The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport. It promotes local vascular and wound healing through controlled corticotomy and gradual distraction. The system is intended for adult patients with bony and/or soft tissuedefects.
Study Type
OBSERVATIONAL
Enrollment
153
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
Helios Klinikum Wuppertal GmbH
Wuppertal, Germany
RECRUITINGGeneral Regional Hospital F. Miulli of Acquaviva delle Fonti
Acquaviva delle Fonti, Bari, Italy
RECRUITINGStellenbosch University
Cape Town, Western Cape, South Africa
Complete ulcer healing
Proportion of subjects achieving complete ulcer healing within 12 months of device removal. Healing is defined as full epithelialisation with no open wound.
Time frame: 12 months
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Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGHull University Teaching Hospitals NHS Trust
Hull, Hull, United Kingdom
RECRUITING