News Release

For Immediate Release -- September 11, 2009

U.S. Army Medical Research and Materiel Command funds orthopaedic clinical studies

(Fort Detrick, Md.) - U.S. Army Medical Research and Materiel Command's Orthopaedic Extremity Trauma Research Program signed an $18.4M cooperative agreement with Johns Hopkins Bloomberg School of Public Health on Aug. 14. Twelve civilian medical centers and several military treatment centers will enroll patients in their trauma centers who have wounded extremities.

"In order to improve practices and outcomes, a larger multi-center clinical trial is necessary because no one center is capable of enrolling enough patients", said Josh Wenke, program manager at U.S. Army Institute of Surgical Research at Fort Sam Houston, Texas.

"This agreement is important because before this, there was no funding for research like this. This consortium has the potential to change practices," said Wenke.

Eighty-two percent of Soldiers in battle have an extremity injury. This research will help medical personnel improve healing open traumatic bone defects, prevent musculoskeletal infection, prevent heterotopic bone formation, improve standards of care with emphasis on tissue viability assessment and wound irrigation/debridement technologies, and repair massive muscle defects.

"The Johns Hopkins Bloomberg School of Public Health is very pleased to be working closely with DOD to establish the OETRP Consortium," said Ellen J. MacKenzie, Fred and Julie Soper professor & chair Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health.

The Bloomberg School of Public Health will serve as the Data Coordinating Center for the Consortium.

"In this role we will provide overall leadership in the design and analysis of the clinical trials conducted by the consortium. We will also coordinate data collection across the clinical centers and make sure the data collected are of the highest quality," said MacKenzie.

Large, multi-center, randomized clinical trials have the best chance of being able to change practice and improve outcome of injured Warriors. The trials to be conducted by the Consortium will include patient follow-up for up to two years after the injury and include measures of both functional and quality of life outcome as well as clinical outcome.

"We can find the best way to treat our patients," said Wenke.

"Results will be used to develop clinical guidelines that will assist the surgeon and the patients formulate a good treatment plan. The initial results will also be considered as the "baseline" and future technologies will be compared to the baseline to determine possible changes in care," said Dr. Michael Bosse, the chair of the Consortium and director of Clinical Research for the Department of Orthopaedic Surgery at Carolinas Medical Center.

The Carolinas Medical Center will serve as one of the core research centers for the Consortium.

He also said that his team feels honored to be allowed to work collaboratively with our military counterparts on issues that are critical to the care of the wounded warrior and too many of our civilian trauma patients. "This is likely to be one the most significant orthopaedic clinical research opportunities of the last 50 years. It's pretty exciting," said Bosse.

"This unique study offers the opportunity to tackle a variety of problems common in the military and civilian community" said Dr. Andrew Pollack, co-chair of the Consortium and head of the Division of Orthopaedic Traumatology Department of Orthopaedics University of Maryland School of Medicine.

"We haven't had sufficient funding for definitive studies on severe open extremities," said Pollack. "The results of the trials to be conducted by the Consortium will give us better insight into the treatment of severe high energy lower extremities."

"Military Orthopaedic Surgeons are challenged by often devastating extremity injuries, more commonly seen on the battlefield amongst our Warriors. This Consortium enables military surgeons, with these challenges and unique internal perspective to partner with our civilian colleagues to capitalize on their expertise and impressive ability to unite such a powerful collaborative consortium. This is indeed a thrilling cooperation," said Col. James Ficke, chairman, Department of Orthopaedics and Rehabilitation, San Antonio Military Medical Center, and senior Orthopaedic consultant.

Wenke said future efforts include securing more funding to increase the number of participating centers and expand the scope of the effort. This will also include rehabilitation program.

"A lot of people came together to do something great," said Wenke.

The twelve core clinical centers currently participating in the Consortium include: Boston University Medical Center, The Florida Orthopaedic Institute, Carolinas Medical Center, Denver Health and Hospital Authority, OrthoIndy and the Indiana Orthopaedic Hospital, Orthopaedic Associates of Michigan, The Orthopaedic Trauma Institute at the University of California at San Francisco, San Francisco General Hospital, The University of Maryland Medical Systems R Adams Cowley Shock Trauma Center, The University of Mississippi Medical Center, The University of Texas Southwestern Medical Center, The University of Washington Harborview Medical Center, and Vanderbilt University Medical Center.

For more information about the U.S. Army Medical Research and Materiel Command, visit http://mrmc.amedd.army.mil/.

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The U.S. Army Medical Research and Materiel Command is the Army's medical materiel developer, with lead agency responsibility for medical research, development and acquisition, medical logistics management, medical information management/information technology and medical health facility planning.