Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures

NCT03097757 | Terminated Results DMC FDA Device

• 1 other identifier: 2016-6637
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the utility of ultrasound guidance in the closed reduction of pediatric forearm fractures in the pediatric emergency department. The investigators will compare post-reduction radiologic outcomes between the experimental group (ultrasound guided closed forearm fracture reduction) and control group (standard of care blinded closed forearm fracture reduction) to determine if there is a difference in the number of adequate reductions between groups. Secondary objectives include comparing provider satisfaction with the reduction procedure, number of patients requiring repeat reductions, time for reduction, number of patients requiring operative repair after reduction, with the reduction procedure and comparison between post-reduction ultrasound and x-ray interpretation.

Conditions

Forearm Fracture; Ultrasound

Keywords

Ultrasound; Forearm Fracture Reduction; Pediatric Emergency Department

Outcome Measures

Primary Outcomes (1)

• Comparing Rate of Reduction Between the Experimental and Control Arm/Group

  To compare the number of patients requiring repeat reduction procedure between the experimental group (ultrasound guided fracture reduction) and control group (standard of care forearm fracture reduction).

  From initiation of bone setting procedure, an average of 10-20 minutes

Secondary Outcomes (6)

• Compare Provider Satisfaction With the Reduction Procedure Between the Experimental and Control Arm/Group

  After completing the bone setting procedure and validation via ultrasound, an average of 2 minutes

• Adequacy of Reduction Based on a Composite Assessment of Degree of Angulation and Displacement

  From initiation of bone setting procedure, an average of 10-20 minutes

• Duration of Reduction

  From initiation of bone setting procedure, an average of 10-20 minutes

• Operative Repair

  From initiation of bone setting procedure, an average of 10-20 minutes

• Post-Reduction Ultrasound Comparison

  From initiation of bone setting procedure, an average of 10-20 minutes

Study Arms (2)

Fracture reduction without ultrasound

ACTIVE COMPARATOR

Fracture reduction as per standard of care involves closed fracture reduction without real-time imaging, or with c-arm or portable x-ray. Closed reduction of a fractured bone. Closed reduction is a procedure to set (reduce) a broken bone without surgery. This allows the bone to grow back together. It works best when it is done as soon as possible after the bone breaks.

Procedure: Standard of care fracture reduction

Fracture reduction with ultrasound

EXPERIMENTAL

Ultrasound guided Fracture reduction involves closed fracture reduction with the use of real-time ultrasound imaging, prior to, during and after the reduction procedure. C-arm or portable x-ray may also be used as an adjunct.

Radiation: Ultrasound - guided fracture reduction; Procedure: Standard of care fracture reduction

Interventions

Ultrasound - guided fracture reduction RADIATION

Ultrasound will be used as a real-time imaging modality to guide forearm fracture reduction.

Fracture reduction with ultrasound

Standard of care fracture reduction PROCEDURE

Closed reduction of a fractured bone.

Fracture reduction with ultrasound; Fracture reduction without ultrasound

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Patients with open fractures.
• Patients with neurovascular compromise.
• Unstable patients with life-threatening injuries who require ongoing resuscitation.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Limitations and Caveats

Early termination leading to small numbers of subjects recruited.

Results Point of Contact

• Title: Roger Hicks
• Organization: Montefiore Medical Center

roger.hicks@einsteinmed.org

718-862-1751

Study Officials

• Joni Rabiner, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The orthopedic surgeon reading the x-rays and determining the degree of angulation and displacement will be blinded to all patient characteristics and to the patient's group assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized, controlled, single blinded study

Study Record Dates

• First Submitted: March 25, 2017
• First Posted: March 31, 2017
• Study Start: January 24, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: January 9, 2023
• Results First Posted: January 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)