Bilateral Knee OsteoarthritisPhase 3NCT02063373
Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
A Phase 3 study testing Hyaluronic acid in people with Bilateral Knee Osteoarthritis, run by University of Malaya.
Trial summary
Treatment: five intro-articular Hyaluronic Acid injection Assessment has two parts, that are as follow: 1. Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test 2. Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Knee Osteoarthritis
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Oct 2013
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild and moderate bilateral knee osteoarthritis
- Age between 50 and 70 years
Who cannot join
- Recent Lower limb injury
- Diabetic
- Knee or hip replacement
- Knees HA injection in last 6 months
- Any neuromuscular disease such as stroke and Parkinson
About this study
Treatment: five intro-articular Hyaluronic Acid injection
Assessment has two parts, that are as follow:
- Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
- Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.
For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.
Read the detailed description
This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA).
Participants were individuals with knee OA (control and treatment) and healthy people.
- Conditions
- Bilateral Knee Osteoarthritis
- Being tested
- Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidOther
Also called Hyalgan, Manufacturer: Fidia Pharmaceutici S.p.A, Italy
treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.
| Study group | Role | What they receive |
|---|---|---|
| biomechanis knee OA and HA injection | Experimental | Weekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks Receives: Other: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postural stability after treatment
Measured: baseline and 6 weeks
Changes in Biomechanics of gait after treatment
Measured: baseline and 6 weeks
Changes in biomechanics of stair climbing after treatment
Measured: baseline and 6 weeks
Secondary outcomes (2)
Change in Pain after treatment
Measured: baseline and 6 weeks
Changes in WOMAC scores after treatment
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2013
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 Bilateral Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nafiseh khalaj, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063373
- Sponsor's protocol ID
- UM/MOHE/HIR D000010-16001
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
PubMed 25136689
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
- ClinicalTrials.gov ID
- NCT02063373
- Acronym / sponsor ID
- UM/MOHE/HIR D000010-16001
- Conditions
- Bilateral Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- First posted
- 14 Feb 2014 (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.
Treatment: five intro-articular Hyaluronic Acid injection
Assessment has two parts, that are as follow:
- Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
- Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.
For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.
Detailed description
This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA).
Participants were individuals with knee OA (control and treatment) and healthy people.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biomechanis knee OA and HA injection | Experimental | Other: Hyaluronic acidWeekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild and moderate bilateral knee osteoarthritis
- Age between 50 and 70 years
Key exclusion criteria (5 listed)
- Recent Lower limb injury
- Diabetic
- Knee or hip replacement
- Knees HA injection in last 6 months
- Any neuromuscular disease such as stroke and Parkinson
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 |
|---|---|---|
| Hyaluronic acidAlso: Hyalgan, Manufacturer: Fidia Pharmaceutici S.p.A, Italytreatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks. | Other | biomechanis knee OA and HA injection |
Primary outcome
Change in Postural stability after treatment
Time frame: baseline and 6 weeks
Changes in Biomechanics of gait after treatment
Time frame: baseline and 6 weeks
Changes in biomechanics of stair climbing after treatment
Time frame: baseline and 6 weeks
2 secondary outcomes
Change in Pain after treatment
Time frame: baseline and 6 weeks
Changes in WOMAC scores after treatment
Time frame: baseline and 6 weeks
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 14 Feb 2014.
- Derived from this study: PubMed 25136689Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic acid in people with Bilateral Knee Osteoarthritis, run by University of Malaya.
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 2 inclusion and 5 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Postural stability after treatment (time frame: baseline and 6 weeks). The study lists 3 primary outcomes in all. 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 NCT02063373, 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 14 Feb 2014.