Supracondylar Humerus FractureNCT01808183
Pediatric Supracondylar Humerus Fracture NIRS Study
An observational study of Supracondylar Humerus Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Supracondylar Humerus Fracture
- What is being tested?
- Near Infrared Spectroscopy Pads
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children presenting to the Levine Children's Hospital / CMC Emergency Department with displaced supracondylar fractures.
Who may be able to join
- supracondylar humerus fracture needing operative treatment
- ages 2-17
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas HealthCare System: Levine Children's Hospital
Charlotte, North Carolina, 28204
About this study
Official title: Near Infrared Spectroscopy for the Evaluation of Pediatric Forearm Compartment Perfusion After Supracondylar Humerus Fracture
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.
Read the detailed 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.
- Conditions
- Supracondylar Humerus Fracture
- Being tested
- Near Infrared Spectroscopy Pads
- Keywords
- supracondylar, pediatric, humerus, NIRS, near Infrared spectroscopy, compartment perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy PadsDevice
Also called NIRS pad, NIRS
NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Near Infrared Spectroscopy Pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes (2)
To correlate NIRS readings with currently utilized methods of assessing perfusion in the upper extremity following supracondylar fractures (palpation of pulse, Doppler vascular examination, capillary refill and pulse oximetry).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
To assess the ability of NIRS measurements of forearm compartment perfusion to detect vascular injury associated with supracondylar fractures in children.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Scannell, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808183
- Sponsor's protocol ID
- 20-10-13B
- Status last verified
- Aug 2017
- First submitted
- 6 Mar 2013
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: undecided
Publications
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.
PubMed 7883927White 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.
PubMed 20502231Choi 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.
PubMed 20032742Lyons 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.
PubMed 10906859Gosens 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.
PubMed 12667778Omid 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.
PubMed 18451407Styf J. Evaluation of injection techniques in recording of intramuscular pressure. J Orthop Res. 1989;7(6):812-6. doi: 10.1002/jor.1100070606.
PubMed 2795320Boody 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.
PubMed 16264116Battaglia 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.
PubMed 12131436Shuler 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.
PubMed 19487513Tobias 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.
PubMed 17414016
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy for the Evaluation of Pediatric Forearm Compartment Perfusion After Supracondylar Humerus Fracture
- ClinicalTrials.gov ID
- NCT01808183
- Acronym / sponsor ID
- 20-10-13B
- Conditions
- Supracondylar Humerus Fracture
- Keywords
- supracondylar, pediatric, humerus, NIRS, near Infrared spectroscopy, compartment perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| supracondylar humerus fractures | – | Device: Near Infrared Spectroscopy PadsAll members of the study will have near Infrared spectroscopy pads placed on their injured and uninjured arms as a part of this study. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children presenting to the Levine Children's Hospital / CMC Emergency Department with displaced supracondylar fractures.
Key inclusion criteria (2 listed)
- supracondylar humerus fracture needing operative treatment
- ages 2-17
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared Spectroscopy PadsAlso: NIRS pad, NIRSNIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia. | Device | supracondylar humerus fractures |
Primary outcome
To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
2 secondary outcomes
To correlate NIRS readings with currently utilized methods of assessing perfusion in the upper extremity following supracondylar fractures (palpation of pulse, Doppler vascular examination, capillary refill and pulse oximetry).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
To assess the ability of NIRS measurements of forearm compartment perfusion to detect vascular injury associated with supracondylar fractures in children.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 7883927Campbell 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.
- Background: PubMed 20502231White 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.
- Background: PubMed 20032742Choi 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.
- Background: PubMed 10906859Lyons 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.
- Background: PubMed 12667778Gosens 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.
- Background: PubMed 18451407Omid 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.
- Background: PubMed 2795320Styf J. Evaluation of injection techniques in recording of intramuscular pressure. J Orthop Res. 1989;7(6):812-6. doi: 10.1002/jor.1100070606.
- Background: PubMed 16264116Boody 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.
- Background: PubMed 12131436Battaglia 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.
- Background: PubMed 19487513Shuler 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.
- Background: PubMed 17414016Tobias 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.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Scannell, MD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supracondylar Humerus Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808183, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.