Use of Cold and Compression Therapy With Total Knee Replacement Patients

CoolSystems

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis; Total Knee Arthroplasty

Treatments: Other: Ice with compressive bandages; Device: Game Ready Injury Treatment System (CoolSystems Inc.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712816

2007-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

A

Experimental group

Treatment:

Device: Game Ready Injury Treatment System (CoolSystems Inc.)

B

Active Comparator group

Treatment:

Other: Ice with compressive bandages