Back to resultsThe Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression bandage
Gauze dressing
Sponsored by
About this trial
This is an interventional supportive care trial for Osteo Arthritis Knee
Eligibility Criteria
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)
Sites / Locations
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Compression bandage group
Standard gauze group
Arm Description
Outcomes
Primary Outcome Measures
swelling of the knee
Swelling of the leg will be determined by measuring circumference of the leg
Secondary Outcome Measures
Full Information
NCT ID
NCT03521869
First Posted
April 30, 2018
Last Updated
May 9, 2018
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03521869
Brief Title
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
Official Title
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 13, 2014 (Actual)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
June 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Only bilateral knee replacements will be utilized so each patient can serve as their internal control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compression bandage group
Arm Type
Active Comparator
Arm Title
Standard gauze group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Compression bandage
Intervention Description
Compression bandage placed after total knee replacement
Intervention Type
Device
Intervention Name(s)
Gauze dressing
Intervention Description
standard of care gauze dressing placed after total knee replacement
Primary Outcome Measure Information:
Title
swelling of the knee
Description
Swelling of the leg will be determined by measuring circumference of the leg
Time Frame
one day following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Morrison, MS, CCRP
Organizational Affiliation
Rothman Institute
Official's Role
Study Director
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
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