Osteoarthritis
Conditions
Brief summary
For patients undergoing total hip and knee arthroplasty, does the use of Aspirin alone compared to using Aspirin along with a mobile compression device provide equivocal results for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty? The investigator will evaluate the prevention of DVT/PE after total hip and knee arthroplasty will be evaluated to see if there is a decreased risk of bleeding while continuing to prevent thromboembolic disease. The equivalency of using the mobile compression devices with aspirin compared to aspirin alone in patients undergoing total hip and knee arthroplasty will be evaluated. A previous study has shown that patient compliance with the pneumatic compression device is less than 80%.
Detailed description
The research question is: does the use of Aspirin alone compared to using Aspirin along with a mobile compression device provide equivocal results for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty? Participants were randomized to either receive aspirin and mobile pneumatic compression devices or aspirin alone as outpatient DVT prophylaxis as their standard of care after primary total hip and total knee arthroplasty. Participants randomized to the compression device group were asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an aspirin (325mg once a day), per standard of care. Participants randomized to aspirin alone took 325 mg per day. Participant usage information from Active Care +S.F.T. mobile devices was collected. The information was recorded at the participant's first follow up visit occurring between 7-21 days post-surgery. All of the participants were asked to keep a checklist indicating aspirin intake compliance each day, which was returned at their first follow up visit. Participants randomized to mobile pneumatic compression device and aspirin (325 mg) were asked to complete a satisfaction questionnaire about the compression device at their first follow up visit. Participants received a phone call from a member of the research team approximately 90 days post-op. The call was necessary to assess if any participants have been diagnosed with DVT at another hospital.
Interventions
DRUGAspirin
If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.
DEVICEPortable Compression Device
If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. All patients, 18+ years of age, scheduled at WVU Medicine Center for Joint Replacement for a History and Physical visit to undergo a total hip or knee surgery. 2. Primary replacements and revisions. 3. Weight bearing as tolerated postoperatively.
Exclusion criteria
1. History of DVT/PE 2. History of hypercoagulable disorder 3. Currently on other blood thinning medication with the exception of aspirin (Plavix, Coumadin, xarelto, pradaxa, lovenox, heparin, other Factor Xa inhibitors). 4. Patients less than 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Venous Thromboembolism | 90 days | Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspirin Usage Over 6 Week Post op Period | 6 week post op | Number of Participants Taking aspirin over the 6 week post op period |
| Compression Pump Compliance Over 2 Weeks Post op | 14 days post operative | Patients found to be compliant with recommended pump use over the course of two weeks. Compliance is defined as the recommended dose of 20 hours during the recommend course of prophylaxis. |
| Overall Pump Experience After 2 Weeks | 2 weeks post op | Correlation of Recorded Pump Compliance with perceived Patient Factors |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.
Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device. | 40 |
| Aspirin With Portable Compression Device Participants randomized to the compression device group are asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an 325mg aspirin per day as their outpatient DVT/PE prophylaxis.
Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.
Portable Compression Device: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Rehab Center denied use of pumps | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Aspirin | Aspirin With Portable Compression Device |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 11.6 | 61.5 years STANDARD_DEVIATION 10 | 60.8 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 39 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 78 Participants | 38 Participants | 40 Participants |
| Region of Enrollment United States | 80 participants | 40 participants | 40 participants |
| Sex: Female, Male Female | 43 Participants | 18 Participants | 25 Participants |
| Sex: Female, Male Male | 37 Participants | 22 Participants | 15 Participants |
| TKA/THA Enrollment Total Hip | 39 Participants | 21 Participants | 18 Participants |
| TKA/THA Enrollment Total Knee | 41 Participants | 19 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Number of Participants With Venous Thromboembolism
Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aspirin | Number of Participants With Venous Thromboembolism | 0 Participants |
| Aspirin With Portable Compression Device | Number of Participants With Venous Thromboembolism | 3 Participants |
Secondary
Aspirin Usage Over 6 Week Post op Period
Number of Participants Taking aspirin over the 6 week post op period
Time frame: 6 week post op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin | Aspirin Usage Over 6 Week Post op Period | 2 participants |
| Aspirin With Portable Compression Device | Aspirin Usage Over 6 Week Post op Period | 1 participants |
Secondary
Compression Pump Compliance Over 2 Weeks Post op
Patients found to be compliant with recommended pump use over the course of two weeks. Compliance is defined as the recommended dose of 20 hours during the recommend course of prophylaxis.
Time frame: 14 days post operative
Population: The outcome measure is specific only to those who used a compression device, the 'aspirin with portable compression device' group. The 'aspirin only group' did not use the compression device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aspirin With Portable Compression Device | Compression Pump Compliance Over 2 Weeks Post op | 10 Participants |
Secondary
Overall Pump Experience After 2 Weeks
Correlation of Recorded Pump Compliance with perceived Patient Factors
Time frame: 2 weeks post op
Population: The outcome measure is specific only to those who used a compression device, the 'aspirin with portable compression device' group. The 'aspirin only group' did not use the compression device.~The correlation between patient experience with pumps and average percent compliance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Overall Experience | 0.36 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were Noisy | 0.26 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were Painful | 0.11 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were Hot | -0.22 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were Itchy | -0.25 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were Difficult on/off | -0.12 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were Tight | -0.23 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps caused Sweating | -0.1 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps caused Numbness | -0.23 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps caused Skin irritation | 0.12 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps caused Tripping/Falling | -0.21 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps caused Insomnia | -0.12 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps felt like a massage | 0.05 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were difficult to use | 0.44 correlation coefficient |
| Aspirin With Portable Compression Device | Overall Pump Experience After 2 Weeks | Pumps were comfortable | -0.27 correlation coefficient |