Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Present for at least 3 months, and

Unresponsive to standard non-surgical or surgical wound management, including but not limited to debridement, negative pressure wound therapy (VAC), offloading, antibiotics, or vascular optimisation

Disqualifiers

Heart rate >90 beats/min

Respiratory rate >20 breaths/min

PaCO2 <32-mm Hg

White blood cell count >12.000 or <4.000/cu mm

Trial design

Treatments tested in this trial

  • Transverse Bone Transport System

Treatment groups

No treatment groups listed

Locations

5
Germany
Helios Klinikum Wuppertal GmbH Wuppertal Germany
Italy
General Regional Hospital F. Miulli of Acquaviva delle Fonti Acquaviva delle FontiBari, Italy
South Africa
Stellenbosch University7505, Cape TownWestern Cape, South Africa
Spain
Hospital de la Santa Creu i Sant Pau08041, Barcelona Spain

Sponsors and collaborators

Orthofix s.r.l.

Lead sponsor

Source ClinicalTrials.gov