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Efficacy of AposTherapy® in Knee OA

Primary Purpose

Osteoarthritis, Knee

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calibrated AposTherapy®
Non-Calibrated Sham Apos Therapy Device
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring AposTherapy® System, Osteoarthritis, Total knee arthroplasties, Degenerative joint disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment Arm

Control Arm

Arm Description

Personally calibrated bio-mechanical device

sham-placebo device (similar shoes without bio-mechanical elements).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 9, 2017
Last Updated
March 23, 2020
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03153956
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Halt in funding
Study Start Date
April 16, 2015 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
AposTherapy® System, Osteoarthritis, Total knee arthroplasties, Degenerative joint disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment Arm
Arm Type
Experimental
Arm Description
Personally calibrated bio-mechanical device
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
sham-placebo device (similar shoes without bio-mechanical elements).
Intervention Type
Device
Intervention Name(s)
Calibrated AposTherapy®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non-Calibrated Sham Apos Therapy Device
Intervention Description
The comparator group will receive a non-calibrated sham device.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster University (WOMAC) Total Score
Description
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
Secondary Outcome Measure Information:
Title
Visual Analog Score (VAS) Score
Description
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
Title
Short-Form 36 (SF-36) Total Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Cardone, DO
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Efficacy of AposTherapy® in Knee OA

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