Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new training program designed to help people who have had a leg amputated above the knee (transfemoral amputation) learn how to use their new osseointegrated prosthesis more effectively. The trial will involve 25 participants, and it aims to see if a 40-week training program that provides feedback on how they load their limb is helpful compared to a standard care group that will not receive this special training. The researchers will assess the participants' progress at different stages: after five weeks of standard care, after 24 weeks of rehabilitation, and again one year after their surgery.

To be eligible for this trial, participants must be at least 18 years old and have undergone a transfemoral amputation for reasons like injury, birth defects, or cancer. They should also have had significant problems with their current prosthesis. However, individuals with certain conditions, such as heart problems, ongoing cancer treatment, or cognitive impairments, will not be included. Participants can expect to engage in a structured training program that aims to improve their mobility and comfort with their new prosthetic limb, while also helping researchers understand the best ways to support people with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
• • ≥ 18 years old
• • History of severe socket-related skin or residual limb problems
• • Schedule for OI prosthesis implantation surgery
• Exclusion Criteria:
• • Vascular amputation etiology
• • Substance abuse
• • Unstable heart condition
• • Acute systemic infection
• • Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24)
• • Active cancer treatment