Interventional Orthopedics Foundation President Dr. Gerard Malanga, MD has received a research grant to treat active-duty military personnel.
Along with Dr. Trevor Dyson-Hudson, MD and Dr. Nathan Hogaboom, PhD, Dr. Malanga received a $590,000 award from the Geneva Foundation for the use of Autologous Micro-Fragmented Adipose Tissue to Treat Meniscal Injuries in Active-Duty Military Personnel.
Knee injuries are common among the general population and even more common among active-duty military personnel, due to the demands that are required by our military men and women in the performance of their duties. Their service often requires hiking with heavy equipment, climbing, running, jumping and other loads to the knee that can cause an injury to the meniscus.
When this injury occurs, the military personnel is unable to continue to perform their duties, which can affect the entire company. Immediately, the soldier may be separated from the military for over one year or assigned a permanent activity limiting duty profile. Over time, meniscal tears may also increase the risk of other knee injuries, such as osteoarthritis which is one of the most common medical reasons for discharge from active duty service.
The current standard of care includes conservative treatments, such as physical therapy and rest. Once conservative treatments fail, surgery is generally the next option. However, there is limited evidence that surgery is effective and some studies suggest it can accelerate the development of osteoarthritis.
“The current surgical treatment for meniscal tears of the knee, which is the number one outpatient procedure in the United States, has been found to be no better than physical therapy and actually no better than when compared to a “sham”, i.e. fake surgery,” says Dr. Malanga. “In addition, there are well-known consequences of the surgery including accelerating any underlying arthritis, which is common with these types of tears. This results in additional pain and limitations in function and can progress to the need for a replacement.”
The goal of this study is to evaluate the efficacy of regenerative treatment for meniscal tears using micro-fragmented adipose tissue to reduce pain and restore activity levels. Active-duty military personnel and civilians with meniscal tears will be provided with either the adipose tissue treatment or a control treatment consisting of saline.
The timeline for the study is to complete Institutional Review Board approval in May 2019 and then begin recruitment this summer. Study participants will then be followed for up to one year. The differences in pain and function between the two groups will be evaluated. The ultimate goal is to show that micro-fragmented adipose tissue is a viable alternative for the treatment of meniscal tears in active-duty military personnel.
The research team has previously completed a 20 subject study on the injection of micro-fragmented adipose tissue in patients with degenerative meniscal tears. The study has been submitted to a journal and is under review at this time. The group has also published a paper on the injection of micro-fragmented adipose tissue and elderly patients with severe osteoarthritis and has completed recruitment on a study looking at micro-fragmented adipose tissue for spinal cord injured patients with rotator cuff pathology.
The military is very interested and treatments including regenerative treatments to enhance military personnel healing of various musculoskeletal conditions. Funding research has been provided through the Collaboratory for Musculoskeletal Injury Rehabilitation Research (CMIRR) and through the Department of Defense.
“When working with injured service members, as is common when treating the general public, there are multiple orthopedic surgical procedures that are quite costly, involve a significant amount of time out of activity (in this case out of active duty) and often have not produced the results that have been desired,” said Dr. Malanaga. “This includes the treatment of meniscal tears and therefore we hope that this innovative treatment will allow for a reduction in the need for surgical interventions, time away from active duty, and a decrease in future related issues, such as degenerative arthritis. Ultimately, this will likely result in significant reductions in cost and improvement in patient outcomes including improvement in pain and function.”
Congratulations to Drs. Malanaga, Dyson-Hudson and Hogaboom on receiving this prestigious award. IOF looks forward to sharing details about the outcome of this study and the impact it has on improving meniscal tear treatment protocol for our service members.