Research / General Information

Research at OrthopaediCare - General Information and Frequently Asked Questions

Our Physicians are always searching for new ways to treat orthopaedic problemsand, as a practice, we are dedicated to the advancement of orthopaedic research.

General questions about clinical trials

We are grateful to our patients who volunteer to participate in a research study. Our Physician Investigators choose Clinical Trials of devices or other treatments which they hope will result in better outcomes, less pain and improved quality of life. Until a trial is completed and the FDA has reviewed the results, of course, we won’t know if the tested device or treatment will be approved for general use.

What about Payments and Costs? (Details will vary by study)

Payments

Many studies offer participants an incentive stipend as acknowledgment for your time and trouble.  The payments may be disbursed at each study visit or on an annual basis.

Costs

• You should not have to incur any additional costs because of your participation in a research study
• Sponsors of Clinical Trials will usually pay the costs of the study once your follow-up visits are solely because of the study (usually at about a year post-op)
• Sponsors will usually also pay if insurance denies payment for otherwise standard of care costs or for the research surgery or treatment
• You would still be responsible for co-pays and deductibles whenever insurance is being billed

What about risks?

• Our Physician Investigators have chosen Clinical Trials for devices or treatments which they believe can be performed safely and with no additional risk than the current standard of care treatment for your condition
• However, the purpose of a new device or new treatment study is to evaluate the safety and effectiveness of the study device or treatment.  Therefore, there may be some risk involved.  This will be covered in the Informed Consent and in the discussion with your Doctor

What if I change my mind after I enroll in a Clinical Trial or Study?

• You will always have the right to withdraw from a study.  Of course, we will prefer that you stay with the study until it is concluded, but you have the right to leave the study if you choose.  We would just request that you notify us if you choose to withdraw
• If you move to another location, we would be glad to assist you in finding another site participating in the study in your new location.  If it is feasible, we will transfer your follow-up to another participating site

What is it like to be in a Clinical Trial or Study? (Details will vary by study)

• Your Physician will advise you if your condition makes you eligible for a trial which is open and enrolling. The Doctor will discuss the study briefly and explain why you may be a candidate and will briefly explain the study device (if this is a device study) and the usual standard of care treatment for your condition
• You will be contacted by the Clinical Research Coordinator, provided some initial information about the study, and you will be given a copy of the Consent to review at home, at your leisure
• If you are still interested, you will need to participate in an Informed Consent discussion with the Clinical Research Coordinator. This discussion usually lasts about an hour and covers all the study procedures
• You will be screened: Screenings vary by study but usually include the following:
  • X-rays
  • MRI - Usually (a recent MRI may be sufficient)
  • Health History
  • Physical Exam
  • Questionnaires
  • Physical Exam
  • Review by the Physician Investigator of the results of your screening to determine if you are eligible to participate
  • Enrollment into the study
  • Randomization (if it is a randomized study) into either the treatment (study device) or the control (usual standard of care) wings.  In many studies, you may not know the result of your randomization assignment until after the treatment surgery
• Study Treatment - Usually this involves a surgical implantation of the new device - or the control surgery or treatment - i.e. the usual treatment for your condition
• Follow-up
  • You will be seen for follow-up evaluation on a schedule similar to non-research patients for the first 3 to 6 months
  • At each follow-up study visit you will have X-rays, complete patient questionnaires and undergo a clinical evaluation.  Some studies may require a MRI at certain intervals
  • Research patients will continue to be followed for as long as 3 to 5 years annually or until the FDA allows the study to stop

Why participate in a Clinical Trial or Study?

• Access to treatment options not yet readily available
  
• Opportunity to participate in improvement of orthopaedic practice
• Possibility of decreased pain and improved quality of life