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Use of Cold and Compression Therapy With Total Knee Replacement Patients

Primary Purpose

Osteoarthritis, Total Knee Arthroplasty

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Game Ready Injury Treatment System (CoolSystems Inc.)
Ice with compressive bandages
Sponsored by
CoolSystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, total knee arthroplasty, cryotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Naval Medical Center, San Diego
  • Tripler Army Medical Center
  • Central DuPage Hospital
  • Orthopaedic Research Foundation
  • Eastern Maine Medical Center
  • Hospital for Special Surgery
  • Cleveland Clinic
  • Brooke Army Medical Center
  • Sports Medicine Associates of San Antonio
  • Madigan Army Medical Center
  • Orthosports

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Physical function performance
Time to reach defined physical therapy milestones

Secondary Outcome Measures

Full Information

First Posted
July 7, 2008
Last Updated
March 19, 2012
Sponsor
CoolSystems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00712816
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoolSystems, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Total Knee Arthroplasty
Keywords
osteoarthritis, total knee arthroplasty, cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Game Ready Injury Treatment System (CoolSystems Inc.)
Intervention Description
Cold with intermittent compression postoperatively for 2 weeks
Intervention Type
Other
Intervention Name(s)
Ice with compressive bandages
Intervention Description
Cold with static compression postoperatively for 2 weeks
Primary Outcome Measure Information:
Title
Physical function performance
Time Frame
2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Title
Time to reach defined physical therapy milestones
Time Frame
2 weeks postoperative, 6 weeks postoperative, 6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Naval Medical Center, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Orthopaedic Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Sports Medicine Associates of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Orthosports
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2137
Country
Australia

12. IPD Sharing Statement

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Use of Cold and Compression Therapy With Total Knee Replacement Patients

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