MMI announces global imaging services collaboration with Micron

Learn More
blog background

MMI Selected as Imaging Core Lab for Five Metal-on-Metal Hip Studies

October 13, 2012
Copied to clipboard
shutterstock_249329467

Medical Metrics, Inc. (MMI), a leading provider of imaging core lab services for orthopedic clinical trials, has been selected by five leading orthopedic device manufacturers to support multiple cross-sectional, post-market, FDA surveillance studies of metal-on-metal (MoM) hip implants.  MMI will independently evaluate radiographs and MRI to assess long-term outcomes in patients implanted with MoM hips.  Over 2,000 subjects will be evaluated at one to ten years post-implantation.

The goal of these studies is to comply with the FDA’s 522 order requiring manufacturers of MoM hip implants to conduct clinical surveillance of the effect of device wear in implanted patients.  Rates of reaction to metal wear debris are of particular interest in patients with MoM implants.  Reactions are assessed from clinical examination, MRI, and blood tests of metal ion concentration.  MMI developed the MR imaging sequences and analysis protocols that will be used for these studies.  At this time, two studies have been approved to begin enrollment, and the others are expected to be approved soon.

MMI’s imaging experts integrated current scientific knowledge with prior clinical experience to develop the imaging sequences for assessing the tissues around the implants.  Dr. Timothy Mosher, Orthopedic Faculty Director at MMI and Chief of Musculoskeletal Radiology at Penn State College of Medicine, oversaw development of the specialized sequences.  Using MRI to assess soft tissue reactions around metal implants can be challenging due to artifact that may obscure the periprosthetic tissues.  MMI’s technical expertise and knowledge of current advances in clinical MRI played a key role in developing the Metal Artifact Reduction Sequences (MARS) that will be used in these studies.

“Data from carefully-designed imaging studies will advance our knowledge and understanding of the long-term performance of MoM hip implants” says Dr. Mosher.  ”Coordinating multiple studies through a single core lab using a standard analysis protocol will provide a unique opportunity for harmonization.  By using a common framework to collect and evaluate data on local tissue response, results may be pooled and compared across studies.  Ultimately, this level of harmonization will improve our understanding of patient outcomes and provide important data for improving patient management.”

MMI is proud to be the imaging core lab selected by these leading orthopedic sponsors to support these important studies.

About Medical Metrics

Medical Metrics, Inc. (MMI) is an experienced, ISO 9001-certified, independent imaging core lab for multi-center clinical trials. Since 2000, MMI has partnered with clinical trial sponsors to conduct comprehensive imaging evaluations of treatments for musculoskeletal, cardiovascular, and neurological disorders. Trials range from pre-clinical and early-phase clinical studies to pivotal trials and post-approval surveillance. With an ISO-certified quality system, experienced project management team, proprietary data management platform, and luminary group of radiology and cardiology thought-leaders, MMI is uniquely positioned to deliver high-quality imaging core lab services for complex clinical trials.

Latest MMI News & Events

Medical Metrics, Inc. Announces Involvement in ReOpen CRS Clinical Trials
Medical Metrics, Inc. is proud to have worked with Optinose on their ReOpen clinical trials, which have recently received FDA approval! A heartfelt thank you to all our amazing collaborators, including our dedicated neuroradiologist readers, Key Opinion Leader consultants, and the incredible project personnel on both teams!
MMI Investigates Spinal Instability Using the Sagittal Plane Shear Index (SPSI)
In a research letter in Spine, MMI collaborated with researchers to investigate the SPSI as an objective measure of instability in lumbar stenosis patients with degenerative spondylolisthesis.
Dr. John Hipp Receives NASS Henry Farfan Award
MMI co-founder, Dr. John Hipp, was recognized for his outstanding contributions to spine basic research.