Efficacy of AposTherapy® in Knee OA

NCT03153956 | Terminated Results FDA Device

• 1 other identifier: 14-02127
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

AposTherapy® System; Osteoarthritis; Total knee arthroplasties; Degenerative joint disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Score (VAS) Score

  12 Months

• Short-Form 36 (SF-36) Total Score

  screening, 3 months, 6 months, 9 months, and 12 months

Study Arms (2)

Active Treatment Arm

EXPERIMENTAL

Personally calibrated bio-mechanical device

Device: Calibrated AposTherapy®

Control Arm

PLACEBO COMPARATOR

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

Device: Non-Calibrated Sham Apos Therapy Device

Interventions

Calibrated AposTherapy® DEVICE

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.

Active Treatment Arm

Non-Calibrated Sham Apos Therapy Device DEVICE

The comparator group will receive a non-calibrated sham device.

Control Arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dennis A. Cardone, DO
• Organization: NYU Langone Health

Dennis.Cardone@nyulangone.org

+1 646 501 7223

Study Officials

• Dennis Cardone, DO

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 15, 2017
• Study Start: April 16, 2015
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

US (1)