Use of Cold and Compression Therapy With Total Knee Replacement Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients

Conditions
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Osteoarthritis, Total Knee Arthroplasty

Intervention / Treatment
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* Device: Game Ready Injury Treatment System (CoolSystems Inc.)
* Other: Ice with compressive bandages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Game Ready Injury Treatment System (CoolSystems Inc.)<br>* Cold with intermittent compression postoperatively for 2 weeks<br>|
| Active Comparator: B<br> | Other: Ice with compressive bandages<br>* Cold with static compression postoperatively for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, total knee arthroplasty, cryotherapy