Clinical trials at University Orthopaedic Associates, LLC are ongoing.

Four of our surgeons act as research principal investigators for various research protocols.

This fall, our trauma surgeons (Drs. Sagebien, Butler, and Delgado) will start to recruit patients for the FAITH trial (Fixation Using Alternative Implants for the Treatment of Hip Fractures). The study is supported by the National Institutes of Health (NIH). It is a multi-center randomized trial with numerous study sites located both nationally and internationally. The goal of the trial is to enroll 2,500 patients who sustain a femoral neck (hip) fracture. The investigators will use one of two surgical strategies in the operating room to repair the hip fracture. The purpose of the study is to determine the best treatment for hip fractures, as the optimal treatment remains controversial.

Timothy M. Hosea, MD, and Charles J. Gatt, Jr., MD, both sports medicine specialists, will resume enrolling patients beginning September 2010 in the CAIS trial. This clinical study is being conducted to obtain FDA approval of the CAIS or Cartilage Autograft Implantation System. Individuals who have knee cartilage damage caused by either trauma or from progressive mechanical degeneration may be screened to participate in this trial and surgical technique. The trial is being sponsored by Advanced Technologies and Regenerative Medicine, LLC (a subsidiary of Johnson & Johnson). Data will be reviewed by both the sponsor and the FDA to determine if this novel CAIS device is both a safe and useful treatment for damaged knee cartilage.

MARS is the title of another ongoing knee trial in which we participate. The acronym MARS stands for Multi-center ACL Revision Study. Timothy Hosea, MD, Jeffrey Bechler, MD, and Charles J. Gatt, Jr., MD, are three of our sports medicine surgeons contributing to this study’s database. This trial is a collaborative effort by over 60 orthopaedic surgical centers nationwide. The study group represents a mix of academic and private practice physicians and has been supported and endorsed by the American Society for Sports Medicine (AOSSM). All study investigators are collecting surgical outcome data on study participants who are undergoing a second ACL knee surgery (ACL revision). The purpose of the study is to determine the effects of modifiable risk factors on quality of life, physical activity levels, and risk of early osteoarthritis following revision ACL reconstruction.

David A. Harwood, MD, our joint replacement surgeon, is the principal investigator in two joint replacement protocols. The studies are sponsored by Smith & Nephew, Inc. The Legion Primary Knee System study is a multi-center trial enrolling patients undergoing knee replacement surgery. The Legion system has previously been approved by the FDA. The purpose of this clinical trial is to determine if expectations from the surgeon and the patient have been met. Recruitment for this trial is ongoing.

Dr. Harwood is also the principal investigator at our site in a clinical trial being conducted in the United States to determine the safety and effectiveness of the Birmingham Hip (BH) Modular Head Hip System. This system is a metal-on-metal hip prosthesis that may be an appropriate hip implant for younger patients who may subject their prosthesis to greater mechanical stresses for a longer period of time. The purpose of the study is to evaluate the safety and efficacy of the BH Modular Hip System for review and approval by the FDA. Recruitment for this trial will begin September 2010.