Actively Recruiting
TrueLok Elevate PMCF Study
Led by Orthofix s.r.l. · Updated on 2026-04-01
153
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TrueLok Elevate PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of surgery
- Willing and able to sign the study consent form according to ethics requirements
- Willing and able to follow the study protocol and attend follow-up visits
- Scheduled for surgery using the TrueLok Elevate Transverse Bone Transport System to treat lower limb ulcers as soft tissue defects
- Have a chronic ulcer present for at least 3 months
- Ulcer has not improved with standard wound care such as debridement, negative pressure therapy, offloading, antibiotics, or vascular optimization
You will not qualify if you...
- Mental or cognitive issues or behavioral conditions that would prevent following care instructions or study procedures
- Signs of systemic inflammatory response syndrome with two or more of: heart rate over 90 beats/min, respiratory rate over 20 breaths/min, low PaCO2, abnormal white blood cell count, or 10% immature white cells
- Known allergy to materials in the TrueLok Elevate device such as stainless steel or titanium
- Currently in another interventional clinical study that might affect this study
- Active cancer or systemic infection that could interfere with healing or the study
- Life expectancy less than 12 months
- Use of the device on both legs at the same time
- Currently incarcerated
- Any condition that the investigator believes makes participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Helios Klinikum Wuppertal GmbH
Wuppertal, Germany
Actively Recruiting
2
General Regional Hospital F. Miulli of Acquaviva delle Fonti
Acquaviva delle Fonti, Bari, Italy
Actively Recruiting
3
Stellenbosch University
Cape Town, Western Cape, South Africa, 7505
Actively Recruiting
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
5
Hull University Teaching Hospitals NHS Trust
Hull, Hull, United Kingdom
Actively Recruiting
Research Team
J
Jay Erturan, MD
CONTACT
D
Daniela Cangiano, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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