Femur FractureNCT07778238
Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing
A study testing Femoral venting+ intramedullary nailing and Standard intramedullary nailing in people with Femur Fracture, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Femoral venting+ intramedullary nailing and Standard intramedullary nailing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Stephen J Warner, MD, PhD, (713) 486-6998, Stephen.J.Warner@uth.tmc.edu
Collyn O'Quin, (713) 486-6536, Collyn.OQuin@uth.tmc.edu
About this study
Official title: 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
- Conditions
- Femur Fracture
- Being tested
- Femoral venting+ intramedullary nailing, Standard intramedullary nailing
- Keywords
- prophylactic intramedullary fixation, femoral vent holes
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral venting+ intramedullary nailingProcedure or surgery
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Standard intramedullary nailingProcedure or surgery
Participants will undergo prophylactic intramedullary fixation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Procedure: Femoral venting+ intramedullary nailing; Procedure: Standard intramedullary nailing |
| Control Group | Active comparator | Not described Receives: Procedure: Standard intramedullary nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
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.
Measured: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
Secondary outcomes (13)
Change in Embolic Burden as assessed by change in Heart rate
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: Intraoperative through hospital discharge (about 2 to 3 days after surgery)
Number of participants that need ICU admission
Measured: at hospital discharge (about 2 to 3 days after surgery)
Length of hospital stay
Measured: at hospital discharge (about 2 to 3 days after surgery)
Number of participants with postoperative hematoma
Measured: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with surgical site infection
Measured: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with wound complications
Measured: 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
Measured: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Warner, The University of Texas Health Science Center, Houston
- Investigators
- Stephen J Warner, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778238
- Sponsor's protocol ID
- HSC-MS-26-0228
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07778238
- Acronym / sponsor ID
- HSC-MS-26-0228
- Conditions
- Femur Fracture
- Keywords
- prophylactic intramedullary fixation, femoral vent holes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Femoral venting+ intramedullary nailing, Procedure: Standard intramedullary nailing |
| Control Group | Active comparator | Procedure: Standard intramedullary nailing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of an impending femur fracture requiring prophylactic intramedullary fixation
- Impending fracture secondary to a pathologic process, including:
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral venting+ intramedullary nailingParticipants will undergo femoral venting prior to prophylactic intramedullary fixation . | Procedure or surgery | Intervention Group |
| Standard intramedullary nailingParticipants will undergo prophylactic intramedullary fixation | Procedure or surgery | Control Group, Intervention Group |
Primary outcome
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
Time frame: 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.
13 secondary outcomes
Change in Embolic Burden as assessed by change in Heart rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: Intraoperative through hospital discharge (about 2 to 3 days after surgery)
Number of participants that need ICU admission
Time frame: at hospital discharge (about 2 to 3 days after surgery)
Length of hospital stay
Time frame: at hospital discharge (about 2 to 3 days after surgery)
Number of participants with postoperative hematoma
Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with surgical site infection
Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with wound complications
Time frame: 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
Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen J Warner, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral venting+ intramedullary nailing and Standard intramedullary nailing in people with Femur Fracture, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Aug 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Warner, MD, PhD ((713) 486-6998, Stephen.J.Warner@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE) (time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.