Use of Cold and Compression Therapy With Total Knee Replacement Patients - Full Text View

Sponsor:	CoolSystems, Inc.
Information provided by:	CoolSystems, Inc.
ClinicalTrials.gov Identifier:	NCT00712816

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Total Knee Arthroplasty	Device: Game Ready Injury Treatment System (CoolSystems Inc.) Other: Ice with compressive bandages	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Further study details as provided by CoolSystems, Inc.:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	224
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Device: Game Ready Injury Treatment System (CoolSystems Inc.) Cold with intermittent compression postoperatively for 2 weeks
Active Comparator: B	Other: Ice with compressive bandages Cold with static compression postoperatively for 2 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712816

Locations

United States, California
Naval Medical Center, San Diego	Recruiting
San Diego, California, United States, 92134
Contact: Diane Wilson, CRC 619-532-7810 Diane.Wilson.ctr@med.navy.mil
Principal Investigator: V. Franklin Sechriest, II, MD
United States, Hawaii
Tripler Army Medical Center	Recruiting
Honolulu, Hawaii, United States, 96859
Contact: Patricia Iwamoto, CRC 808-433-1149 patricia.iwamoto@us.army.mil
Principal Investigator: Gregory Lee, MD
United States, Illinois
Central DuPage Hospital	Recruiting
Winfield, Illinois, United States, 60190
Contact: Linda Abella, RN, BSN, ONC 630-933-6807 Linda_Abella@cdh.org
Principal Investigator: Scott Sporer, MD
United States, Indiana
Orthopaedic Research Foundation	Recruiting
Indianapolis, Indiana, United States, 46278
Contact: Darrell Whinnery, BS 317-802-2000 dwhinnery@orthoindy.com
Principal Investigator: Joseph Randolph, MD
United States, Maine
Eastern Maine Medical Center	Recruiting
Bangor, Maine, United States, 04401
Contact: Denise Michaud 207-973-7175 dmichaud@emh.org
Principal Investigator: John Bradford, MD
United States, New York
Hospital for Special Surgery	Recruiting
New York, New York, United States, 10021
Contact: Michelle Perna, CRC 212-774-2127 pernam@hss.edu
Principal Investigator: Edwin Su, MD
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alison Klika 216-444-4954 klikaa@ccf.org
Principal Investigator: Wael Barsoum, MD
United States, Texas
Brooke Army Medical Center	Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Mary Fan, RN, BSN 210-916-5688 mary.fan@us.army.mil
Principal Investigator: Tad Gerlinger, MD
Sports Medicine Associates of San Antonio	Recruiting
San Antonio, Texas, United States, 78240
Contact: Clarissa Chapa-Radke, BS 210-949-0807 cchaparadke@EndeavorCT.com
Principal Investigator: David Schmidt, MD
United States, Washington
Madigan Army Medical Center	Recruiting
Tacoma, Washington, United States, 98431
Contact: Tammy Scott, LPN 253-968-3710 tammy.white1@us.army.mil
Principal Investigator: Edward Arrington, MD
Australia, New South Wales
Orthosports	Recruiting
Concord, New South Wales, Australia, 2137
Contact: Judy Taylor 61 2 9744 2666 judyt@orthosports.com.au
Principal Investigator: Warwick Bruce, Professor

Sponsors and Collaborators

CoolSystems, Inc.

More Information

No publications provided

Responsible Party:	Marianne Baldwin, CoolSystems, Inc.
ClinicalTrials.gov Identifier:	NCT00712816 History of Changes
Other Study ID Numbers:	2007-02
Study First Received:	July 7, 2008
Last Updated:	May 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by CoolSystems, Inc.:

osteoarthritis
total knee arthroplasty
cryotherapy

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012