Overview
In a commitment to achieve a higher level of care for our patients, SOS established a Clinical Research Department in 2008 to support our orthopedic research goals. We aim to incorporate promising innovations in the care of our patients while maintaining the safety of research subjects. Our organization specializes in musculoskeletal clinical trials, including Investigational Device Exemption (IDE) and post-approval device trials. Past and future projects include collaborating with orthopedic device companies as well as conducting research studies driven by SOS physician investigators themselves.
Previous trials and outcomes research have involved hip resurfacing, total joint replacement, and posterior lumbar fusion with orthopedic companies such as Zimmer, Wright Medical Technology, Stryker, and Baxter. Other investigator-initiated study interests have included radiostereoanalysis of acetabular cup micromotion in total hip replacement, the effect of UV light on the infection rate for total joint replacement, and developing a joint registry.
Information for Patients
As an SOS patient, you may be invited to participate in a research study or clinical trial by your physician or a member of the research team. Our research initiatives have included clinical trials in hip resurfacing and ceramic-on-ceramic total hip replacements, as well as studies on tracking patient outcomes after lumbar fusion, total hip replacements, and pain management after total joint replacement.
The following information from the National Institutes of Health (NIH) provides detailed information about clinical trials. Additionally, it is helpful to speak with your physician, family members, and friends before deciding to participate in a trial. The study doctor and research staff can answer your questions about specific trials conducted at SOS.
What is a Clinical Trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
Why Participate in a Clinical Trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who Can Participate in a Clinical Trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What Happens During a Clinical Trial?
The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is Informed Consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are the Benefits and Risks of Participating in a Clinical Trial?
Benefits - Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
Risks - There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including
- trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is Safety of the Participant Protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
What Should People Consider Before Participating in a Trial?
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. Some of the answers to these questions are found in the informed consent document.
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 results of the trials be provided to me?Who will be in charge of my care?
Additional information on clinical trials can be found at www.clinicaltrials.gov.