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Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)

Primary Purpose

Arthropathy of Knee

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCSI Rehabilitator brace
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 50 years or older

Exclusion Criteria:

  • BMI > 40
  • Radiographic deformity of greater than 10 degrees

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Bracing group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Physical Therapy Visits
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.

Secondary Outcome Measures

Visual Analog Scale (VAS) for Pain (0-10 Scale)
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.
Timed up and go Test (Timed Measurement)
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)
Timed Stair Climb (Timed Measurement Over Fixed Distance)
Used to assess a person's mobility and balance
One-leg Stance Time (Timed Measurement)
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.
6 Minute Walk Test (Distance Measurement)
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.
Knee Society Score Questionnaire
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.
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
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.
Hospital for Special Surgery (HSS) Score (0-100 Scale)
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.
Type of Pain Medication Used
Investigators will monitor the medical record for types of pain medications used.
Amount of Pain Medication Used
Investigators will monitor the medical record for the amount of pain medication used

Full Information

First Posted
July 10, 2017
Last Updated
September 24, 2019
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03260699
Brief Title
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
Official Title
To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Study terminated per Ongoing Care Solutions, Inc.
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Bracing group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OCSI Rehabilitator brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Physical Therapy Visits
Description
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.
Time Frame
Total number of visits from date of surgery to 12 weeks after surgery
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for Pain (0-10 Scale)
Description
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.
Time Frame
Change from baseline to 12 weeks after surgery
Title
Timed up and go Test (Timed Measurement)
Description
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)
Time Frame
Change from baseline to 12 weeks after surgery
Title
Timed Stair Climb (Timed Measurement Over Fixed Distance)
Description
Used to assess a person's mobility and balance
Time Frame
Change from baseline to 12 weeks after surgery
Title
One-leg Stance Time (Timed Measurement)
Description
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.
Time Frame
Change from baseline to 12 weeks after surgery
Title
6 Minute Walk Test (Distance Measurement)
Description
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.
Time Frame
Change from baseline to 12 weeks after surgery
Title
Knee Society Score Questionnaire
Description
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.
Time Frame
Change from baseline to 12 weeks after surgery
Title
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
Description
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.
Time Frame
Change from baseline to 12 weeks after surgery
Title
Hospital for Special Surgery (HSS) Score (0-100 Scale)
Description
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.
Time Frame
Change from baseline to 12 weeks after surgery
Title
Type of Pain Medication Used
Description
Investigators will monitor the medical record for types of pain medications used.
Time Frame
Change from baseline to 12 weeks after surgery
Title
Amount of Pain Medication Used
Description
Investigators will monitor the medical record for the amount of pain medication used
Time Frame
Change from baseline to 12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 50 years or older Exclusion Criteria: BMI > 40 Radiographic deformity of greater than 10 degrees
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spindler Kurt, MD
Organizational Affiliation
Department Chair
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)

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