Abstract
Introduction:
Arthroscopic reconstruction of the anterior cruciate ligament (ACL) is common in patients with ACL injuries. To enhance recovery after surgery, various nutritional supplements have been proposed as adjuvant treatments to physical therapy.
Objectives:
Efficacy and tolerability of a nutritional supplement containing hydrolyzed collagen, a complex of HA and CS (HC-15), and a plasma protein concentrate as adjuvant treatment to physical therapy in healing augmentation after ACL reconstruction.
Methods:
Prospective, multicenter, randomized, open-label trial including patients who underwent arthroscopic ACL reconstruction after injury. 80 patients were randomized into two groups to receive physical therapy only (control group) or combined with a nutritional supplement (composed of hydrolyzed collagen, a complex of hyaluronic acid and chondroitin sulfate, and plasma proteins) (Progen group). Efficacy assessments included a pain VAS score and the International Knee Documentation Committee (IKDC) index. Indirect measures of efficacy included analgesic consumption, the number of days to return to pre-injury activities, the number of rehabilitation sessions needed, and MRI graft maturation. The perceived efficacy and tolerability were assessed by patients and physicians.
Results:
At baseline, the demographic and clinical characteristics of both groups showed no significant differences. Both interventions showed efficacy in reducing the VAS and IKDC scores, with no significant differences between groups. Compared with patients in the control group, those in the Progen group required fewer rehabilitation sessions (mean [SD] of 48.4 [11.3] sessions vs. 38.0 [9.3] sessions; p < 0.001), thus returning earlier to their pre-injury activities. At the end of the follow-up, analgesic consumption was lower in the Progen group (8.6% of patients vs. 50.0%). According to the MRI findings, 61.8% and 38.2% of patients showed a high or complete maturation of the graft in the Progen and control groups, respectively. No serious adverse events were recorded. Both physicians and patients showed a trend towards a better perceived efficacy and tolerability in the Progen group.
Conclusion:
Adjuvant oral supplementation may increase the efficacy of physical therapy by shortening the time needed to return to pre-injury activity and the analgesic consumption. Also, MRI assessment revealed that more patients in the Progen group experienced a high or complete maturation of the graft, in line with the consistent trend observed in indirect measures of efficacy and patients’ quality of life at three months of treatment.