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Clinical Trials in the UK / NCT07079774
Recruiting Observational

TrueLok Elevate PMCF Study

NCT07079774 · tracked via the Priya Life Science UK tracker
Sponsor
Orthofix s.r.l.
Phase
Observational
Started
2025-11-24
Last updated
2026-09-04

Condition(s) studied

Wound of SkinUlcersSoft Tissue Defect

Investigational drug(s) / intervention(s)

Transverse Bone Transport System

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Aged 18 years or older at the time of surgery Willing and able to sign and date the study-specific informed consent form in accordance with national and institutional ethics requirements Willing and able to comply with requirements of the protocol, including follow-up requirements Indicated for surgical intervention using the TrueLok Elevate Transverse Bone Transport System for the treatment of soft tissue defects in the form of lower limb ulcers Presence of a chronic ulcer, defined as: * 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 Exclusion Criteria: Mental or cognitive impairment or physiological or behavioural conditions that, in the opinion of the investigator, would preclude reliable adherence to postoperative care instructions, follow-up assessments, or study procedures Known or presenting with the following signs of a systemic inflammatory response syndrome (SIRS) as exhibiting two or more of the following conditions: o * 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 * 10% immature (band) forms Known hypersensitivity or allergy to any material used in the TrueLok Elevate Transverse Bone Transport System (e.g., stainless steel, titanium) Current participation in another interventional clinical study that, in the opinion of the investigator, may interfere with the objectives or outcomes of this study Presence of active malignancy or systemic infection that, in the investigator's opinion, may interfere with wound healing or the study protocol Life expectancy of less than 12 months Simultaneous bilateral application of the TrueLok Elevate Transverse Bone Transport System Current incarceration at the time of enrolment Any condition or clinical circumstance that, in the opinion of the investigator, would make participation not in the best interest of the subject or would interfere with the study objectives

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
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
Official registry record

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