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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 40 - 40
1 May 2016
Bergadano D Lambert P Bernardoni M Siccardi F
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Since its introduction in total hip replacements in the 1960's, Ultra High Molecular Weight Polyethylene (UHMWPE) has played a major role as a bearing component material for joint arthroplasty. Concerns were raised when issues of wear resistance became apparent, and therefore Highly Crosslinked Polyethylenes were introduced. Such materials undergo a thermal treatment to quench the free radicals and reduce progressive oxidation.

However, said thermal treatment weakens the material mechanical properties and hence the use of antioxidants has been proposed and implemented in clinical use, mainly Vitamin-E. This can be added to the material before or after irradiation. If it is done before, part of the anti-oxydant is consumed during irradiation and so will not be available for its main purpose, and part reacts before irradiation with the free radicals thus reducing the crosslinking effect. If it is added after irradiation, high temperatures are required in order to diffuse it in the bulk material, and anyway the surface will be mainly rich in antioxidant. However, Vitamin-E tends to neutralize the free radicals on the oxidized lipid chain present in our body fluids and so in direct contact with the prosthetic components: such mechanism reduces the Vitamin-E quantity available for anti-oxidation purposes in the long run.

A UHMWPE doped with Hindered Amine Light Stabilizer (HALS) has been developed and tested for applications in large joint replacements where highest resistance to wear and tough mechanical properties are simultaneously required, such as tibial inserts for knee joints or acetabular inserts for large diameter heads.

Mechanical and biocompatibility tests were run in accordance with ASTM F 2565-06 and ISO 10993-1 with successful results and good reproducibility.

In particular, electro spin resonance exhibited a very high level of free radicals in the three samples, which confirms the properties of this new material. Free radicals are the result of the activation of the HALS molecules during irradiation, creating nitroxide radicals that will destroy the residual alkyl radicals responsible for the oxidation before and after implantation.

Biocompatibility tests proved absence of cytotoxicity, sensitization, irritation, genotoxicity or pyrogenic reactions.

The possible future applications for this new material in the arthroplasty field will be discussed along with the expected advances and advantages.


Introduction

Patient-specific cutting guides entered into clinical practice few years ago, first introduced in total knee replacement and recently also for other joint replacements. Advantages claimed are improving accuracy and repeatability in implant placement. New patient-specific guides to perform an accurate femoral neck resection and provide a precise alignment reference for acetabular reaming in total hip arthroplasty (THA) were recently developed by Medacta International: MyHip Technology. To date femoral guides can be designed for both anterior and posterior approaches, whereas acetabular guides are available only for posterior approach.

Evaluation of the repeatability and reproducibility of MyHip guides placement on cadavers is performed using a navigation system. Accuracy of femoral MyHip guides is evaluated also through one author's clinical experience (RP).

Materials and Methods

During each cadaveric session one body (2 hips) was available. A pre-operative CT scan has been obtained and used in order to create the 3D bone model of the pelvis and proximal femurs. Afterwards, a surgical planning for THA has been performed for each case, and, once it was approved by the surgeons, the designed patient-specific blocks were made.

Intraobserver and interobserver agreement in positioning the guides was assessed getting measures of femoral head resection height (mm), femoral head plane inclination/anteversion (°) and acetabular reaming axis orientation (°). 9 surgeons, through 2 cadaveric sessions, positioned each guide, removed it and re-positioned it 5 times alternatively. The system is judged as accurate if all measures differ less than 3mm and 5°for lengths and angles respectively from the average among all the acquisitions.

Clinical experience includes 68 THA which were performed between March 2014 and April 2015. Anterior femoral MyHip guides were used for the femoral head resection, while the acetabular side was prepared using the standard metal instrumentation for minimally invasive anterior approach. Intra-operative complications, as well post-operative leg length difference and implant positioning are assessed.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 352 - 352
1 Mar 2004
Mass• A Bosetti M Buratti C Visentin O Bergadano D Gallinaro P Cannas M
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Aims: A prospective multicentric study was carried out in patients having metal-on-metal METASUL components to check if the concentration markers of chromosomal damage (Sister Chromatid Exchanges (SCEñs) and Micronuclei (Mni) and that of Co, Cr, Ni and Mb in the body ßuids are affected by the implant of METASUL components within 6 months. Methods: 30 patients were enrolled homogeneous as to the exposition to mutagenic agents. Observation times were pre-op., 7 days, 2 months, 6 months; blood and urine samples were taken at each observation time, and the markers of chromosomal damage (blood) and the ion concentration (blood and urine) were measured. Results: measurements showed a 2-fold increase of Co in blood, a 10-fold increase of Co in urine, a 1.5-fold increase of Cr in the blood and a 3-fold increase of Cr in the urine at a follow-up of 6 months from the operation; the Ni blood concentration was also increased at the 7 day check-up. The study cohort did not show any modiþcation in the frequency of markers of chromosomal damage at any of the observation times. The amount of the SCEñs and Mni recorded at all the observation times did non correlate with each other nor with any of the ion levels measured in the blood and in the urine. Conclusions: the implant of prostheses with METASUL components determines an increase in the concentrations of mainly Co and Cr in blood and urine, but that this increase has no genotoxic effects on the peripheral lymphocytes in the selected group at a follow-up of 6 months.