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NCT Number: NCT07079774

TrueLok Elevate PMCF Study

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.

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Key information

Conditions

Wound of Skin Pathologic Processes Pathological Conditions, Signs and Symptoms Soft Tissue Defect Ulcer Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helios Klinikum Wuppertal GmbH, Wuppertal, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Treatment and study plan

Transverse Bone Transport System

Device

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

Primary outcomes

Complete ulcer healing

Time frame: 12 months

Proportion of subjects achieving complete ulcer healing within 12 months of device removal. Healing is defined as full epithelialisation with no open wound.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Cangiano, PhD

CONTACT

[email protected]

0456719000 ext. +39

Jay Erturan, MD

CONTACT

[email protected]

7779 32 32 44 ext. +44

Sponsors and collaborators

Lead sponsor

Orthofix s.r.l.

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 23, 2025
Registry last updated: Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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