Post-Market Follow-Up Study of the TrueLok Elevate Bone Transport Device for Treating Lower Limb Ulcers and Soft Tissue Defects in Adults

What this Trial Is About

Researchers are evaluating the TrueLok Elevate Transverse Bone Transport System, a modular external fixation device designed to aid healing in adults with bone and soft tissue defects in the lower limbs, especially chronic ulcers. The study is a prospective, international post-market clinical follow-up conducted at multiple centers across the US, Europe, the UK, and South Africa. It aims to observe the devices impact on wound healing over time. Participants will receive treatment using the TrueLok Elevate system according to the manufacturers instructions. The study follows a phased schedule starting with the index surgery, then monitoring through stages such as the end of distraction, end of compression, and device removal. After device removal, participants will be followed up at 3, 6, and 12 months to track progress and healing. Throughout the study, participants will undergo assessments at each phase to record device parameters, adverse events, and ulcer status. The primary outcome measured is complete ulcer healing at 12 months. The study involves monitoring wound healing, device safety, and patient adherence during and after treatment, with a total follow-up period extending to one year post-device removal.

TrueLok Elevate PMCF Study