Use of Cold and Compression Therapy With Total Knee Replacement Patients

March 19, 2012 updated by: CoolSystems, Inc.

Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients

The purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of cryotherapy with compression for orthopedic postoperative recovery has not been fully investigated. A new device has been developed that combines cold and intermittent pneumatic compression in a single system. A well-controlled clinical study evaluating the clinical effectiveness of cryotherapy with compression in an orthopedic postoperative application is the subject of this protocol. Patients diagnosed with osteoarthritis of the knee and scheduled for primary total knee arthroplasty procedure will be invited to participate in this study.

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2137
        • Orthosports
  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center, San Diego
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46278
        • Orthopaedic Research Foundation
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • San Antonio, Texas, United States, 78240
        • Sports Medicine Associates of San Antonio
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 but no more than 85 years of age
  • Body Mass Index not greater than 40
  • Diagnosis of osteoarthritis of the knee
  • Medically cleared for total knee replacement surgery
  • Physically and mentally able and willing to participate in and follow the study protocol and schedule
  • Able and willing to have all postoperative physical therapy visits in a physical therapy clinic associated with the research site
  • Signed informed consent document for the study

Exclusion Criteria:

  • Rheumatoid arthritis
  • Severe pitting edema in the ipsilateral limb
  • History of thrombophlebitis in lower extremities
  • An active systemic disease such as AIDS, HIV, hepatitis, etc.
  • Is immunologically suppressed or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
  • Is pregnant or planning to become pregnant during the study period
  • Any condition that would contraindicate using the Game Ready
  • Currently enrolled in another clinical trial that could affect outcome of this study
  • Previously enrolled in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Other: Ice with compressive bandages
Cold with static compression postoperatively for 2 weeks
Experimental: A
Device: Game Ready Injury Treatment System (CoolSystems Inc.)
Cold with intermittent compression postoperatively for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical function performance
Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Time to reach defined physical therapy milestones
Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
2 weeks postoperative, 6 weeks postoperative, 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoolSystems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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