Use of Cold and Compression Therapy With Total Knee Replacement Patients

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00712816
• Other study ID #: 2007-02
• 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

• Osteoarthritis
• Total Knee Arthroplasty

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