NCT07079774

TrueLok Elevate PMCF Study

Post-Market Clinical Follow-up Study of the TrueLok Elevate Transverse Bone Transport System for the Treatment of Lower Limb Ulcers as Soft Tissue Defects

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 153 (estimated)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Wound of Skin
• Ulcers
• Soft Tissue Defect

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-11-24
• Primary completion: 2028-11-24
• Completion: 2028-11-24
• First posted: 2025-07-23
• Last updated: 2026-04-01

Locations

5 sites across 5 countries: Germany, Italy, South Africa, Spain, United Kingdom