- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03260699
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
September 24, 2019 updated by: Carlos Higuera-Rueda, The Cleveland Clinic
To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined.
Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Age: 50 years or older
Exclusion Criteria:
- BMI > 40
- Radiographic deformity of greater than 10 degrees
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
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Experimental: Bracing group
Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery.
This brace will be worn for 6 weeks before surgery.
The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study.
Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.
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Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces.
Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Physical Therapy Visits
Time Frame: Total number of visits from date of surgery to 12 weeks after surgery
|
Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.
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Total number of visits from date of surgery to 12 weeks after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) for Pain (0-10 Scale)
Time Frame: Change from baseline to 12 weeks after surgery
|
Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies.
It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had.
Therefore, starting from zero point, increasing numbers demonstrate worse pain.
Patient can pick a point on the scale that they believe represent their pain level at a given moment.
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Change from baseline to 12 weeks after surgery
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Timed up and go Test (Timed Measurement)
Time Frame: Change from baseline to 12 weeks after surgery
|
Used to assess a person's mobility and balance.
It is measured in time units (seconds or minutes) using a stopwatch by a study personnel.
To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified.
At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace.
The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)
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Change from baseline to 12 weeks after surgery
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Timed Stair Climb (Timed Measurement Over Fixed Distance)
Time Frame: Change from baseline to 12 weeks after surgery
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Used to assess a person's mobility and balance
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Change from baseline to 12 weeks after surgery
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One-leg Stance Time (Timed Measurement)
Time Frame: Change from baseline to 12 weeks after surgery
|
Used to assess a person's balance.
Performed with eyes open and arms on hips.
The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips.
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Change from baseline to 12 weeks after surgery
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6 Minute Walk Test (Distance Measurement)
Time Frame: Change from baseline to 12 weeks after surgery
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Used to assess a person's endurance and aerobic capacity.
The score of the test is distance a patient walks in 6 minutes.
Longer distances walked by the patient in 6 minutes correlates with better performance.
Distance is measured using distance measuring wheel.
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Change from baseline to 12 weeks after surgery
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Knee Society Score Questionnaire
Time Frame: Change from baseline to 12 weeks after surgery
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Clinical outcome questionnaire developed by the consensus of the Knee Society.
It comprises, a "Knee score" and a "Functional score."
The Knee score assesses pain, stability, and range of motion.
A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability.
Deductions are made for flexion contracture, extension lag, and malalignment.
The Functional score assesses walking distance and stair climbing.
A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally.
Deductions are made for use of a walking stick or crutches.
Therefore, higher scores correlate with better function and outcome.
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Change from baseline to 12 weeks after surgery
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Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
Time Frame: Change from baseline to 12 weeks after surgery
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Clinical outcome questionnaire that measure joint-specific pain and physical function.
It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living.
Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table.
The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health.
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Change from baseline to 12 weeks after surgery
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Hospital for Special Surgery (HSS) Score (0-100 Scale)
Time Frame: Change from baseline to 12 weeks after surgery
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Clinical outcome assessment tool.
It is based on a total of 100 points.
The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions.
The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria.
The higher the score, the better the outcome.
Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
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Change from baseline to 12 weeks after surgery
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Type of Pain Medication Used
Time Frame: Change from baseline to 12 weeks after surgery
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Investigators will monitor the medical record for types of pain medications used.
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Change from baseline to 12 weeks after surgery
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Amount of Pain Medication Used
Time Frame: Change from baseline to 12 weeks after surgery
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Investigators will monitor the medical record for the amount of pain medication used
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Change from baseline to 12 weeks after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Spindler Kurt, MD, Department Chair
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2017
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
July 10, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (Actual)
August 24, 2017
Study Record Updates
Last Update Posted (Actual)
October 9, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHB-OCSI007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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