Current Lines of Investigation

Major Extremity Trauma and Rehabilitation Consortium (METRC)

Site Lead investigators:
Josh Wenke, PhD (ISR)
Sarah Pierrie, MD

The Major Extremity Trauma Research Consortium (METRC) was initially established in September of 2009 with funding from the Department of Defense (DOD) and the Orthopaedic Extremity Trauma Research Program (OETRP) and was expanded in both size and scope one year later. It consists of a network of clinical centers and one data-coordinating center that will work together with the DOD to conduct multi-center clinical research studies relevant 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 of the wounded warrior and ultimately improve the clinical, functional and quality of life outcomes of both service members and civilians who sustain high energy trauma to the extremities. Anchored by a Data Coordinating and Research Center at the Johns Hopkins Bloomberg School of Public Health, the Consortium includes 22 core Level I civilian trauma centers and 4 of the Military Treatment Facilities (MTFs) – with the ability to expand patient recruitment into more than 30 additional satellite trauma centers.

The Consortium and its Steering Committee are chaired by Dr. Michael Bosse of the Carolinas Medical Center.  Dr. Ellen MacKenzie directs the Data Coordinating Center at the Johns Hopkins Bloomberg School of Public Health.

SAMMC is currently the #9/67 enrolling site and, by far, the #1 among MTFs. 

METRC studies in which SAMMC has participated or is participating:

• BIOBURDEN Study: The primary objective of this study is to characterize the contemporary extremity wound “bioburden” at the time of definitive wound coverage or closure of severe extremity wounds employing new polymerase chain reaction PCR technology. We will also determine the relationship of subsequent infections to the initial bioburden screen as defined by both PCR technology and standard microbiology techniques. Read more about the BIOBURDEN study here.

• FIXIT Study: This study will compare two standard options for treating severe open tibia fractures: internal fixation with a nail or plate and external ring fixation. Read more about the FIXIT study here.

• METALS II Study: This study will provide a comprehensive longitudinal assessment of the clinical, functional and mental health consequences of major limb trauma and add to our understanding of the long-term benefits of reconstruction vs. amputation for the most severely injured. Importantly, we will be able to examine potential differences in care and outcomes for those injured earlier and later in OIF/OEF/OND to identify changes in care that may have influenced service use and outcomes. Read more about the METALS II study here.

• NERVE Study: This study will collect information about the treatment of peripheral nerve injury (PNI) resulting from upper extremity trauma.

• OUTLET Study: The purpose of this study is to compare 18-month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/ or ankle articular surface loss.

• PACS Study: The long-term objective of this research is to develop a tool that can aid clinicians in making a timely and accurate diagnosis of acute compartment syndrome (ACS) so that early fasciotomy can be done and unnecessary fasciotomy avoided.

• POvIV Study: The goal of this study is to investigate the efficacy of oral (par oris - PO) antibiotic therapy versus intravenous (IV) systemic antibiotics in the treatment of acute infection after plate fixation of fractures.

• PREVENT CLOT Study: The purpose of this research study is to see what medicine is better to use for preventing death and clinically important blood clots in the lungs in patients who sustain trauma. There are two types of medicine we will compare in this study: Low Molecular Weight Heparin (Lovenox/Enoxaparin) and Aspirin. Our goal is to find the simplest, most effective medication for orthopaedic trauma patients. Read more about the PREVENT CLOT study here.

• PRIORITI-MTF Study: The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment. Read more about the PRIORITI-MTF study here and visit the recruitment website: www.prioriti-mtf.org.

• ProFit Study: The aims of this study address an exploratory endpoint in the Transtibial Amputation Outcomes Study (TAOS), which will investigate prosthesis fit, alignment and condition of the residual limb. Read more about the ProFit study here.

• pTOG Study: The purpose of this study is to determine if rhBMP-2, a bone graft substitute, is as effective as using bone from the hip (iliac crest autograft) to help promote healing of open, tibia fractures with a bone defect. Read more about the pTOG study here.

• REPAIR Study: The purpose of this study is to test the effectiveness of the REPAIR intervention (physical therapy (PT) plus blood flow restricted (BFR) training) when compared to usual care PT alone.

• STREAM Study: This study will examine the reliability, validity and responsiveness of the PROMIS tools for clinical research following orthopaedic trauma. Read more about the STREAM study here.

• TAOS Study: The primary objective of this study is to compare levels of impairment and functional outcomes for patients undergoing a transtibial amputation and randomized to receive an endbearing tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure). Read more about the TAOS study here.

• Vanco Study: The primary objective of this study is to compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powders compared to those treated without local Vancomycin powder.

The Military Orthopaedic Trauma Registry (MOTR)

Custodian:  Patrick Osborn, MD
Administrator:  Renee Greer

The Military Orthopaedic Trauma Registry (MOTR) is an organized approach to providing improved trauma care to Warriors from all branches of the Department of Defense who sustain Extremity War Injuries.  It is part of the Joint Trauma System’s Department of Defense Trauma Registry. MOTR address all the components identified with optimal care of the injured warrior from point of injury, initial stabilization, evacuation, definitive reconstruction at a Level V medical treatment facility, rehabilitation, and return-to-duty or VA care. MOTR seeks to improve functional outcomes of combat casualties by using a systematic approach to determine the acute and long term outcomes of all battlefield injuries, improvement in treatment, and the logistical implications. Individual records are abstracted form handwritten and electronic medical records and scored according to the Abbreviated Injury Scoring System (AIS), AO, G&A, MESS scores.  Requests for identified or de-identified data can include patient counts, injuries, treatments, and complications as well as dates and demographic information for each warrior along the continuum of care. For additional information, please contract Ms. Renee Greer at renee.m.greer.civ@mail.mil or 210-916-0715

Amputee and Limb Salvage Rehabilitation

This cutting-edge research takes place at the Center for the Intrepid and involves three current lines of investigation:

1. Employ Artificial Intelligence and Department of Energy supercomputing resources in order to interpret clinical decisions pre-hospital, en-route care, initial resuscitation, and at various stages of care and transport through the echelon continuum of care to predict life threatening medical conditions for patients en-route to a Level V Military Treatment Facility.

2. Define the relationship between functional outcomes and amputation type and/or length.

3. Surgeons must make critical decisions on where to perform definitive amputation. A transtibial level amputation that spares the anatomical knee joint seems to be a logical approach yet there may be instances where tissue viability would result in a very short transtibial limb.  In these scenarios, there may not be sufficient length to be biomechanically efficient which could result in less function than could be attained with disarticulation of the knee joint.  Knee disarticulation provides a weight bearing surface and a long lever arm, albeit, without a functional anatomical knee joint, and could provide superior function to a short transtibial amputation.  The question becomes, at what length would a knee disarticulation be more functional and improve the patient's quality of life relative to the short transtibial amputation.   This would involve developing a definition for "function" for people with amputation (something that is critically needed) as well as condensing data from different sources into one database that would be used to address the question.  This study could be run in parallel with study #1 and would build the capacity and finalize the methods required to address project idea #3.

4. Use AI to predict who would best benefit from an amputation versus limb salvage.

This would build from lessons learned in projects #1 & #2.  It would incorporate the use of AI to interpret clinical notes, the definition of function, and the combination of multiple data sources to answer the question at hand.  This would help surgical teams make the difficult decision of who would do best with limb salvage vs. an amputation. The question would be very complicated to address, but would have enormous impact for patient with extremity trauma.   

Blood Flow Restriction Therapy

Blood flow restriction (BFR) therapy involves the obstruction of venous outflow from an extremity using an inflatable tourniquet while the patient performs resistance exercises. It originally gained popularity in athletics as BFR induced localized and systemic changes leading to an increase in muscular hypertrophy, thereby increasing strength. Researchers found these changes could be obtained at lower loads and over a shorter course of therapy than with traditional resistance training. Since then research here in the Department of Orthopaedics has centered on expanding the use of BFR to rehabilitation protocols following injury or surgery. First showing promising results following knee arthroscopy, it has since been applied following Achilles tendon rupture, total knee arthroplasty, and distal radius fractures. 

Surgical Timing and Rehabilitation of Multi-ligament Knee Injuries (STAR)
Lead Investigator: Andrew J. Sheean, MD

This study is a funded multicenter randomized trial comparing surgical timing and types of rehabilitation for multi-ligament knee injuries.  The main study site is University of Pittsburgh.  The study groups will be divided into early versus late surgical intervention to determine if timing of surgery influences outcome.  The patient's rehabilitation will also be divided into aggressive versus conservative regimens comparing early full range of motion and early weightbearing with a regimen of more limited motion and limited weightbearing in the early postoperative period.   A member of our staff is on the executive steering committee of the study.

Academic Network of Conservative Hip Outcomes Research (ANCHOR)
Lead investigator: Matthew R. Schmitz, MD

This study group is focused on improving the diagnosis and treatment of adolescent and young adult patients with pre-arthritic hip disease (femoroacetabular impingement and dysplasia). The study group currently includes 27 surgeons at sixteen institutions.*  The investigators collect prospective multi-center data on hip preservation procedures including outcome measures of hip function, hip pain, quality of life, overall health, high-level activity and economic value.  

*Washington University in St. Louis (Clohisy, Pascual-Garrido, Schoenecker, Nepple), Harvard Medical School / Boston Children’s Hospital (Novais, Millis, Kim, Yen, Matheney), Texas Scottish Rite Hospital (Ellis, Sucato, Podeszwa), Mayo Clinic (Trousdale, Sierra), Beaumont Hospital (Zaltz), University of Ottawa (Beaule), Minnesota Orthopedic Sports Medicine Institute (Larson), University of Michigan (Bedi), Hospital del Enfant-Jesus CHU de Quebec (Belzile), Boca Raton Regional Hospital (Ross), Hospital for Special Surgery (Sink, Buly), San Antonio – USUHS (Schmitz), University of Utah (Peters), Children’s Hospital of Philadelphia (Sankar), University Hospitals Cleveland (Salata), Northwestern Medical Group (Stover

Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION)
Lead investigator: Matthew R. Schmitz, MD

MOTION is a multicenter registry at multiple MTFs focused on studying orthopaedic outcomes on military members and dependents.  We currently have modules built for shoulder and knee arthroscopy with a hip preservation module coming in the next few months.  The goal is to collect patient reported outcomes on any and all types of orthopaedic surgery patients to answer important questions regarding surgical techniques and outcomes.  

RANGER
BAMC hand surgeons participate in the RANGER multicenter Registry of Avance Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction.  This is an active, multicenter clinical registry designed to continuously monitor and collect injury, repair, safety, and outcomes data for peripheral nerve injuries repaired with processed nerve allograft (Avance Nerve Graft), nerve autograft, and manufactured conduits.