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

To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03260699

Enrollment

Registered

2017-08-24

Start date

2017-10-05

Completion date

2018-01-01

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee

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.

Interventions

DEVICEOCSI Rehabilitator brace

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

Age: 50 years or older

Exclusion criteria

* BMI \> 40 * Radiographic deformity of greater than 10 degrees

Design outcomes

Primary

Measure	Time frame	Description
Number of Physical Therapy Visits	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.

Secondary

Measure	Time frame	Description
Timed up and go Test (Timed Measurement)	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)
Timed Stair Climb (Timed Measurement Over Fixed Distance)	Change from baseline to 12 weeks after surgery	Used to assess a person's mobility and balance
One-leg Stance Time (Timed Measurement)	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.
6 Minute Walk Test (Distance Measurement)	Change from baseline to 12 weeks after surgery	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.
Visual Analog Scale (VAS) for Pain (0-10 Scale)	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.
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires	Change from baseline to 12 weeks after surgery	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)	Change from baseline to 12 weeks after surgery	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	Change from baseline to 12 weeks after surgery	Investigators will monitor the medical record for types of pain medications used.
Amount of Pain Medication Used	Change from baseline to 12 weeks after surgery	Investigators will monitor the medical record for the amount of pain medication used
Knee Society Score Questionnaire	Change from baseline to 12 weeks after surgery	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	5
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. OCSI Rehabilitator brace: 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.	4
Total	9

Baseline characteristics

Characteristic	Control Group	Bracing Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	3 Participants	4 Participants
Age, Categorical Between 18 and 65 years	4 Participants	1 Participants	5 Participants
Age, Continuous	64.2 years	67.7 years	65 years
Body-mass Index	34.3 kg/m^2	26.9 kg/m^2	31 kg/m^2
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	1 Participants	6 Participants
Region of Enrollment United States	5 Participants	4 Participants	9 Participants
Sex: Female, Male Female	0 Participants	3 Participants	3 Participants
Sex: Female, Male Male	5 Participants	1 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 5	0 / 2
other Total, other adverse events	2 / 5	1 / 2
serious Total, serious adverse events	0 / 5	0 / 2

Outcome results

Primary

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.

Time frame: Total number of visits from date of surgery to 12 weeks after surgery

Arm	Measure	Value (MEAN)
Control Group	Number of Physical Therapy Visits	14 visit
Bracing Group	Number of Physical Therapy Visits	4 visit

Secondary

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.