Long Beach Knee Osteoarthritis Clinical Trial



Long Beach Knee Osteoarthritis Clinical Trial

Knee Osteoarthritis Clinical Trial

Knee Osteoarthritis Clinical Trial

Knee osteoarthritis (OA) is a prevalent joint disease that results from the gradual wearing off of the protective cartilage in the knee. Due to this cartilage thinning out, people usually experience stiffness, pain, and difficulty moving.

There are many treatments for knee OA, including disease-modifying osteoarthritis drugs (DMOADs). However, most of these treatments just help alleviate symptoms; they do not prevent the illness from worsening.

Clinical Trials Overview

A clinical trial is a research study that tests treatment options in a controlled and systematic way. They enable scientists to determine whether a new medication, injection, medical procedure, or exercise program is effective and safe.

Clinical trials are conducted in four distinct phases, based on the researchers’ goals.

  • Phase I tests whether a new treatment or medication is safe and effective.
  • Phase II tests determine whether the treatment is effective.
  • Phase III compares the treatment to a placebo or any other standard treatment plan in a larger population.
  • Phase IV examines the long-term effects of a treatment option following its approval.

Why Knee Osteoarthritis Clinical Trials Are Important

Knee OA worsens gradually with time. Doctors usually recommend weight management, exercise, injections, or medicines such as NSAIDs for patients with this condition. For severe cases, a patient may ultimately require surgery, like a knee replacement.

These options can help alleviate pain and improve function. However, none of them clearly reverses the damage in the joint. Hence, clinical research is necessary to test and compare new treatments and determine whether any of them could reverse the disease.

Additionally, knee OA clinical trials enable scientists and doctors to understand how the condition develops and advances. Since knee osteoarthritis varies among patients, some experience more inflammation than others. Others experience more bone changes, while others mainly experience pain. Consequently, researchers require carefully planned research to establish treatment options that work perfectly for what types of patients.

Knee Osteoarthritis Clinical Trial in Long Beach

Our knee osteoarthritis clinical trial in Long Beach is a randomized, placebo-controlled, double-blind research study for individuals with knee osteoarthritis. The clinical research assesses an investigational IA (intra-articular) injectable intended to alleviate pain and enhance function while investigating the possible effect on knee joint structure. The participants in this study will receive research-related imaging (MRI and X-rays) to monitor their knee health condition over time.
The study lasts about 52 weeks, and the schedule includes the following:

This involves conducting an eligibility check, a baseline X-ray, and, if you qualify, a baseline MRI.

These visits involve routine in-clinic evaluations. The visits happen weeks apart, for example, weeks four, twelve, twenty-four, thirty-six, and fifty-two. The research coordinator will conduct safety checks and questionnaires during these visits.

On your day one visit, you will receive one study IA injection into your knee

Before concluding the study, the research coordinator conducts an X-ray or MRI.

This typical schedule reflects many present knee osteoarthritis injection clinical trials. Several of these trials run between 12 and 52 weeks. The research coordinator will confirm the precise timing during the screening process.

Qualification for Knee Osteoarthritis Clinical Trial in Long Beach

Qualification for Knee Osteoarthritis Clinical Trial in Long Beach

To qualify for our knee osteoarthritis clinical trial in Long Beach, you must meet particular criteria. The sponsor’s protocol determines the final criteria, which are then confirmed during the screening procedure. However, general qualification requirements include the following:

  • You must generally be between 40 and 80 years old (some research studies accept between 35 and 75 years)
  • Your body mass index (BMI) should be a maximum of 40 kg/m² (some BMI ranges vary, for example, between 18.5 and 40 or 20 and 35 kg/m²).
  • The knee pain must meet study thresholds, for instance, WOMAC or numeric rating scale pain range
  • Radiographic knee osteoarthritis: KL Grade 2 to 4 in the knee undergoing study

What to Expect During Our Knee Osteoarthritis Clinical Trial in Long Beach

This is what to expect if you participate in our clinical trial:

  • Pre-screening. The research coordinator will place a quick call to you to verify your basic eligibility.
  • Screening and baseline visit. Your research coordinator will review your medical history, conduct a physical examination of your knee, and administer questionnaires. They will also conduct radiographs to verify radiographic osteoarthritis. The coordinator will also carry out a knee MRI if you qualify to assess synovitis, bone marrow lesions, menisci, and cartilage.
  • Investigational treatment. The research coordinator will administer a placebo-controlled IA injection into your affected knee during your first day of visit. Some studies include the administration of a second IA at week twelve. Your research coordinator will inform you of the precise schedule for this research.

Importance of Imaging in Knee Osteoarthritis Research

X-ray is the standard imaging technique for staging and diagnosing knee osteoarthritis. It can detect subchondral sclerosis, osteophytes, and joint space narrowing. MRI, on the other hand, can visualize meniscus, synovitis, bone marrow lesions, and cartilage. It provides a more detailed picture of treatment effects and joint health.

In clinical studies, MRI has demonstrated a greater ability to visualize cartilage changes within a period of time. Imaging guidelines stress radiographs and MRIs as appropriate, and this research adheres to these guidelines.

Possible Benefits of Joining a Knee Osteoarthritis Clinical Trial in Long Beach

Participating in our knee osteoarthritis clinical trial in Long Beach has several benefits:

  • You will have access to investigational treatments that are unavailable outside of clinical research.
  • Expert research clinicians will closely monitor you
  • The research is free of charge. The study sponsor commonly covers the costs for the required imaging for the study (MRIs and X-rays) and assessments. You might be billed for regular care items as usual.
  • Some participants feel functional improvement and pain relief. However, this benefit is not guaranteed, as that is what the research aims to determine.

Risks and Safety Information

The risks associated with the knee OA clinical trial are

  • IA knee injection: Common risks related to IA injection include swelling, pain at the injection site, and post-injection flare. These risks are temporary and rare. Another risk includes bleeding and septic arthritis (infection). However, a low risk of infection has been reported.
  • MRI safety and contrast: MRI does not use ionizing radiation. Based on the research protocol, your coordinator may perform a knee MRI with or without contrast. And if they use contrast, the coordinator will use a gadolinium-based agent. Reactions are rare, and the coordinator will review kidney function in advance as appropriate.
  • X-ray. X-rays utilize low-dose ionizing radiation, making the risks relatively low.

The coordinator will explain all risks, procedures, and alternatives during the informed consent process.

Find a Professional Knee Osteoarthritis Clinical Research Center Near Me

Knee OA impacts millions of individuals and lowers their quality of life. With continued research studies, clinical trials may result in more targeted and effective treatment options that not only alleviate pain but also change or slow down the progression of knee OA.

If you would like to participate in a knee osteoarthritis clinical trial in Long Beach, we at Paragon RX Clinical can enroll you. We conduct our studies using modern equipment. Our team comprises skilled clinicians in musculoskeletal research and family medicine, with experience in rapid start-up and the execution of high-quality trials. Call us at 714-539-3013 for more information on our clinical trials.

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