TrueLok Elevate PMCF Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOrthofix s.r.l.
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
Sponsors and collaborators
Source ClinicalTrials.gov