OsteoarthritisPhase 4NCT00712816
Use of Cold and Compression Therapy With Total Knee Replacement Patients
A Phase 4 study testing Game Ready Injury Treatment System (CoolSystems Inc.) and Ice with compressive bandages in people with Osteoarthritis and Total Knee Arthroplasty, run by CoolSystems, Inc. at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Game Ready Injury Treatment System (CoolSystems Inc.) and Ice with compressive bandages
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2008to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Eastern Maine Medical Center
Bangor, Maine, 04401
Cleveland Clinic
Cleveland, Ohio, 44195
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Orthopaedic Research Foundation
Indianapolis, Indiana, 46278
Hospital for Special Surgery
New York, New York, 10021
Sports Medicine Associates of San Antonio
San Antonio, Texas, 78240
Naval Medical Center, San Diego
San Diego, California, 92134
Madigan Army Medical Center
Tacoma, Washington, 98431
Central DuPage Hospital
Winfield, Illinois, 60190
About this study
Official title: Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
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.
Read the 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.
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Game Ready Injury Treatment System (CoolSystems Inc.), Ice with compressive bandages
- Keywords
- osteoarthritis, total knee arthroplasty, cryotherapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Ready Injury Treatment System (CoolSystems Inc.)Device
Cold with intermittent compression postoperatively for 2 weeks
Ice with compressive bandagesOther
Cold with static compression postoperatively for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Game Ready Injury Treatment System (CoolSystems Inc.) |
| B | Active comparator | Not described Receives: Other: Ice with compressive bandages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function performance
Measured: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Time to reach defined physical therapy milestones
Measured: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoolSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712816
- Sponsor's protocol ID
- 2007-02
- Status last verified
- Mar 2012
- First submitted
- 7 Jul 2008
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT00712816
- Acronym / sponsor ID
- 2007-02
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Keywords
- osteoarthritis, total knee arthroplasty, cryotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- CoolSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Game Ready Injury Treatment System (CoolSystems Inc.) |
| B | Active comparator | Other: Ice with compressive bandages |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Ready Injury Treatment System (CoolSystems Inc.)Cold with intermittent compression postoperatively for 2 weeks | Device | A |
| Ice with compressive bandagesCold with static compression postoperatively for 2 weeks | Other | B |
Primary outcome
Physical function performance
Time frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Time to reach defined physical therapy milestones
Time frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
Related trials for Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Game Ready Injury Treatment System (CoolSystems Inc.) and Ice with compressive bandages in people with Osteoarthritis and Total Knee Arthroplasty, run by CoolSystems, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function performance (time frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.