Efficacy of AposTherapy® in Knee OA

A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis

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).

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Calibrated AposTherapy®; Device: Non-Calibrated Sham Apos Therapy Device

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment Arm; Personally calibrated bio-mechanical device	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.
Placebo Comparator: Control Arm; sham-placebo device (similar shoes without bio-mechanical elements).	Device: Non-Calibrated Sham Apos Therapy Device; The comparator group will receive a non-calibrated sham device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	screening, 3 months, 6 months, 9 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Months
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.	screening, 3 months, 6 months, 9 months, and 12 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Dennis Cardone, DO, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2015
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Degenerative joint disease; AposTherapy® System; Total knee arthroplasties
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 14-02127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes