TrueLok Elevate PMCF Study

"This is a prospective, international, multicentre, observational post-market clinical follow-up (PMCF) study. Adult subjects will be treated according to the manufacturer's Instructions for Use, with follow-up extending to 12 months post-device removal. Participating sites include centres in the US, Europe, the UK, and South Africa.~Subjects will be followed using a phased framework:~T0: Index Surgery (baseline data, operative details, ulcer status) T1: End of Distraction (device parameters, adverse events, ulcer status) T2: End of Compression (similar to T1) T3: Device Removal (confirmation of union, ulcer status)~Post-removal visits:~F3: 3 months F6: 6 months F12: 12 months"