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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00712816




Registration number
NCT00712816
Ethics application status
Date submitted
7/07/2008
Date registered
10/07/2008
Date last updated
20/03/2012

Titles & IDs
Public title
Use of Cold and Compression Therapy With Total Knee Replacement Patients
Scientific title
Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
Secondary ID [1] 0 0
2007-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Total Knee Arthroplasty 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Game Ready Injury Treatment System (CoolSystems Inc.)
Other interventions - Ice with compressive bandages

Experimental: A -

Active Comparator: B -


Treatment: Devices: Game Ready Injury Treatment System (CoolSystems Inc.)
Cold with intermittent compression postoperatively for 2 weeks

Other interventions: Ice with compressive bandages
Cold with static compression postoperatively for 2 weeks

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical function performance
Timepoint [1] 0 0
2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Primary outcome [2] 0 0
Time to reach defined physical therapy milestones
Timepoint [2] 0 0
2 weeks postoperative, 6 weeks postoperative, 6 months postoperative

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Orthosports - Concord
Recruitment postcode(s) [1] 0 0
2137 - Concord
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maine
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CoolSystems, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00712816
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00712816