NCT00509171

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

May 7, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

8 years

First QC Date

July 30, 2007

Results QC Date

April 2, 2019

Last Update Submit

May 6, 2020

Conditions

EmbolismFemoral Fractures

Keywords

embolismfemur fracturelavageTEEreamerIM nail

Outcome Measures

Primary Outcomes (1)

  • 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%

    Duration of surgical procedure.

Study Arms (2)

1-Standard reamer

ACTIVE COMPARATOR

Standard reamer

Device: Reamer Irrigator Aspirator

2-Use of the Reamer-Irrigator Aspirator

ACTIVE COMPARATOR

Use of the Reamer-Irrigator Aspirator

Device: Reamer Irrigator Aspirator

Interventions

Reamer Irrigator AspiratorDEVICE

Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures

1-Standard reamer2-Use of the Reamer-Irrigator Aspirator

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant aged 16 to 65 years of age
  • Skeletally mature
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

MeSH Terms

Conditions

EmbolismFemoral Fractures

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesFractures, BoneWounds and InjuriesLeg Injuries

Results Point of Contact

Title
Emil H. Schemitsch, MD, FRCS
Organization
London Health Sciences Centre
emil.schemistch@lhsc.on.ca
5196633349

Study Officials

  • Jeremy A Hall, MD, FRCSC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Emil Schemitsch

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

January 1, 2005

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 14, 2020

Results First Posted

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)