Trial Outcomes & Findings for Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial (NCT NCT01003080)
NCT ID: NCT01003080
Last Updated: 2018-09-21
Results Overview
This is a measure of the average drain output collected in the first 24 hours following surgery.
COMPLETED
NA
111 participants
First 24 hours following surgery.
2018-09-21
Participant Flow
Patients were recruited from the medical clinics of Weiler and Montefiore hospitals under the Montefiore system in the Bronx, NY. Patients undergoing a total knee arthroplasty (TKA) were recruited over a 10 month period and either received hemostasis with the standard unipolar cauterizing device or the bipolar saline system.
Patients who were on anticoagulation therapy prior to their TKA were excluded from our study as this potentially would increase their amount of post-operative bleeding complicating the results of our study.
Participant milestones
| Measure |
TKA With the Aquamantys for Hemostasis
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
|
TKA Without the Aquamantys for Hemostasis
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
61
|
|
Overall Study
COMPLETED
|
50
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
Baseline characteristics by cohort
| Measure |
TKA With the Aquamantys for Hemostasis
n=50 Participants
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
|
TKA Without the Aquamantys for Hemostasis
n=61 Participants
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
|
Total
n=111 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
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
66 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
61 participants
n=7 Participants
|
111 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 24 hours following surgery.This is a measure of the average drain output collected in the first 24 hours following surgery.
Outcome measures
| Measure |
TKA With the Aquamantys for Hemostasis
n=50 Participants
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
|
TKA Without the Aquamantys for Hemostasis
n=61 Participants
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
|
|---|---|---|
|
Drain Output.
|
776 mL
Standard Deviation 334
|
778 mL
Standard Deviation 331.1
|
Adverse Events
TKA With the Aquamantys for Hemostasis
TKA Without the Aquamantys for Hemostasis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place