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Use of Cold and Compression Therapy With Total Knee Replacement Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00712816
Recruitment Status : Unknown
Verified March 2012 by CoolSystems, Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 10, 2008
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
CoolSystems, Inc.

Tracking Information
First Submitted Date  ICMJE July 7, 2008
First Posted Date  ICMJE July 10, 2008
Last Update Posted Date March 20, 2012
Study Start Date  ICMJE July 2008
Actual 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 ]
  • Time to reach defined physical therapy milestones [ Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Arms  ICMJE
  • 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 9, 2008)
224
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712816
Other Study ID Numbers  ICMJE 2007-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CoolSystems, Inc.
Study Sponsor  ICMJE CoolSystems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CoolSystems, Inc.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP