Trial Outcomes & Findings for Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism (NCT NCT00509171)

Results Overview

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%

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Duration of surgical procedure.

Results posted on

2020-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	1-Standard Reamer Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	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
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1-Standard Reamer n=11 Participants Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	2-Use of the Reamer-Irrigator Aspirator n=11 Participants 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 n=22 Participants Total of all reporting groups
Age, Continuous	39.2 years n=5 Participants	39.2 years n=7 Participants	39.2 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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%

Outcome measures

Outcome measures
Measure	1-Standard Reamer n=11 Participants Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	2-Use of the Reamer-Irrigator Aspirator n=11 Participants Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Measurement of Embolic Debris	5.3 score on a scale Standard Deviation 1.81	4.05 score on a scale Standard Deviation 2.19

Adverse Events

1-Standard Reamer

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

2-Use of the Reamer-Irrigator Aspirator

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1-Standard Reamer n=11 participants at risk Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	2-Use of the Reamer-Irrigator Aspirator n=11 participants at risk Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Respiratory, thoracic and mediastinal disorders prolonged intubation	18.2% 2/11 • Number of events 2	0.00% 0/11
Musculoskeletal and connective tissue disorders femoral neck fracture	0.00% 0/11	9.1% 1/11 • Number of events 1
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/11	9.1% 1/11 • Number of events 1

Other adverse events

Other adverse events
Measure	1-Standard Reamer n=11 participants at risk Standard reamer Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures	2-Use of the Reamer-Irrigator Aspirator n=11 participants at risk Use of the Reamer-Irrigator Aspirator Reamer Irrigator Aspirator: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Musculoskeletal and connective tissue disorders hardware irritation	27.3% 3/11 • Number of events 3	9.1% 1/11 • Number of events 1
Blood and lymphatic system disorders decrease in hemoglobin	0.00% 0/11	9.1% 1/11 • Number of events 1

Additional Information

Emil H. Schemitsch, MD, FRCS

London Health Sciences Centre

Phone: 5196633349

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60