Background: Venous thromboembolic events, either deep venous thrombosis or pulmonary embolism, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.) with or without aspirin compared with current pharmacological protocols for prophylaxis against venous thromboembolism in patients undergoing elective primary unilateral arthroplasty of a lower-extremity joint.
Methods: A multicenter registry was established to capture the rate of symptomatic venous thromboembolic events following primary knee arthroplasty (1551 patients) or hip arthroplasty (1509 patients) from ten sites. All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism.
Results: Of 3060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thrombi, three proximal deep venous thrombi, and five pulmonary emboli). One death occurred, with no autopsy performed. Symptomatic venous thromboembolic rates observed in patients who had an arthroplasty of a lower-extremity joint using the mobile compression device were noninferior (not worse than), at a margin of 1.0%, to the rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran, except in the knee arthroplasty group, in which the mobile compression device fell short of the rate reported for rivaroxaban by 0.06%.
Conclusions: Use of the mobile compression device with or without aspirin for patients undergoing arthroplasty of a lower-extremity joint provides a noninferior risk for the development of venous thromboembolism compared with current pharmacological protocols.
Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
1Shiley Center for Orthopaedic Research and Education at Scripps Clinic, 11025 North Torrey Pines Road, Suite 200, La Jolla, CA 92037. E-mail address for C.W. Colwell Jr.: firstname.lastname@example.org
2Euclid Cleveland Clinic, Euclid Hospital – Administration, 18901 Lake Shore Boulevard, Euclid, OH 44119
3Twin Cities Orthopaedics, 4010 West 65th Street, Edina, MN 55435
4VA Palo Alto Health Care System, 3801 Miranda Avenue (112), Palo Alto, CA 94304
5Anderson Orthopaedic Clinic, 2501 Parkers Lane, Alexandria, VA 22306
6Department of Orthopaedic Surgery, Washington University School of Medicine, Campus Box 8233, 660 South Euclid Avenue, St. Louis, MO 63110
7The Center, Orthopedic & Neurosurgical Care & Research, 2200 N.E. Neff Road, Suite 200, Bend, OR 977041-4281
8Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, 2401 West Belvedere Avenue, Baltimore, MD 21215
9Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021-4892
10Arkansas Specialty Orthopaedics, 1701 Aldersgate Road, Suite 3, Little Rock, AR 72205