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

NCT05971745 | Completed

• 1 other identifier: 19-117
• Study Type: observational
• Target: 161
• Locations: 2 countries
• Sites: 6

Brief 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).

Conditions

Hip Effusion; Septic Arthritis; Transient Synovitis, Hip

Keywords

Point of Care Ultrasound; Hip Effusion; Pediatric Emergency Medicine

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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.

  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.

  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.

Other Outcomes (2)

• Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.

  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.

• Association between point-of-care ultrasound and Kocher score (0-4).

  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.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• Columbia University: collaborator
• Newark Beth Israel Medical Center: collaborator
• Cohen Children's Medical Center: collaborator
• Gold Coast Hospital and Health Service: collaborator
• Yale University: collaborator

Study Sites (6)

Ruchika M Jones

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06550, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Cohen Children's Medical Center

New Hyde Park, New York, 11042, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Gold Coast Hospital and Health Service

Southport, Queensland, 4211, Australia

Location

Related Publications (17)

• 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.

  PMID: 16757758 RESULT

• 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.

  PMID: 10608376 RESULT

• 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.

  PMID: 9170376 RESULT

• 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.

  PMID: 1443834 RESULT

• 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.

  PMID: 6630490 RESULT

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

  PMID: 455855 RESULT

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

  PMID: 307996 RESULT

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

  PMID: 1499198 RESULT

• 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.

  PMID: 15292409 RESULT

• 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.

  PMID: 29581924 RESULT

• 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.

  PMID: 25560622 RESULT

• 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.

  PMID: 25588046 RESULT

• 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.

  PMID: 8623569 RESULT

• 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.

  PMID: 21748477 RESULT

• 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.

  PMID: 26189923 RESULT

• 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.

  PMID: 19695738 RESULT

• 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.

  PMID: 15118038 RESULT

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Ruchika M Jones, MD, MS

  Connecticut Children's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 2, 2023
• Study Start: October 15, 2019
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Shared as patients are seen throughout the course of the study.
• Access Criteria: Only the designated study investigator at each participating site will have Redcap access for purposes of data entry only. Primary investigators at the lead site will have access to the combined data set for data analyses.

Locations

US (5); AU (1)