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      A cementless, elastic press-fit socket with and without screws : A 2-year randomized controlled radiostereometric analysis of 37 hips

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          Abstract

          Background

          The acetabular component has remained the weakest link in hip arthroplasty regarding achievement of long-term survival. Primary fixation is a prerequisite for long-term performance. For this reason, we investigated the stability of a unique cementless titanium-coated elastic monoblock socket and the influence of supplementary screw fixation.

          Patient and methods

          During 2006–2008, we performed a randomized controlled trial on 37 patients (mean age 63 years (SD 7), 22 females) in whom we implanted a cementless press-fit socket. The socket was implanted with additional screw fixation (group A, n = 19) and without additional screw fixation (group B, n = 18). Using radiostereometric analysis with a 2-year follow-up, we determined the stability of the socket. Clinically relevant migration was defined as > 1 mm translation and > 2º rotation. Clinical scores were determined.

          Results

          The sockets without screw fixation showed a statistically significantly higher proximal translation compared to the socket with additional screw fixation. However, this higher migration was below the clinically relevant threshold. The numbers of migratory sockets were not significantly different between groups. After the 2-year follow-up, there were no clinically relevant differences between groups A and B regarding the clinical scores. 1 patient dropped out of the study. In the others, no sockets were revised.

          Interpretation

          We found that additional screw fixation is not necessary to achieve stability of the cementless press-fit elastic RM socket. We saw no postoperative benefit or clinical effect of additional screw fixation.

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          Most cited references40

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          Guidelines for standardization of radiostereometry (RSA) of implants.

          There is a need for standardization of radiostereometric (RSA) investigations to facilitate comparison of outcome reported from different research groups. In this document, 6 research centers have agreed upon standards for terminology, description and use of RSA arrangement including radiographic set-up and techniques. Consensus regarding minimum requirements for marker stability and scatter, choice of coordinate systems, and preferred way of describing prosthetic micromotion is of special interest. Some notes on data interpretation are also presented. Validation of RSA should be standardized by preparation of protocols for assessment of accuracy and precision. Practical issues related to loading of the joint by weight bearing or other conditions, follow-up intervals, length of follow-up, radiation dose, and the exclusion of patients due to technical errors are considered. Finally, we present a checklist of standardized output that should be included in any clinical RSA paper.This document will form the basis of a detailed standardization protocol under supervision of ISO and the European Standards Working Group on Joint Replacement Implants (CEN/TC 285/WG4). This protocol will facilitate inclusion of RSA in a standard protocol for implant testing before it is released for general use. Such a protocol-also including other recognized clinical outcome parameters-will reduce the risk of implanting potentially inferior prostheses on a large scale.
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            Notes on the use and interpretation of radiostereometric analysis

            ABSTRACT With increasing numbers of research groups carrying out radiostereometric analysis (RSA), it is important to reach a consensus on how the main aspects of the technique should be carried out and how the results should be presented in an appropriate and consistent way. In this collection of guidelines, we identify a number of methodological and reporting issues including: measurement error and precision, migration and migration direction data, and the use of RSA as a screening technique. Alternatives are proposed, and a statistical analysis is presented, from which a sample size of 50 is recommended for screening of newly introduced prostheses.
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              Effect of augmented cup fixation on stability, wear, and osteolysis: a 5-year follow-up of total hip arthroplasty with RSA.

              To evaluate different modes of cementless fixation of hemispherical cups, we operated on 87 hips in 81 patients using 4 different means of cup fixation. The hips were randomly assigned to fixation with press-fit technique only (PF), or with augmentation with screws (S), pegs (P), or hydroxyapatite (HA) coating. The patients were evaluated with radiostereometric analysis (RSA) for cup migration and wear, conventional radiography for osteolysis, and Harris Hip Score for clinical outcome over 5 years. The fixation of the cups did not differ between the groups, but HA showed a tendency to decrease proximal migration. HA-coated cups displayed the best interface with hardly any signs of radiolucent lines, indicating a superior sealing effect of the HA coating. Cups with screws or pegs had more radiolucent lines and osteolytic lesions than the other groups. Radiolucent lines were correlated to higher proximal migration, young age, and female gender (r2=.2). The wear rate of the ethylene oxide-sterilized polyethylene liner was high (0.2 mm/y) but did not differ between the groups. Two cups with a perioperative fracture of the acetabular rim showed large initial migration but stabilized thereafter.
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                Author and article information

                Journal
                Acta Orthop
                Acta Orthop
                ORT
                Acta Orthopaedica
                Informa Healthcare
                1745-3674
                1745-3682
                October 2012
                22 October 2012
                : 83
                : 5
                : 481-487
                Affiliations
                1Department Orthopaedic and Trauma Surgery, Orthopaedic Centre OCON , Hengelo
                2Departments of Research, Development and Education
                3Orthopaedic Surgery, Sint Maartenskliniek, Nijmegen , the Netherlands
                Author notes
                Article
                ORT_A_720116_O
                10.3109/17453674.2012.720116
                3488174
                23083434
                c4516a95-eaf5-4c29-825b-36002194e8af
                Copyright: © Nordic Orthopaedic Federation

                This is an open-access article distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the source is credited.

                History
                : 29 March 2011
                : 19 April 2012
                Categories
                Hip

                Orthopedics
                Orthopedics

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