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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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ClinicalTrials.gov Identifier: NCT03521869
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date May 11, 2018
Actual Study Start Date  ICMJE November 13, 2014
Actual Primary Completion Date June 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
swelling of the knee [ Time Frame: one day following surgery ]
Swelling of the leg will be determined by measuring circumference of the leg
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
Official Title  ICMJE The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Only bilateral knee replacements will be utilized so each patient can serve as their internal control
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • Device: Compression bandage
    Compression bandage placed after total knee replacement
  • Device: Gauze dressing
    standard of care gauze dressing placed after total knee replacement
Study Arms  ICMJE
  • Active Comparator: Compression bandage group
    Intervention: Device: Compression bandage
  • Active Comparator: Standard gauze group
    Intervention: Device: Gauze dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2, 2017
Actual Primary Completion Date June 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521869
Other Study ID Numbers  ICMJE 14WHoz
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rothman Institute Orthopaedics
Study Sponsor  ICMJE Rothman Institute Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tiffany Morrison, MS, CCRP Rothman Institute
PRS Account Rothman Institute Orthopaedics
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP