Hip EffusionNCT05971745
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
An observational study of Hip Effusion and Septic Arthritis, run by Connecticut Children's Medical Center at 6 sites in 2 countries.
Trial summary
The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hip Effusion, Septic Arthritis, Transient Synovitis, Hip
- How many people
- 161 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 Oct 2019to 25 Apr 2024
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The target population are children 18 years and younger presenting to the Emergency Department at Connecticut Children's Medical Center with a chief complaint that necessitates hip ultrasonography as determined by the physician caring for the patient at the time of the visit. Those presenting during the study period of October 2019-December 2023 will be recruited. This is a multi-center, international study that will also be conducted in the Pediatric Emergency Departments at the following institutions: Connecticut Children's, Cohen Children's Medical Center, New York-Presbyterian / Columbia University Medical Center, Yale New Haven Hospital, Newark Beth Israel Medical Center, and Gold Coast Hospital (Queensland, Australia).
Who may be able to join
- Age 18 years or younger
- Clinical presentation necessitating hip ultrasonography as determined by the evaluating clinician
- Study physician available at the time of presentation to ED
- Patient or legal guardian provides consent
Who cannot join
- Children who present when a study physician is not available or those for whom consent is not given.
- Children who have had hip ultrasound imaging prior to their ED visit. Children with prior hip/pelvis x-rays will not be excluded.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Ruchika M Jones
Hartford, Connecticut, 06106
Yale University
New Haven, Connecticut, 06550
Cohen Children's Medical Center
New Hyde Park, New York, 11042
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Australia1 site
Gold Coast Hospital and Health Service
Southport, Queensland, 4211
About this study
The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).
Read the detailed description
The purpose of this study is to determine that the accuracy of trained pediatric emergency medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the investigators seek to compare how POCUS performs against other clinical tests or investigations for the diagnosis of septic arthritis. The investigators hypothesize that trained EM providers will be able to diagnose hip effusions with high (>90%) accuracy compared to studies conducted by the Department of Radiology.
- Conditions
- Hip Effusion, Septic Arthritis, Transient Synovitis, Hip
- Keywords
- Point of Care Ultrasound, Hip Effusion, Pediatric Emergency Medicine
- Medical subject headings
- Arthritis, Infectious
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of a hip effusion.
The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).
Measured: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.
The presence of absence of a hip effusion.
The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.
Measured: From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.
Secondary outcomes (2)
The size of the effusion.
As measured by the pediatric emergency medicine provider in millimeters.
Measured: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years
The location of the measurement of the effusion.
Pediatric emergency medicine physicians will measure an effusion at two designated locations. One location is based off of current published literature whereas the second is to provide a comparison to determine if the exact location alters the final diagnosis (effusion or no effusion). Investigators will determine whether the location along the angle of the neck affects the measurement obtained when compared with the current standard practice of measuring fluid along the widest part of the femoral neck.
Measured: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start15 Oct 2019
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hip EffusionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Newark Beth Israel Medical Center, Cohen Children's Medical Center, Gold Coast Hospital and Health Service, Yale University
- Responsible party
- Principal investigator, Ruchika Jones, Connecticut Children's Medical Center
- Investigators
- Ruchika M Jones, MD, MS, Principal investigator, Connecticut Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971745
- Sponsor's protocol ID
- 19-117
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Each study site will enter data into Redcap hosted by the lead site, Connecticut Children's. Data will be available for review and combined by Connecticut Children's investigators for data analysis. Each participating site has completed a data use agreement with the lead site agreeing to this plan.
Publications
Caird MS, Flynn JM, Leung YL, Millman JE, D'Italia JG, Dormans JP. Factors distinguishing septic arthritis from transient synovitis of the hip in children. A prospective study. J Bone Joint Surg Am. 2006 Jun;88(6):1251-7. doi: 10.2106/JBJS.E.00216.
PubMed 16757758Kocher MS, Zurakowski D, Kasser JR. Differentiating between septic arthritis and transient synovitis of the hip in children: an evidence-based clinical prediction algorithm. J Bone Joint Surg Am. 1999 Dec;81(12):1662-70. doi: 10.2106/00004623-199912000-00002.
PubMed 10608376Klein DM, Barbera C, Gray ST, Spero CR, Perrier G, Teicher JL. Sensitivity of objective parameters in the diagnosis of pediatric septic hips. Clin Orthop Relat Res. 1997 May;(338):153-9. doi: 10.1097/00003086-199705000-00022.
PubMed 9170376Del Beccaro MA, Champoux AN, Bockers T, Mendelman PM. Septic arthritis versus transient synovitis of the hip: the value of screening laboratory tests. Ann Emerg Med. 1992 Dec;21(12):1418-22. doi: 10.1016/s0196-0644(05)80052-6.
PubMed 1443834Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.
PubMed 6630490Lunseth PA, Heiple KG. Prognosis in septic arthritis of the hip in children. Clin Orthop Relat Res. 1979 Mar-Apr;(139):81-5.
PubMed 455855Hallel T, Salvati EA. Septic arthritis of the hip in infancy: end result study. Clin Orthop Relat Res. 1978 May;(132):115-28.
PubMed 307996Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.
PubMed 1499198Kocher MS, Mandiga R, Zurakowski D, Barnewolt C, Kasser JR. Validation of a clinical prediction rule for the differentiation between septic arthritis and transient synovitis of the hip in children. J Bone Joint Surg Am. 2004 Aug;86(8):1629-35. doi: 10.2106/00004623-200408000-00005.
PubMed 15292409Cruz AI Jr, Anari JB, Ramirez JM, Sankar WN, Baldwin KD. Distinguishing Pediatric Lyme Arthritis of the Hip from Transient Synovitis and Acute Bacterial Septic Arthritis: A Systematic Review and Meta-analysis. Cureus. 2018 Jan 25;10(1):e2112. doi: 10.7759/cureus.2112.
PubMed 29581924Plumb J, Mallin M, Bolte RG. The role of ultrasound in the emergency department evaluation of the acutely painful pediatric hip. Pediatr Emerg Care. 2015 Jan;31(1):54-8; quiz 59-61. doi: 10.1097/PEC.0000000000000332.
PubMed 25560622Laine JC, Denning JR, Riccio AI, Jo C, Joglar JM, Wimberly RL. The use of ultrasound in the management of septic arthritis of the hip. J Pediatr Orthop B. 2015 Mar;24(2):95-8. doi: 10.1097/BPB.0000000000000134.
PubMed 25588046Ehrendorfer S, LeQuesne G, Penta M, Smith P, Cundy P. Bilateral synovitis in symptomatic unilateral transient synovitis of the hip: an ultrasonographic study in 56 children. Acta Orthop Scand. 1996 Apr;67(2):149-52. doi: 10.3109/17453679608994660.
PubMed 8623569Yabunaka K, Ohue M, Morimoto N, Kitano N, Shinohara K, Takamura M, Gotanda T, Sanada S. Sonographic measurement of transient synovitis in children: diagnostic value of joint effusion. Radiol Phys Technol. 2012 Jan;5(1):15-9. doi: 10.1007/s12194-011-0128-z. Epub 2011 Jul 12.
PubMed 21748477Agarwal A, Aggarwal AN. Bone and Joint Infections in Children: Septic Arthritis. Indian J Pediatr. 2016 Aug;83(8):825-33. doi: 10.1007/s12098-015-1816-1. Epub 2015 Jul 21.
PubMed 26189923
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
- ClinicalTrials.gov ID
- NCT05971745
- Acronym / sponsor ID
- 19-117
- Conditions
- Hip Effusion, Septic Arthritis, Transient Synovitis, Hip
- Keywords
- Point of Care Ultrasound, Hip Effusion, Pediatric Emergency Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- Columbia University, Newark Beth Israel Medical Center, Cohen Children's Medical Center, Gold Coast Hospital and Health Service, Yale University
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- 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 determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).
Detailed description
The purpose of this study is to determine that the accuracy of trained pediatric emergency medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the investigators seek to compare how POCUS performs against other clinical tests or investigations for the diagnosis of septic arthritis. The investigators hypothesize that trained EM providers will be able to diagnose hip effusions with high (>90%) accuracy compared to studies conducted by the Department of Radiology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The target population are children 18 years and younger presenting to the Emergency Department at Connecticut Children's Medical Center with a chief complaint that necessitates hip ultrasonography as determined by the physician caring for the patient at the time of the visit. Those presenting during the study period of October 2019-December 2023 will be recruited. This is a multi-center, international study that will also be conducted in the Pediatric Emergency Departments at the following institutions: Connecticut Children's, Cohen Children's Medical Center, New York-Presbyterian / Columbia University Medical Center, Yale New Haven Hospital, Newark Beth Israel Medical Center, and Gold Coast Hospital (Queensland, Australia).
Key inclusion criteria (4 listed)
- Age 18 years or younger
- Clinical presentation necessitating hip ultrasonography as determined by the evaluating clinician
- Study physician available at the time of presentation to ED
- Patient or legal guardian provides consent
Key exclusion criteria (2 listed)
- Children who present when a study physician is not available or those for whom consent is not given.
- Children who have had hip ultrasound imaging prior to their ED visit. Children with prior hip/pelvis x-rays will not be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence or absence of a hip effusion.
Time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.
The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).
The presence of absence of a hip effusion.
Time frame: From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.
The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.
2 secondary outcomes
The size of the effusion.
Time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years
The location of the measurement of the effusion.
Time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
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 22 Aug 2024.
- Results publication: PubMed 16757758Caird MS, Flynn JM, Leung YL, Millman JE, D'Italia JG, Dormans JP. Factors distinguishing septic arthritis from transient synovitis of the hip in children. A prospective study. J Bone Joint Surg Am. 2006 Jun;88(6):1251-7. doi: 10.2106/JBJS.E.00216.
- Results publication: PubMed 10608376Kocher MS, Zurakowski D, Kasser JR. Differentiating between septic arthritis and transient synovitis of the hip in children: an evidence-based clinical prediction algorithm. J Bone Joint Surg Am. 1999 Dec;81(12):1662-70. doi: 10.2106/00004623-199912000-00002.
- Results publication: PubMed 9170376Klein DM, Barbera C, Gray ST, Spero CR, Perrier G, Teicher JL. Sensitivity of objective parameters in the diagnosis of pediatric septic hips. Clin Orthop Relat Res. 1997 May;(338):153-9. doi: 10.1097/00003086-199705000-00022.
- Results publication: PubMed 1443834Del Beccaro MA, Champoux AN, Bockers T, Mendelman PM. Septic arthritis versus transient synovitis of the hip: the value of screening laboratory tests. Ann Emerg Med. 1992 Dec;21(12):1418-22. doi: 10.1016/s0196-0644(05)80052-6.
- Results publication: PubMed 6630490Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.
- Results publication: PubMed 455855Lunseth PA, Heiple KG. Prognosis in septic arthritis of the hip in children. Clin Orthop Relat Res. 1979 Mar-Apr;(139):81-5.
- Results publication: PubMed 307996Hallel T, Salvati EA. Septic arthritis of the hip in infancy: end result study. Clin Orthop Relat Res. 1978 May;(132):115-28.
- Results publication: PubMed 1499198Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.
- Results publication: PubMed 15292409Kocher MS, Mandiga R, Zurakowski D, Barnewolt C, Kasser JR. Validation of a clinical prediction rule for the differentiation between septic arthritis and transient synovitis of the hip in children. J Bone Joint Surg Am. 2004 Aug;86(8):1629-35. doi: 10.2106/00004623-200408000-00005.
- Results publication: PubMed 29581924Cruz AI Jr, Anari JB, Ramirez JM, Sankar WN, Baldwin KD. Distinguishing Pediatric Lyme Arthritis of the Hip from Transient Synovitis and Acute Bacterial Septic Arthritis: A Systematic Review and Meta-analysis. Cureus. 2018 Jan 25;10(1):e2112. doi: 10.7759/cureus.2112.
- Results publication: PubMed 25560622Plumb J, Mallin M, Bolte RG. The role of ultrasound in the emergency department evaluation of the acutely painful pediatric hip. Pediatr Emerg Care. 2015 Jan;31(1):54-8; quiz 59-61. doi: 10.1097/PEC.0000000000000332.
- Results publication: PubMed 25588046Laine JC, Denning JR, Riccio AI, Jo C, Joglar JM, Wimberly RL. The use of ultrasound in the management of septic arthritis of the hip. J Pediatr Orthop B. 2015 Mar;24(2):95-8. doi: 10.1097/BPB.0000000000000134.
- Individual participant dataSharing planned: Yes. Each study site will enter data into Redcap hosted by the lead site, Connecticut Children's. Data will be available for review and combined by Connecticut Children's investigators for data analysis. Each participating site has completed a data use agreement with the lead site agreeing to this plan.
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.
Ruchika M Jones, MD, MS principal investigator
Connecticut Children's
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Effusion and Septic Arthritis, run by Connecticut Children's Medical Center at 6 sites in 2 countries.
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 4 inclusion and 2 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. 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?
The presence or absence of a hip effusion. (time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.). The study lists 2 primary outcomes in all. 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 NCT05971745, which also lists 17 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 22 Aug 2024.