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Clinical Trials

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Clinical Trials

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

OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion Trial (ClinicalTrials.gov identifier: NCT04775537)

 UOA has recently begun recruiting patients into a prospective, post-marketing, open label clinical multicenter study in patients undergoing a spinal fusion.  Dr. Matthew McDonnell heads the trial in our Somerset office and is recruiting patients to participate in a two-year follow-up after spine surgery.

Bioactive is a bone implant that allows bony ingrowth at the surgical fusion site and may promote the healing process after a spinal fusion. The product has FDA approval and the study design is intended to examine the implant’s performance in selected patients. 

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

UOA has participated in a 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 complete at UOA but continues at other research sites.  In January 2023, there were 83 patients enrolled at UOA, LLC and all research subjects completed the trial visits as per the protocol.  Research data continues to be analyzed since many sites are continuing to recruit and enroll subjects.

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

In November 2022, MARS study investigators met at UOA in Somerset and completed a comprehensive evaluation of MARS study subjects that had undergone an ACL surgery more than 10 years ago.  Investigators plan to publish study results documenting the long term survival of ACL grafts in the cohort of patients.  UOA continues to follow and contact these post-operative patients.  Dr. Gatt and Dr. Swan are the co-investigators in this trial.