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

17. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervensjonsgruppe
Fremgangsmåte: Femoral venting+ intramedullary nailing
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Fremgangsmåte: Standard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation
Aktiv komparator: Kontrollgruppe
Fremgangsmåte: Standard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
Tidsramme: 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)

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Texas Health Science Center, Houston

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

17. august 2026

Først lagt ut (Faktiske)

21. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HSC-MS-26-0228

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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