Total Knee Arthroplasty (TKA)
Conditions
Brief summary
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.
Detailed description
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA. Patients will be given the opportunity to participate, and enrolled and consented participants will be treated and followed by physicians from OSI Orthopedic & Sports Medicine. Upon consent, patients will be randomized to receive the active range of motion monitor (the knee glider) two weeks prior to surgery, near day of surgery to use postoperatively, or standard of care (no knee glider). All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic & Sports Medicine. Enrolled subjects will be followed from the time of consent, through 6 months following surgery. Patients who are randomized into groups receiving the knee glider will receive the knee glider for up to 4 weeks following surgery, and compliance will be monitored. The hypothesis of this study is that patients who utilize an active range of motion monitor (the knee glider) will have improved clinical outcomes over patients receiving standard of care.
Interventions
DEVICEKnee Glider
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.
Sponsors
OSI Orthopedics and Sports Medicine
Rehab 360 Knee Glider
Force Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
This study includes 3 arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.
Exclusion criteria
* Individuals who have not undergone TKA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Patient Characteristics | Baseline | Intended to collect patient demographics, contact information, birth date, surgery date, age and other baseline demographic variables. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) | Baseline, 2 Weeks Post Op, 6 Weeks Post Op, 12 Weeks Post Op, 6 Months Post Op, | Intended to elicit people's opinions about the difficulties they experience due to problems with their knee and covers aspects of pain, functional limitations and knee-related quality of life. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline | 1. The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness in the past 48 hours. 2. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). 3. Scores can be calculated for each subscale and a total score is calculated by adding all 3 subscale scores. Higher points signify higher levels of functional difficulty. |
| Veterans RAND 12 (VR-12) | Baseline | a. The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. |
| Force Patient Engagement | Baseline | Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access |
| Range of Motion via the Knee Glider | Baseline | Daily Knee Flexion and Extension for the duration of utilizing the knee glider |
| Range of Motion (Exam / Patient Reported) | Baseline | a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform |
| Daily NRS Pain (Continuous) | Baseline | The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain |
| Discharge Services Utilization & Cost | 6 Weeks Post Op | The Discharge Services Utilization & Cost survey is intended collect patient discharge information. The survey consists of 16 questions asking about where they went for physical therapy, how much it costs, and if any adverse events resulted in admission to an Emergency Room or Urgent Care. |
| Knee Glider Satisfaction | 2 Weeks Post Op | The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider. |
| Total Joint Replacement (TJR) Satisfaction | 12 Weeks Post Op | The TJR Satisfaction survey intends to understand patient experience and satisfaction results with their total joint replacement procedure. |
Contacts
Primary ContactJoyce Harary, BA
Backup ContactBen Koerner, DO, MBA
Outcome results
None listed