Use of Cold and Compression Therapy With Total Knee Replacement Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement

NCT02217202

Osteoarthritis

WITHDRAWN NA

Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

NCT01478386

Knee Osteoarthritis

TERMINATED NA

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf

NCT02251522

Osteoarthritis

COMPLETED

Postoperative Function Following Partial and Total Knee Replacement

NCT00492219

Osteoarthritis Post-traumatic Arthritis

TERMINATED NA

Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study

NCT02228759

Knee Osteoarthritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Total Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Game Ready Injury Treatment System (CoolSystems Inc.)

Intervention Type DEVICE

Cold with intermittent compression postoperatively for 2 weeks

B

Group Type ACTIVE_COMPARATOR

Ice with compressive bandages

Intervention Type OTHER

Cold with static compression postoperatively for 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Game Ready Injury Treatment System (CoolSystems Inc.)

Cold with intermittent compression postoperatively for 2 weeks

Intervention Type DEVICE

Ice with compressive bandages

Cold with static compression postoperatively for 2 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No