Status:
UNKNOWN
Use of Cold and Compression Therapy With Total Knee Replacement Patients
Lead Sponsor:
CoolSystems, Inc.
Conditions:
Osteoarthritis
Total Knee Arthroplasty
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 repla...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00712816
Start Date
July 1 2008
End Date
May 1 2012
Last Update
March 20 2012
Active Locations (11)
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1
Naval Medical Center, San Diego
San Diego, California, United States, 92134
2
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
3
Central DuPage Hospital
Winfield, Illinois, United States, 60190
4
Orthopaedic Research Foundation
Indianapolis, Indiana, United States, 46278