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AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)
Sponsored by
Apos Medical and Sports Technology Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AposTherapy center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Research

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2012
Last Updated
March 23, 2012
Sponsor
Apos Medical and Sports Technology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01562652
Brief Title
AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apos Medical and Sports Technology Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)
Primary Outcome Measure Information:
Title
Changes in self-evaluation questionnaires between baseline and after 6 months of therapy
Description
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.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Changes in spatio-temporal gait parameters between basline and after 6 months of therapy
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Aloni
Organizational Affiliation
AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649
Official's Role
Principal Investigator
Facility Information:
Facility Name
AposTherapy center
City
Singapore
ZIP/Postal Code
248649
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
24383821
Citation
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.
Results Reference
derived

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AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

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