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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Game Ready Injury Treatment System (CoolSystems Inc.) | Device | Cold with intermittent compression postoperatively for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical function performance | 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative | |
| Time to reach defined physical therapy milestones | 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center, San Diego | San Diego | California | 92134 | United States | ||
| Tripler Army Medical Center |
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| Ice with compressive bandages | Other | Cold with static compression postoperatively for 2 weeks |
|
| Honolulu |
| Hawaii |
| 96859 |
| United States |
| Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| Orthopaedic Research Foundation | Indianapolis | Indiana | 46278 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Sports Medicine Associates of San Antonio | San Antonio | Texas | 78240 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| Orthosports | Concord | New South Wales | 2137 | Australia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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