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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 22 - 22
1 Apr 2019
Massari L Bistolfi A Grillo PP Causero A
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Introduction

Trabecular Titanium is a biomaterial characterized by a regular three-dimensional hexagonal cell structure imitating trabecular bone morphology. Components are built via Electron Beam Melting technology in aone- step additive manufacturing process. This biomaterial combines the proven mechanical properties of Titanium with the elastic modulus provided by its cellular solid structure (Regis 2015 MRS Bulletin). Several in vitro studies reported promising outcomes on its osteoinductive and osteoconductive properties: Trabecular Titanium showed to significantly affect osteoblast attachment and proliferation while inhibiting osteoclastogenesis (Gastaldi 2010 J Biomed Mater Res A, Sollazzo 2011 ISRN Mater Sci); human adipose stem cells were able to adhere, proliferate and differentiate into an osteoblast-like phenotype in absence of osteogenic factors (Benazzo 2014 J Biomed Mater Res A). Furthermore, in vivo histological and histomorphometric analysis in a sheep model indicated that it provided bone in-growth in cancellous (+68%) and cortical bone (+87%) (Devine 2012 JBJS). A multicentre prospective study was performed to assess mid-term outcomes of acetabular cups in Trabecular Titanium after Total Hip Arthroplasty (THA).

Methods

89 patients (91 hips) underwent primary cementless THA. There were 46 (52%) men and 43 (48%) women, with a median (IQR) age and BMI of 67 (57–70) years and 26 (24–29) kg/m2, respectively. Diagnosis was mostly primary osteoarthritis in 80 (88%) cases. Radiographic and clinical evaluations (Harris Hip Score [HHS], SF-36) were performed preoperatively and at 7 days, 3, 6, 12, 24 and 60 months. Bone Mineral Density (BMD) was determined by dual-emission X-ray absorptiometry (DEXA) according to DeLee &Charnley 3 Regions of Interest (ROI) postoperatively at the same time-points using as baseline the measureat 1 week. Statistical analysis was carried out using Wilcoxon test.


Bone & Joint Research
Vol. 6, Issue 8 | Pages 481 - 488
1 Aug 2017
Caruso G Bonomo M Valpiani G Salvatori G Gildone A Lorusso V Massari L

Objectives

Intramedullary fixation is considered the most stable treatment for pertrochanteric fractures of the proximal femur and cut-out is one of the most frequent mechanical complications. In order to determine the role of clinical variables and radiological parameters in predicting the risk of this complication, we analysed the data pertaining to a group of patients recruited over the course of six years.

Methods

A total of 571 patients were included in this study, which analysed the incidence of cut-out in relation to several clinical variables: age; gender; the AO Foundation and Orthopaedic Trauma Association classification system (AO/OTA); type of nail; cervical-diaphyseal angle; surgical wait times; anti-osteoporotic medication; complete post-operative weight bearing; and radiological parameters (namely the lag-screw position with respect to the femoral head, the Cleveland system, the tip-apex distance (TAD), and the calcar-referenced tip-apex distance (CalTAD)).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 416 - 416
1 Dec 2013
Massari L Causero A Rossi P Grillo PP Bistolfi A Gigliofiorito G Pari C Francescotto A Tosco P Deledda D Carli G Burelli S
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Introduction

Trabecular Titanium™ is a highly porous biomaterial with a regular hexagonal cell structure, which has shown excellent mechanical properties. Several in vitro studies reported promising data on its osteoinductive and osteoconductive properties. Furthermore, it has demonstrated in vivo to enhance bone in-growth. Aim of this multicentre prospective study was to assess Trabecular Titanium™ osseointegration by measuring change in bone mineral density (BMD) around a cementless DELTA-TT cup with dual-emission X-ray absorptiometry (DXA).

Methods

89 patients (91 hips) underwent primary THA with DELTA-TT cups (Lima Corporate) between 2009 and 2010. There were 46 (52%) men and 43 (48%) women, with a median (IQR) age of 67 (57–70) years and a median (IQR) BMI of 26 (24–29) kg/m2. Right side and left side were affected in 44 (48%) and 47 (52%) cases, respectively. Underlying pathology was primary osteoarthritis in 80 (88%) cases, osteonecrosis in 5 (6%), post-traumatic osteoarthritis in 3 (3%), developmental dysplasia of the hip in 2 (2%) and oligoarthritis in 1 (1%). BMD was determined by DXA using DeLee and Charnley 3 Regions of Interest (ROI) at 7 days, 3, 6, 12 and 24 months. Clinical evaluation (Harris Hip Score, HHS), patient health status survey (SF-36) and radiographic assessment were performed preoperatively and at the same time-points. Data were analyzed using non-parametric tests (Mann-Whitney, Wilcoxon signed-rank) and a p < 0.05 as threshold for statistical significance.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 546 - 546
1 Sep 2012
Caruso G Lorusso V Setti S Cadossi R Massari L
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A multicenter retrospective analysis of patients treated for tibial fracture was conducted to develop a score that correlates with fracture healing time and, ultimately, to identify the risk gradient of delayed healing.

The clinical records of 93 patients treated for tibial fracture at three orthopaedic centers were evaluated. Patients were considered healed when full weight bearing was allowed and no further controls were scheduled. For the purpose of our analysis, we separated patients healed within or after 180 days.

Patient's risk factors known to be associated to delay healing, as well as fracture morphology and orthopaedic treatment were recorded in an electronic Case Report Form (e-CRF). Information available in the literature was used to weight the relative risk (RR) associated to each risk factor; values were combined to calculate a score to be correlated to the fracture healing time: L-ARRCO (Literature-Algoritmo Rischio Ritardo Consolidazione Ossea). Among all information collected in e-CRFs, we identified other risk factors, associated to delayed healing, that were used to calculate a new score: ARRCO. Univariate logistic analysis was used to determine a correlation between the score and healing time. Analysis by receiver operating characteristic (ROC) and calculation of the area under the curve (AUC) were used for sensitivity and specificity.

Complete information was available for 53 patients. The mean value of the L-ARRCO score among patients healed within 180 days was 5.78 ± 1.59 and 7.05 ± 2.46 among those healed afterwards, p=0.044. The mean value of the ARRCO score of patients healed within 180 days was 5.92 ± 1.78 and 9.03 ± 2.79 among those healed afterwards, p<0.0001. The ROC curve shows an AUC of 0.62±0.09 for L-ARRCO and an AUC of 0.82±0.07 for ARRCO, (p<0.0001).

We have shown that the ARRCO score value is significantly correlated to fracture healing time. The score may be used to identify fractures at risk of delayed healing, thus allowing surgeon's early intervention to stimulate osteogenesis.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 139 - 139
1 Sep 2012
Massari L Rossi P Grillo P Crova M Bistolfi A Causero A
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Trabecular TitaniumTM is a tri-dimensional material composed by multi-planar regular hexagonal cells and characterised by a highly open porosity that has been studied to optimise bone osteointegration. The aim of this study is to evaluate bone remodelling measuring BMD changes around an acetabular cup made from Trabecular TitaniumTM in primary total hip arthroplasty (THA).

Between February 2009 and December 2010, 89 patients (91 hip) underwent primary THA with a modular acetabular cup in Trabecular TitaniumTM (DELTA-TT cup, Limacorporate, Villanova di San Daniele, Italy). The average age was 63.5± 9.4 years, the average height and weight were 75.9± 12.9 kg and 168.8± 8.9 cm, respectively (av. BMI 26.8± 4.2). There were 46 (51.7%) males and 43 (48.3%) females affected by primary coxarthrosis in 80 (87.9%) cases, avascular necrosis in 5 (5.5%), posttraumatic coxarthrosis in 3 (3.3%), dysplasia in 2 (2.2) and oligoarthritis in 1 (1.1%) case. The study includes the clinical evaluation with Harris Hip Score (HHS) and SF-36, radiographic evaluation and dual-energy x-ray absorptiometry (DEXA) analysis preoperatively and postoperatively at 1 week, 3, 6, 12 and 24 months.

Preliminary results are currently available for 47 patients at 12 months, 68 at 6 months and 80 at 3 months. The average HHS significantly improved from 48.7± 14.99 preoperatively to 93.8± 5.91 at 12 months, with a constant progression in the intermediate follow-ups. All patients showed a significant ROM increase, with an average flexion from 86.6°± 15.9° preoperatively to 105°±13.14 at 12 months. Sf-36 highlighted a satisfactory improvement of general health status from an average preoperative value of 50.8± 18.7 to 80.7± 12.9 at 12 months (from 42.9 to 80.1 for physical health; from 58.4 to 81.3 for mental one). All cups were stable at 12 months with no radiolucent lines. Preliminary DXA analysis reported an initial bone mineral density decrease from 1 week baseline values (BMD R1: 1.40± 0.37; R2: 1.20± 0.45; R3:1.16± 0.31) to 3 months (BMD R1: 1.31± 0.41; R2: 1.17± 0.3; R3: 1.06± 0.37) followed by BMD recovery up to initial values (BMD R1: 1.37± 0.3; R2:1.18± 0.34; R3: 1.12± 0.36) at 12 months.

Trabecular TitaniumTM demonstrates a good primary and secondary stability. Preliminary densitometric outcome confirms an optimal osseointegration of the DELTA-TT cup and early clinical and patient subjective results are very promising at a short term follow-up. However, the completions of follow-up evaluation are necessary to draw a conclusive analysis.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 142 - 142
1 Jun 2012
Massari L Bistolfi A Grillo PP Causero A Burelli S Gigliofiorito G Menosso P Carli G Bloch HR
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INTRODUCTION

Trabecular Titanium™ is an innovative material characterised by an high open porosity and composed by multi-planar regular hexagonal cells. It is not a traditional coating and its tri-dimensional structure has been studied to optimise osteointegration. Furthermore, it has excellent mechanical properties, as a very high tensile and fatigue resistance and an elastic module very similar to the that of the trabecular bone. The aim of this study is to evaluate the osteointegration and bone remodelling measuring the longitudinal pattern of change in BMD around a cementless acetabular cup made from Trabecular Titanium™ (Delta TT cup, Lima Corporate, Italy) in primary total hip arthroplasty (THA).

METHODS

Dual-energy x-ray absorptiometry (DEXA) analysis, radiographic evaluation on standard AP and lateral views and clinical evaluation with Harris Hip Score (HHS) and SF-36 were performed at 1 week, 3, 6, 12 months after surgery.