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OpenTrials
Completed

NCT Number: NCT01562652

AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AposTherapy center

Singapore, 248649

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Primary outcomes

  1. Changes in self-evaluation questionnaires between baseline and after 6 months of therapy

    Time frame: Baseline, 6 months

    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.

Secondary outcomes

  1. Changes in spatio-temporal gait parameters between basline and after 6 months of therapy

    Time frame: Baseline, 6 months

Sponsors and collaborators

Lead sponsor

Apos Medical and Sports Technology Ltd.

Industry

Registry information

Important dates

First posted
Mar 26, 2012
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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