Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA. The main objectives of this study are: 1. To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for Total Knee Replacement (TKR). 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.
Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Future projections of the prevalence of OA predict an increase in prevalence, mainly due to the aging of the population and obesity. Total knee replacement (TKR) is the end-stage solution for patients with knee OA. The total annual cost of arthritis in the U.S. in 2013 reached over $300 billion. Expenditure is expected to grow significantly in response to the increase in prevalence and the projected number of TKRs. Successful and beneficial non-invasive treatment options for knee OA are limited. More specifically, although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA. The main objectives of this study are: 1. To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for TKR. 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
AposHealth is comprised of a unique footwear (Apos device) and uses two convex pods called "Pertupods", which are screwed into the plantar surface of the sole so that a person walks on these pods. A trained Apos therapist calibrates the devices. The location of the pods is adjusted according to the treatment methodology, depending on the needed effect on unloading the knee and with the purpose of potentially alleviating pain immediately.
A total knee replacement occurs when a diseased or damaged knee joint is totally replaced with an artificial joint called an implant. The implant consists of high-grade metal and plastic components that fuse to the resurfaced bone. It is designed to move like a healthy human joint.
Geisinger Medical Center
Danville, Pennsylvania, United States
RECRUITINGGeisinger - Orthopaedics Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States
RECRUITINGpain: Numerical Pain Rating Scale
score range: worst 0 - 10 best
Time frame: 12 months
Veterans RAND 12 Health Survey (VR-12) physical component score
patient's overall perspective of their physical health; worst 15 - 63 best
Time frame: 3, 6, and 12 months
Koos Jr
short form of knee injury and osteoarthritis outcome questionnaire; worst 0 - 100 best
Time frame: 3, 6, and 12 months
pain: Numerical Pain Rating Scale
score range: worst 0 - 10 best
Time frame: 3 and 6 months
Step length (left and right)
A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated for step length (in centimeters).
Time frame: 6 and 12 months
Single limb support (SLS): % gait cycle (left and right)
A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated. A single gait cycle is defined from heel strike of one limb to the next heel strike (of the mane limb). A gait cycle is comprised of 2 phases: Stance (limb on the ground) and swing (limb swings forward). The stance phase is divided into SLS (one limb is on the ground while the other limb swings forward) and double limb support (both feet are on the ground). The absolute time of SLS will be converted to percent of gait cycle for standardization purposes.
Time frame: 6 and 12 months
Gait velocity
A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated for velocity (meter/second).
Time frame: 6 and 12 months
Symmetry index (SI) for step length
A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated for step length (in centimeters). Temporal distance (T-D) symmetry is used to calculate Symmetry Index (SI) for step length using the formula: (involved-uninvolved)/\[(involved+uninvolved)/2)\] x 100. SI value of zero represents perfect symmetry and up to 5% difference between limbs is considered normal.
Time frame: 6 and 12 months
Symmetry index (SI) for single limb support (SLS)
A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). Each gait test included 6 walks and the mean value is calculated. A single gait cycle is defined from heel strike of one limb to the next heel strike (of the mane limb). A gait cycle is comprised of 2 phases: Stance (limb on the ground) and swing (limb swings forward). The stance phase is divided into SLS (one limb is on the ground while the other limb swings forward) and double limb support (both feet are on the ground). The absolute time of SLS will be converted to % of gait cycle for standardization purposes. Temporal distance (T-D) symmetry is used to calculate Symmetry Index (SI) for SLS (% gait cycle) using the formula: (involved-uninvolved)/\[(involved+uninvolved)/2)\] x 100. SI value of zero represents perfect symmetry and up to 5% difference between limbs is considered normal.
Time frame: 6 and 12 months
Decay rate in AposTherapy group
Number of patients assigned to AposTherapy only group who schedule a TKR before end of study period
Time frame: 12 months
Pain medication intake
Self-reported daily total milligrams of analgesic medication consumed
Time frame: 3, 6, and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.