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      Early aseptic loosening of a mobile-bearing total knee replacement : A case-control study with retrieval analyses

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          Abstract

          Background and purpose

          Registry-based studies have reported an increased risk of aseptic tibial loosening for the cemented Low Contact Stress (LCS) total knee replacement compared with other cemented designs; however, the reasons for this have not been established. We made a retrieval analysis with the aim of identifying the failure mechanism.

          Patients and methods

          We collected implants, cement, tissue, blood, and radiographs from 32 failed LCS Complete cases. Damage to the tibial baseplate and insert was assessed. Exposure to wear products was quantified in 11 cases through analysis of periprosthetic tissue and blood. Implant alignment and bone cement thickness was compared with a control group of 43 non-revised cases.

          Results

          Loosening of the tibial baseplate was the reason for revision in 25 retrievals, occurring at the implant–cement interface in 16 cases. Polishing was observed on the lower surface of the baseplate and correlated to the level of cobalt, chromium, and zirconium in the blood. No evidence of abnormally high polyethylene wear was present. For each 1 mm increase in cement thickness the odds of failure due to aseptic loosening decreased by 61%. Greater varus alignment was associated with a shorter time to failure. The roughness, Ra, of a new LCS baseplate’s lower surface was 3.7 (SD 0.7) µm.

          Interpretation

          Debonding of the tibial component at the implant–cement interface was the predominant cause of tibial aseptic loosening. A thin cement layer may partly explain the poor performance. Furthermore, the comparatively low tibial surface roughness and the lack of a keeled stem may have played a role in the failures observed.

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          Most cited references33

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          The effect of alignment and BMI on failure of total knee replacement.

          The purpose of this study was to determine the effect of tibiofemoral alignment, femoral and tibial component alignment, and body-mass index (BMI) on implant survival following total knee replacement. We retrospectively reviewed 6070 knees in 3992 patients with a minimum of two years of follow-up. Each knee was classified on the basis of postoperative alignment (overall tibiofemoral alignment and alignment of the tibial and the femoral component in the coronal plane). Failures (defined as revision for any reason other than infection) were analyzed with use of Cox regression; patient covariates included overall alignment, component alignments, and preoperative BMI. Failure was most likely to occur if the orientation of the tibial component was <90° relative to the tibial axis and the orientation of the femoral component was ≥8° of valgus (failure rate, 8.7%; p < 0.0001). In contrast, failure was least likely to occur if both the tibial and the femoral component were in a neutral orientation (≥90° and <8° of valgus, respectively) (failure rate, 0.2% [nine of 4633]; p < 0.0001). "Correction" of varus or valgus malalignment of the first implanted component by placement of the second component to attain neutral tibiofemoral alignment was associated with a failure rate of 3.2% (p = 0.4922) for varus tibial malalignment and 7.8% (p = 0.0082) for valgus femoral malalignment. A higher BMI was associated with an increased failure rate. Compared with patients with a BMI of 23 to 26 kg/m2, the failure rate in patients with a BMI of ≥41 kg/m2 increased from 0.7% to 2.6% (p = 0.0046) in well-aligned knees, from 1.6% to 2.9% (p = 0.0180) in varus knees, and from 1.0% to 7.1% (p = 0.0260) in valgus knees. Attaining neutrality in all three alignments is important in maximizing total knee implant survival. Substantial "correction" of the alignment of one component in order to compensate for malalignment of the other component and thus produce a neutrally aligned total knee replacement can increase the risk of failure (p = 0.0082). The use of conventional guides to align a total knee replacement provides acceptable alignment; however, the surgeon should be aware that the patient's size, as determined by the BMI, is also a major factor in total knee replacement failure.
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            The relationship between the survival of total knee arthroplasty and postoperative coronal, sagittal and rotational alignment of knee prosthesis.

            Our study sought to address four issues: (1) the relationship between postoperative overall anatomical knee alignment and the survival of total knee prostheses; (2) the relationship between postoperative coronal alignment of the femoral and tibial component and implant survival; (3) the relationship between postoperative sagittal alignment of the femoral and tibial components and implant survival; and (4) the relationship between postoperative rotational alignment of the femoral and tibial component and implant survival. We reviewed 1,696 consecutive patients (3,048 knees). Radiographic and computed tomographic examinations were performed to determine the alignment of the femoral and tibial components. The mean duration of follow-up was 15.8 years (range, 11-18 years). Thirty (1.0%) of the 3,048 total knee arthroplasties failed for a reason other than infection and periprosthetic fracture. Risk factors for failure of the components were: overall anatomical knee alignment less than 3° valgus, coronal alignment of the femoral component less than 2.0° valgus, flexion of the femoral component greater than 3°, coronal alignment of the tibial component less than 90°, sagittal alignment of the tibial component less than 0° or greater than 7° slope, and external rotational alignment of the femoral and tibial components less than 2° In order to improve the survival rate of the knee prosthesis, we believe that a surgeon should aim to place the total knee components in the position of: overall anatomical knee alignment at an angle of 3-7.5° valgus; femoral component alignment, 2-8.0° valgus; femoral sagittal alignment, 0-3°; tibial coronal alignment, 90°; tibial sagittal alignment, 0-7°; femoral rotational alignment, 2-5° external rotation; and tibial rotational alignment, 2-5° external rotation.
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              Osteolysis around total knee arthroplasty: a review of pathogenetic mechanisms.

              Aseptic loosening and other wear-related complications are some of the most frequent late reasons for revision of total knee arthroplasty (TKA). Periprosthetic osteolysis (PPOL) pre-dates aseptic loosening in many cases, indicating the clinical significance of this pathogenic mechanism. A variety of implant-, surgery- and host-related factors have been delineated to explain the development of PPOL. These factors influence the development of PPOL because of changes in mechanical stresses within the vicinity of the prosthetic device, excessive wear of the polyethylene liner, and joint fluid pressure and flow acting on the peri-implant bone. The process of aseptic loosening is initially governed by factors such as implant/limb alignment, device fixation quality and muscle coordination/strength. Later, large numbers of wear particles detached from TKA trigger and perpetuate particle disease, as highlighted by progressive growth of inflammatory/granulomatous tissue around the joint cavity. An increased accumulation of osteoclasts at the bone-implant interface, impairment of osteoblast function, mechanical stresses and increased production of joint fluid contribute to bone resorption and subsequent loosening of the implant. In addition, hypersensitivity and adverse reactions to metal debris may contribute to aseptic TKA failure, but should be determined more precisely. Patient activity level appears to be the most important factor when the long-term development of PPOL is considered. Surgical technique, implant design and material factors are the most important preventative factors, because they influence both the generation of wear debris and excessive mechanical stresses. New generations of bearing surfaces and designs for TKA should carefully address these important issues in extensive preclinical studies. Currently, there is little evidence that PPOL can be prevented by pharmacological intervention.
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                Author and article information

                Journal
                Acta Orthop
                Acta Orthop
                IORT
                Acta Orthopaedica
                Taylor & Francis
                1745-3674
                1745-3682
                February 2018
                06 November 2017
                : 89
                : 1
                : 77-83
                Affiliations
                [1 ]Department of Clinical Medicine, University of Bergen, Norway
                [2 ]The Norwegian Arthroplasty Register, Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway
                [3 ]Julius Wolff Institute, Charité—Universitätsmedizin Berlin, Germany
                [4 ]Department of Mechanical Engineering, Imperial College London, UK
                [5 ]Orthopedic Department, Baerum Hospital, Vestre Viken Hospital Trust, Norway
                [6 ]Haugesund Hospital, Haugesund, Norway
                Author notes
                Article
                iort-89-77
                10.1080/17453674.2017.1398012
                5810837
                29105532
                a1391d53-20f8-43f1-b7d7-8424c7168580
                © The Author(s). Published by Taylor & Francis on behalf of the Nordic Orthopedic Federation.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License ( https://creativecommons.org/licenses/by-nc/3.0)

                History
                : 28 February 2017
                : 29 September 2017
                Categories
                Knee

                Orthopedics
                Orthopedics

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