Induce XT™ Bone Graft in Foot and Ankle Fusion

Launched by RED ROCK REGENERATION INC. · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new bone graft material called Induce XT, which is used during foot and ankle surgeries to help heal areas where bone is missing. The main goal is to see how effective this bone graft is for patients who need surgery to fix foot deformities or ankle issues. If you participate, you will go through a screening to see if you qualify and then have a series of appointments, including one on the day of your surgery and five follow-ups over a year. During these visits, doctors will check your recovery through X-rays, ask about any pain you’re experiencing, and have you fill out some questionnaires.

To be eligible for the study, you need to be between 65 and 74 years old and have a specific type of bone defect in your foot or ankle that requires surgery. You should also be having a fusion procedure, which is a surgery to join bones together. However, if you're under 18, have an active infection, have had previous surgery at the same site, or have certain cognitive disorders, you won't be able to participate. This trial is not yet recruiting participants, but it aims to provide valuable information about how Induce XT can help improve recovery after foot and ankle surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients meeting all of the following criteria will be considered eligible for study participation:
• • 1. Patient has a bone defect in the hindfoot or ankle; and
• • 2. Is requiring fusion using an open surgical technique with supplemental bone graft/substitute; and
• • 3. Fusion site is able to be rigidly stabilized with no more than 3 screws across the fusion site; and
• 4. Patient is requiring one of the following procedures:
• • Ankle joint fusion
• • Subtalar fusion
• • Calcaneocuboid fusion
• • Talonavicular fusion
• • Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
• • Double fusions (talonavicular and calcaneocuboid joints).
• Exclusion Criteria:
• * Patient meeting any of the following criteria will be excluded from study participation:
• • 1. Patient is under 18 years of age at the time of consent;
• • 2. Patient has an active (local or systemic) infection or is undergoing adjunctive treatment for infection;
• • 3. Patient has previous fusion surgery of the proposed fusion site;
• • 4. Patient has cognitive disorders or is unable to complete questionnaires or provide consent.