Military Extremity Trauma Amputation/Limb Salvage (METALS) Study: Long-Term Follow-Up
Abstract
The purpose of this research study is to examine the long-term outcomes and well-being of Service members who received severe limb injuries as part of recent military conflicts and to contribute to the body of knowledge in treating these injuries, both initially and as part of rehabilitation and recovery afterward. Of particular interest is comparing two approaches to the treatment of these injuries: surgical reconstruction of the limb and amputation. The name of the study is the Military Extremity Trauma and Amputation/Limb Salvage (METALS) study. The study will identify individuals who sustained a bad leg injury in Operations Enduring Freedom/Iraqi Freedom/New Dawn (OIF/OEF/OND) between the years 2003 and 2013. These individuals will be contacted by the METALS Study team and asked for their willingness to participate in an interview over the phone. Some of the individuals will have been interviewed as part of an earlier study. We are contacting them again (several years after the first interview) to see if things have changed for them. The interview will ask questions about their daily activities, including going to work and school, their participation in sport and leisure activities, and symptoms of depression, post-traumatic stress, and chronic pain. We will also ask questions about their need for services as well as the use and satisfaction with orthotic or prosthetic devices in order to identify potential problems and propose solutions in these areas. Participants will also be asked to allow the study team to access their medical records to better understand the details of their treatment and use of health and rehabilitation services since the injury. This will include linking data available from the Military Health System (MHS) and the Department of Veterans Affairs (VA). In addition to looking at differences in outcomes for those undergoing amputation versus reconstruction of the limb, we will compare shorter term (2- to 5-year) outcomes for those injured early (2003-2007) and later (2008-2013) in OIF/OEF/OND to assess whether improvements in care delivery have led to improvements in outcome. Following separation from military service and reintegration into society, disability from major limb trauma will impact Service members for the remainder of their lives. Results from this study will help clinicians determine what kind of treatment will result in the best outcomes for these individuals. There is no direct benefit to patients for participation in this study, though individually, they may feel they are contributing to the advancement and knowledge of best practices for the treatment of patients with bad limb injuries. There are no physical risks to the participant, but there may be a slight psychological risk associated with recalling the injury or discussing how the injury has changed a person s ability to function or do specific activities. The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Any time information is collected for a study there is a small risk of breach of confidentiality. However, this risk is not greater than the risk that already exists in clinical settings when handling medical data. Understanding the long-term outcomes following severe limb injury through research like METALS will ultimately lead to improved acute care and rehabilitation that will benefit Service members in future military conflicts.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 29, 2016
- Source ID
- W81XWH1520058
Entities
People
- Ellen J. MacKenzie
Organizations
- Johns Hopkins University
- United States Army