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.
| Original language | English |
|---|---|
| Pages (from-to) | 72-79 |
| Number of pages | 8 |
| Journal | Biomaterials |
| Volume | 33 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 2012 |
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Keywords
- Bone healing
- Demineralized bone matrix
- Nano-structured Mg-hydroxyapatite
- Osteotomy
ASJC Scopus subject areas
- Biomaterials
- Bioengineering
- Ceramics and Composites
- Mechanics of Materials
- Biophysics
Cite this
A prospective, randomised, controlled trial using a Mg-hydroxyapatite - demineralized bone matrix nanocomposite in tibial osteotomy. / Dallari, Dante; Savarino, Lucia; Albisinni, Ugo; Fornasari, Piermaria; Ferruzzi, Alberto; Baldini, Nicola; Giannini, Sandro.
In: Biomaterials, Vol. 33, No. 1, 01.2012, p. 72-79.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A prospective, randomised, controlled trial using a Mg-hydroxyapatite - demineralized bone matrix nanocomposite in tibial osteotomy
AU - Dallari, Dante
AU - Savarino, Lucia
AU - Albisinni, Ugo
AU - Fornasari, Piermaria
AU - Ferruzzi, Alberto
AU - Baldini, Nicola
AU - Giannini, Sandro
PY - 2012/1
Y1 - 2012/1
N2 - 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.
AB - 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.
KW - Bone healing
KW - Demineralized bone matrix
KW - Nano-structured Mg-hydroxyapatite
KW - Osteotomy
UR - http://www.scopus.com/inward/record.url?scp=82855161331&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=82855161331&partnerID=8YFLogxK
U2 - 10.1016/j.biomaterials.2011.09.029
DO - 10.1016/j.biomaterials.2011.09.029
M3 - Article
C2 - 21955688
AN - SCOPUS:82855161331
VL - 33
SP - 72
EP - 79
JO - Biomaterials
JF - Biomaterials
SN - 0142-9612
IS - 1
ER -