EXOGEN Mitigates Risk of Fifth Metatarsal Fracture Nonunion: Results of a Novel Real-World Clinical Study.

Category:: Midfoot/Forefoot

Introduction/purpose:: Fifth metatarsal fractures are the most commonly fractured metatarsal in adults and are associated with high rates of nonunion. This study compared the 9-month incidence of nonunion in fifth metatarsal fracture patients using EXOGEN (Bioventus LLC), low-intensity pulsed ultrasound, versus a control cohort of patients receiving standard of care.

Methods:: Adults (21-80 years) prescribed EXOGEN for any acute or delayed fifth metatarsal fracture and initiated treatment within 91 days of the fracture were enrolled via prescription record abstraction and direct-to-patient outreach.

A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis.

Objective: Characterization of a novel human placental tissue-derived biologic, PTP-001, which is in development as a candidate therapeutic for the treatment of osteoarthritis symptoms and pathophysiology.

Methods: Human placental tissues from healthy donors were prepared as a particulate formulation, PTP-001. PTP-001 extracts were assayed for the presence of disease-relevant biofactors which could have beneficial effects in treating osteoarthritis.

Breaking Barriers: Studying Fracture Healing in the BONES Program.

The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion.

Preparation and characterization of antimicrobial wound dressings based on silver, gellan, PVA and borax.

Silver-loaded dressings are designed to provide the same antimicrobial activity of topical silver, with the advantages of a sustained silver release and a reduced number of dressing changes. Moreover, such type of dressing must provide a moist environment, avoiding fiber shedding, dehydration and adherence to the wound site. Here we describe the preparation of a novel silver-loaded dressing based on a Gellan/Hyaff(®) (Ge-H) non woven, treated with a polyvinyl alcohol (PVA)/borax system capable to enhance the entrapment of silver in the dressing and to modulate its release.

In vivo characterization of Hyalonect, a novel biodegradable surgical mesh.

Background: Musculoskeletal reconstructive surgery often requires removal of significant quantities of bone tissue, such as the periosteum, causing critical problems following surgery like friction between different tissues and adhesion of soft tissues to the underlying bone. We studied the long-term host response and closure of large bone defects for periosteal reconstruction using Hyalonect, a novel membrane comprising knitted fibers of esterified hyaluronan, (HYAFF11).

Materials And Methods: For biological characterization, 162 rats were used in a defect model in which a section of the dorsal muscular fascia was removed, and the membrane behavior observed over 540 d using conventional histology, with sham operated rats as controls.