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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty

NCT01559532

Deep Vein Thrombosis

COMPLETED

Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT

NCT02148757

Number of Deep Venous Thrombosis (DVT)

COMPLETED NA

Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

NCT03274466

Surgical Wound Revision Total Knee Arthroplasty Wounds and Injuries +6 more

COMPLETED NA

Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques

NCT00755300

Total Knee Replacement Venous Thromboembolism

COMPLETED

Reparel Knee Sleeve vs. TED Hose for Post-op Swelling, Pain and Range of Motion After Total Knee Replacement

NCT04751942

Osteoarthritis Knees Both

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep Venous Thrombosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

intermittent pneumatic compression

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

active ankle pumping with a regular watch alarm

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No