The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements

NCT ID: NCT03521869

Last Updated: 2018-05-11

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-13

Study Completion Date

2017-06-02

Brief Summary

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The purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following TKA.

The primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without the application of compression bandage.

Detailed Description

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Only bilateral knee replacements will be utilized so each patient can serve as their internal control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Compression bandage group

Group Type ACTIVE_COMPARATOR

Compression bandage

Intervention Type DEVICE

Compression bandage placed after total knee replacement

Standard gauze group

Group Type ACTIVE_COMPARATOR

Gauze dressing

Intervention Type DEVICE

standard of care gauze dressing placed after total knee replacement

Interventions

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Compression bandage

Compression bandage placed after total knee replacement

Intervention Type DEVICE

Gauze dressing

standard of care gauze dressing placed after total knee replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients receiving elective simultaneous bilateral primary total knee arthroplasty, treated by Rothman physicians at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.

Exclusion Criteria

* Previous venous thromboembolic event.
* Lymph edema in one or both legs.
* BMI \> 40
* Prior surgery (other than arthroscopy)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany Morrison, MS, CCRP

Role: STUDY_DIRECTOR

Rothman Institute

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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14WHoz

Identifier Type: -

Identifier Source: org_study_id

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