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Clinical Trials

The ongoing research represents our interests in trauma, knee surgery, sports medicine, osteoporosis, and joint replacement.

Antibiotic Prophylaxis in Patients Undergoing Elective TKA – Multi-center Trial (ClinicalTrials.gov identifier: NCT03283878)

UOA has recently begun a new clinical trial in collaboration with Duke University’s Department of Orthopaedic Surgery. The study’s principal investigator, Thorsten Seyler, MD, PhD, along with the American Association of Hip and Knee Surgeons, invited UOA surgeon Dr. Stephen Kayiaros to be a co-investigator in this multicenter endeavor.

The clinical research study seeks to determine what is the optimal time and dosing of prophylactic antibiotic therapy in patients undergoing knee replacement surgery. Study participants will be randomized to either receive a single antibiotic or multiple antibiotics in the first 24 hours following surgery. All participants will be monitored for an entire year post surgery.

The study investigators hope to determine if there is a difference in the amount of antibiotic and the timing of the antibiotic administration on the incidence of surgical site infections. Although infections are rare following knee replacement, a risk of infection does exist with all patients and prevention is paramount.

Enrollment is open and recruitment is ongoing.

Multi-center ACL Revision Study (MARS) (ClinicalTrials.gov identifier: NCT00625885)

UOA surgeons Charles J. Gatt, Jr. and Jeffrey Bechler have been collaborating with Vanderbilt Medical Center and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on a study that has been examining the effects of patient reported risk factors and the risk of early osteoarthritis following revision anterior cruciate ligament (ACL) reconstruction. Enrollment is complete in this trial and we are ready to assess our study participants for their 10-year post surgery visit.  Unfortunately, the study has been put on hold due to the Corona virus pandemic and we are waiting patiently to resume study visits once we have received instructions from the study coordinating center.

UOA is also participating in a post-marketing trial for an approved knee implant. Our joint reconstruction surgeon, David A. Harwood, is a co-investigator in this knee replacement protocol. We have enrolled a total of 28 total knee replacement patients that are part of this phase IV clinical trial to examine the long-term outcome of the Smith & Nephew Legion Knee implant. We are now having study patients return for their 10-year final study visit. The anticipated completion of this trial is in the fall of 2020.  Data will then be reviewed from all participating research sites, and a manuscript publication is planned to publish the study’s findings.

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