Use of Cold and Compression Therapy With Total Knee Replacement Patients

Phase 4

• Conditions: Osteoarthritis; Total Knee Arthroplasty
• Interventions: Device: Game Ready Injury Treatment System (CoolSystems Inc.); Other: Ice with compressive bandages

• Registration Number: NCT00712816
• Lead Sponsor: CoolSystems, Inc.

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Primary Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Game Ready Injury Treatment System (CoolSystems Inc.)	-
B	Ice with compressive bandages	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Naval Medical Center, San Diego; 🇺🇸 San Diego, California, United States

Orthopaedic Research Foundation; 🇺🇸 Indianapolis, Indiana, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Central DuPage Hospital; 🇺🇸 Winfield, Illinois, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

Orthosports; 🇦🇺 Concord, New South Wales, Australia

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Sports Medicine Associates of San Antonio; 🇺🇸 San Antonio, Texas, United States