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

NCT04979026 | Completed

• 1 other identifier: RB19013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Outcome Measures

Primary Outcomes (4)

• change of peak flow velocity

  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

  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

  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

  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.

Study Arms (3)

active ankle pumping without any reminders

NO INTERVENTION

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

intermittent pneumatic compression

ACTIVE COMPARATOR

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

active ankle pumping with a regular watch alarm

EXPERIMENTAL

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

Interventions

active ankle pumping with a regular watch alarm 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.

active ankle pumping with a regular watch alarm

intermittent pneumatic compression 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.

intermittent pneumatic compression

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who underwent total knee replacement surgery

You may not qualify if:

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

Sponsors & Collaborators

• Show Chwan Memorial Hospital: lead

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 29466159 BACKGROUND

• 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.

  PMID: 19751691 BACKGROUND

• 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.

  PMID: 28209273 BACKGROUND

• 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.

  PMID: 18310761 BACKGROUND

• 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.

  PMID: 27509603 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 27, 2021
• Study Start: October 17, 2019
• Primary Completion: November 20, 2020
• Study Completion: December 31, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)