Pediatric Supracondylar Humerus Fracture NIRS Study

Status Completed

Clinical Trial Summary

The purpose of this study is to use a device to compare the blood flow in the patient's injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for this device for a child's forearm and may in the future help us detect children that have injured the blood vessels that go to the forearm when they have an elbow fracture. The patient will be one of approximately 100 people involved in this research project at Carolinas Medical Center, and the patient's participation will last until the patient is discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS device will be different than on the uninjured arm.

Clinical Trial Description

Supracondylar humerus fractures (fracture just above the elbow) are common in children. Supracondylar humerus fractures account for 60% of the elbow fractures in children. Some supracondylar fractures injure the brachial artery and a small percentage of children present with an absent radial pulse after supracondylar humerus fracture, and these injuries may result in insufficient blood flow to the ipsilateral forearm. This can lead to compartment syndrome and/or ischemic contracture of the forearm muscles, and may result in permanent disability. Currently, physicians do not have objective data to determine whether or not the forearm muscles below a supracondylar humerus fracture are receiving adequate blood flow and must rely on the clinical exam of the wrist and hand distally. The purpose of this study is to use near infrared spectroscopy (NIRS) to compare the blood flow in the forearm muscle compartments of an injured arm compared to an uninjured arm. This will provide data to establish normal readings for this device for a child's forearm, and may then help clinicians detect children with insufficient perfusion of the forearm muscles after supracondylar humerus fracture. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01808183
Study type	Observational
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase
Start date	February 2012
Completion date	February 2017

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05640674` - Post-operative Pain Management in Children With Supracondylar Humerus Fractures	Phase 4
Not yet recruiting	`NCT05501834` - Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial	N/A
Not yet recruiting	`NCT05780398` - Long Term Follow up in Pediatric Supracondylar Humeral Fracture
Completed	`NCT00871793` - Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures	N/A
Terminated	`NCT04905563` - NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures	Phase 4
Recruiting	`NCT04288206` - Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial	N/A
Completed	`NCT04582123` - Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins	N/A
Completed	`NCT04780308` - Pediatric Type III Supracondylar Humeral Fracture
Recruiting	`NCT03759028` - Supracondylar Post-Operative Pain Study	Phase 4
Completed	`NCT03261830` - Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)	Phase 4
Recruiting	`NCT04122781` - Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices	N/A
Enrolling by invitation	`NCT06187584` - SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.