Thrombosis Prevention after Total Hip Arthroplasty:
A Prospective Randomized Trial Comparing a Mobile Compression Device with Low Molecular Weight Heparin
C. Colwell, M. Froimson, M. Mont, M. Ritter, R.Trousdale, K. Buehler, A. Spitzer, T. Donaldson, D. Padgett.
The Journal of Bone and Joint Surgery, March 2010; 92(3): 527-535
See link to abstract
Efficacy: There was no statistical difference between the groups in the incidence of VTE
Safety: The ActiveCare®+SFT showed a significant decrease in major bleeding events versus Enoxaparin.
Learn more about the study
What did the study compare?
The S.A.F.E. Study is the first study which compared ActiveCare® device head to head with Lovenox® after total hip replacement surgery through 10 day duration of in-hospital and post-discharge treatment.
How was the study designed?
410 adult patients undergoing total hip replacement surgery were randomly divided into 2 groups. One group received ActiveCare® Therapy with or without Baby Aspirin® supplement, and another other group received Lovenox® as VTE prevention treatment.
How were the study results tested?
At the end of the treatment period, a duplex scan was used with all patients for DVT detection. Any symptomatic VTE events were collected for up to 90 days postoperatively.
There was no statistical difference between the groups in VTE prevention. However, ActiveCare® therapy showed a significant decrease in major bleeding complications – 5.6% with Lovenox®, compared to 0% with ActiveCare®.