Department of Orthopaedic Surgery

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Spine

A look at Clinical Studies

What is a clinical study?

Clinical studies are considered the highest level of scientific evidence. Generally, they are studies that are tightly controlled and use people as the subjected of research. There are two major types of clinical studies, interventional and observational.

Interventional studies are typically called clinical trials and are studies where the patients involved in studies, or subjects, are assigned to a specific treatment. In this type fo trial, there ae usually two or more groups of patients receiving different types of treatments. the choice of treatment is usually chose by the head of the study, or principal investigator, or randomly assigned. This type of study allows different types of treatments to be compared and new treatments to be evaluated.

In observational studies, the treatment is chosen by the patient with their doctor and nothing about the patient’s regular, standard-of-care treatment is changed. In this type of study, the principal investigator simply observes and records the outcomes of different patient groups.

Why participate in a clinical study?

There are many reasons to participate in clinical studies. Participating in clinical studies can often allow patients to have access to new, cutting edge treatments that are not otherwise available. Additionally, many participants in clinical studies feel that they are able to take a more active role in their health care. Anyone who participates in clinical studies helps to advance medical science and research, which will help provide better treatments for current and future generations.

Who can participate in a clinical study?

Clinical studies have specific, individual guidelines about who can participate in the study. These are called “inclusion or exclusion criteria”. Inclusion criteria are the guidelines that define who may participate (e.g., patients with spinal stenosis) and exclusion criteria are guidelines that define who is not eligible to participate (e.g., patients under age 18). It is important that the inclusion/ exclusion criteria aer strictly followed in each study. This helps to keep the participating subjects safe and also guarantee that the researchers will be able to keep the scientific standards of the study high and accurately answer their research question.

What should people consider before participating in a clinical study?

According to the National Institutes of Health, people should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective?
  • Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow-up care is part of this study?
  • How will I know that the experimental treatment is working?
  • Will the results of the trial be provided to me?
  • Who will be in charge of my care?