EmbolismRIANCT00509171
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
A study testing Reamer Irrigator Aspirator in people with Embolism and Femoral Fractures, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Embolism, Femoral Fractures
- What is being tested?
- Reamer Irrigator Aspirator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participant aged 16 to 65 years of age
- Skeletally mature
- Isolated, closed femoral shaft fracture (participant may also have sustained a distal radius/wrist, distal tibia/ankle, hand, and/or foot fractures for eligible inclusion)
- Fracture amenable to an antegrade I.M. nail
- Fracture amenable to insertion of a 12 mm RIA
- Fracture ≤ 48 hrs post injury
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- Participant has a 'Thorax' Abbreviated Injury Score (AIS) of < 2
- Participant has a 'Head \& Neck' AIS score of < 2
- Provision of informed consent
Who cannot join
- Fracture proximal to the lesser trochanter
- Open fracture
- Participant has a humeral, tibial, contralateral femoral, spinal,and/or pelvic fracture
- Pathological fracture
- Fractures > 48 hrs post injury
- Limited life expectancy due to significant medical co-morbidities
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- Previous history of esophageal/gastric surgery
- Previous history of esophageal/gastric tumor
- Previous history of esophageal varices
- Medical contraindication to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial Investigating the Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism and Respiratory Function During Intramedullary Nailing of Femoral Shaft Fractures
The purpose of this study is to determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures
Read the detailed description
The current practice of reaming the medullary canal for the fixation of femur fractures is recommended, however, there is an associated increase in the level of embolic events which confers morbidity and, occasionally, mortality.
The RIA is a single device which is able to ream the medullary canal, irrigate the canal and subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and other contents responsible for these adverse embolic events.
A novel Reamer-Irrigator-Aspirator (RIA) (Synthes, Inc) will be evaluated in a randomized study, to determine its effect on the incidence of fat emboli events during reamed IM nail fixation of consecutive femoral shaft fractures as measured by intra-operative transesophageal echocardiogram and pulmonary function.
- Conditions
- Embolism, Femoral Fractures
- Being tested
- Reamer Irrigator Aspirator
- Keywords
- embolism, femur fracture, lavage, TEE, reamer, IM nail
- Medical subject headings
- Embolism, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reamer Irrigator AspiratorDevice
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
| Study group | Role | What they receive |
|---|---|---|
| 1-Standard reamer | Active comparator | Standard reamer Receives: Device: Reamer Irrigator Aspirator |
| 2-Use of the Reamer-Irrigator Aspirator | Active comparator | Use of the Reamer-Irrigator Aspirator Receives: Device: Reamer Irrigator Aspirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Embolic Debris
The differences in total emboli score (Embolism Grading Scal3) between the 2 experimental groups were analyzed with a 2-sample 2-tailed t test.
Embolism Grading Scale:
Amount: Amount of right atrium fill by echogenic particles none = 0 less than ½ = 1 more than ½ = 2 complete fill = 3 Duration: Duration of echogenesis during 1-minute video segment (seconds) none = 0 less than 5 seconds = 1 5-30 seconds = 2 over 30 seconds = 3
Size: Diameter of largest echogenic particle (mm):
none = 0 less than 5mm = 1 5-10mm = 2 larger than 10mm = 3 Percent: 0 =no fill
- = less than 66 %
- = greater than 66%
Measured: Duration of surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJan 2005
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EmbolismStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Synthes Inc.
- Responsible party
- Sponsor
- Investigators
- Jeremy A Hall, MD, FRCSC, Principal investigator, Unity Health TorontoEmil Schemitsch, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509171
- Sponsor's protocol ID
- R-6-30-MAR-07
- Acronym
- RIA
- Status last verified
- May 2020
- First submitted
- 30 Jul 2007
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Investigating the Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism and Respiratory Function During Intramedullary Nailing of Femoral Shaft Fractures
- ClinicalTrials.gov ID
- NCT00509171
- Acronym / sponsor ID
- RIA / R-6-30-MAR-07
- Conditions
- Embolism, Femoral Fractures
- Keywords
- embolism, femur fracture, lavage, TEE, reamer, IM nail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Synthes Inc.
- Study start
- Jan 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Posted 7 May 2020
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 determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures
Detailed description
The current practice of reaming the medullary canal for the fixation of femur fractures is recommended, however, there is an associated increase in the level of embolic events which confers morbidity and, occasionally, mortality.
The RIA is a single device which is able to ream the medullary canal, irrigate the canal and subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and other contents responsible for these adverse embolic events.
A novel Reamer-Irrigator-Aspirator (RIA) (Synthes, Inc) will be evaluated in a randomized study, to determine its effect on the incidence of fat emboli events during reamed IM nail fixation of consecutive femoral shaft fractures as measured by intra-operative transesophageal echocardiogram and pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Standard reamer | Active comparator | Device: Reamer Irrigator AspiratorStandard reamer |
| 2-Use of the Reamer-Irrigator Aspirator | Active comparator | Device: Reamer Irrigator AspiratorUse of the Reamer-Irrigator Aspirator |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participant aged 16 to 65 years of age
- Skeletally mature
- Isolated, closed femoral shaft fracture (participant may also have sustained a distal radius/wrist, distal tibia/ankle, hand, and/or foot fractures for eligible inclusion)
- Fracture amenable to an antegrade I.M. nail
- Fracture amenable to insertion of a 12 mm RIA
Key exclusion criteria (10 listed)
- Fracture proximal to the lesser trochanter
- Open fracture
- Participant has a humeral, tibial, contralateral femoral, spinal,and/or pelvic fracture
- Pathological fracture
- Fractures > 48 hrs post injury
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 |
|---|---|---|
| Reamer Irrigator AspiratorUse of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures | Device | 1-Standard reamer, 2-Use of the Reamer-Irrigator Aspirator |
Primary outcome
Measurement of Embolic Debris
Time frame: Duration of surgical procedure.
The differences in total emboli score (Embolism Grading Scal3) between the 2 experimental groups were analyzed with a 2-sample 2-tailed t test. Embolism Grading Scale: Amount: Amount of right atrium fill by echogenic particles none = 0 less than ½ = 1 more than ½ = 2 complete fill = 3 Duration: Duration of echogenesis during 1-minute video segment (seconds) none = 0 less than 5 seconds = 1 5-30 seconds = 2 over 30 seconds = 3 Size: Diameter of largest echogenic particle (mm): none = 0 less than 5mm = 1 5-10mm = 2 larger than 10mm = 3 Percent: 0 =no fill 1. = less than 66 % 2. = greater than 66%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Jeremy A Hall, MD, FRCSC principal investigator
Unity Health Toronto
Emil Schemitsch principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reamer Irrigator Aspirator in people with Embolism and Femoral Fractures, run by Unity Health Toronto at 1 site in Canada.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 14 May 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Embolic Debris (time frame: Duration of surgical procedure.). 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 14 May 2020.