Trial Outcomes & Findings for Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA) (NCT NCT03260699)

NCT ID: NCT03260699

Last Updated: 2019-10-09

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Total number of visits from date of surgery to 12 weeks after surgery
• Results posted on: 2019-10-09

Participant Flow

Participant milestones

Measure	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.	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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Overall Study STARTED	5	4
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Group n=5 Participants 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.	Bracing Group n=4 Participants 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.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	64.2 years n=5 Participants	67.7 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Body-mass Index	34.3 kg/m^2 n=5 Participants	26.9 kg/m^2 n=7 Participants	31 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Number of Physical Therapy Visits	14 visit Interval 6.0 to 22.0	4 visit Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Visual Analog Scale (VAS) for Pain (0-10 Scale)	3 units on a scale Interval 2.0 to 4.0	2 units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Timed up and go Test (Timed Measurement)	4 Seconds Interval 2.0 to 6.0	10 Seconds Interval 6.0 to 14.0

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks after surgery

Used to assess a person's mobility and balance

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Timed Stair Climb (Timed Measurement Over Fixed Distance)	10 seconds Interval 8.0 to 12.0	17 seconds Interval 15.0 to 19.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
One-leg Stance Time (Timed Measurement)	21 seconds Interval 13.0 to 29.0	32 seconds Interval 30.0 to 34.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
6 Minute Walk Test (Distance Measurement)	68 meters Interval 60.0 to 79.0	89 meters Interval 80.0 to 89.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Knee Society Score Questionnaire	29 units on a scale Interval 23.0 to 36.0	33 units on a scale Interval 29.0 to 37.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires	35 units on a scale Interval 28.0 to 42.0	41 units on a scale Interval 39.0 to 43.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Hospital for Special Surgery (HSS) Score (0-100 Scale)	21 units on a scale Interval 15.0 to 27.0	21 units on a scale Interval 17.0 to 25.0

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks after surgery

Investigators will monitor the medical record for types of pain medications used.

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Type of Pain Medication Used Patients who used opioids	5 Participants	2 Participants
Type of Pain Medication Used Patients who did not use opioid medications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks after surgery

Investigators will monitor the medical record for the amount of pain medication used

Outcome measures

Measure	Control Group n=5 Participants 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.	Bracing Group n=2 Participants 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Amount of Pain Medication Used	30 morphine equivalents/day Standard Deviation 8	45 morphine equivalents/day Standard Deviation 8

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Bracing Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Group n=5 participants at risk 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.	Bracing Group n=2 participants at risk 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 new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function.
Nervous system disorders Transient right sided numbness	0.00% 0/5 • 9 months postoperative for each patient Definitions are similar to clinicaltrials.gov. Systmatic assessment was performed for patients with follow-up visit and at the 9 months point for each by chart review. The adverse events were then recorded for the cohort.	50.0% 1/2 • Number of events 3 • 9 months postoperative for each patient Definitions are similar to clinicaltrials.gov. Systmatic assessment was performed for patients with follow-up visit and at the 9 months point for each by chart review. The adverse events were then recorded for the cohort.
Musculoskeletal and connective tissue disorders Knee stiffness	40.0% 2/5 • Number of events 2 • 9 months postoperative for each patient Definitions are similar to clinicaltrials.gov. Systmatic assessment was performed for patients with follow-up visit and at the 9 months point for each by chart review. The adverse events were then recorded for the cohort.	0.00% 0/2 • 9 months postoperative for each patient Definitions are similar to clinicaltrials.gov. Systmatic assessment was performed for patients with follow-up visit and at the 9 months point for each by chart review. The adverse events were then recorded for the cohort.
Cardiac disorders Shortness of breath	20.0% 1/5 • Number of events 1 • 9 months postoperative for each patient Definitions are similar to clinicaltrials.gov. Systmatic assessment was performed for patients with follow-up visit and at the 9 months point for each by chart review. The adverse events were then recorded for the cohort.	0.00% 0/2 • 9 months postoperative for each patient Definitions are similar to clinicaltrials.gov. Systmatic assessment was performed for patients with follow-up visit and at the 9 months point for each by chart review. The adverse events were then recorded for the cohort.

Additional Information

Alison Klika, Research Manager

Department of Orthopaedic Surgery, Cleveland Clinic

Phone: 216 444-4954

Email: klikaa@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place