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

July 15, 2021 updated by: Ming-Chou Ku, Show Chwan Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Show Chwan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who underwent total knee replacement surgery

Exclusion Criteria:

  • Patients with a history of cardiovascular disease, such as DVT, dyslipidemia, hypertension, myocardial infarction, and hemorrhagic disease were excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: active ankle pumping without any reminders
In group 1, active ankle pumping exercise for the operative limb was performed without any reminder during hospitalization and at home after being discharged.
Active Comparator: intermittent pneumatic compression
In group 2, intermittent pneumatic compression was applied to the operative low limb during hospitalization, while active ankle pumping exercise was adopted without any reminder 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.
Experimental: active ankle pumping with a regular watch alarm
In group 3, 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. The watch was continuously used until the 14th day when the patients returned to the hospital for examination.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of peak flow velocity
Time Frame: The peak flow velocity was determined on the 1st, 3rd, and 14th days after surgery.
The peak flow velocity was directly detected using the Doppler images. The examination was conducted by an experienced technician.
The peak flow velocity was determined on the 1st, 3rd, and 14th days after surgery.
change of flow volume
Time Frame: The flow volume was determined on the 1st, 3rd, and 14th days after surgery.
The flow volume was directly detected using the Doppler images. The examination was conducted by an experienced technician.
The flow volume was determined on the 1st, 3rd, and 14th days after surgery.
Number of Participants with stasis
Time Frame: Stasis was determined on the 1st, 3rd, and 14th days after surgery.
Venous stasis was determined by a peak flow velocity lower than 10 cm/s, and the color of the blood inside the vein represented in the echo image was gray. In addition, the contour of the vein was compressible under a slight compression force with an echo transducer.
Stasis was determined on the 1st, 3rd, and 14th days after surgery.
Number of Participants with deep venous thrombosis
Time Frame: Deep venous thrombosis was determined on the 1st, 3rd, and 14th days after surgery.
If the peak blood flow, flow volume, and blood echo image were the same as that of stasis, but the contour of the vein was incompressible under a slight compression, the cases were recorded as deep venous thrombosis.
Deep venous thrombosis was determined on the 1st, 3rd, and 14th days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Show Chwan Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2019

Primary Completion (Actual)

November 20, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB19013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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