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AzTrials

Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)CHEFFNCT06765083

Can we 'Hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures

A study testing POCUS of the hip in people with Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), run by Frisius Medisch Centrum at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
POCUS of the hip
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteNetherlands
Study dates
11 Jan 2025to 11 Feb 2026
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

Other trials in Netherlands

About this study

Official title: Can we 'Hear' Femoral Neck Fractures? Ultrasound Guided Diagnosis of Femoral Neck Fractures.

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.

Read the detailed description

Rationale: 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).

Objective: Our primary objective 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.

Study design: Prospective cohort study. Study population: All patients aged 18 and older presenting to the ED with a painful hip after trauma suspected of hip fracture are eligible to be enrolled in this study.

Intervention: Patients enrolled in the study will undergo POCUS of the hip (femoral neck) by the (resident) emergency physician, prior to radiograph imaging.

Main study parameters/endpoints: Sensitivity, specificity, positive predicting value (PPV) and negative predicting value (NPV) of POCUS in detecting hip fractures by assessing for posttraumatic changes (cortical disruptions, joint effusion and peritrochanteric edema).

Informed consent will be requested and documented.

Being tested
POCUS of the hip
Keywords
femoral neck, pertrochanteric, hip, fracture, POCUS, ultrasound, diagnostic, Emergency Department, proximal femur
Medical subject headings
Hip Fractures, Fractures, Bone, Disease, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POCUS of the hipDiagnostic test

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

Study groups in NCT06765083
Study groupRoleWhat they receive
All participantsExperimentalAll patients enrolled in the study will undergo POCUS of the hip by the (resident) emergency physician, prior to radiograph imaging.
Receives: Diagnostic Test: POCUS of the hip

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (4)
  1. Difference in diagnostic accuracy of POCUS in diagnosing a femoral neck or pertrochanteric fracture

    Difference in diagnostic accuracy (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in diagnosing a femoral neck or pertrochanteric fracture

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

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

    Difference in diagnostic accuracy (sensitivity, specificity, negative predicting value (NPV) and positive predicting value (PPV)) of POCUS in detecting hip fractures stratified by operator experience (in years) using POCUS

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

  3. Difference in effusion measured in mm between the ipsilateral and contralateral hip

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

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

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

    Evaluate the added value of POCUS in detecting hip fractures compared to the likelihood determined through clinical assessment by the treating physician (questionnaire: hip fracture clinical suspected yes or no)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start11 Jan 2025
  3. Primary completion20 Nov 2025
  4. Study completion11 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765083
Sponsor's protocol ID
202400397
Acronym
CHEFF
Status last verified
Feb 2026
First submitted
3 Dec 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26511519
  • Koski JM, Anttila PJ, Isomaki HA. Ultrasonography of the adult hip joint. Scand J Rheumatol. 1989;18(2):113-7. doi: 10.3109/03009748909099926.

    PubMed 2660254
  • Cohen A, Li T, Greco J, Stankard B, Mingione P, Huang V, Gold A, Zarider N, Nutovits A, Nelson M. Hip effusions or iliopsoas hematomas on ultrasound in identifying hip fractures in the emergency department. Am J Emerg Med. 2023 Feb;64:129-136. doi: 10.1016/j.ajem.2022.11.034. Epub 2022 Dec 1.

    PubMed 36521235
  • 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.

    PubMed 24582925
  • 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.

    PubMed 31229391
  • 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.

    PubMed 26354332
  • 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.

    PubMed 26330019
  • 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.

    PubMed 32393287
  • 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.

    PubMed 26587053
  • 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.

    PubMed 26403984
  • 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.

    PubMed 28669695
  • 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.

    PubMed 29202925
  • 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.

    PubMed 27916021
  • Landelijke Traumaregistratie 2018 - 2022, Landelijk Netwerk Acute zorg. Publicated September 2023.

Questions about this trial

What is this clinical trial studying?

A study testing POCUS of the hip in people with Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), run by Frisius Medisch Centrum at 1 site in Netherlands.

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 5 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 23 Jul 2026. 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 Netherlands. 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?

Diagnostic accuracy of POCUS (time frame: From enrollment to the end of POCUS, approximately 10 to 30 minutes). 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 NCT06765083, which also lists 14 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 23 Jul 2026.

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