Pediatric Supracondylar Humerus Fracture NIRS Study

NCT ID: NCT01808183

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Supracondylar Humerus Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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supracondylar humerus fractures

All members of the study will have near Infrared spectroscopy pads placed on their injured and uninjured arms as a part of this study.

Near Infrared Spectroscopy Pads

Intervention Type DEVICE

NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.

Interventions

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Near Infrared Spectroscopy Pads

NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.

Intervention Type DEVICE

Other Intervention Names

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NIRS pad NIRS

Eligibility Criteria

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Inclusion Criteria

* supracondylar humerus fracture needing operative treatment
* ages 2-17

Exclusion Criteria

* Bilateral (both sides) arm injuries
* Other injuries to the same arm
* Open fractures
* Previous vascular (blood vessels) injury to the upper extremity (arm)
* Vascular disease or insufficiency
* Not willing to consent to participate
* Only having one arm
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Scannell, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

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Carolinas HealthCare System: Levine Children's Hospital

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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Campbell CC, Waters PM, Emans JB, Kasser JR, Millis MB. Neurovascular injury and displacement in type III supracondylar humerus fractures. J Pediatr Orthop. 1995 Jan-Feb;15(1):47-52. doi: 10.1097/01241398-199501000-00011.

Reference Type BACKGROUND
PMID: 7883927 (View on PubMed)

White L, Mehlman CT, Crawford AH. Perfused, pulseless, and puzzling: a systematic review of vascular injuries in pediatric supracondylar humerus fractures and results of a POSNA questionnaire. J Pediatr Orthop. 2010 Jun;30(4):328-35. doi: 10.1097/BPO.0b013e3181da0452.

Reference Type BACKGROUND
PMID: 20502231 (View on PubMed)

Choi PD, Melikian R, Skaggs DL. Risk factors for vascular repair and compartment syndrome in the pulseless supracondylar humerus fracture in children. J Pediatr Orthop. 2010 Jan-Feb;30(1):50-6. doi: 10.1097/BPO.0b013e3181c6b3a8.

Reference Type BACKGROUND
PMID: 20032742 (View on PubMed)

Lyons ST, Quinn M, Stanitski CL. Neurovascular injuries in type III humeral supracondylar fractures in children. Clin Orthop Relat Res. 2000 Jul;(376):62-7. doi: 10.1097/00003086-200007000-00010.

Reference Type BACKGROUND
PMID: 10906859 (View on PubMed)

Gosens T, Bongers KJ. Neurovascular complications and functional outcome in displaced supracondylar fractures of the humerus in children. Injury. 2003 May;34(4):267-73. doi: 10.1016/s0020-1383(02)00312-1.

Reference Type BACKGROUND
PMID: 12667778 (View on PubMed)

Omid R, Choi PD, Skaggs DL. Supracondylar humeral fractures in children. J Bone Joint Surg Am. 2008 May;90(5):1121-32. doi: 10.2106/JBJS.G.01354.

Reference Type BACKGROUND
PMID: 18451407 (View on PubMed)

Styf J. Evaluation of injection techniques in recording of intramuscular pressure. J Orthop Res. 1989;7(6):812-6. doi: 10.1002/jor.1100070606.

Reference Type BACKGROUND
PMID: 2795320 (View on PubMed)

Boody AR, Wongworawat MD. Accuracy in the measurement of compartment pressures: a comparison of three commonly used devices. J Bone Joint Surg Am. 2005 Nov;87(11):2415-22. doi: 10.2106/JBJS.D.02826.

Reference Type BACKGROUND
PMID: 16264116 (View on PubMed)

Battaglia TC, Armstrong DG, Schwend RM. Factors affecting forearm compartment pressures in children with supracondylar fractures of the humerus. J Pediatr Orthop. 2002 Jul-Aug;22(4):431-9.

Reference Type BACKGROUND
PMID: 12131436 (View on PubMed)

Shuler MS, Reisman WM, Whitesides TE Jr, Kinsey TL, Hammerberg EM, Davila MG, Moore TJ. Near-infrared spectroscopy in lower extremity trauma. J Bone Joint Surg Am. 2009 Jun;91(6):1360-8. doi: 10.2106/JBJS.H.00347.

Reference Type BACKGROUND
PMID: 19487513 (View on PubMed)

Tobias JD, Hoernschemeyer DG. Near-infrared spectroscopy identifies compartment syndrome in an infant. J Pediatr Orthop. 2007 Apr-May;27(3):311-3. doi: 10.1097/BPO.0b013e3180326591.

Reference Type BACKGROUND
PMID: 17414016 (View on PubMed)

Other Identifiers

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20-10-13B

Identifier Type: -

Identifier Source: org_study_id

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