A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kinamed Incorporated
ClinicalTrials.gov Identifier:
NCT00736125
First received: August 14, 2008
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.


Condition Intervention Phase
Postoperative Complications
Memory Disorders
Device: pulsatile saline lavage
Device: carbon dioxide lavage
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Kinamed Incorporated:

Primary Outcome Measures:
  • The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Patients With Emboli in the High Category [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
  • Changes in Neurocognitive Tests Following Surgery [ Time Frame: 2 weeks prior to 1 year following surgery ] [ Designated as safety issue: No ]
  • Delirium During Hospital Stay [ Time Frame: First 3 days after surgery ] [ Designated as safety issue: No ]
  • Changes in Pulmonary and Renal Function [ Time Frame: Within 3 days after surgery ] [ Designated as safety issue: Yes ]
  • Cardiac Injury [ Time Frame: Within 3 days after surgery ] [ Designated as safety issue: Yes ]
  • Systemic Inflammatory Response (SIRS) Markers [ Time Frame: Within 72 hours after surgery ] [ Designated as safety issue: No ]
  • Biomarkers of Neuronal Damage [ Time Frame: Within 72 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2007
Study Completion Date: March 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: pulsatile saline lavage
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
Active Comparator: 2 Device: carbon dioxide lavage
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage

Detailed Description:

Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.

The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design

Exclusion Criteria:

  • Dementia or severe cognitive impairment
  • Severe visual or hearing impairments
  • Inability to follow directions or comprehend the English language
  • Females who are pregnant
  • Abnormal distal femur geometry
  • Pre-existing hardware or abnormal bony architecture in the proximal tibia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736125

Locations
United States, North Carolina
Veterans Affairs Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Kinamed Incorporated
Investigators
Principal Investigator: Terri G Monk, MD Duke University
  More Information

No publications provided

Responsible Party: Kinamed Incorporated
ClinicalTrials.gov Identifier: NCT00736125     History of Changes
Other Study ID Numbers: 01226
Study First Received: August 14, 2008
Results First Received: March 5, 2013
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Kinamed Incorporated:
postoperative cognitive dysfunction
total knee arthroplasty
cerebral emboli
carbon dioxide lavage
pulsatile saline lavage

Additional relevant MeSH terms:
Memory Disorders
Postoperative Complications
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014