RIA: Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT00509171
• Collaborator: Orthopaedic Trauma Association (Other), Synthes Inc. (Industry)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Embolism; Femoral Fractures	Device: Reamer Irrigator Aspirator	N/A

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

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1-Standard reamer Standard reamer	Device: Reamer Irrigator Aspirator; Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Active Comparator: 2-Use of the Reamer-Irrigator Aspirator Use of the Reamer-Irrigator Aspirator	Device: Reamer Irrigator Aspirator; Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures

Outcome Measures

Primary Outcome Measures

1. 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 = less than 66 % = greater than 66%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5C 1R6

Sponsors and Collaborators

• Unity Health Toronto
• Orthopaedic Trauma Association
• Synthes Inc.

Investigators

• Principal Investigator: Jeremy A Hall, MD, FRCSC, Unity Health Toronto
• Principal Investigator: Emil Schemitsch, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT00509171
• Other Study ID Numbers: R-6-30-MAR-07; NCT00753376
• First Posted: Jul 31, 2007
• Last Update Posted: May 14, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Unity Health Toronto: embolism; femur fracture; lavage; TEE; reamer; IM nail
• Additional relevant MeSH terms: Embolism; Embolism, Fat; Fractures, Bone; Femoral Fractures

Study Results

Participant Flow

Arm/Group Title	1-Standard Reamer	2-Use of the Reamer-Irrigator Aspirator
Arm/Group Description	Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Period Title: Overall Study
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	1-Standard Reamer	2-Use of the Reamer-Irrigator Aspirator	Total
Arm/Group Description	Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	Total of all reporting groups
Overall Participants	11	11	22
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	39.2	39.2	39.2
Sex: Female, Male (Count of Participants)
Female	4 36.4%	3 27.3%	7 31.8%
Male	7 63.6%	8 72.7%	15 68.2%

Outcome Measures

1. Primary Outcome

Title	Measurement of Embolic Debris
Description	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%
Time Frame	Duration of surgical procedure.

Outcome Measure Data

Analysis Population Description

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/Group Title	1-Standard Reamer	2-Use of the Reamer-Irrigator Aspirator
Arm/Group Description	Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Measure Participants	11	11
Mean (Standard Deviation) [score on a scale]	5.3 (1.81)	4.05 (2.19)

Adverse Events

Arm/Group Title	1-Standard Reamer		2-Use of the Reamer-Irrigator Aspirator
Arm/Group Description	Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures		Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
All Cause Mortality
	1-Standard Reamer		2-Use of the Reamer-Irrigator Aspirator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1-Standard Reamer		2-Use of the Reamer-Irrigator Aspirator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/11 (18.2%)		2/11 (18.2%)
Musculoskeletal and connective tissue disorders
femoral neck fracture	0/11 (0%)	0	1/11 (9.1%)	1
Respiratory, thoracic and mediastinal disorders
prolonged intubation	2/11 (18.2%)	2	0/11 (0%)	0
pulmonary embolism	0/11 (0%)	0	1/11 (9.1%)	1
Other (Not Including Serious) Adverse Events
	1-Standard Reamer		2-Use of the Reamer-Irrigator Aspirator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)		1/11 (9.1%)
Blood and lymphatic system disorders
decrease in hemoglobin	0/11 (0%)	0	1/11 (9.1%)	1
Musculoskeletal and connective tissue disorders
hardware irritation	3/11 (27.3%)	3	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.