NCT04979026

Clinical Investigation of a Novel Approach for the Prevention of Deep Venous Thrombosis After Total Knee Replacement

Completed NA Last updated 27 July 2021

What this trial tests

NA trial testing active ankle pumping with a regular watch alarm in Deep Venous Thrombosis in 90 participants. Completed in 31 December 2020.

Timeline

17 October 2019

Primary endpoint
20 November 2020

31 December 2020

Quick facts

Lead sponsor	Show Chwan Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	90
Start date	17 October 2019
Primary completion	20 November 2020
Estimated completion	31 December 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• active ankle pumping with a regular watch alarm
• intermittent pneumatic compression

Conditions studied

• Deep Venous Thrombosis — all drugs for Deep Venous Thrombosis →

Sponsor

Show Chwan Memorial Hospital

Who can join

Adults 40 to 90, any sex, with Deep Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.