Clinical Trials

Updated February 2017

Ongoing Clinical Trials at University Orthopaedic Associates, LLC
By Patricia Seuffert, MS, ANP

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

Carlos A. Sagebien, MD, is the principal site investigator for an NIH (National Institutes of Health) trial entitled HEALTH –   Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH).

University Orthopaedic Associates (UOA) is one of 62 clinical sites recruiting subjects in this international clinical trial. There are a total of 15 American sites and as of February 2017, the recruitment target is at 95.7 percent of its goal; 1,373 patients are actively participating in the trial.

To summarize the trial, patients who have sustained a displaced femoral neck fracture will be randomized to one of two surgical interventions. The first surgical intervention involves total hip arthroplasty (i.e., replacement of the femoral head and hip socket). The second surgical intervention involves a hemi-arthroplasty (i.e., replacement of the femoral head only). Each participating site will have on staff surgeons with expertise in both interventions. Study personnel will monitor critical aspects of operative care and rehabilitation. They will assess patients at hospital admission (baseline), 1 week, 10 weeks, 6 months, 9 months, 12 months, 18 months and 24 months after surgery.  UOA joint replacement surgeons David A. Harwood, MD, and Stephen Kayiaros, MD, will be investigators together with Dr. Sagebien on the HEALTH study.

UOA is also participating in a post-marketing trial for an approved knee implant.  David A. Harwood, MD, is the principal investigator in this joint replacement protocol.  UOA has enrolled a total of 28 total knee replacement patients who are part of a Phase IV clinical trial to examine the long-term outcome of the Smith & Nephew Legion Knee implant.  Study participants have been closely followed for the last 7 years post knee surgery, and they will continue to undergo study visits for another 3 years to examine long-term surgical outcomes with the Legion knee replacement.

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