Knee Arthroplasty
Conditions
Keywords
The evaluation of hemostasis during total knee arthroplasty using the aquamantys device.
Brief summary
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.
Interventions
DEVICEAquamantys Device
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
OTHERStandard of care treatment for hemostasis during a total knee arthroplasty.
The active comparator arm will receive the standard-of-care for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient indicated for total knee arthroplasty
Exclusion criteria
* Patients undergoing revision total knee arthroplasty * Patients with blood disorders * Patients on chronic anti-thrombotic medication such as Coumadin * Patients with a history of deep vein thrombosis * Patients with a history of pulmonary embolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drain Output. | First 24 hours following surgery. | This is a measure of the average drain output collected in the first 24 hours following surgery. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| TKA With the Aquamantys for Hemostasis This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. | 50 |
| TKA Without the Aquamantys for Hemostasis This group will receive total knee arthroplasty using the standard treatment for hemostasis. | 61 |
| Total | 111 |
Baseline characteristics
| Characteristic | TKA Without the Aquamantys for Hemostasis | Total | TKA With the Aquamantys for Hemostasis |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 58 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 53 Participants | 26 Participants |
| Age, Continuous | 66.3 years STANDARD_DEVIATION 9.6 | 66 years STANDARD_DEVIATION 9.96 | 64.9 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 61 participants | 111 participants | 50 participants |
| Sex: Female, Male Female | 51 Participants | 89 Participants | 38 Participants |
| Sex: Female, Male Male | 10 Participants | 22 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 61 |
| serious Total, serious adverse events | 0 / 50 | 0 / 61 |
Outcome results
Primary
Drain Output.
This is a measure of the average drain output collected in the first 24 hours following surgery.
Time frame: First 24 hours following surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TKA With the Aquamantys for Hemostasis | Drain Output. | 776 mL | Standard Deviation 334 |
| TKA Without the Aquamantys for Hemostasis | Drain Output. | 778 mL | Standard Deviation 331.1 |