TrueLok Elevate PMCF study
Research type
Research Study
Full 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
IRAS ID
360766
Contact name
Daniela Cangiano
Contact email
Sponsor organisation
Orthofix S.r.l.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 8 days
Research summary
The proposed clinical investigation is a prospective, international, multicenter, observational post-market clinical follow-up (PMCF) study using the regulatory approved (CE-marked) medical device - TrueLok™ Elevate System.
The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport. Transverse bone transport is the procedure where bone is cut after application of external fixator in the leg and this cut bone is gradually pulled apart and then pushed back to its original position. This promotes increased blood supply and wound in chronic non healing ulcers.
Chronic (long standing) lower limb ulcers are a complex and growing clinical challenge, particularly in aging populations and individuals with diabetes or vascular disease. These ulcers often leading to prolonged morbidity, recurrent infections, and often amputation.
Tibial transverse transport (TTT), also known as Transverse Bone Transport (TBT) and lateral bone transport (LBT) has emerged as a novel approach to address chronic ulcers with gradual distraction; principle which is well known and practiced by limb reconstruction surgeons.
The study aims to assess the proportion of patients achieving complete ulcer healing within 12 months of device removal. Ulcer healing and limb preservation in this high-risk population is crucial, given the risks of progression to amputation, high morbidity, and limited efficacy of current treatments. A regenerative, non-amputation approach offers strong clinical value.
The study will be conducted at least 12 sites in the United States, the United Kingdom, Europe and South Africa and it is planned to enroll up to 153 subjects. The patient recruitment will be competitive, with each site expected to enroll approximately 13 subjects. In the United Kingdom the study will be conducted at two investigational sites.
The Sponsor - Orthofix S.r.l, is funding the study.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0297
Date of REC Opinion
27 Nov 2025
REC opinion
Further Information Favourable Opinion