NCT00815958

Brief Summary

The embolisation of fat and bone marrow during long bone instrumentation is a well-known complication of major joint replacement surgery. Clinically significant venous thromboembolic disease, cardiopulmonary dysfunction,cerebral emboli, and death have all been described. Because the intravasation of medullary contents is caused by increased pressure during canal instrumentation, the use of the Synthes RIA (Reamer-Irrigator-Aspirator), a negative pressure-irrigated high-speed reamer, may result in a lower incidence of embolism. This controlled clinical trial will evaluate the utility of the RIA in reducing the frequency and severity of embolic events as detected by intraoperative transesophageal echocardiography (TEE) and transcranial Doppler (TCD) during total knee arthroplasty (TKA) surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

December 30, 2008

Last Update Submit

January 20, 2017

Conditions

Total Knee Replacement

Keywords

knee replacement surgeryReamer-Irrigator-Aspiratorfemoral reamingfat embolism

Outcome Measures

Primary Outcomes (1)

  • The incidence of intraoperative embolic events detected with transesophageal echocardiography and transcranial Doppler and the grade or size of these embolic events

    During surgery

Secondary Outcomes (1)

  • Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation.

    Post-surgery

Study Arms (2)

A

EXPERIMENTAL

Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)

Procedure: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)

B

ACTIVE COMPARATOR

Reaming with conventional reamer

Procedure: Reaming with conventional reamer

Interventions

Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)PROCEDURE

During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the RIA group (Arm A), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines up until femoral reaming. These patients will receive reaming with RIA. The remainder of the surgery will also be done according to the standard of care. TEE and TCD data will be recorded throughout the surgery.

Also known as: Synthes Reamer-Irrigator-Aspirator, RIA
A
Reaming with conventional reamerPROCEDURE

During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the control group (Arm B), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines. These patients will receive reaming with the conventional method/reamer. TEE and TCD data will be recorded throughout the surgery.

Also known as: Synthes Reamer-Irrigator-Aspirator, RIA
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is 18 years of age or older
  • Scheduled or soon to be scheduled for elective total knee replacement surgery
  • No previous history of hip or (ipsilateral) knee replacement

You may not qualify if:

  • Subject is under 18
  • Prior instrumentation of the medullary canal (knee or hip)
  • History of esophageal or GI disease or other contraindication for TEE
  • Previous history of DVT
  • Currently on anti-coagulant therapy (i.e. Coumadin or others)
  • Currently on supplemental oxygen or SpO2 is below 90 on room air
  • Cognitive or language barriers limiting comprehension of study materials in English
  • Subject is pregnant or planning pregnancy
  • Current or impending incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center, University Hospital East

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Embolism, Fat

Condition Hierarchy (Ancestors)

EmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Cornel Van Gorp, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2008

First Posted

December 31, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(1)