Efficacy of AposTherapy® in Knee OA

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03153956
• Other study ID #: 14-02127
• Status: Terminated
• Phase: N/A
• Start date: April 16, 2015
• Est. completion date: November 15, 2018

Study information

• Verified date: March 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Non-Calibrated Sham Apos Therapy Device
The comparator group will receive a non-calibrated sham device.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	screening, 3 months, 6 months, 9 months, and 12 months
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.	12 Months
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.	screening, 3 months, 6 months, 9 months, and 12 months