This trial is active, not recruiting.

Conditions osteoarthritis, total knee arthroplasty
Treatments game ready injury treatment system (coolsystems inc.), ice with compressive bandages
Phase phase 4
Sponsor CoolSystems, Inc.
Start date July 2008
End date December 2011
Trial size 224 participants
Trial identifier NCT00712816, 2007-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
game ready injury treatment system (coolsystems inc.)
Cold with intermittent compression postoperatively for 2 weeks
(Active Comparator)
ice with compressive bandages
Cold with static compression postoperatively for 2 weeks

Primary Outcomes

Physical function performance
time frame: 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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by CoolSystems, Inc..