Clinical trial NCT00712816: Use of Cold and Compression Therapy With Total Knee Replacement Patients
Official title: Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Total Knee Arthroplasty
Keywords: osteoarthritis
total knee arthroplasty
cryotherapy
Lead sponsor: CoolSystems, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Physical function performance
timeFrame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
measure: Time to reach defined physical therapy milestones
timeFrame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center, San Diego
state: California
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Orthopaedic Research Foundation
state: Indiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Sports Medicine Associates of San Antonio
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Concord
country: Australia
facility: Orthosports
state: New South Wales
Study officials:
References: