DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

The Major Extremity Trauma and Rehabilitation Research Consortium

Principal Investigator: CASTILLO, RENAN
Institution Receiving Award: JOHNS HOPKINS UNIVERSITY
Program: PRORP
Proposal Number: OR150208
Award Number: W81XWH-16-2-0060
Funding Mechanism: Orthopaedic Care and Rehabilitation Consortium Award
Partnering Awards:
Award Amount: $17,969,441.00


PUBLIC ABSTRACT

The objective of this proposal is to expand on an existing consortium of military treatment facilities and civilian trauma centers to establish the Major Extremity Trauma and Rehabilitation Consortium (METRC) that will produce the evidence needed to improve injury care along the treatment continuum, from acute care at the time of injury through recovery, rehabilitation, and re-integration into the workforce and society. METRC includes a multidisciplinary research team of surgeons and therapists representing the fields of orthopaedics, trauma, and rehabilitation. The team will work together to design and implement research studies aimed at improving care for the Wounded Warrior. In this application, we propose studies (study abbreviations in parentheses) that will address the following challenges:

--Early Treatment Decisions: It is challenging for doctors to know when to performing fracture surgery on critically injured patients. If the timing is wrong, it can have bad impact on multiple major organs, sometimes resulting in death. This study (PSTI) will produce guidelines that will help surgeons decide when to operate based on patient-specific measures of tissue damage, biomarkers, and vital signs.

--Weight Bearing for Lower Extremity Fractures: Early weight bearing after surgery may result in better function and a faster return to work/duty. We propose a randomized study (AlterG) to look at the effects of early advanced weight bearing using an anti-gravity treadmill on function as well as bone and muscle health.

--Post-Operative Pain Management: Patients at high risk for poor outcomes following surgical treatment for a lower extremity injury may benefit from therapy that addresses their ability to manage pain and fear of recovery. We are proposing a randomized controlled trial (CBPT) to evaluate the impact of a phone-based cognitive-behavioral therapy delivered by trained therapists aimed to improve outcomes for these patients.

--Improving Outcomes Following Complex Pelvic Ring Injuries: Severe pelvic fractures are often associated with life-threatening bleeding. Applying external compression to the pelvis might stabilize the fracture and limit the blood loss. We are proposing an observational study (EMS-BinD) of severe pelvic fractures to determine the impact of this stabilization on blood loss. By studying the treatments received by each patient, we aim to determine the optimal care of these injuries in major trauma centers and military trauma units.

--Rehabilitation Outcomes: We propose a study (Resilience) to develop and validate a measure of resiliency and reintegration for orthopaedic trauma. The availability of a valid measure would benefit military patients by facilitating the design and implementation of research studies to improve resiliency, return to usual major activity, and overall outcomes for these patients.

--Optimal PT strategies: Physical therapy (PT) is prescribed by many surgeons after fracture fixation as it is considered to be the standard of care. However, for some injuries, these exercises could be done at home, following a structured exercise program. Sending everyone to formal PT ties up resources that could be focused on more severely injured Soldiers, Marines, Sailors, and Airmen. We propose a pilot study (SDEP) to provide the data needed to design a large study that will identify patients that would benefit most from formal PT.

--Secondary Health Effects and Economic Impact of Traumatic Injury: Scientists believe that the effects of traumatic injuries can last far beyond the acute treatment of these injuries. We propose a study (LTE) to pilot the long-term follow-up of previously enrolled METRC study participants that will be used to develop a larger study designed to estimate prevalence of poor outcomes 3-5 years following trauma, factors associated with developing poor outcomes, and economic costs of these outcomes.

Potential Clinical Applications: (1) PSTI and EMS_BinD may reduce related deaths and lower the rates of major complications. (2) Alter-G, CBPT, and SDEP are focused on faster and more functional recovery. (3) Resilience can be applied to measure impact of interventions, and LTE will provide the data needed to develop a large clinical study to determine patient and injury risk factors that lead to long-term major health problems after injury. None of the studies pose significant risk to patients. Actionable clinical data are anticipated within 4 years from study start dates.

Military Benefits: All of the studies are designed in response the ongoing Department of Defense extremity trauma care "gap analysis" and are expected to have direct impact on improving the outcomes and lowering the disability burden on the Wounded Warrior.