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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. 91-B, Issue SUPP_III | Pages 455 - 455
1 Sep 2009
Bistolfi A Bracco P Lee Y Crova M Thornhill T Bellare A
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The performance of ultra-high molecular weight polyethylene (UHMWPE) used in total joint replacement prosthesis depends on its wear resistance, oxidation resistance and mechanical properties. Several studies have now established that radiation crosslinking by applying a dose of 50–100 kGy gamma or electron beam radiation followed by remelting to quench free radicals fulfils the criterion of high wear resistance as well as oxidation resistance. However, post-irradiation remelting leads to a decrease in several mechanical properties of UHMWPE including fracture toughness and resistance to fatigue crack propagation, which are deemed important for components in joints where they are subjected to high stresses, such as in tibial components.

In this study, we used uniaxial compression and high-pressure crystallization to disentangle UHMWPE, expecting that this would assist in increasing its crystallinity since disentangled polymer chains would be more readily incorporated into crystalline lamellae, thereby increasing overall crystallinity. This could then result in an increase in some mechanical properties of irradiated, remelted UHMWPE since high crystallinity is associated with high modulus and yield stress. Uniaxial compression of irradiated, remelted GUR 1050 UHMWPE at 130C to a compression ratio up to 2.5 followed by remelting to recover crystallographic orientation showed no statistically significant increase in crystallinity (p> 0.05, ANOVA). High-pressure crystallization at 500 MPa and temperatures in a range of 130-220C also did not show statistically significant increase in crystallinity of irradiated, remelted UHMWPE. However high-pressure crystallization at 500MPa pressure and 240C, where crystallization occurs via the hexagonal phase, increased the crystallinity from 46.2% to 56.4% (p< 0.05, ANOVA).

We conclude that high-pressure crystallization via the hexagonal phase is more effective than uniaxial compression followed by strain recovery or high-pressure crystallization via the orthorhombic phase in increasing the crystallinity of irradiated, remelted UHMWPE, with potential to recover some mechanical properties.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 273 - 273
1 May 2009
Bistolfi A Testa D Massazza G Damilano M Molino L Pautasso P Gallo A Faletti C Crova M
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Aims: Crosslinked acetabular inserts have been introduced as a solution to the wear related periacetabular osteolysis, caused by the polyethylene wear debris. Laboratory tests and simulators have demonstrated that crosslinked-polyethylene has a higher resistance to wear than conventional polyethylene. However, studies have shown early crack or degeneration of crosslinked inserts. Concerns still remain about the clinical performances of crosslinked inserts. Although questionable, the roentgenographic measurement of the wear of the cup represents an indicator of the performance of the implant. Early catastrophic failures of other inserts taught us that for new materials it is mandatory to conduct an accurate clinical surveillance. In this work the radiographic-evaluated linear wear of a group of cross-linked inserts is compared to that of a non-crosslinked inserts for the same socket at 5 years.

Methods: From 2000 to 2002 we implanted a series of cups in which crosslinked and conventional acetabular inserts were placed randomly. Patients from each group underwent radiographic assessment after implantation, at 3 and 6 months and then yearly. Radiographs were obtained using a digitalized image system, which allowed a computerized bi-dimensional measurement by a specially developed Auto-CAD program. 12 healthy and active patients (6 crosslinke – 6 conevtional UHMWPE) have been selected for measurement.

Results: No macroscopic signs of loosening, mobilization and osteolysis were detected. Despite an increased wear rate for the conventional insert, no statistically sig-nificant differences of the linear wear were detected at five years for the two groups.

Conclusions: Longer follow-up and larger case studies are needed for more definitive conclusions. Nevertheless, this preliminary study shows that crosslinked polyethylene in vivo at 5 years does not give early failures and that its linear wear in the short term does not differ from that of a conventional polyethylene. Several other factors, such as the number and dimension of the debris, which are not detected by roentgenographic measurements, might be taken into consideration. Moreover it has been hypothesized for the crosslinked polyethylene an early plastic deformation, with consequent penetration of the head without wearing, which could affect the measurement on plan radiographs. Despite these limitations, roentgenographic measurements are quick and easy to perform, and therefore might be useful for the clinical practice of the periodical evaluation of the implants.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 274 - 275
1 May 2009
Drocco L Graziano E Testa D Dolfin M Massazza G Bistolfi A Cenna E Crova M
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Aims: ACL lesion is one of the most frequent event in sport injuries. It is generally a complete lesion which does not evolve to a spontaneous healing. In particular, after non surgical treatment, ACL often repairs on PCL with a residual articular laxity. A healing response technique has been described to treat ACL incomplete tears in skeletally immature athletes. Our technique is based on microfractures next to the ACL femoral insertion to obtain a scar reinforcement thanks to the action of mes-enchymal stem cells.

Methods: The authors report their experience using the same surgical technique and rehabilitation protocol in patients selected by type of lesion, age and time from injury.

The authors selected for the study young-middle age active patients, with incomplete ACL lesion: 27 patients (mean age of 23 years) have been evaluated, inclusion criteria was Lachman test < 1 cm, negative Jerk test and a proximal partial tear of ACL on MRI. Before and after surgery the patients have been evaluated using KT1000, MRI, clinical examination and Lysholm score with a 3 years average follow up.

Results: Clinical examination showed a significative improvement in Lysholm score from 63 to 85 and a minor anterior tibial translation measured with KT1000 (from a mean difference between the two legs of 5 mm preoperatively to 2 mm postoperatively). In only one case the ACL didn’t seem to heal and was necessary the traditional reconstruction. MRI at one year pointed out a reparative healing in almost all cases.

Conclusions: according to these results the healing response procedure can restore a subjective and objective stability and knee function, with proper patient selection and strictly following the rehabilitation protocol despite of age and time of lesion.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 61 - 62
1 Mar 2005
Bistolfi A Bracco P Costa L del Prever EB Bellare A Crova M Gallinaro P
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Aims: to investigate the mechanical properties of a new nanocomposite bone cement radiopacified with Barium Sulfate (BaSu) nanoparticles added at different concentrations, compared to a control cement with the classical BaSu microparticles.

Methods: the starting material was Endurance (J& J/ DePuy, USA) bone cement without BaSu; the radi-opacifier particles have been mixed into the cement powder in several different concentrations of 5, 10, 20, 30, 40% of the weight respectively. Two groups were studied: controls, with classical medical grade BaSu particles (average size 1000 nm) and nanocomposites, with nanoparticles (av. size 100 nm). In accordance with the ASTM, an Instron 4201 machine tested a minimum of 6 specimens for each concentration. Tensile tests were performed at cross-head speeds of 1mm/sec, while compression tests were performed at 25,4 mm/sec. Results were statistically analysed.

Results: nanocomposites had higher compressive Yield strength in all groups except 30 and 40% and lower compressive Modulus in all but 5% group (no significant difference). Nanocomposites had higher tensile values in 5%, 10%, and 40% concentrations for Strain-to-failure, yield stress, and Work-of-Fracture, and no significant differences in the other concentrations. Tensile modulus had not statistically significant variations. Higher BaSu concentrations give increases in tensile modulus and decreases in the other tensile properties for both the groups. The nanocomposite outperformed the control in the 5, 10, and 20% groups, while the 30 and 40% groups had no significant differences; all the results were above ASTM requirements.

Conclusions: bone cement has several uses, like joint replacement, filling defects in tumour or revision surgery, and more recently vertebroplasty. These applications require different properties and would have benefits from the possibility to change viscosity, radiopacity, time of polymerisation, mechanical features. Previous studies have demonstrated the improved performances of the new nanocomposite cement at the clinical used concentration of 10%. This study investigated the possibility to augment the concentration of BaSu and therefore the radiopacity and their relative effect on the mechanical properties; the results demonstrated the good compliance of the nanoparticles cement in this field. This would be useful in particular for specific applications such vertebroplasty. Further studies are needed to investigate and determine the ideal fatigue, handling and mixing properties, viscosity and radiopacity.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 63 - 63
1 Mar 2005
Elena MBDP Costa L Bracco P Bistolfi A Crova M Gallinaro P
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Aims: To understand why during routine analyses of the physico-chemical properties of retrieved UHMWPE prosthetic components (Pes), it was noticed that some cups, which were directly in contact with bone, evidence a material loss in correspondence with the area adjacent to bone.

Methods: PEs retrieved during revision surgery and stored in formalin prior to observation, have been analysed by Fourier Transform InfraRed (FTIR) spectroscopy and Scanning Electron Microscopy (SEM).

Results: The results of the FTIR analyses did not display appreciable differences compared to those of the majority of the retrieved prostheses. Oxidation of UHMWPE was detected, but it is known to be due to sterilisation with high energy radiation in air, under uncontrolled conditions.

The SEM analyses indicated that the PEs surface which was directly in contact with bone shows an anomalous degradation. The surface looks as it has been corroded or “bitten” and its morphology is significantly different from that of surfaces abraded either in vivo or in vitro.

Conclusions: The results so far obtained seem to indicate that the surfaces, which have been in contact with bone during the implant time, undergo a selective biodegradation process, facilitated by gamma in air sterilisation, and influenced by the biological reactivity of the patient (such as osteclast activation).


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 376 - 376
1 Mar 2004
Lagalla F Bistolfi A Graziano E Errichello D Crova M
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Introduction: At the 2nd Orthopaedic Clinic of Turin the subcutaneous rupture of the Achillis tendon is treated with the Ma-Grifþth technique, followed by cast for eight weeks, weight bearing is possible after 2 months. Aim of this work is to evaluate 61 patients operated. Materials and methods: 61 patients were evaluated, divided into 2 groups: group A) 20 male patients treated from 1991 to 1996, mean age 37 years, follow-up 3,3 years, in the 1997 they had a clinical, echosonographic and isokinetic evaluation. Group B) 41 patients, 4 female, treated from 1997 to may 2002, mean age 37,5, mean follow-up 3,6 years, in the 2002 they were clinically evaluated. Results: Group A): the ecographic analysis revealed the thickening of the operated tendon, the isokinetich analysis revealed the same range of movement of the not-affected side, without lack of strength. Group A and B): at the clinical evaluation a normal walking and all the patients came back to the athletic activities in 5 months.

The 5% of the cases presented cicatricial adhaesions, the 10% of the cases presented a light hypoesthesia of the sural nerve. Only one rupture occurred after the re-beginning of the sport activity. Conclusion: This technique has several vantages, like the mini-invasivity, the rapidity of esecution and a low rate of severe complications and gave us good results, therefore we think that could be indicated in the non agonistic patient.