AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562652
• Other study ID #: Apos_Sing_01
• Status: Completed
• Phase: N/A
• First received: March 14, 2012
• Last updated: March 23, 2012

Study information

• Verified date: March 2012
• Source: Apos Medical and Sports Technology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Singapore	AposTherapy center	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Apos Medical and Sports Technology Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in self-evaluation questionnaires between baseline and after 6 months of therapy	Western Ontario and MacMaster osteoarthritis questionnaire (WOMAC) and SF-36 Health Survey will be evaluated.; The WOMAC questionnaire is measured on a 10cm visual analogue scale (VAS) and the SF-36 is scored between 0-100.	Baseline, 6 months	No
Secondary	Changes in spatio-temporal gait parameters between basline and after 6 months of therapy		Baseline, 6 months	No