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

NCT ID: NCT06765083

Last Updated: 2025-01-09

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All participants

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

Group Type EXPERIMENTAL

POCUS of the hip

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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POCUS of the hip

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Svenja Haak

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Lisanne M van der Lek, Drs

Role: CONTACT

0031612289385

Svenja L Haak, MD

Role: CONTACT

0031582867466

Facility Contacts

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Svenja L Haak, MD

Role: primary

0031582867466

Svenja L Haak, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26511519 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2660254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36521235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24582925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31229391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26354332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26330019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32393287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26587053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26403984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28669695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29202925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27916021 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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202400397

Identifier Type: -

Identifier Source: org_study_id

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