N/A
N=20
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
Postoperative Complications · Memory Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00736125 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) — 0; 3 emboli
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pulsatile saline lavage (Device); carbon dioxide lavage (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Kinamed Incorporated
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) |
0; 3 | — |
| SECONDARY Number of Patients With Emboli in the High Category |
9; 5 | — |
| SECONDARY Number of Patients With Delirium During Hospital Stay |
1; 4 | >0.05 |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00736125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.