Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2012
Actual
Sample size
Target
224
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00712816