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Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial

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ClinicalTrials.gov Identifier: NCT01003080
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : April 7, 2011
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Jin Kim, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Knee Arthroplasty
Interventions Device: Aquamantys Device
Other: Standard of care treatment for hemostasis during a total knee arthroplasty.
Enrollment 111
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis
Hide Arm/Group Description This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. This group will receive total knee arthroplasty using the standard treatment for hemostasis.
Period Title: Overall Study
Started 50 61
Completed 50 61
Not Completed 0 0
Arm/Group Title TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis Total
Hide Arm/Group Description This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. This group will receive total knee arthroplasty using the standard treatment for hemostasis. Total of all reporting groups
Overall Number of Baseline Participants 50 61 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 61 participants 111 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  52.0%
27
  44.3%
53
  47.7%
>=65 years
24
  48.0%
34
  55.7%
58
  52.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 61 participants 111 participants
64.9  (10.4) 66.3  (9.6) 66  (9.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 61 participants 111 participants
Female
38
  76.0%
51
  83.6%
89
  80.2%
Male
12
  24.0%
10
  16.4%
22
  19.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 61 participants 111 participants
50 61 111
1.Primary Outcome
Title Drain Output.
Hide Description This is a measure of the average drain output collected in the first 24 hours following surgery.
Time Frame First 24 hours following surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis
Hide Arm/Group Description:
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
Overall Number of Participants Analyzed 50 61
Mean (Standard Deviation)
Unit of Measure: mL
776  (334) 778  (331.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis
Hide Arm/Group Description This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. This group will receive total knee arthroplasty using the standard treatment for hemostasis.
All-Cause Mortality
TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TKA With the Aquamantys for Hemostasis TKA Without the Aquamantys for Hemostasis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/61 (0.00%) 
Operator dependent modifications may affect the standardization of the procedure; Surgeon is not blinded to the treatment used on each patient.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Sun Jin Kim
Organization: Montefiore Medical Center
Phone: 718-920-2060
Responsible Party: Sun Jin Kim, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01003080     History of Changes
Other Study ID Numbers: 09-05-145
First Submitted: October 27, 2009
First Posted: October 28, 2009
Results First Submitted: November 19, 2010
Results First Posted: April 7, 2011
Last Update Posted: September 21, 2018