Abstract
Study design: In order to evaluate a new CECT (Continuous Enhanced Circulation Therapy) based on protocol for DVT prevention a prospective, randomize, single-blind study was designed to compare the effect of the new protocol to the current standard of care in DCT prophylaxis (LMWH).
Objectives: To evaluate and compare the incidence and severity of DVT between the two groups.
Background: Total hip and knee replacements are operations particularly prone to thromboembolic complications. Recommendations regarding prophylaxis have changed over the years. A treatment protocol was proposed, based upon the CECT system as the primary DVT prophylaxis method with the addition of low dose aspirin. This protocol is using two very safe treatment modalities with very low risk for adverse effects. The CECT system applies continuous mechanical enhancement of venous blood flow through a miniature, mobile, battery operated system.
Methods: 39 patients, who underwent total hip or knee replacement, were prospectively randomized into two groups. In the study group the patients received CECT system starting immediately after the induction of anesthesia and covering the operation and the first 5 postoperative days, within 12 hours after surgery aspirin 100 mg per day was added. In the control group the patients received Enoxaparin 40 mg per day for 5 postoperative days. A venography was performed at the 5th to 8th post-operative day and the DVT prevalence was compared.
Results: In the study group 3 patients out of 21 (14.3%) were found to have DVT (1 of them proximal), compared to 8 patients out of 18 (44.4%) in the control group (5 of them proximal). The differences between the two groups are statistically significant for both total and proximal DVT rates (p=0.037).
In the study group only 1 patient needed prolonged high dose anticoagulant treatment while 6 patients in the enoxaparin group were treated (p=0.020).
The cumulative incidence of adverse events in the study group was significantly lower than that observed in the control group (p=0.000). Average postoperative hospital stay was 8.4 days in the study group and 11.7 days in the control group (p=0.002).
The CECT device was very well tolerated by the patients and facilitated early mobilization.
Conclusions: The protocol combining CECT and Aspirin was found to be both safe the effective. Comparison to the standard prophylaxis with enoxaparin revealed significant advantage of the proposed protocol with: better DVT prevention, less adverse events and shorter hospital stay. Further research is needed in order to establish the place of this prophylaxis protocol as the treatment of choice in orthopaedic patients.
The abstracts were prepared by Orah Naor. Correspondence should be addressed to him at the Israel Orthopaedic Association, PO Box 7845, Haifa 31074, Israel.
