AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

Apos Health

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562652

Apos_Sing_01

Details and patient eligibility

About

Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of the disease are pain and functional disability.

This study has two aims:

1. To characterise the gait patterns and clinical parameters of patients with knee osteoarthritis (KOA) in Singapore at baseline, prior to treatment.
2. To investigate the changes in gait patterns and the clinical benefits of treatment with a new biomechanical device, AposTherapy, for patients with KOA.

Enrollment: 60 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from symptomatic bilateral knee osteoarthritis at the medial compartment for at least six months, fulfilling the ACR clinical criteria for OA of the knee, and having radiographically assessed OA of the knee according to the Kellgren and Lawrence scale.
• Patients with an overall WOMAC score of >2cm (as measured at baseline).
• Males and females between the ages of 50-70.

Exclusion criteria

• Patients suffering from acute septic arthritis.
• Patients suffering from inflammatory arthritis.
• Patients who received a corticosteroid injection within 3 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.
• 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 back or hip joint symptoms.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Research

Experimental group

Treatment:

Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)