Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
CoolSystems, Inc. |
---|---|
Information provided by: | CoolSystems, Inc. |
ClinicalTrials.gov Identifier: | NCT00712816 |
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: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients |
Estimated Enrollment: | 224 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Device: Game Ready Injury Treatment System (CoolSystems Inc.)
Cold with intermittent compression postoperatively for 2 weeks
|
B: Active Comparator |
Other: Ice with compressive bandages
Cold with static compression postoperatively for 2 weeks
|
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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: Basem Aziz, MD 212-606-1128 azizb@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: Socorro Garcia, RN 210-916-2368 socorro.garcia1@us.army.mil | |
Principal Investigator: Tad Gerlinger, MD | |
Sports Medicine Associates of San Antonio | Recruiting |
San Antonio, Texas, United States, 78240 | |
Contact: Lisa Rodriguez 210-949-0807 lrodriguez@endeavorclinicaltrials.com | |
Principal Investigator: David Schmidt, MD | |
United States, Washington | |
Madigan Army Medical Center | Recruiting |
Tacoma, Washington, United States, 98431 | |
Contact: Erinn Morris, RN, MN 253-968-6590 erinn.morris@us.army.mil | |
Principal Investigator: Edward Arrington, MD |
Responsible Party: | CoolSystems, Inc. ( Marianne Baldwin ) |
Study ID Numbers: | 2007-02 |
Study First Received: | July 7, 2008 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00712816 History of Changes |
Health Authority: | United States: Institutional Review Board |
osteoarthritis total knee arthroplasty cryotherapy |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |