Clinical Investigation of a Novel Approach for the Prevention of Deep Venous Thrombosis After Total Knee Replacement
Condition: Deep Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Venous thromboembolism, including deep vein thrombosis (DVT), has long been recognized as the
      most frequent complication within 7 to 14 days after orthopedic surgery, especially total
      joint arthroplasty. Without prophylactic therapy, the incidence of DVT and pulmonary embolism
      reaches up to 60% following orthopedic surgery. The possible damage to the vessel wall during
      the operation, the venous stasis caused by long-term bed rest, and the hypercoagulability of
      the blood after the surgery are the 3 main reasons for the formation of DVT. In most cases,
      the thrombi resolve spontaneously; however, some of them (about 1~4%) may develop into
      symptomatic and even fatal DVT.

      Ankle pumping exercise is currently suggested for the patients with joint placement surgery
      to prevent the formation of lower-extremity DVT after orthopedic surgery. However, the
      compliance of the exercise at home is unclear. In order to remind the patients to the active
      ankle exercise and record the executive rate, a device was developed to help the patient to
      exercise in the hospital and at home. The device will remind the patient to exercise at
      specific time point by verbal and vibrations, and detect the range of motion during the
      exercise for further analysis. The aim of this study is to access the effect of a
      non-invasive novel device in preventing the formation of lower limb DVT. Maximum venous
      outflow, maximum venous capacity, and blood rheology were measured and the incidence of DVT
      was recorded for the data analysis.
    

Detailed description: 
      Background. Deep vein thrombosis (DVT) has long been recognized as the most frequent
      complication that occurs 7-14 days after total knee replacement (TKR). Physical therapy,
      including active ankle pumping exercises and intermittent pneumatic compression, is suggested
      for the prevention of DVT. However, the exercise implementation rate is not clear,
      particularly at home. In order to remind the patients to exercise after TKR, a watch with
      voice and vibration alarms at the set time was used.

      Objective The first aim of this study was to compare the effect of active ankle movement with
      and without reminders on the prevention of DVT. The second aim was to compare the difference
      in the effect of intermittent pneumatic compression and active ankle movement on the
      prevention of DVT.

      Design. A Pilot Randomized Controlled Trial Methods. The patients were divided into three
      groups according to the therapeutic protocols. The patients in group 1 conducted active ankle
      pumping without any reminders, those in group 2 underwent intermittent pneumatic compression,
      and those in group 3 conducted active ankle pumping with a regular watch alarm. The
      parameters of blood flow, namely peak flow velocity and flow volume, in the bilateral common
      femoral vein and popliteal vein on the 1st, 3rd, and 14th days after surgery were measured
      using the echo technique, as an index to evaluate the effect of DVT prevention among the
      three groups.
    

Intervention name(s): active ankle pumping with a regular watch alarm; intermittent pneumatic compression
Intervention type(s): Device; Device
Intervention description(s): In addition to the active ankle pumping exercise for the operative limb, the patients were reminded to exercise at specific time points with a vocal alarm and vibration through a wrist watch during the hospitalization period and at home after discharge.; In this group, intermittent pneumatic compression was applied to the operative low limb during hospitalization, while active ankle pumping exercise was adopted without any reminder after discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention