Transtibial Osseointegration Surgery Study (TOSS)
Abstract
This work addresses the FY22 PRORP Clinical Translational Research Award area of Osseointegration. Osseointegration is a relatively novel procedure derived from dentistry. In the 1950’s, Osseointegration (OI) was first used to anchor teeth directly to the skeleton via a metal fixture. In the 1990’s, OI was developed for long bones, like the femur and humerus, in a two-stage procedure. During the first stage (Stage I), a titanium rod is inserted into the long bone and allowed to anchor to the bone over a period of 3 months. During the second stage (Stage II), a titanium abutment is introduced into the internal fixture and secured under tension with a titanium alloy screw. Stage II is also when soft tissue rearrangement is performed, when needed. Much work has been done in studying OI procedures on the femur (transfemoral) and even the humerus (transhumeral), however, much less work has been done on the tibia (transtibial) for persons with limb loss. In order to better serve the military community and Service Members that may undergo a transtibial OI procedure, we have designed a research plan that focuses on filling the gaps of knowledge in transtibial procedures with a goal of advancing the U.S. Food and Drug Administration approval of OI for persons living with transtibial amputations. We have five hypotheses we will address: Hypothesis 1: Persons that have undergone a transtibial OI procedure will have similar rates of complications as other OI procedures; Hypothesis 2: Persons that have undergone a transtibial OI procedure will have an improved quality of life and other important functional measures compared to before they had their OI procedure; Hypothesis 3: Persons that have undergone a transtibial OI procedure will have improved physical function compared to before they underwent the OI procedure; Hypothesis 4: Persons that have undergone a transtibial OI procedure will have a change in bone quality that mirrors their outcome measures; and Hypothesis 5: Persons that have undergone a transtibial OI procedure will have comparable results as those persons that underwent a transfemoral OI procedure. In addition to our hypotheses, we have five specific aims we will reach by the end of the study: Aim 1: We will quantify skin complications and infections for transtibial participants; Aim 2: Determine whether transtibial participants are improving in their outcome measures; Aim 3: Determine whether transtibial participants are improving in their mobility and physical function; Aim 4: Determine if change in the residual bone quality mirror the changes in the outcome measures; and finally, Aim 5: Compare the outcomes of transtibial participants to transfemoral participants. We will achieve these aims and address our hypotheses by following 30 Service Members or beneficiaries that have the need for a transtibial OI procedure. We will first collect information before the procedure (baseline) to later compare their outcomes to follow-up visits at specific time points. We will also perform biomechanical tests, like walking and getting up from a chair, to determine if the procedure allows Service Members to achieve improved physical function. We also collect bone quality data using radiographs, computed tomography scans, dual-energy X-ray absorptiometry, and other tools to quantify the bone quality throughout their time in the study. This work will allow us to better understand the transtibial OI procedure and will allow us to better serve both the military amputee community and the limb loss community as a whole.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252320012
Entities
People
- Benjamin K. Potter
Organizations
- United States Army
- Walter Reed National Military Medical Center