What is the purpose of this study?

To investigate why patients respond differently for a given standard osteoarthritis (OA) treatment. Example: Why not everyone experience improvement after knee Hyaluronic Acid (HA) injection.

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Why is this study important?

This study will help clinicians and patients identify which patients should be given which treatment.

 

What type of study is this?

This is an observational follow up study – meaning you will not be asked to undergo any procedure/ treatment beyond those prescribed or planned by your treating physician. However, we would like to request for you to answer some questions and perform some examinations to gauge your physical wellbeing. This include examining the way you walk using cameras and sensors (picture below) in a lab.

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How many visits in total? What are the locations for the visit venues?

Approximately 7 visits in total as follow:

Before recruit 
One visit for screening at Faculty of Engineering, Universiti Malaya

If eligible 
One visit to Lifecare Diagnostic Medical Centre for MRI
One visit to Sports centre for gait at Faculty of Sports and Exercise Science, Universiti Malaya
One visit to Universiti Malaya Medical Centre (UMMC) for injection
One visit at 3 months, 6 months and 1 year at Universiti Malaya Medical Centre (UMMC).

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Does the investigatory product contain cultural sensitive ingredients eg: bovine or porcine? (if applicable)

Not relevant.

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Why have I been invited to participate in this study?

You represent the many knee OA that are seeking treatment for their pain and we would like to follow your progress to help us understand more about why and when a specific treatment (e.g. Hyaluronic Acid (HA) injection) will work. 

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Who is eligible to participate in the study?

Those who have/had​

• confirmed knee osteoarthritis diagnosis

• knee pain (with pain scale at least 3 out of 10) that lasts at least one year on one side of knee

• the other side of knee should either be pain-free or have minimal pain

• Body Mass Index (BMI) < 25, indicating that they are not overweight

• able to attend all visits for the study

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What will happen to me if I take part?

You will continue your usual follow up with the attending doctor. However, we may contact you to obtain information at specific dates which may not coincide with your usual follow-up.

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How long will I be involved in this study?

Ideally, we would like to have you in the study up to 1 year after your injection.

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What are the possible disadvantages and risks?

No risks are involved but it may require you to take some time to answer the questions and perform some physical fitness tests and examination. You will also be asked to attend a separate session to assess your gait.

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What are the possible benefits to me?

Although no immediate benefit is expected, the result of the study will hopefully allow clinicians and patients to save resources by administering HA to the right type of patients only. Cost for MRI and the injection you received will be covered by the research.

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Who will have access to my medical records and research data?

Investigators involved in this research.

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Will my records/data be kept confidential?

Yes.

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What will happen to the results of the research study?

Results will be reported in academic journals, share with other clinicians and patients to help them decide their treatment options.

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Do I need to cover the expenses for the HA injection, MRI scan, and any other costs associated with the study?

Due to restriction in the payment policy, participants may be required to advance some charges incurred (e.g. approximately RM800 for MRI and RM15 for clinic registration). The reimbursement will need to be processed centrally by the university bursary and may take as long as 2-3 months. However, participants will not be required to pay for HA injection. It should be noted that we will not cover transportation cost.

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Will I receive compensation for participating in this study?

Yes. RM100 at the end of the 1-year study.

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Who funds this study?

University research grant.

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What should I do if I want to register as a volunteer?

Please fill in the registration form here.

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How long do I need to wait to receive a final decision regarding my selection?

We will contact you within a month after your registration.