Clinical trial NCT03153956: Efficacy of AposTherapy® in Knee OA
Official title: A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: AposTherapy® System
Osteoarthritis
Total knee arthroplasties
Degenerative joint disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 77
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster University (WOMAC) Total Score
timeFrame: screening, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes:
measure: Visual Analog Score (VAS) Score
timeFrame: 12 Months
measure: Short-Form 36 (SF-36) Total Score
timeFrame: screening, 3 months, 6 months, 9 months, and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Dennis Cardone, DO
role: PRINCIPAL_INVESTIGATOR
References: