Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound

NCT ID: NCT05971745

Last Updated: 2024-08-22

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

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-15

Study Completion Date

2024-04-25

Brief Summary

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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

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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

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Hip Effusion Septic Arthritis Transient Synovitis, Hip

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Newark Beth Israel Medical Center

OTHER

Sponsor Role collaborator

Cohen Children's Medical Center

OTHER

Sponsor Role collaborator

Gold Coast Hospital and Health Service

OTHER_GOV

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ruchika Jones

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruchika M Jones, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's

Locations

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Ruchika M Jones

Hartford, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Cohen Children's Medical Center

New Hyde Park, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Gold Coast Hospital and Health Service

Southport, Queensland, Australia

Site Status

Countries

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United States Australia

References

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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.

Reference Type RESULT
PMID: 16757758 (View on PubMed)

Kocher 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.

Reference Type RESULT
PMID: 10608376 (View on PubMed)

Klein 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.

Reference Type RESULT
PMID: 9170376 (View on PubMed)

Del 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.

Reference Type RESULT
PMID: 1443834 (View on PubMed)

Fabry 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.

Reference Type RESULT
PMID: 6630490 (View on PubMed)

Lunseth PA, Heiple KG. Prognosis in septic arthritis of the hip in children. Clin Orthop Relat Res. 1979 Mar-Apr;(139):81-5.

Reference Type RESULT
PMID: 455855 (View on PubMed)

Hallel T, Salvati EA. Septic arthritis of the hip in infancy: end result study. Clin Orthop Relat Res. 1978 May;(132):115-28.

Reference Type RESULT
PMID: 307996 (View on PubMed)

Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.

Reference Type RESULT
PMID: 1499198 (View on PubMed)

Kocher 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.

Reference Type RESULT
PMID: 15292409 (View on PubMed)

Cruz 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.

Reference Type RESULT
PMID: 29581924 (View on PubMed)

Plumb 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.

Reference Type RESULT
PMID: 25560622 (View on PubMed)

Laine 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.

Reference Type RESULT
PMID: 25588046 (View on PubMed)

Ehrendorfer 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.

Reference Type RESULT
PMID: 8623569 (View on PubMed)

Yabunaka 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.

Reference Type RESULT
PMID: 21748477 (View on PubMed)

Agarwal 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.

Reference Type RESULT
PMID: 26189923 (View on PubMed)

Vieira RL, Levy JA. Bedside ultrasonography to identify hip effusions in pediatric patients. Ann Emerg Med. 2010 Mar;55(3):284-9. doi: 10.1016/j.annemergmed.2009.06.527. Epub 2009 Aug 20.

Reference Type RESULT
PMID: 19695738 (View on PubMed)

Luhmann SJ, Jones A, Schootman M, Gordon JE, Schoenecker PL, Luhmann JD. Differentiation between septic arthritis and transient synovitis of the hip in children with clinical prediction algorithms. J Bone Joint Surg Am. 2004 May;86(5):956-62. doi: 10.2106/00004623-200405000-00011.

Reference Type RESULT
PMID: 15118038 (View on PubMed)

Other Identifiers

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19-117

Identifier Type: -

Identifier Source: org_study_id

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