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

17. August 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Interventionsgruppe
Verfahren: Femoral venting+ intramedullary nailing
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Verfahren: Standard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation
Aktiver Komparator: Kontrollgruppe
Verfahren: Standard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change in Embolic Burden as assessed by change in Heart rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at hospital discharge (about 2 to 3 days after surgery)
at hospital discharge (about 2 to 3 days after surgery)
Length of hospital stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The University of Texas Health Science Center, Houston

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. August 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

17. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. August 2026

Zuerst gepostet (Tatsächlich)

21. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HSC-MS-26-0228

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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