Trial Outcomes & Findings for Evaluating the Need for Pneumatic Compression Devices (NCT NCT02641080)

NCT ID: NCT02641080

Last Updated: 2020-11-06

Results Overview

Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

90 days

Results posted on

2020-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	40	40
Overall Study COMPLETED	38	33
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	0	1
Overall Study Rehab Center denied use of pumps	0	3
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Evaluating the Need for Pneumatic Compression Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=40 Participants 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.	Aspirin With Portable Compression Device n=40 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.	Total n=80 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	60.8 years STANDARD_DEVIATION 13.0 • n=7 Participants	61.2 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
TKA/THA Enrollment Total Knee	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
TKA/THA Enrollment Total Hip	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative.

Outcome measures

Outcome measures
Measure	Aspirin n=40 Participants 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.	Aspirin With Portable Compression Device n=40 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.
Number of Participants With Venous Thromboembolism	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 week post op

Number of Participants Taking aspirin over the 6 week post op period

Outcome measures

Outcome measures
Measure	Aspirin n=40 Participants 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.	Aspirin With Portable Compression Device n=40 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.
Aspirin Usage Over 6 Week Post op Period	2 participants	1 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Aspirin With Portable Compression Device n=39 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.
Compression Pump Compliance Over 2 Weeks Post op	—	10 Participants

SECONDARY outcome

Timeframe: 2 weeks post op

Correlation of Recorded Pump Compliance with perceived Patient Factors

Outcome measures

Outcome measures
Measure	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.	Aspirin With Portable Compression Device n=40 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.
Overall Pump Experience After 2 Weeks Overall Experience	—	0.36 correlation coefficient Interval 0.01 to 0.63
Overall Pump Experience After 2 Weeks Pumps were Noisy	—	0.26 correlation coefficient Interval -0.09 to 0.55
Overall Pump Experience After 2 Weeks Pumps were Painful	—	0.11 correlation coefficient Interval -0.44 to 0.25
Overall Pump Experience After 2 Weeks Pumps were Hot	—	-0.22 correlation coefficient Interval -0.52 to 0.14
Overall Pump Experience After 2 Weeks Pumps were Itchy	—	-0.25 correlation coefficient Interval -0.55 to 0.11
Overall Pump Experience After 2 Weeks Pumps were Difficult on/off	—	-0.12 correlation coefficient Interval -0.46 to 0.24
Overall Pump Experience After 2 Weeks Pumps were Tight	—	-0.23 correlation coefficient Interval -0.53 to 0.13
Overall Pump Experience After 2 Weeks Pumps caused Sweating	—	-0.1 correlation coefficient Interval -0.44 to 0.26
Overall Pump Experience After 2 Weeks Pumps caused Numbness	—	-0.23 correlation coefficient Interval -0.53 to 0.13
Overall Pump Experience After 2 Weeks Pumps caused Skin irritation	—	0.12 correlation coefficient Interval -0.23 to 0.45
Overall Pump Experience After 2 Weeks Pumps caused Tripping/Falling	—	-0.21 correlation coefficient Interval -0.5 to 0.15
Overall Pump Experience After 2 Weeks Pumps caused Insomnia	—	-0.12 correlation coefficient Interval -0.45 to 0.24
Overall Pump Experience After 2 Weeks Pumps felt like a massage	—	0.05 correlation coefficient Interval -0.3 to 0.4
Overall Pump Experience After 2 Weeks Pumps were difficult to use	—	0.44 correlation coefficient Interval 0.1 to 0.68
Overall Pump Experience After 2 Weeks Pumps were comfortable	—	-0.27 correlation coefficient Interval -0.51 to 0.15

Adverse Events

Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aspirin With Portable Compression Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew J. Dietz, MD

West Virginia University Department of Orthopaedics

Phone: 304-285-7445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place