Actively Recruiting
Post-Market Clinical Follow-up Study of the TrueLok Elevate Transverse Bone Transport System for Treatment of Lower Limb Ulcers and Soft Tissue Defects
Led by Orthofix s.r.l. · Updated on 2026-04-01
153
Participants Needed
5
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the TrueLok Elevate Transverse Bone Transport System, a modular external fixation device designed to aid healing in adults with bone and soft tissue defects in the lower limbs, especially chronic ulcers. The study is a prospective, international post-market clinical follow-up conducted at multiple centers across the US, Europe, the UK, and South Africa. It aims to observe the device's impact on wound healing over time. Participants will receive treatment using the TrueLok Elevate system according to the manufacturer’s instructions. The study follows a phased schedule starting with the index surgery, then monitoring through stages such as the end of distraction, end of compression, and device removal. After device removal, participants will be followed up at 3, 6, and 12 months to track progress and healing. Throughout the study, participants will undergo assessments at each phase to record device parameters, adverse events, and ulcer status. The primary outcome measured is complete ulcer healing at 12 months. The study involves monitoring wound healing, device safety, and patient adherence during and after treatment, with a total follow-up period extending to one year post-device removal.
CONDITIONS
Brief 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 and date the study-specific informed consent form
- Willing and able to comply with protocol requirements, including follow-up visits
- Indicated for surgery using the TrueLok Elevate Transverse Bone Transport System for lower limb ulcers
- Presence of a chronic ulcer for at least 3 months
- Ulcer unresponsive to standard non-surgical or surgical wound management, including debridement, negative pressure therapy, offloading, antibiotics, or vascular optimisation
You will not qualify if you...
- Mental or cognitive impairments or conditions that prevent reliable adherence to care or study procedures
- Signs of systemic inflammatory response syndrome (SIRS) with two or more specified clinical signs
- Known allergy to materials used in the TrueLok Elevate system, such as stainless steel or titanium
- Current participation in another interventional clinical study interfering with this study
- Presence of active malignancy or systemic infection affecting wound healing
- Life expectancy less than 12 months
- Simultaneous bilateral application of the device
- Current incarceration at enrollment
- Any condition or circumstance that would interfere with study participation or objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to device removal
Participants undergo surgery using the TrueLok Elevate Transverse Bone Transport System, with baseline data and operative details collected during the index surgery.
Visits at index surgery, end of distraction, end of compression, and device removal
Duration - 12 months post-device removal
Participants are followed after device removal to monitor ulcer healing and recovery.
Visits at 3 months, 6 months, and 12 months post device removal
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
D
Daniela Cangiano, PhD
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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