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Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing

17 augustus 2026 bijgewerkt door: Stephen Warner, The University of Texas Health Science Center, Houston

Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing: A Feasibility Study

The purpose of this study is to measure intraoperative embolic burden during prophylactic intramedullary nailing of impending femur fractures in patients treated with versus without venting, to find the association between embolic burden and intraoperative physiologic changes, measured using standard anesthesia monitors and charted data, to measure Immediate and short-term cardiopulmonary outcomes assessed during hospitalization and to assess procedure-related complications associated with venting

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Diagnosis of an impending femur fracture requiring prophylactic intramedullary fixation

  • Impending fracture secondary to a pathologic process, including:

    • Long-term bisphosphonate use, or
    • Oncologic disease without radiographic evidence of cortical disruption
  • Ability to provide informed consent

Exclusion Criteria:

  • Inability to obtain adequate intraoperative transthoracic echocardiography (TTE) imaging windows for visualization of right-sided cardiac structures
  • Inability to tolerate or safely undergo TTE monitoring per anesthesia determination
  • Any intraoperative technical limitation preventing reliable echocardiographic data acquisition

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Interventie Groep
Procedure: Femoral venting+ intramedullary nailing
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Procedure: Standard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation
Actieve vergelijker: Controlegroep
Procedure: Standard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
Embolic burden is defined as the presence, frequency, and severity (graded semi-quantitatively) of echogenic embolic events within the right atrium, right ventricle, and pulmonary artery outflow tract.
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in Embolic Burden as assessed by change in Heart rate
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
Change in Embolic Burden as assessed by change in Mean arterial pressure
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
Change in Embolic Burden as assessed by change in oxygen saturation
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
Change in Embolic Burden as assessed by change in end-tidal carbon dioxide
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
Embolic Burden as assessed by change in vasopressor requirement
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
Embolic Burden as assessed by change in arterial blood gas parameters (PaO₂, partial pressure of carbon dioxide in arterial blood(PaCO₂), A-a gradient when obtained as part of clinical care).
Tijdsspanne: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
Need for postoperative vasopressor or respiratory support
Tijdsspanne: Intraoperative through hospital discharge (about 2 to 3 days after surgery)
Intraoperative through hospital discharge (about 2 to 3 days after surgery)
Number of participants that need ICU admission
Tijdsspanne: at hospital discharge (about 2 to 3 days after surgery)
at hospital discharge (about 2 to 3 days after surgery)
Length of hospital stay
Tijdsspanne: at hospital discharge (about 2 to 3 days after surgery)
at hospital discharge (about 2 to 3 days after surgery)
Number of participants with postoperative hematoma
Tijdsspanne: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with surgical site infection
Tijdsspanne: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with wound complications
Tijdsspanne: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with peri-implant fracture or iatrogenic fracture
Tijdsspanne: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The University of Texas Health Science Center, Houston

Onderzoekers

  • Hoofdonderzoeker: Stephen J Warner, MD, PhD, The University of Texas Health Science Center, Houston

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2026

Eerst geplaatst (Werkelijk)

21 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HSC-MS-26-0228

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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