Use of Cold and Compression Therapy With Total Knee Replacement Patients

Status unconfirmed · Phase 4

Conditions studied: Osteoarthritis, Total Knee Arthroplasty

In brief

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.

Key facts

Study ID

NCT00712816

Run by

CoolSystems, Inc.

People needed

224

Starts

2008-07-01

Expected to finish

2012-05-01

Last updated by the study team

2012-03-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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