Source: Major Extremity Trauma Research Consortium

Johns Hopkins University-based Major Extremity Trauma Research Consortium (METRC) is the 2023 Kappa Delta Elizabeth Winston Lanier Award winner for its 34-study research platform which addresses issues related to the evaluation, treatment, and recovery after severe extremity trauma.

This award recognizes musculoskeletal research which demonstrates a great potential to advance patient care.

METRC is a network of clinical centers and one data-coordinating center that work together with the U.S. Department of Defense (DoD) to conduct multi-center clinical research studies. METRC has grown to encompass data from 22,000 patients across 70 sites and that study information has been published via 57 published papers and a multitude of presentations.

METRC is a coordinated effort of trauma research teams from the Lower Extremity Assessment Project study, the Southeast Fracture Consortium and the Orthopaedic Trauma Research Consortium, as well as other highly regarded experts from around the U.S.

“By establishing a military-civilian research collaboration, investigators are able to translate learnings across sectors, continue research during interwar periods and the research dollars benefit from an economy of scale by sharing resources and reducing cost per study, while increasing productivity,” said Michael J. Bosse, M.D., clinical chair emeritus of METRC.

METRC attributes the program’s success to:

  • Conducting randomized clinical trials and employing a “gaps driven” approach to define research that purposefully identifies challenging surgical and scientific questions
  • Organizing a multi-center approach to conduct timely and clinically impactful research
  • Developing a coordinated, standardized approach to protocol development and data collection
  • Understanding that METRC’s growth allows for the design and execution of large pragmatic trials
  • Establishing quality assessment and improvement strategies to learn, evolve, and improve from each study
  • Supporting individual participating investigators and academic centers to receive extremity trauma research funding

METRC is focused on seven research areas:

  • Prevention and management of acute and chronic musculoskeletal infections
  • Early acute management of orthopedic injury
  • Reconstruction surgery and nonsurgical management to improve bone healing
  • Prediction, prevention and amelioration of secondary conditions and long-term physical health effects
  • Management of pain and psychosocial sequelae
  • Rehabilitation interventions to improve functional outcomes and quality of life
  • Amputation and limb salvage outcomes including optimization of prosthetics and orthotic devices

Some of the Consortium’s research findings include:

  • The Prevent CLOT study (12,000 patients)—Low dose aspirin was non-inferior to low-molecular-weight heparin in preventing death and was associated with a low incidence of deep-vein thrombosis and pulmonary embolism in the care of trauma patients with operatively treated extremity fractures or with any pelvic or acetabular fractures.
  • The VANCO study—Use of a low-cost 1,000 mg dose of topical vancomycin to wounds prior to closure resulted in a 35% overall reduced risk of infection and a 50% reduction in gram positive infections.

In his interview with OTW, Dr. Bosse described the genesis and immense effort required to build such a research network, “The development of the research platform and infrastructure was the biggest hurdle. Once we were able finalize the initial site participants, the selection of the research agenda topics and division of responsibilities to enable the launch of the early studies came into focus.”

“For such an ambitious endeavor as METRC, communication is key. We basically started at zero, then developed the guiding SOPs [standard operating procedures] and CRFs [case report forms] for the initial studies. All members of the team were critical to the final success. All deserved engagement, inclusion, and transparency in terms of the conduct of all consortium matters. Once established, ensuring data quality, enthusiastic recruitment, and patient follow-up became ongoing areas that we always paid attention to.”

“The ‘lessons learned’ in the first five years of METRC informed our approach to current studies and to the changes needed for the organization and governance of the consortium,” Said Dr. Bosse, “as a result of this planned and continuous process, our current research is better focused and more efficient.”

“We established a customized, distributed data collection system through REDCap and a core data set to be collected across all studies including demographics and common injury domains such as fracture and wound characteristics, and associated injuries.”

“Clinical outcomes such as infection, nonunion, and complications were assessed using validated measurements and, in many studies, were corroborated by a trained surgeon adjudication team. The same patient reported outcomes were collected in all studies whenever possible. We developed and employed standardized approaches for the collection of clinical follow-up data which allowed METRC to efficiently train for and implement complex studies.”

“We also worked to establish normative data for timeliness of data entry and successful long-term follow-up with completion of the critical patient reported outcome measures. Sites were provided their specific quality profiles in comparison to the METRC average, and we worked with the research teams and PIs of challenged sites to help improve their clinical research capabilities.”

Robert O’Toole M.D., the current Clinical Chair of METRC, discussed future projects for the group, saying, “METRC is currently focusing on three main research areas. Improving geriatric fracture care was added to METRC’s existing work that focused on the prevention and treatment of fracture (injury) related infection and the optimization of psychosocial outcomes following trauma. We also are of course interested in other topics that broadly fall into complication reduction or optimization of outcomes with a particular interest in issues of relevance to the military populations.”

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