Use of Cold and Compression Therapy With Total Knee Replacement Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

CoolSystems, Inc.

ClinicalTrials.gov Identifier:

NCT00712816

First received: July 7, 2008

Last updated: March 19, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 7, 2008
Last Updated Date	March 19, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 9, 2008)	Physical function performance [ Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative ] [ Designated as safety issue: No ] Time to reach defined physical therapy milestones [ Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00712816 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of Cold and Compression Therapy With Total Knee Replacement Patients
Official Title ^ICMJE	Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
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 Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis Total Knee Arthroplasty
Intervention ^ICMJE	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
Study Arm (s)	Experimental: A Intervention: Device: Game Ready Injury Treatment System (CoolSystems Inc.) Active Comparator: B Intervention: Other: Ice with compressive bandages
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	224
Estimated Completion Date	May 2012
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia

Administrative Information
NCT Number ^ICMJE	NCT00712816
Other Study ID Numbers ^ICMJE	2007-02
Has Data Monitoring Committee	No
Responsible Party	CoolSystems, Inc.
Study Sponsor ^ICMJE	CoolSystems, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CoolSystems, Inc.
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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