N/A
Completed N=20
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
Postoperative Complications · Memory Disorders
Source: ClinicalTrials.gov NCT00736125 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) — 0; 3 emboli
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.
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 |
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. Informational only — not medical advice.