title: A prospective, randomised, controlled trial using a Mg-hydroxyapatite - demineralized bone matrix nanocomposite in tibial osteotomy.
abstract: We in vivo investigated the bone healing ability of a nanocomposite (DBSint®), constituted by biomimetic nano-structured Mg-hydroxyapatite (SINTlife®) and human demineralized bone matrix. Thirty-one subjects undergoing high tibial osteotomy for genu varus were randomly assigned to three groups: during surgery, DBSint® was inserted into nine patients, SINTlife® in thirteen patients and lyophilised bone chips, that is the routine surgery, in nine subjects. As outcome measures, clinical, radiographic and histomorphometry scores were calculated. The osseointegration was evaluated by imaging six weeks, three, six and twelve months after surgery. At six-week follow-up, DBSint® showed a significantly higher osseointegration rate in comparison with lyophilised bone chips (p = 0.008). At the same follow-up, CT-guided bone biopsies were obtained and analysed by histomorphometry: a good osteogenetic potential was demonstrated with DBSint®, as well as with SINTlife® and controls. Unresorbed material was evident with DBSint® and SINTlife®, with a significantly higher percentage in SINTlife® group. At 1-year follow-up, DBSint® was demonstrated as effective and safe as SINTlife® and lyophilized bone chips. More significant results could be obtained by continuing the clinical trial, by increasing the patient number and the study power. Eventually, the role of non-resorbed graft remnants is still unclear and requires further investigation.
authors.affiliation: Orthopaedic and Traumathological Department I, Istituto Ortopedico Rizzoli, via di Barbiano 1/10, Bologna, Italy.
authors.forename: Dante
authors.initials: D
authors.lastname: Dallari
authors.forename: Lucia
authors.initials: L
authors.lastname: Savarino
authors.forename: Ugo
authors.initials: U
authors.lastname: Albisinni
authors.forename: Piermaria
authors.initials: P
authors.lastname: Fornasari
authors.forename: Alberto
authors.initials: A
authors.lastname: Ferruzzi
authors.forename: Nicola
authors.initials: N
authors.lastname: Baldini
authors.forename: Sandro
authors.initials: S
authors.lastname: Giannini
mesh_terms: D000328:Adult; D001857:Bone Matrix / Q000737:chemistry*; D017886:Durapatite / Q000737:chemistry*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053761:Nanocomposites / Q000737:chemistry* / Q000627:therapeutic use; D010027:Osteotomy / Q000379:methods*; D011859:Radiography; D013977:Tibia / Q000000981:diagnostic imaging / Q000601:surgery*; D055815:Young Adult
chemical_list: D017886:Durapatite