Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
osteoarthritis, total knee arthroplasty, cryotherapy
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 replacement.
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.
Interventions
DEVICEGame Ready Injury Treatment System (CoolSystems Inc.)
Cold with intermittent compression postoperatively for 2 weeks
OTHERIce with compressive bandages
Cold with static compression postoperatively for 2 weeks
Sponsors
CoolSystems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Australia, United States
Outcome results
None listed