NCT00712816

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 Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
2 countries

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

3.4 years

First QC Date

July 7, 2008

Last Update Submit

March 19, 2012

Conditions

OsteoarthritisTotal Knee Arthroplasty

Keywords

osteoarthritistotal knee arthroplastycryotherapy

Outcome Measures

Primary Outcomes (2)

  • Physical function performance

    2 weeks postoperative, 6 weeks postoperative, 6 months postoperative

  • Time to reach defined physical therapy milestones

    2 weeks postoperative, 6 weeks postoperative, 6 months postoperative

Study Arms (2)

A

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

B

ACTIVE COMPARATOR
Other: Ice with compressive bandages

Interventions

Game Ready Injury Treatment System (CoolSystems Inc.)DEVICE

Cold with intermittent compression postoperatively for 2 weeks

A
Ice with compressive bandagesOTHER

Cold with static compression postoperatively for 2 weeks

B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Naval Medical Center, San Diego

San Diego, California, 92134, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Orthopaedic Research Foundation

Indianapolis, Indiana, 46278, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Sports Medicine Associates of San Antonio

San Antonio, Texas, 78240, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Orthosports

Concord, New South Wales, 2137, Australia

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ice

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public Health

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 10, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(10)AU(1)