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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%.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Active Comparator | Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis. |
|
| Aspirin with portable Compression Device | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Venous Thromboembolism | Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Aspirin Usage Over 6 Week Post op Period | Number of Participants Taking aspirin over the 6 week post op period | 6 week post op |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Dietz, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine Department of Orthopaedics | Morgantown | West Virginia | 26506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Venous Thromboembolism | Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative. | Posted | Count of Participants | Participants | 90 days |
|
Adverse event data was collected for 3 months.
No adverse events occurred in any participant enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew J. Dietz, MD | West Virginia University Department of Orthopaedics | 304-285-7445 | mdietz@hsc.wvu.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
|
| Portable Compression Device | 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. |
|
| 14 days post operative |
| Overall Pump Experience After 2 Weeks | Correlation of Recorded Pump Compliance with perceived Patient Factors | 2 weeks post op |
| Rehab Center denied use of pumps |
|
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| TKA/THA Enrollment | Count of Participants | Participants |
|
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.
|
|
| Secondary | Aspirin Usage Over 6 Week Post op Period | Number of Participants Taking aspirin over the 6 week post op period | Posted | Number | participants | 6 week post op |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 14 days post operative |
|
|
|
| Secondary | Overall Pump Experience After 2 Weeks | Correlation of Recorded Pump Compliance with perceived Patient Factors | 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. | Posted | Number | 95% Confidence Interval | correlation coefficient | 2 weeks post op |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Title | Measurements |
|---|---|
|
| Pumps were Hot |
|
| Pumps were Itchy |
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| Pumps were Difficult on/off |
|
| Pumps were Tight |
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| Pumps caused Sweating |
|
| Pumps caused Numbness |
|
| Pumps caused Skin irritation |
|
| Pumps caused Tripping/Falling |
|
| Pumps caused Insomnia |
|
| Pumps felt like a massage |
|
| Pumps were difficult to use |
|
| Pumps were comfortable |
|