This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
Pain improvement
Assessed using a 100-mm Visual Analog Scale (VAS)
Time frame: 90 days
Knee function
Assessed using the International Knee Documentation Committee (IKDC) index. The final score was interpreted as a measure of function, with higher scores representing higher levels of function
Time frame: 90 days
Analgesic consumption
Analgesic consumption and frequency of analgesic intake during follow-up
Time frame: 90 days
Number of rehabilitation sessions required
Number of required rehabilitation sessions at the end of follow-up.
Time frame: 90 days
Maduration of the graft
Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences
Time frame: Day 0, day 90
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