AO Clinic Study Center, Platinum level
In April 2012, Geisinger Orthopaedic Institute received the certificate indicating that it is now an AO Clinical Study Center (AOCSC) site, and was awarded the Platinum status, which is the highest level of certification offered. Geisinger is the second site in the United States to receive this level of certification. Certification was granted after a two-day site survey where investigators determined Geisinger met rigorous investigator and institutional criteria.
"This certification will reflect our quality standards and abilities to participate in and manage clinical studies (not only with the AO but with industry as well)," says Dr. Suk. "AO Centers will be the destination of choice for implant testing, comparative research projects and innovations in biologic materials. It promises to open an important pipeline to sponsored research."
The AO Foundation is the largest and most respected organization dedicated to the study of orthopaedic trauma. Geisinger's Orthopaedic Institute will now be included in a database with a list of certified clinics which could best fit specific study needs.
Major Extremity Trauma Research Consortium
Geisinger Orthopaedic Institute was approved as a Major Extremity Trauma Research Consortium (METRC) satellite clinical site in July 2012, and hopes to soon be enrolling in two METRC clinical studies: the Antibacterial Plate Sleeves (APS) study and the OUTLET study.
METRC was established in 2009 with funding from the Department of Defense (DOD). METRC consists of clinical centers and one data-coordinating center that work together with the DOD conduct multicenter clinical research studies associated to the treatment and outcomes of orthopaedic trauma sustained in the military. The overall goal of the consortium is to produce the evidence needed to establish treatment guidelines for the optimal care and outcomes of the service members and civilians who sustain high-energy trauma to the extremities.
The Force-TJR project is a national research effort that is collecting data from over 30,000 diverse Total Joint Replacement (TJR) patients of 120 orthopaedic surgeons in varied hospital and practice settings. Force TRJ focuses on working adults under 65 years of age. Its goals are to:
- Guide decisions on optimal implant timing, surgical approach, implant selection and perioperative management.
- Decrease complications and to improve implant longevity and function following surgery.
- Inform policy to reach currently underserved minority populations. Geisinger is a high enrolling center for this project; 690 patients were enrolled by the end of 2012.
"Each year, more than 700,000 adults in the United States elect total knee replacement (TKR) or total hip replacement (THR) surgery to restore physical function and eliminate the persistent pain of advanced knee or hip arthritis," says Dr. Suk. "By 2030, primary and revision TKR and THR use is projected to grow significantly, especially among patients under 65 years of age."
Geisinger poised to conduct musculoskeletal outcomes research
Through the 2010 Affordable Care Act, legislation established the Patient-Centered Outcomes Research Institute through which a variety of innovative funding opportunities exist. It is anticipated that much of future research will be orthopaedic in nature, so it's important to be able to provide critical input on the clinical effectiveness and appropriateness of medical treatments and services. Michael Suk, MD, is the principal author of the only textbook on Musculoskeletal Outcomes Instruments and Measures, which well positions Geisinger to quickly establish a Center for Musculoskeletal Outcomes Research. Geisinger's electronic medical record offers a distinct advantage for conducting outcomes research.
"We can harness the electronic medical record for epidemiologic data to help identify trends in musculoskeletal disease, track clinical outcomes and develop registries," said Dr. Suk. "These are just a few obvious things that can be a critical component of our efforts to continually seek ways to improve and maximize Geisinger's competitive edge."