Knee OsteoarthritisNCT01562652
AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)
A study testing AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel) in people with Knee Osteoarthritis, run by Apos Medical and Sports Technology Ltd. at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)Device
| Study group | Role | What they receive |
|---|---|---|
| Research | Experimental | Not described Receives: Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (1)
Changes in spatio-temporal gait parameters between basline and after 6 months of therapy
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apos Medical and Sports Technology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoav Aloni, Principal investigator, AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562652
- Sponsor's protocol ID
- Apos_Sing_01
- Status last verified
- Mar 2012
- First submitted
- 14 Mar 2012
- Last updated
- 26 Mar 2012
- Results posted
- No
Publications
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.
PubMed 24383821
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT01562652
- Acronym / sponsor ID
- Apos_Sing_01
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Apos Medical and Sports Technology Ltd.Industry (pharma, biotech, devices)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research | Experimental | Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel) | Device | Research |
Primary outcome
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.
1 secondary outcome
Changes in spatio-temporal gait parameters between basline and after 6 months of therapy
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 24383821Elbaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoav Aloni principal investigator
AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel) in people with Knee Osteoarthritis, run by Apos Medical and Sports Technology Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-evaluation questionnaires between baseline and after 6 months of therapy (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.