Anaheim Knee Osteoarthritis Clinical Trial



Anaheim Knee Osteoarthritis Clinical Trial

Knee Osteoarthritis Clinical Trial

Knee Osteoarthritis Clinical Trial

Knee osteoarthritis is a degenerative condition characterized by the gradual breakdown of the cartilage in the knee joint. Although osteoarthritis is a progressive, lifelong condition, treatment can help manage it. Osteoarthritis is a prevalent cause of pain and disability among adults in the United States, with knee osteoarthritis being the most common. Around 32-33 million people live with osteoarthritis, with the prevalence of the condition having doubled since the 1990s. Modeling indicates that by 2050, approximately 1 billion people may be affected by osteoarthritis, primarily knee osteoarthritis.

Despite the prevalence of this condition, there are no approved osteoarthritis drugs. Most people undergo therapy, but only to relieve…

Understanding The Knee Osteoarthritis Clinical Trial Anaheim

Our randomized, placebo-controlled clinical trial is conducted in adults with knee osteoarthritis. An investigational intra-articular injection is administered to the participants. This injection aims to alleviate pain and enhance knee function. Upon administering the injection, the potential effects on the joint structure are explored. The participants’ knee health is monitored over time through X-rays and MRIs. An MRI makes it easy to visualize bone marrow lesions, cartilage, and meniscus.

Duration And Schedule For The Clinical Study

The total duration of our knee osteoarthritis clinical trial in Anaheim is 52 weeks, which translates to approximately one year. Before participating in the clinical trial, you will undergo screening, during which we will perform eligibility checks, baseline X-rays, and an MRI if necessary. On day one, patients receive a single intra-articular injection into their knee. Patients undergo consistent follow-ups with in-clinic assessments that involve completing questionnaires and performing safety checks.

A baseline X-ray is performed at the beginning of the study and at its completion. A baseline MRI is also performed at the beginning and completion of the study, although the timing could vary based on the protocol. The exact timing of the clinical study will be confirmed during the initial screening.

What To Expect During The Study

Here is what to expect during the knee osteoarthritis clinical trial Anaheim:

We will review your medical history, conduct a knee examination, and complete a questionnaire. We will administer X-rays (radiographs) to confirm radiographic osteoarthritis. If eligible, you could undergo an MRI of your knee to enable us to evaluate the bone marrow lesions, menisci, cartilage, and synovitis.

On day 1, we will administer an intra-articular injection into the affected knee. The treatment is placebo-controlled. Some clinical trials may include an additional injection, typically administered in week 12; however, the study coordinator will communicate the exact treatment plan.

During follow-up appointments, we will assess pain and knee function and complete a questionnaire.

Why Imaging Is Important In Osteoarthritis Research

Why Imaging Is Important In Osteoarthritis Research

X-ray is crucial as the first-line imaging modality for the diagnosis and staging of knee osteoarthritis. It can reveal joint space narrowing, subchondral sclerosis, and osteophytes. MRI imaging can reveal cartilage, synovitis, meniscus, and bone marrow lesions. The imaging provides a clear picture of the joint condition and treatment outcome. MRI imaging is more effective in detecting changes in the cartilage over time. The clinical trial prioritizes radiographs as the primary imaging modality, followed by MRI if a participant is eligible.

Risk And Safety Details

Here are the risks and safety details of the different procedures involved in the clinical trials:

Intra-articular Knee Injections

You may experience mild reactions to the intra-articular knee injections, but these side effects are uncommon. Some of the potential reactions include pain at the injection site, post-injection flare, swelling, infection, and bleeding. Cases of infection are rare.

MRI Imaging

MRI uses no ionizing radiation. The MRI can be performed using or without contrast,but this will depend on the study protocol. If contrast is necessary, the MRI technician will inject a gadolinium-based agent. Reactions to gadolinium are rare. The participant’s kidney function is also reviewed before the MRI procedure.

X-rays

X-rays have low doses of ionizing radiation. A knee radiograph exposes the patient to significantly lower levels of radiation compared to other procedures, such as a chest X-ray.

Qualifying For The Knee Osteoarthritis Clinical Trial Anaheim

Whether or not a participant qualifies to participate in the clinical trial depends on the sponsor’s protocol. The qualification will be confirmed during the initial screening. Basically, the qualification criteria for a knee osteoarthritis clinical trial include:

  • Age — Usually, participants should be between 40 and 80 years, but some studies accept participants between 35 and 75 years

  • BMI — The ideal BMI is up to 40kg/m2

The Potential Benefits Of Participating In a Knee Osteoarthritis Clinical Trial Anaheim

Some of the potential benefits that participants can derive from the clinical trial include the following:

  • Participants have access to investigational therapy that is unavailable outside clinical trials

  • Expert research clinicians monitor the participants closely

  • Participants do not incur any costs to undergo imaging and treatment, as all costs are paid by the sponsors.

Our Values At Paragon Rx Clinical

Here is our commitment to the clinical trial participants:

  • Prompt and Respectful Screening — Our staff are compassionate and friendly and will explain every step clearly. We have a bilingual team that speaks Spanish, English, and Vietnamese

  • Convenient Imaging – We organize same-week imaging, including X-rays and MRI, to ensure that participants are not involved in back and forth

  • Diversity and Accessibility — We are committed to enrolling a diverse population, ensuring that our research findings are relevant and applicable to a broad range of individuals.

  • Integrity and Transparency — Our staff will guide you through all the costs involved, including those covered by sponsors and routine care costs. We will disclose all the cost details before you commence treatment.

  • Experienced Investigator Team — Our team of investigators comprises qualified professionals, including experts in musculoskeletal research and family medicine. Our experts have a track record in quality clinical trial execution.

How To Get Started

Here is how you can get started with the clinical trial:

  • Prescreen Call — You can establish your basic eligibility through our prescreen call

  • Screening Visit — This stage involves signing a consent form, undergoing an initial examination, completing a questionnaire, and undergoing imaging.

  • Study Drug Administration — You will receive the study drug on the first day.

  • Check-ins — Participants undergo short follow-ups and end-of-study imaging.

Find Professional Knee Osteoarthritis Clinical Trials Near Me

Knee osteoarthritis can occur if the cartilage within your joint breaks down, resulting in the bones rubbing together. This friction can cause pain and inflammation in the knee, causing stiffness. Despite the prevalence of knee osteoarthritis, there are no FDA-approved drugs for the condition. Many patients benefit from clinical trials, whereby they undergo treatment, and the treatment outcomes are recorded.

For a quality and proven knee osteoarthritis clinical trial Anaheim, contact Paragon RX Clinical. We have an experienced team of clinicians and research experts who will ensure your comfort throughout the clinical trial. Call us today at 714-539-3013 to speak to one of our experts.

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