TrueLok Elevate PMCF Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-24

Study Completion Date

2028-11-24

Brief Summary

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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.

Detailed Description

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Conditions

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Wound of Skin Ulcers Soft Tissue Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Helios Klinikum Wuppertal GmbH

Wuppertal, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jay Erturan, MD

Role: CONTACT

[email protected]

7779 32 32 44 ext. +44

Daniela Cangiano, PhD

Role: CONTACT

[email protected]

0456719000 ext. +39

Facility Contacts

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Marco Speicher, MD

Role: primary

Other Identifiers

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CIP-TLEL-25

Identifier Type: -

Identifier Source: org_study_id