By Patricia Seuffert, MS, ANP

Our current research is being conducted by several orthopaedic surgeons within our group. The ongoing research represents our interests in trauma, knee surgery, sports medicine, osteoporosis, and joint replacement. Several of our surgeons act as research principal investigators in various research protocols.

Dr. Sagebien is the principal investigator in a study that involves subjects currently taking osteoporosis medication (bisphosphonates) for more than five years. The study’s purpose is to determine what relationship exists between long term bisphosphonate therapy and the incidence of potential stress fractures.

We are currently exploring the patients that have undergone surgery to repair atypical fractures that may have been associated with prolonged use of bisphosphonates. All study participants will have orthopaedic exams to determine the outcome of their surgery along with completion of both bone density scans and self-administered questionnaires. Currently we have approximately 30 patients that have undergone orthopaedic surgery for atypical fractures and have a history of prolonged therapy with bisphosphonate medications.

Dr. Sagebien is also the principal investigator in an NIH (National Institute of Health) government sponsored trial. The title of the study is Fixation using Alternative Implants for the Treatment of Hip Fractures. The acronym for the trial is FAITH. This study examines two different surgical treatments utilized to repair traumatic hip fractures. Patients are randomized by a central study location and will undergo one of two clinically acceptable surgical treatments available for newly sustained hip fractures. The purpose to the trial is to determine if one of the surgical methods has better outcomes than the other. Our site officially began recruitment for this trial in March 2011 and we have just added another sub-investigator to the trial.

Timothy M. Hosea, MD and Charles J. Gatt, Jr., MD, both sports medicine specialists, are ready to begin our third trial investigating the CAIS or Cartilage Autograft Implantation System. This project is sponsored by Advanced Technologies and Regenerative Medicine, LLC. and overseen by the FDA . Data will be presented to the FDA to determine the safety and efficacy of the novel CAIS device. Study participants who qualify for enrollment will have knee cartilage damage caused by either trauma or from progressive mechanical degeneration. We are actively recruiting subjects into this trial.

Interested candidates can go to the link on our web page that will guide them to the study screening web site to a central study screening committee. Interested candidates must complete the self administered questionnaire to determine if they qualify for this clinical trial.

MARS is the title of another ongoing knee trial we participate in. The acronym MARS stands for Multicenter ACL Revision Study. This trial is a collaborative effort by over 60 orthopaedic surgical centers. Surgical outcome data is being collected over a ten year period on patients who underwent a second ACL knee surgery (revision surgery). The purpose of the study is to determine what predictors show better surgical outcomes in this type of surgery. Recruitment has been completed.

Our group is also participating in joint replacement studies, both knee and hip. David A. Harwood, MD who currently performs the majority of the joint replacement surgery at UOA, LLC, is the principal investigator in the joint replacement protocols. We have enrolled a total of 28 total knee replacement patients that are part of a phase IV clinical trial to examine the long term outcome of the Smith & Nephew Legion Knee implant. Study participants will be followed for the next 10 years to determine the successful longevity of the Legion knee implant. Recruitment in this trial has been completed.

We are also enrolling patients into a hip replacement study sponsored by Smith & Nephew, the manufacturer of the implant. Dr. Harwood has enrolled three subjects into this study that will assist the FDA in the approval of the metal on metal Smith & Nephew hip implant. We are actively recruiting patients into this trial. Study follow-up lasts for at least two years post surgery.