Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

Comparison between groups of the number of painkillers and NSAIDs consumed.

Comparison of the number of adverse events and serious adverse events reported.

Comparison between groups of participant compliance with study product intake

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.