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

Primary Purpose

Deep Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
active ankle pumping with a regular watch alarm
intermittent pneumatic compression
Sponsored by
Show Chwan Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Venous Thrombosis

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Show Chwan Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

active ankle pumping without any reminders

intermittent pneumatic compression

active ankle pumping with a regular watch alarm

Arm Description

In group 1, active ankle pumping exercise for the operative limb was performed without any reminder during hospitalization and at home after being discharged.

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.

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.

Outcomes

Primary Outcome Measures

change of peak flow velocity
The peak flow velocity was directly detected using the Doppler images. The examination was conducted by an experienced technician.
change of flow volume
The flow volume was directly detected using the Doppler images. The examination was conducted by an experienced technician.
Number of Participants with stasis
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.
Number of Participants with deep venous thrombosis
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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2021
Last Updated
July 15, 2021
Sponsor
Show Chwan Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04979026
Brief Title
Clinical Investigation of a Novel Approach for the Prevention of Deep Venous Thrombosis After Total Knee Replacement
Official Title
Clinical Investigation of a Novel Approach for the Prevention of Deep Venous Thrombosis After Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Show Chwan Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active ankle pumping without any reminders
Arm Type
No Intervention
Arm Description
In group 1, active ankle pumping exercise for the operative limb was performed without any reminder during hospitalization and at home after being discharged.
Arm Title
intermittent pneumatic compression
Arm Type
Active Comparator
Arm Description
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.
Arm Title
active ankle pumping with a regular watch alarm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active ankle pumping with a regular watch alarm
Intervention Description
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
Intervention Name(s)
intermittent pneumatic compression
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of peak flow velocity
Description
The peak flow velocity was directly detected using the Doppler images. The examination was conducted by an experienced technician.
Time Frame
The peak flow velocity was determined on the 1st, 3rd, and 14th days after surgery.
Title
change of flow volume
Description
The flow volume was directly detected using the Doppler images. The examination was conducted by an experienced technician.
Time Frame
The flow volume was determined on the 1st, 3rd, and 14th days after surgery.
Title
Number of Participants with stasis
Description
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.
Time Frame
Stasis was determined on the 1st, 3rd, and 14th days after surgery.
Title
Number of Participants with deep venous thrombosis
Description
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.
Time Frame
Deep venous thrombosis was determined on the 1st, 3rd, and 14th days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Show Chwan Memorial Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29466159
Citation
Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.
Results Reference
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PubMed Identifier
19751691
Citation
Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.
Results Reference
background
PubMed Identifier
28209273
Citation
Boylan MR, Perfetti DC, Kapadia BH, Delanois RE, Paulino CB, Mont MA. Venous Thromboembolic Disease in Revision vs Primary Total Knee Arthroplasty. J Arthroplasty. 2017 Jun;32(6):1996-1999. doi: 10.1016/j.arth.2016.12.051. Epub 2017 Jan 11.
Results Reference
background
PubMed Identifier
18310761
Citation
Changulani M, Kalairajah Y, Peel T, Field RE. The relationship between obesity and the age at which hip and knee replacement is undertaken. J Bone Joint Surg Br. 2008 Mar;90(3):360-3. doi: 10.1302/0301-620X.90B3.19782.
Results Reference
background
PubMed Identifier
27509603
Citation
Chen Q, Huang S, Chen X, Feng L, Zhu X. [Clinical efficacy of multi-pattern detumescence after total knee arthroplasty treated with acupoint massage and mild moxibustion]. Zhongguo Zhen Jiu. 2016 May;36(5):471-5. Chinese.
Results Reference
background

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

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