Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Synthes Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Standard reamer | Active Comparator | Standard reamer |
|
| 2-Use of the Reamer-Irrigator Aspirator | Active Comparator | Use of the Reamer-Irrigator Aspirator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reamer Irrigator Aspirator | Device | Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Duration of surgical procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeremy A Hall, MD, FRCSC | Unity Health Toronto | Principal Investigator |
| Emil Schemitsch | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1-Standard Reamer | Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1-Standard Reamer | Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures |
| BG001 | 2-Use of the Reamer-Irrigator Aspirator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| 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 | Posted | Mean | Standard Deviation | score on a scale | Duration of surgical procedure. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-Standard Reamer | Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| prolonged intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | prolonged intubation due to oxygen desaturation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hardware irritation | Musculoskeletal and connective tissue disorders | Systematic Assessment | local irritation near proximal locking screws, which resolved with locking screw removal |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emil H. Schemitsch, MD, FRCS | London Health Sciences Centre | 5196633349 | emil.schemistch@lhsc.on.ca |
Not provided
| ID | Term |
|---|---|
| D004617 | Embolism |
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Use of the Reamer-Irrigator Aspirator
Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 1-Standard Reamer |
Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures |
| OG001 | 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 |
|
|
| 2 |
| 11 |
| 3 |
| 11 |
| EG001 | 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 | 2 | 11 | 1 | 11 |
|
| femoral neck fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
|
| decrease in hemoglobin | Blood and lymphatic system disorders | Systematic Assessment | decrease in hemoglobin requiring transfusion on day 2 postoperatively |
|
Not provided
| D014947 |
| Wounds and Injuries |
| D007869 | Leg Injuries |