Osteoarthritis, Knee
Conditions
Keywords
AposTherapy® System, Osteoarthritis, Total knee arthroplasties, Degenerative joint disease
Brief summary
A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).
Interventions
DEVICECalibrated AposTherapy®
a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.
DEVICENon-Calibrated Sham Apos Therapy Device
The comparator group will receive a non-calibrated sham device.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I - A prospective, interventional, randomized, double-arm clinical evaluation of patients who have been diagnosed with OA of the knee. The active treatment arm (personally calibrated biomechanical device) will be compared to a control arm (sham-placebo device) (similar shoes without biomechanical elements). Phase II - Open-label, cross-over study design. After the completion of phase one patients will be un-blinded to their group allocation. Patients that were allocated to the sham-placebo control group will cross to the active group and will receive the AposTherapy treatment. Patients that were allocated to the active group will continue with treatment.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months; * Fulfilling the ACR clinical criteria; * Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and, * Having VAS-Pain ≥ 3, on a scale between 0-10. * Patients who have a shoe size between US 4 and US 12
Exclusion criteria
* Patients suffering from acute septic arthritis. * Patients who received a corticosteroid injection within 3 months of the study. * Patients who received hyaluronic acid (HA) injections within 6 months of the study * Patients suffering from avascular necrosis of the knee. * Patients with a history of knee buckling or recent knee injury. * Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side). * Patients suffering from neuropathic arthropathy. * Patients with an increased tendency to fall. * Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure. * Patients with a history of pathological osteoporotic fracture. * Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees. * Patients with referred pain in the knees from primary back or hip joint pain. * Patients with neurological deficits to the lower extremity (ex. foot drop) * Patients whose shoe size is less than US 4 and greater than US 12 * Patients who have had arthroscopy within 6 months of the study * Patients with inflammatory arthropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster University (WOMAC) Total Score | screening, 3 months, 6 months, 9 months, and 12 months | WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score (VAS) Score | 12 Months | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. |
| Short-Form 36 (SF-36) Total Score | screening, 3 months, 6 months, 9 months, and 12 months | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Arm Personally calibrated bio-mechanical device
Calibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. | 39 |
| Control Arm sham-placebo device (similar shoes without bio-mechanical elements).
Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device. | 38 |
| Total | 77 |
Baseline characteristics
| Characteristic | Active Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 9 | 61 years STANDARD_DEVIATION 8.2 | 61 years STANDARD_DEVIATION 8.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 38 |
| other Total, other adverse events | 0 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 38 |
Outcome results
Primary
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: screening, 3 months, 6 months, 9 months, and 12 months
Population: Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total score - screen | 1062.7 score on a scale | Standard Deviation 545.96 |
| Active Treatment Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total score - 3 months | 548.8 score on a scale | Standard Deviation 440.22 |
| Active Treatment Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total Score - 6 months | 420.2 score on a scale | Standard Deviation 391.7 |
| Active Treatment Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total Score - 12 months | 396.5 score on a scale | Standard Deviation 324.99 |
| Control Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total Score - 12 months | 433 score on a scale | Standard Deviation 352.32 |
| Control Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total Score - 6 months | 524.8 score on a scale | Standard Deviation 448.83 |
| Control Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total score - screen | 975.1 score on a scale | Standard Deviation 580.87 |
| Control Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total Score - 9 months | 280.2 score on a scale | Standard Deviation 194.84 |
| Control Arm | Western Ontario and McMaster University (WOMAC) Total Score | WOMAC Total score - 3 months | 601.1 score on a scale | Standard Deviation 467.39 |
Secondary
Short-Form 36 (SF-36) Total Score
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.
Time frame: screening, 3 months, 6 months, 9 months, and 12 months
Population: Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - screening | 55.6 score on a scale | Standard Deviation 15.03 |
| Active Treatment Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 3 months | 64.6 score on a scale | Standard Deviation 16.8 |
| Active Treatment Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 6 months | 69.7 score on a scale | Standard Deviation 14.8 |
| Active Treatment Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 12 month | 71 score on a scale | Standard Deviation 9.77 |
| Control Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 12 month | 66.6 score on a scale | Standard Deviation 15.38 |
| Control Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 6 months | 68 score on a scale | Standard Deviation 17.21 |
| Control Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - screening | 56.6 score on a scale | Standard Deviation 16.77 |
| Control Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 9 months | 74.5 score on a scale | Standard Deviation 6.37 |
| Control Arm | Short-Form 36 (SF-36) Total Score | SF-36 total score - 3 months | 63.0 score on a scale | Standard Deviation 17.09 |
Secondary
Visual Analog Score (VAS) Score
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Time frame: 12 Months
Population: Data was not collected for this outcome measure due to study termination.