Embolism, Femoral Fractures
Conditions
Keywords
embolism, femur fracture, lavage, TEE, reamer, IM nail
Brief 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
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.
Interventions
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Sponsors
Orthopaedic Trauma Association
Synthes Inc.
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Participant has a 'Thorax' Abbreviated Injury Score (AIS) of \< 2 * Participant has a 'Head & Neck' AIS score of \< 2 * Provision of informed consent
Exclusion criteria
* 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 * Previous history of esophageal/gastric surgery * Previous history of esophageal/gastric tumor * Previous history of esophageal varices * Medical contraindication to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Embolic Debris | 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% |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-Standard Reamer Standard reamer
Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures | 11 |
| 2-Use of the Reamer-Irrigator Aspirator Use of the Reamer-Irrigator Aspirator
Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | 1-Standard Reamer | 2-Use of the Reamer-Irrigator Aspirator | Total |
|---|---|---|---|
| Age, Continuous | 39.2 years | 39.2 years | 39.2 years |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 11 | 1 / 11 |
| serious Total, serious adverse events | 2 / 11 | 2 / 11 |
Outcome results
Primary
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 1. = less than 66 % 2. = greater than 66%
Time frame: Duration of surgical procedure.
Population: Antegrade IM nailing of a femoral shaft fracture with standard reamers or the RIA device. All patients were monitored intraoperatively with a continuous TEE to assess embolic events in the right atrium. Total emboli score was measured when using the RIA device during the REAM
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Standard Reamer | Measurement of Embolic Debris | 5.3 score on a scale | Standard Deviation 1.81 |
| 2-Use of the Reamer-Irrigator Aspirator | Measurement of Embolic Debris | 4.05 score on a scale | Standard Deviation 2.19 |