Researchers receive national attention through large-scale clinical trials

The clinician scientists at the Marshall Clinical Research Center (MCRC) are drawing national attention for their participation in large-scale clinical trials through the Marshall University Joan C. Edwards School of Medicine.

Most recently, through the MCRC, the school’s department of orthopaedic surgery received recognition for its participation in a clinical trial titled Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures (HEALTH). It is a multi-national, multi-year, randomized clinical trial to evaluate partial versus total hip replacement for the treatment of displaced femoral neck fractures in patients 50 and older. According to the results published in the New England Journal of Medicine and presented at the Orthopedic Trauma Association meeting in Denver, Colorado, no functional outcome differences were present in the two groups.

The study included 80 sites in 10 countries, including Marshall University. Marshall topped the list with the highest rate of patient recruitment in North America. A total of 1,495 patients were enrolled in the study (ClinicalTrials.gov Identifier: NCT00556842) worldwide.

“Participation in the Level I HEALTH clinical trial with publication in the prestigious New England Journal of Medicine is a landmark project for our department and the Marshall School of Medicine," said Franklin D. Shuler, M.D., Ph.D., professor and vice chair of research in the department of orthopaedic surgery, who served as principal site investigator on the study. "The published results help clarify the standard of care for hip fracture management."

The HEALTH trial was one of several clinical trials at the school of medicine’s MCRC that resulted in four publications in the New England Journal of Medicine. Amongst dozens of other active national studies available through the MCRC are a Phase 3 AURORA study through Allergen for non-alcoholic steatohepatitis (NASH), a Premia Spine study evaluating the TOPS™ System for spinal surgery; meningococcal vaccine and maternal RSV vaccine studies through Pfizer; a chronic migraine study through Amgen; and a Parkinson’s study through Enterin.

"The clinical trials at the MCRC not only bring cutting-edge treatment options to our patients in West Virginia, but also result in the publication of important clinical information on how to best care for patients in some of the best journals in the country," said Uma Sundaram, M.D., vice dean of research and graduate education at the school of medicine.