Can We 'hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures

NCT06765083 | Not Yet Recruiting

• 1 other identifier: 202400397
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Hip (femoral neck and pertrochanteric) fractures account for a significant part of Emergency Department (ED) visits after trauma. Studies suggest that point-of-care ultrasound (POCUS) is a reliable diagnostic tool for fracture assessment. POCUS has several advantages over conventional radiography, such as being portable, cheaper and radiation free. In addition, immediate conversion to ultrasound guided regional anaesthesia upon diagnosis of fracture can improve patient's time to proper analgesia. Moreover, POCUS can potentially be used pre-hospital to rule out hip fractures reducing ED crowding, as well as being a solution for areas where radiography is not readily available (e.g. rural or developing areas). The primary objective of this study, is to evaluate the diagnostic capabilities of POCUS regarding patients with suspected hip fracture after trauma compared to radiography, the current standard of care diagnostic tool.

Conditions

Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)

Keywords

femoral neck; pertrochanteric; hip; fracture; POCUS; ultrasound; diagnostic; Emergency Department; proximal femur

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of POCUS

  Diagnostic accuracy (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in detecting hip fractures by assessing for posttraumatic changes (cortical disruptions, joint effusion and peritrochanteric edema).

  From enrollment to the end of POCUS, approximately 10 to 30 minutes

Secondary Outcomes (4)

• Difference in diagnostic accuracy of POCUS in diagnosing a femoral neck or pertrochanteric fracture

  From enrollment to the end of POCUS, approximately 10 to 30 minutes

• Difference in diagnostic accuracy of POCUS in detecting hip fractures stratified by operator experience (in years) using POCUS

  From enrollment to the end of POCUS, approximately 10 to 30 minutes

• Difference in effusion measured in mm between the ipsilateral and contralateral hip

  From enrollment to the end of POCUS, approximately 10 to 30 minutes

• Added value of POCUS in detecting hip fractures compared to the likelihood determined through clinical assessment by the treating physician

  From enrollment to the end of POCUS, approximately 10 to 30 minutes

Study Arms (1)

All participants

EXPERIMENTAL

All patients enrolled in the study will undergo POCUS of the hip by the (resident) emergency physician, prior to radiograph imaging.

Diagnostic Test: POCUS of the hip

Interventions

POCUS of the hip DIAGNOSTIC_TEST

POCUS of the hip (proximal femur) by the (resident) emergency physician, prior to radiograph imaging.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• presenting to the ED with a painful hip after trauma, suspected of hip fracture as defined by the attending clinician

You may not qualify if:

• History of hip fracture or surgical procedure on the bones of the ipsilateral hip (ultrasound images may be unreliable)
• Presence of foreign body material in the ipsilateral hip
• Skin defects at the POCUS site e.g. lacerations, infected skin
• Extensive injuries, extreme pain or neurovascular damage where urgent intervention is required
• Inability to give informed consent (cognitive impairments, no proficient understanding of the Dutch or English language)

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Related Publications (14)

• Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.

  PMID: 26511519 BACKGROUND

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  PMID: 2660254 BACKGROUND

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  PMID: 36521235 BACKGROUND

• Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.

  PMID: 24582925 BACKGROUND

• Berg LM, Ehrenberg A, Florin J, Ostergren J, Discacciati A, Goransson KE. Associations Between Crowding and Ten-Day Mortality Among Patients Allocated Lower Triage Acuity Levels Without Need of Acute Hospital Care on Departure From the Emergency Department. Ann Emerg Med. 2019 Sep;74(3):345-356. doi: 10.1016/j.annemergmed.2019.04.012. Epub 2019 Jun 20.

  PMID: 31229391 BACKGROUND

• Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016 Jul;18(4):245-52. doi: 10.1017/cem.2015.94. Epub 2015 Sep 10.

  PMID: 26354332 BACKGROUND

• Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.

  PMID: 26330019 BACKGROUND

• Akimoto T, Kobayashi T, Maita H, Osawa H, Kato H. Initial assessment of femoral proximal fracture and acute hip arthritis using pocket-sized ultrasound: a prospective observational study in a primary care setting in Japan. BMC Musculoskelet Disord. 2020 May 11;21(1):291. doi: 10.1186/s12891-020-03326-x.

  PMID: 32393287 BACKGROUND

• Deleanu B, Prejbeanu R, Tsiridis E, Vermesan D, Crisan D, Haragus H, Predescu V, Birsasteanu F. Occult fractures of the proximal femur: imaging diagnosis and management of 82 cases in a regional trauma center. World J Emerg Surg. 2015 Nov 18;10:55. doi: 10.1186/s13017-015-0049-y. eCollection 2015.

  PMID: 26587053 BACKGROUND

• Medero Colon R, Chilstrom ML. Diagnosis of an Occult Hip Fracture by Point-of-Care Ultrasound. J Emerg Med. 2015 Dec;49(6):916-9. doi: 10.1016/j.jemermed.2015.06.077. Epub 2015 Sep 26.

  PMID: 26403984 BACKGROUND

• Pourmand A, Shokoohi H, Maracheril R. Diagnostic accuracy of point-of-care ultrasound in detecting upper and lower extremity fractures: An evidence-based approach. Am J Emerg Med. 2018 Jan;36(1):134-136. doi: 10.1016/j.ajem.2017.06.052. Epub 2017 Jun 27. No abstract available.

  PMID: 28669695 BACKGROUND

• Schmid GL, Lippmann S, Unverzagt S, Hofmann C, Deutsch T, Frese T. The Investigation of Suspected Fracture-a Comparison of Ultrasound With Conventional Imaging. Dtsch Arztebl Int. 2017 Nov 10;114(45):757-764. doi: 10.3238/arztebl.2017.0757.

  PMID: 29202925 BACKGROUND

• Chartier LB, Bosco L, Lapointe-Shaw L, Chenkin J. Use of point-of-care ultrasound in long bone fractures: a systematic review and meta-analysis. CJEM. 2017 Mar;19(2):131-142. doi: 10.1017/cem.2016.397. Epub 2016 Dec 5.

  PMID: 27916021 BACKGROUND

• Landelijke Traumaregistratie 2018 - 2022, Landelijk Netwerk Acute zorg. Publicated September 2023.

  BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Fractures, Bone; Disease; Emergencies

Condition Hierarchy (Ancestors)

Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Lisanne M van der Lek, Drs

CONTACT

0031612289385; lisannevdlek@gmail.com

Svenja L Haak, MD

CONTACT

0031582867466; svenja.haak2@mcl.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)