NCT01562652

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

First QC Date

March 14, 2012

Last Update Submit

March 23, 2012

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    Baseline, 6 months

Study Arms (1)

Research

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

Interventions

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

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AposTherapy center

Singapore, 248649, Singapore

Location

Related Publications (1)

  • Elbaz A, Mor A, Segal G, Aloni Y, Teo YH, Teo YS, Das-De S, Yeo SJ. Patients with knee osteoarthritis demonstrate improved gait pattern and reduced pain following a non-invasive biomechanical therapy: a prospective multi-centre study on Singaporean population. J Orthop Surg Res. 2014 Jan 2;9:1. doi: 10.1186/1749-799X-9-1.

    PMID: 24383821DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yoav Aloni

    AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 26, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

SG(1)