Clinical Research Directory

Naringenin Supplementation in Bone Fracture Patients

Fractures of the lower extremities represent a significant proportion of injuries sustained by polytrauma patients, with a notable association with prolonged hospitalization, chronic disability, and impaired physical functioning. The occurrence of surgical site infections (SSI) represents a significant threat to the efficacy of osteosynthesis procedures. As with other traumas and surgical procedures, the secretion of inflammatory mediators is markedly elevated in this cohort of patients following surgery. Naringenin is one of the most prevalent flavonoids, occurring naturally in grapefruit and other citrus fruits. In vitro studies have demonstrated that naringenin may stimulate the release of osteogenic cytokines and suppress the production of pro-inflammatory factors, which can result in a reduction in bone resorption. Based on these findings, naringenin may prove an effective agent for accelerating the rate of fusion and controlling inflammation. Furthermore, it may enhance quality of life and augment functional activity.

Effectiveness of Pulsed Electromagnetic Fields and Nutraceutical Supplementation in Women With Distal Radius Fracture

This single-center randomized controlled trial tests whether adding a daily nutraceutical supplement to standard pulsed electromagnetic field (PEMF) therapy improves recovery after a recent distal radius (wrist) fracture in women. The study asks: does PEMF plus a supplement of vitamin D, vitamin K, magnesium, vitamin C, zinc, and copper produce faster bone healing, greater pain relief, less soft-tissue swelling, and fewer complications (including complex regional pain syndrome) than PEMF alone? Sixty women aged 45-55 with a recent radiographically confirmed distal radius fracture and baseline pain NRS ≥ 4 are randomized 1:1. One group receives PEMF 9 hours per day for 30 days. The other group receives the same PEMF regimen plus the daily oral nutraceutical for 30 days. Assessments occur at baseline, 15 days (early ultrasound and laboratory markers), and 30 days (radiographic healing, Budapest criteria for complex regional pain syndrome, pain NRS, and functional measures). The primary outcomes are change in pain (NRS) and early callus formation at 15 days, with radiographic healing at 30 days. Secondary outcomes include biochemical markers of bone turnover, 24-hour calciuria and phosphaturia, soft-tissue edema by ultrasound, functional recovery, safety, and tolerability. The hypothesis is that the combined treatment leads to earlier and clinically meaningful improvements in pain, function, and bone repair compared with PEMF alone.

Opioid Management for Discharged Emergency Department Patients

The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid consumption, and determine whether this intervention is acceptable to patients.

Study on Safety and Performance of AdvanCore Bone Void Filler

The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.