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

Arthropathy of Knee Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03260699
• Other study ID #: SHB-OCSI007
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: September 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

Age: 50 years or older

Exclusion Criteria:

• BMI > 40

• Radiographic deformity of greater than 10 degrees

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Total number of visits from date of surgery to 12 weeks after surgery
Secondary	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.	Change from baseline to 12 weeks after surgery
Secondary	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)	Change from baseline to 12 weeks after surgery
Secondary	Timed Stair Climb (Timed Measurement Over Fixed Distance)	Used to assess a person's mobility and balance	Change from baseline to 12 weeks after surgery
Secondary	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.	Change from baseline to 12 weeks after surgery
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.	Change from baseline to 12 weeks after surgery
Secondary	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.	Change from baseline to 12 weeks after surgery
Secondary	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.	Change from baseline to 12 weeks after surgery
Secondary	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.	Change from baseline to 12 weeks after surgery
Secondary	Type of Pain Medication Used	Investigators will monitor the medical record for types of pain medications used.	Change from baseline to 12 weeks after surgery
Secondary	Amount of Pain Medication Used	Investigators will monitor the medical record for the amount of pain medication used	Change from baseline to 12 weeks after surgery