Effect of bioactive coating of the tibial component on migration pattern in uncemented total knee arthroplasty: a randomized RSA study of 14 knees presented according to new RSA-guidelines.
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SUBMITTER: Therbo M
PROVIDER: S-EPMC2656955 | biostudies-other | 2008 Jun
REPOSITORIES: biostudies-other
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Project description:Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.
| S-EPMC6066768 | biostudies-literature
Project description:BackgroundAseptic loosening is one of the major reasons for late revision in total knee arthroplasty (TKA). The risk of aseptic loosening can be detected using radiostereometric analysis (RSA), whereby micromovements (migration) can be measured, and thus RSA is recommended in the phased introduction of orthopedic implants. Decrease in bone mineral density (BMD), as measured by dual-energy x ray absorptiometry (DXA), is related to the breaking strength of the bone, which is measured concurrently by RSA. The aim of the study was to evaluate bone remodeling and implant migration with cemented asymmetrical tibial and uncemented femoral components after TKA with a follow up period of 2 years.MethodsThis was a prospective longitudinal cohort study of 29 patients (number of female/male patients 17/12, mean age 65.2 years), received a hybrid Persona® TKA (Zimmer Biomet, Warsaw, IN, USA) consisting of a cemented tibial, an all-polyethylene patella, and uncemented trabecular metal femoral components. Follow up: preoperative, 1 week, and 3, 6, 12 and 24 months after surgery, and double examinations for RSA and DXA were performed at 12 months. RSA results were presented as maximal total point of motion (MTPM) and segmental motion (translation and rotation), and DXA results were presented as changes in BMD in different regions of interest (ROI).ResultsMTPM at 3, 6, 12, and 24 months was 0.65 mm, 0.84 mm, 0.92 mm, and 0.96 mm for the femoral component and 0.54 mm, 0.60 mm, 0.64 mm, and 0.68 mm, respectively, for the tibial component. The highest MTPM occurred within the first 3 months. Afterwards most of the curves flattened and stabilized. Between 12 and 24 months after surgery, 16% of femoral components had migrated by more than 0.10 mm and 15% of tibial components had migrated by more than 0.2 mm. Percentage change in BMD in each ROI for distal femur was as follows: ROI I 26.7%, ROI II 9.2% and ROI III 3.3%. BMD and at the proximal tibia: ROI I 8.2%, ROI II 8.6% and ROI III 7.0% after 2 years compared with 1 week postoperative results. There was no significant correlation between maximal percentwise change in BMD and MTPM after 2 years.ConclusionMigration patterns and changes in BMD related to femoral components after TKA in our study correspond well with previous studies; we observed marginally greater migration with the tibial component.
| S-EPMC8369662 | biostudies-literature
Project description:Background and purposeIt is still being debated whether HA coating of uncemented stems used in total hip arthroplasty (THA) improves implant survival. We therefore investigated different uncemented stem brands, with and without HA coating, regarding early and long-term survival.Patients and methodsWe identified 152,410 THA procedures using uncemented stems that were performed between 1995 and 2011 and registered in the Nordic Arthroplasty Register Association (NARA) database. We excluded 19,446 procedures that used stem brands less than 500 times in each country, procedures performed due to diagnoses other than osteoarthritis or pediatric hip disease, and procedures with missing information on the type of coating. 22 stem brands remained (which were used in 116,069 procedures) for analysis of revision of any component. 79,192 procedures from Denmark, Norway, and Sweden were analyzed for the endpoint stem revision. Unadjusted survival rates were calculated according to Kaplan-Meier, and Cox proportional hazards models were fitted in order to calculate hazard ratios (HRs) for the risk of revision with 95% confidence intervals (CIs).ResultsUnadjusted 10-year survival with the endpoint revision of any component for any reason was 92.1% (CI: 91.8-92.4). Unadjusted 10-year survival with the endpoint stem revision due to aseptic loosening varied between the stem brands investigated and ranged from 96.7% (CI: 94.4-99.0) to 99.9% (CI: 99.6-100). Of the stem brands with the best survival, stems with and without HA coating were found. The presence of HA coating was not associated with statistically significant effects on the adjusted risk of stem revision due to aseptic loosening, with an HR of 0.8 (CI: 0.5-1.3; p = 0.4). The adjusted risk of revision due to infection was similar in the groups of THAs using HA-coated and non-HA-coated stems, with an HR of 0.9 (CI: 0.8-1.1; p = 0.6) for the presence of HA coating. The commonly used Bimetric stem (n = 25,329) was available both with and without HA coating, and the adjusted risk of stem revision due to aseptic loosening was similar for the 2 variants, with an HR of 0.9 (CI: 0.5-1.4; p = 0.5) for the HA-coated Bimetric stem.InterpretationUncemented HA-coated stems had similar results to those of uncemented stems with porous coating or rough sand-blasted stems. The use of HA coating on stems available both with and without this surface treatment had no clinically relevant effect on their outcome, and we thus question whether HA coating adds any value to well-functioning stem designs.
| S-EPMC4366665 | biostudies-literature
Project description:Background and purpose - Thresholds of implant migration for predicting long-term successful fixation of tibial components in total knee arthroplasty have not separated cemented and uncemented fixation. We compared implant migration of cemented and uncemented components at 1 year and as the change in migration from 1 to 2 years. Patients and methods - Implant migration of 360 tibial components measured using radiostereometric analysis was compared at 1 year and as the change in migration from 1 to 2 years in 222 cemented components (3 implant designs) and 138 uncemented components (5 implant designs). Results - 1-year maximum total point motion was lower for the cemented tibial components compared with the uncemented components (median = 0.31 mm [0.03-2.98] versus 0.63 mm [0.11-5.19] respectively, p < 0.001, mixed model). The change in migration from 1 to 2 years, however, was equivalent for cemented and uncemented components (mean [SD] 0.06 mm [0.19] and 0.07 mm [0.27] mm respectively, p = 0.6, mixed model). Interpretation - These findings suggest that current thresholds of acceptable migration at 1 year may be better optimized by considering cemented and uncemented tibial components separately as higher early migration of uncemented components was not associated with decreased stability from 1 to 2 years.
| S-EPMC6461081 | biostudies-literature
Project description:BACKGROUND:Inferior placement of a femoral stem is predictive for early loosening and failure, but does restoration of the original hip anatomy benefit the function and survival of a total hip replacement? METHODS:Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem were randomized for either standard or modular stems. We used 50 ABG II stems with modular necks and 25 standard stems (control group). We measured the symmetry in hip anatomy between healthy and operated side. The anatomical restoration variables were anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota. We performed measurements using a CT-based 3D templating and measuring software. Migratory behavior of the stems was then measured postoperatively with repeated radiostereometry (RSA) examinations over 5?years. RESULTS:Both stem types showed an early (within 3?months) good stabilization after an initial slight rotation into retroversion and subsidence. There were no significant differences in RSA migration between modular and standard stems. Postoperative anteversion and FO/AO quota had no impact on stem migration. The standard stem tended to result in insufficient global offset (GO), whereas the modular stem did not. CONCLUSIONS:The modular stem gave good symmetrical anatomical restoration and, like the standard version, a benign migratory behavior. Anteversion, GO, and FO/AO quota had no significant impact on stem migration. It therefore seems to be of no importance whether we choose a modular or a standard stem with regard to postoperative stem migration for this stem type. We overestimated the effect anatomical parameters have on stem movement; hence, we believe the study to be underpowered. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01512550. Registered 19 January 2012-retrospectively registered.
| S-EPMC7301498 | biostudies-literature
Project description:Background and purpose - The uncemented Symax hip stem has shown early proximal ingrowth as result of the BONIT-hydroxyapatite (HA) coating and the distal DOTIZE surface treatment. We evaluated 2-year postoperative radiostereometric analysis (RSA) migration of the Symax hip stem in THA patients. We also investigated the correlation between migration at 4 weeks and clinical outcomes after 2 years.Patients and methods - Patients in a 2-year clinical follow-up single-centre RSA randomized controlled trial were randomized to 2 different cup designs. All 45 patients received a Symax hip stem. RSA migration patterns of the Symax hip stem is presented here as a single cohort. RSA examinations were performed postoperatively, but before weight-bearing, and subsequently after 1, 3, 6, 12, and 24 months. Clinical outcomes and radiographic evaluations were assessed 3, 6, 12, and 24 months postoperatively.Results - During the first 4 weeks, the Symax hip stem subsided, rotated into retroversion, and translated posteriorly, after which the migration ceased and the prosthesis stabilized. All clinical outcomes improved from preoperatively to 2 years. There was no clinically or statistically significant correlation between subsidence and retroversion at 4 weeks and clinical outcomes after 2 years.Interpretation - RSA evaluation of the uncemented Symax hip stem confirms that the design principles and coating properties lead to early stabilization of the stem, as early as 4 weeks postoperatively. There was no correlation between subsidence and retroversion at 4 weeks and clinical outcomes after 2 years. Based on the predictive potential of the RSA technique, we anticipate excellent long-term survival of this hip stem.
| S-EPMC7144261 | biostudies-literature
Project description:Background and purpose - Differences in stress distribution in a mobile-bearing and fixed-bearing unicompartmental knee arthroplasty (UKA) design might lead to a difference in fixation of the tibial component. We compared tibial component migration of a mobile-bearing (MB) UKA and a fixed-bearing (FB) UKA using radiostereometric analysis.Patients and methods - In a randomized, patient-blinded clinical trial 62 patients received either the MB Oxford UKA or the FB Sigma UKA. The patients were followed for 24 months with radiostereometric analysis. Clinical outcome was assessed with Oxford Knee Score (OKS), RAND-36 and leg extension power.Results - Migration of the tibial components was similar between groups throughout follow-up. At 12 months, MTPM of the tibial component was 0.44?mm (95% CI 0.34-0.55) for the MB group and 0.40?mm (CI 0.31-0.50) for the FB group. Between 12 and 24 months, the tibial components migrated with a median MTPM increase of 0.03?mm (CI -0.02 to 0.08) in the MB group and 0.03?mm (CI -0.02 to 0.07) in the FB group. Continuous migration of the tibial component was found for 1?MB UKA and 2 FB UKAs. Both groups showed similar and clinically relevant improvement in clinical outcome.Interpretation - MB and FB tibial components had similar good fixation and clinical improvement until 2 years. Based on this study, a low 5- to 10-year revision rate can be expected for both implants.
| S-EPMC6844442 | biostudies-literature
Project description:BackgroundIt is unclear whether there is a clinical benefit to adding hydroxyapatite (HA) coatings to total knee implants, especially with the tibial component, where failure of the implant more often occurs. A systematic review of the literature was undertaken to identify all prospective randomized trials for determining whether the overall clinical results (as a function of durability, function, and adverse events) favored HA-coated tibial components.MethodsA comprehensive literature search was performed for the years 1990 to September 16, 2010. We restricted our search to randomized controlled trials involving participants receiving either an HA-coated tibia or other forms of tibial fixation. The primary outcome measures evaluated were durability, function, and acute adverse events.ResultsData from 926 evaluable primary total knee implants in 14 studies were analyzed. Using an RSA definition for durability, HA-coated tibial components (porous or press-fit) without screw fixation were less likely to be unstable at 2 years than porous and cemented metal-backed tibial components (RR = 0.58, 95% CI: 0.34-0.98; p = 0.04, I(2) = 39%, M-H random effects model). There was no significant difference in durability, as measured from revision and evaluated at 2 and 8-10 years, between groups. Also, functional status using different validated measures showed no significant difference at 2 and 5 years, no matter what measure was used. Lastly, there was no significant difference in adverse events. Limitations included small numbers of evaluable patients (≤ 50) in 7 of the 14 trials identified, and a lack of "hard" evidence of durability with need for replacement (i.e. frank failure, pain, or loss of functionality).InterpretationIn patients > 65 years of age, an HA-coated tibial implant may provide better durability than other forms of tibial fixation. Larger trials should be undertaken comparing the long-term durability, function, and adverse events of HA-coated implants with those of other porous-coated tibial implants in younger, more active OA patients.
| S-EPMC3237036 | biostudies-literature
Project description:BackgroundCemented and uncemented fixation are the primary methods of tibial prosthesis fixation in total knee arthroplasty. However, the optimal fixation method remains controversial. This article explored whether uncemented tibial fixation has better clinical and radiological outcomes, fewer complications, and revision rates compared to cemented tibial fixation.MethodsWe searched the PubMed, Embase, Cochrane Library, and Web of Science databases up to September 2022 to identify randomized controlled trials (RCTs) that compared uncemented total knee arthroplasty (TKA) and cemented TKA. The outcome assessment consisted of clinical and radiological outcomes, complications (aseptic loosening, infection, and thrombosis), and revision rate. Subgroup analysis was used to explore the effects of different fixation methods on knee scores in younger patients.ResultsNine RCTs were finally analyzed with 686 uncemented knees and 678 cemented knees. The mean follow-up time was 12.6 years. The pooled data revealed significant advantages of uncemented fixations over cemented fixations in terms of the Knee Society Knee Score (KSKS) (p = 0.01) and the Knee Society Score-Pain (KSS-Pain) (p = 0.02). Cemented fixations showed significant advantages in maximum total point motion (MTPM) (p < 0.0001). There was no significant difference between uncemented fixation and cemented fixation regarding functional outcomes, range of motion, complications, and revision rates. When comparing among young people (<65 years), the differences in KSKS became statistically insignificant. No significant difference was shown in aseptic loosening and the revision rate among young patients.ConclusionsThe current evidence shows better knee score, less pain, comparable complications and revision rates for uncemented tibial prosthesis fixation, compared to cemented, in cruciate-retaining total knee arthroplasty.
| S-EPMC10003978 | biostudies-literature
Project description:Background and purpose - Backside wear of the polyethylene insert in total knee arthroplasty (TKA) can produce clinically significant levels of polyethylene debris, which can lead to loosening of the tibial component. Loosening due to polyethylene debris could theoretically be reduced in tibial components of monoblock polyethylene design, as there is no backside wear. We investigated the effect of 2 different tibial component designs, monoblock and modular polyethylene, on migration of the tibial component in uncemented TKA. Patients and methods - In this randomized study, 53 patients (mean age 61 years), 32 in the monoblock group and 33 in the modular group, were followed for 2 years. Radiostereometric analysis (RSA) was done postoperatively after weight bearing and after 3, 6, 12, and 24 months. The primary endpoint of the study was comparison of the tibial component migration (expressed as maximum total point motion (MTPM)) of the 2 different implant designs. Results - We did not find any statistically significant difference in MTPM between the groups at 3 months (p = 0.2) or at 6 months (p = 0.1), but at 12 and 24 months of follow-up there was a significant difference in MTPM of 0.36 mm (p = 0.02) and 0.42 mm (p = 0.02) between groups, with the highest amount of migration (1.0 mm) in the modular group. The difference in continuous migration (MTPM from 12 and 24 months) between the groups was 0.096 mm (p = 0.5), and when comparing MTPM from 3-24 months, the difference between the groups was 0.23 mm (p = 0.07). Interpretation - In both study groups, we found the early migration pattern expected, with a relatively high initial amount of migration from operation to 3 months of follow-up, followed by stabilization of the implant with little migration thereafter. However, the modular implants had a statistically significantly higher degree of migration compared to the monoblock. We believe that the greater stiffness of the modular implants was the main reason for the difference in migration, but an initial creep in the polyethylene metal-back locking mechanism of the modular group could also be a possible explanation for the observed difference in migration between the 2 study groups.
| S-EPMC5119444 | biostudies-literature