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

NCT04979026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-07-27

No results posted yet for this study

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.

Conditions

  • Deep Venous Thrombosis

Interventions

DEVICE

active ankle pumping with a regular watch alarm

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.

DEVICE

intermittent pneumatic compression

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.

Sponsors & Collaborators

  • Show Chwan Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2020-11-20
Completion
2020-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979026 on ClinicalTrials.gov