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Ongoing clinical trials at University Orthopaedic Associates, LLC

By Patricia Seuffert, MS, ANP

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

Multi-Center Clinical Investigation of the ATTUNE Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty

(Study DSJ – 2019-05)

Stephen Kayiaros, MD has qualified to be a co-investigator in a multi-center international clinical trial sponsored by DePuy Synthes. In 2011, DePuy introduced the Attune Knee System which is a cementless fixation implant system for elective total knee replacement. The benefits of the cementless fixation include preservation of bone stock, shorter OR room time, ease of revision (if necessary) and excellent long term fixation with is particularly beneficial in younger more active patients that undergo knee replacement.

The study will begin enrolling study participants in October 2021.

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. Our site has over 60 patients enrolled to date (Sept. 2021).

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

UOA surgeons Charles J. Gatt, Jr. & 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.

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