Trial Outcomes & Findings for A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events (NCT NCT00736125)

NCT ID: NCT00736125

Last Updated: 2019-09-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: During surgery
• Results posted on: 2019-09-26

Participant Flow

during pre-op workup for TKA, patients were informed about study and asked if they wanted to participate.

Participant milestones

Measure	1 Pulsatile Saline Lavage pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage	2 Carbon Dioxide Lavage carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Overall Study STARTED	10	10
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	1 Pulsatile Saline Lavage n=10 Participants pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage	2 Carbon Dioxide Lavage n=10 Participants carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 3.3 • n=5 Participants	63.9 years STANDARD_DEVIATION 3.7 • n=7 Participants	63.1 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: During surgery

Outcome measures

Measure	1 Pulsatile Saline Lavage n=7 Participants pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage	2 Carbon Dioxide Lavage n=6 Participants carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)	0 emboli	3 emboli

SECONDARY outcome

Timeframe: During surgery

Outcome measures

Measure	1 Pulsatile Saline Lavage n=9 Participants pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage	2 Carbon Dioxide Lavage n=8 Participants carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Number of Patients With Emboli in the High Category	9 Patients w/ emboli in high category	5 Patients w/ emboli in high category

SECONDARY outcome

Timeframe: First 3 days after surgery

Outcome measures

Measure	1 Pulsatile Saline Lavage n=10 Participants pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage	2 Carbon Dioxide Lavage n=10 Participants carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Number of Patients With Delirium During Hospital Stay	1 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months following surgery

Hopkins Verbal Learning Test (HVLT).This is a test of verbal learning and memory.

The scale is the number of words retained. The total score for the test administered ranges from 0 to 12. Higher values represent better outcomes.

Outcome measures

Measure	1 Pulsatile Saline Lavage n=9 Participants pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage	2 Carbon Dioxide Lavage n=10 Participants carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Changes in Neurocognitive Tests Following Surgery	1.67 score on a scale Standard Error 1.6	4.7 score on a scale Standard Error 1.5

Adverse Events

1 Pulsatile Saline Lavage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Carbon Dioxide Lavage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Terri Monk

Duke University Medical Center

Phone: 919-286-6938

Email: terri.monk@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place