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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00712816
Other study ID # 2007-02
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received July 7, 2008
Last updated March 19, 2012
Start date July 2008
Est. completion date May 2012

Study information

Verified date March 2012
Source CoolSystems, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 224
Est. completion date May 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Game Ready Injury Treatment System (CoolSystems Inc.)
Cold with intermittent compression postoperatively for 2 weeks
Other:
Ice with compressive bandages
Cold with static compression postoperatively for 2 weeks

Locations

Country Name City State
Australia Orthosports Concord New South Wales
United States Eastern Maine Medical Center Bangor Maine
United States Cleveland Clinic Cleveland Ohio
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Tripler Army Medical Center Honolulu Hawaii
United States Orthopaedic Research Foundation Indianapolis Indiana
United States Hospital for Special Surgery New York New York
United States Sports Medicine Associates of San Antonio San Antonio Texas
United States Naval Medical Center, San Diego San Diego California
United States Madigan Army Medical Center Tacoma Washington
United States Central DuPage Hospital Winfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
CoolSystems, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical function performance 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative No
Primary Time to reach defined physical therapy milestones 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative No
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