This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
oral gel containing cetilated fatty acids
oral gel coloured and flavoured as the IP
AZ Monica
Deurne, Antwerp, Belgium
RECRUITINGAlgemeen Ziekenhuis Herentals
Herentals, Antwerp, Belgium
RECRUITINGHôpital Erasme - Cliniques Universitaires de Bruxelles
Brussels, Brussels Capital, Belgium
Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST).
Comparison between groups of radiographic assessment of the callus formation using mRUST 6 weeks after fracture stabilisation. The mRUST scale ranges from 4 to 16 points, where higher scores indicate better fracture healing (greater callus formation and union).
Time frame: 6 weeks after fracture stabilization
Pain Assessment at Fracture Site using the Visual Analog Scale (VAS)
Change from baseline in pain perception in clinical assessment using the VAS 4 weeks after fracture stabilization. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes (greater pain intensity).
Time frame: 4 weeks after fracture stabilization
Ultrasonographic Assessment of Callus Formation
Change from placebo group in ultrasonographic evaluation of hypervascularisation and callus formation. Measurement of callus size (length and thickness) in millimeters using B-mode ultrasound imaging at the fracture site. The assessment is performed 4 weeks after fracture stabilization. Larger callus size indicates better bone healing.
Time frame: 4 weeks after fracture stabilization
Radiographic Assessment of Callus Formation (modified Radiographic Union Score for Tibia - mRUST)
Radiographic union will be evaluated using the modified Radiographic Union Score for Tibia (mRUST), which rates healing on a 4-16 scale, with higher scores indicating better callus formation and more advanced fracture healing. Comparison between groups at Week 12.
Time frame: 12 weeks after fracture stabilization
Pain Assessment at Fracture Site (Visual Analog Scale - VAS)
Pain at the fracture site will be assessed using the Visual Analog Scale (VAS), a 0-100 mm scale, where higher scores indicate worse pain. The endpoint evaluates the change from baseline to Week 12.
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Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Flanders, Belgium
RECRUITINGZiekenhuis Oost-Limburg
Genk, Limburg, Belgium
RECRUITINGTime frame: 12 weeks after fracture stabilization
Incidence of Complications
Comparison between groups of the number of complications observed at 4 and 12 weeks after fracture stabilization. Complications include superficial infection, deep infection, wound breakage, failure of fixation, bleeding, severe blood loss, nerve damage, swelling, deep vein thrombosis, and delayed healing.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Minimal Clinically Important Improvement (MCII)
The MCII is calculated using the Visual Analog Scale (VAS) for pain, a 0-100 mm scale where higher scores indicate worse pain. MCII is defined as an absolute improvement of ≥15 mm or a relative improvement of ≥20% from baseline. The measure represents the proportion of participants achieving clinically meaningful pain improvement at each time point.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Participant Acceptable Symptom State (PASS)
PASS is determined using the Visual Analog Scale (VAS) for pain, a 0-100 mm scale where higher scores indicate worse pain. PASS is defined as achieving a pain score \<30 mm, corresponding to a symptom state considered acceptable by the participant. The measure represents the proportion of participants reaching this threshold.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Participant Global Assessment (PGA)
PGA is assessed using a Visual Analog Scale (VAS), a 0-100 mm scale where higher scores indicate worse overall perception of recovery. Participants rate their overall status, taking into account pain, function, and wellbeing. Between-group comparison will be performed at each time point.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Lower Extremity Functional Scale (LEFS)
Lower-limb functional recovery will be assessed using the Lower Extremity Functional Scale (LEFS), a validated 20-item questionnaire where each item is scored on a 0-4 scale. Total scores range from 0 to 80, with higher scores indicating better lower-extremity function. Between-group comparison will be performed at each visit.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Quality of Life using the Short Form-36 (SF-36) questionnaire.
Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire. The SF-36 includes 8 domains, each scored from 0 to 100, where higher scores indicate better health status. Summary and domain-level results will be compared between groups at each time point.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Painkiller and NSAID Consumption
Comparison between groups of the number of painkillers and NSAIDs consumed.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Comparison of the number of adverse events and serious adverse events reported.
Time frame: 4 weeks and 12 weeks after fracture stabilization
Participant Compliance Rate
Comparison between groups of participant compliance with study product intake
Time frame: 4 weeks and 12 weeks after fracture stabilization
Participant Satisfaction
Participant satisfaction with the study product will be assessed using a Likert scale, ranging from 1 to 5, where higher scores indicate greater satisfaction. The measure evaluates the participant's subjective perception of the product's acceptability and overall experience with the supplementation regimen. Comparison between groups will be performed at each study visit where data are collected.
Time frame: 4 weeks and 12 weeks after fracture stabilization