Transverse Bone Transport System: 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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Universitätsklinikum Halle | Halle | Germany | Not Yet Recruiting |
| Krankenhaus GmbH Landkreis Weilheim-Schongau | Weilheim | Germany | Not Yet Recruiting |
| Helios Klinikum Wuppertal GmbH | Wuppertal | Germany | Recruiting |
| General Regional Hospital F. Miulli of Acquaviva delle Fonti | Acquaviva delle Fonti | Bari | Active Not Recruiting |
| Azienda Ospedaliero Universitaria di Parma | Parma | PR | Not Yet Recruiting |
| Sant'Andrea Hospital - University of Rome "La Sapienza" | Roma | RM | Active Not Recruiting |
| San Giovanni Evangelista Hospital | Tivoli | RM | Not Yet Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Italy | Not Yet Recruiting |
| Fakultná nemocnica s poliklinikou Žilina | Žilina | Slovakia | Not Yet Recruiting |
| Stellenbosch University | Cape Town | Western Cape | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Universitario Parc Taulí | Barcelona | Spain | Recruiting |
| Hull University Teaching Hospitals NHS Trust | Hull | United Kingdom | Recruiting |
| Newcastle's Royal Victoria Infirmary | Newcastle upon Tyne | United Kingdom | Active Not Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07079774 on ClinicalTrials.gov ↗ ← All trials in the UK