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

NCT03521869 | Completed FDA Device

• 1 other identifier: 14WHoz
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• swelling of the knee

  Swelling of the leg will be determined by measuring circumference of the leg

  one day following surgery

Study Arms (2)

Compression bandage group

ACTIVE COMPARATOR

Device: Compression bandage

Standard gauze group

ACTIVE COMPARATOR

Device: Gauze dressing

Interventions

Compression bandage DEVICE

Compression bandage placed after total knee replacement

Compression bandage group

Gauze dressing DEVICE

standard of care gauze dressing placed after total knee replacement

Standard gauze group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Compression Bandages

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Tiffany Morrison, MS, CCRP

  Rothman Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Only bilateral knee replacements will be utilized so each patient can serve as their internal control

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: November 13, 2014
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)