Legs, Activity, Cry, Consolability - FLACC pain scale), and treatment-related adverse events are determined as secondary outcomes of the study.

The investigators calculated the sample size and decided to include 117 patients in each group.

Conditions

  • Emergencies
  • Orthopedics
  • Radial Head Subluxation

Interventions

PROCEDURE

Supination-flexion maneuver

In the Supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint (Supination-flexion maneuver).

PROCEDURE

Hyperpronation maneuver

In the hyperpronation group, the forearm will be pronated with the child's palm facing down (hyperpronation maneuver).

Sponsors & Collaborators

  • Umraniye Education and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2024-03-26
Completion
2024-03-26

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828641 on ClinicalTrials.gov