A clinical investigation into a new bone void filler is giving
first data on systemic and local exposure to the anti-infective
substance after implantation. A total of 20 patients with post-traumatic/post-operative bone
infections were enrolled in this open-label, prospective study.
After radical surgical debridement, the bone cavity was filled with
this material. The 21-day hospitalisation phase included determination
of gentamicin concentrations in plasma, urine and wound exudate, assessment
of wound healing, infection parameters, implant resorption, laboratory
parameters, and adverse event monitoring. The follow-up period was
six months. Objective
Method
We reviewed 59 bone graft substitutes marketed
by 17 companies currently available for implantation in the United Kingdom,
with the aim of assessing the peer-reviewed literature to facilitate
informed decision-making regarding their use in clinical practice.
After critical analysis of the literature, only 22 products (37%)
had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita),
Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question
the need for so many different products, especially with limited
published clinical evidence for their efficacy, and conclude that
there is a considerable need for further prospective randomised
trials to facilitate informed decision-making with regard to the
use of current and future bone graft substitutes in clinical practice. Cite this article:
Deep bone and joint infections (DBJI) are directly intertwined with health, demographic change towards an elderly population, and wellbeing. The elderly human population is more prone to acquire infections, and the consequences such as pain, reduced quality of life, morbidity, absence from work and premature retirement due to disability place significant burdens on already strained healthcare systems and societal budgets. DBJIs are less responsive to systemic antibiotics because of poor vascular perfusion in necrotic bone, large bone defects and persistent biofilm-based infection. Emerging bacterial resistance poses a major threat and new innovative treatment modalities are urgently needed to curb its current trajectory. We present a new biphasic ceramic bone substitute consisting of hydroxyapatite and calcium sulphate for local antibiotic delivery in combination with bone regeneration. Gentamicin release was measured in four setups: 1) Objectives
Materials and Methods
