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Aims. The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs). Methods. A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints. Results. There was no clinically relevant difference in terms of tibial component migration, insert wear, and PROMs between the HXLPE and PE groups. The mean difference in tibial component migration (maximal total point migration (MTPM)) was 0.02 mm (95% confidence interval (CI) -0.07 to 0.11), which is below the value of 0.2 mm considered to be clinically relevant. Wear after five years for HXLPE was 0.16 mm (95% CI 0.05 to 0.27), and for PE was 0.23 mm (95% CI 0.12 to 0.35). The mean difference in wear rate was 0.01 mm/year (95% CI -0.02 to 0.05) in favour of the HXLPE group. Wear is mainly present on the medial side of the insert. Conclusion. There is no clinically relevant difference in tibial component migration and insert wear for up to five years between the HXLPE conventional PE inserts. For the implant studied, the potential advantages of a HXLPE insert remain to be proven under clinical conditions at longer-term follow-up. Cite this article: Bone Joint J 2023;105-B(5):518–525


Aims. The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients. Methods. A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up. Results. There was no clinically relevant difference in terms of migration of the femoral component or PROMs between the HXLPE and PE groups. The mean difference in migration (maximum total point motion), five years postopeatively, was 0.04 mm (95% CI -0.06 to 0.16) in favour of the PE group. Conclusion. There was no clinically relevant difference in migration of the femoral component, for up to five years between the two groups. These findings will help to establish a benchmark for future studies on migration of femoral components in TKA. Cite this article: Bone Joint J 2024;106-B(8):826–833


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 801 - 810
1 Jul 2022
Krull P Steinbrück A Grimberg AW Melsheimer O Morlock M Perka C

Aims. Registry studies on modified acetabular polyethylene (PE) liner designs are limited. We investigated the influence of standard and modified PE acetabular liner designs on the revision rate for mechanical complications in primary cementless total hip arthroplasty (THA). Methods. We analyzed 151,096 primary cementless THAs from the German Arthroplasty Registry (EPRD) between November 2012 and November 2020. Cumulative incidence of revision for mechanical complications for standard and four modified PE liners (lipped, offset, angulated/offset, and angulated) was determined using competing risk analysis at one and seven years. Confounders were investigated with a Cox proportional-hazards model. Results. Median follow-up was 868 days (interquartile range 418 to 1,364). The offset liner design reduced the risk of revision (hazard ratio (HR) 0.68 (95% confidence interval (CI) 0.50 to 0.92)), while the angulated/offset liner increased the risk of revision for mechanical failure (HR 1.81 (95% CI 1.38 to 2.36)). The cumulative incidence of revision was lowest for the offset liner at one and seven years (1.0% (95% CI 0.7 to 1.3) and 1.8% (95% CI 1.0 to 3.0)). No difference was found between standard, lipped, and angulated liner designs. Higher age at index primary THA and an Elixhauser Comorbidity Index greater than 0 increased the revision risk in the first year after surgery. Implantation of a higher proportion of a single design of liner in a hospital reduced revision risk slightly but significantly (p = 0.001). Conclusion. The use of standard acetabular component liners remains a good choice in primary uncemented THA, as most modified liner designs were not associated with a reduced risk of revision for mechanical failure. Offset liner designs were found to be beneficial and angulated/offset liner designs were associated with higher risks of revision. Cite this article: Bone Joint J 2022;104-B(7):801–810


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1791 - 1801
1 Dec 2021
Bhalekar RM Nargol ME Shyam N Nargol AVF Wells SR Collier R Pabbruwe M Joyce TJ Langton DJ

Aims. The aim of this study was to investigate whether wear and backside deformation of polyethylene (PE) tibial inserts may influence the cement cover of tibial trays of explanted total knee arthroplasties (TKAs). Methods. At our retrieval centre, we measured changes in the wear and deformation of PE inserts using coordinate measuring machines and light microscopy. The amount of cement cover on the backside of tibial trays was quantified as a percentage of the total surface. The study involved data from the explanted fixed-bearing components of four widely used contemporary designs of TKA (Attune, NexGen, Press Fit Condylar (PFC), and Triathlon), revised for any indication, and we compared them with components that used previous generations of PE. Regression modelling was used to identify variables related to the amount of cement cover on the retrieved trays. Results. A total of 114 explanted fixed-bearing TKAs were examined. This included 76 used with contemporary PE inserts which were compared with 15 used with older generation PEs. The Attune and NexGen (central locking) trays were found to have significantly less cement cover than Triathlon and PFC trays (peripheral locking group) (p = 0.001). The median planicity values of the PE inserts used with central locking trays were significantly greater than of those with peripheral locking inserts (205 vs 85 microns; p < 0.001). Attune and NexGen inserts had a characteristic pattern of backside deformation, with the outer edges of the PE deviating inferiorly, leaving the PE margins as the primary areas of articulation. Conclusion. Explanted TKAs with central locking mechanisms were significantly more likely to debond from the cement mantle. The PE inserts of these designs showed characteristic patterns of deformation, which appeared to relate to the manufacturing process and may be exacerbated in vivo. This pattern of deformation was associated with PE wear occurring at the outer edges of the articulation, potentially increasing the frictional torque generated at this interface. Cite this article: Bone Joint J 2021;103-B(12):1791–1801


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1695 - 1701
1 Nov 2021
Currier JH Currier BH Abdel MP Berry DJ Titus AJ Van Citters DW

Aims. Wear of the polyethylene (PE) tibial insert of total knee arthroplasty (TKA) increases the risk of revision surgery with a significant cost burden on the healthcare system. This study quantifies wear performance of tibial inserts in a large and diverse series of retrieved TKAs to evaluate the effect of factors related to the patient, knee design, and bearing material on tibial insert wear performance. Methods. An institutional review board-approved retrieval archive was surveyed for modular PE tibial inserts over a range of in vivo duration (mean 58 months (0 to 290)). Five knee designs, totalling 1,585 devices, were studied. Insert wear was estimated from measured thickness change using a previously published method. Linear regression statistical analyses were used to test association of 12 patient and implant design variables with calculated wear rate. Results. Five patient-specific variables and seven implant-specific variables were evaluated for significant association with lower insert wear rate. Six were significant when controlling for other factors: greater patient age, female sex, shorter duration in vivo, polished tray, highly cross-linked PE (HXLPE), and constrained knee design. Conclusion. This study confirmed that knee wear rate increased with duration in vivo. Older patients and females had significantly lower wear rates. Polished modular tibial tray surfaces, HXLPE, and constrained TKA designs were device design factors associated with significantly reduced wear rate. Cite this article: Bone Joint J 2021;103-B(11):1695–1701


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1774 - 1782
1 Dec 2021
Divecha HM O'Neill TW Lunt M Board TN

Aims. The aim of this study was to determine if uncemented acetabular polyethylene (PE) liner geometry, and lip size, influenced the risk of revision for instability or loosening. Methods. A total of 202,511 primary total hip arthroplasties (THAs) with uncemented acetabular components were identified from the National Joint Registry (NJR) dataset between 2003 and 2017. The effect of liner geometry on the risk of revision for instability or loosening was investigated using competing risk regression analyses adjusting for age, sex, American Society of Anesthesiologists grade, indication, side, institution type, surgeon grade, surgical approach, head size, and polyethylene crosslinking. Stratified analyses by surgical approach were performed, including pairwise comparisons of liner geometries. Results. The distribution of liner geometries were neutral (39.4%; 79,822), 10° (34.5%; 69,894), 15° (21.6%; 43,722), offset reorientating (2.8%; 5705), offset neutral (0.9%; 1,767), and 20° (0.8%; 1,601). There were 690 (0.34%) revisions for instability. Compared to neutral liners, the adjusted subhazard ratios of revision for instability were: 10°, 0.64 (p < 0.001); 15°, 0.48 (p < 0.001); and offset reorientating, 1.6 (p = 0.010). No association was found with other geometries. 10° and 15° liners had a time-dependent lower risk of revision for instability within the first 1.2 years. In posterior approaches, 10° and 15° liners had a lower risk of revision for instability, with no significant difference between them. The protective effect of lipped over neutral liners was not observed in laterally approached THAs. There were 604 (0.3%) revisions for loosening, but no association between liner geometry and revision for loosening was found. Conclusion. This registry-based study confirms a lower risk of revision for instability in posterior approach THAs with 10° or 15° lipped liners compared to neutral liners, but no significant difference between these lip sizes. A higher revision risk is seen with offset reorientating liners. The benefit of lipped geometries against revision for instability was not seen in laterally approached THAs. Liner geometry does not seem to influence the risk of revision for loosening. Cite this article: Bone Joint J 2021;103-B(12):1774–1782


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1669 - 1677
1 Nov 2021
Divecha HM O'Neill TW Lunt M Board TN

Aims

To determine if primary cemented acetabular component geometry (long posterior wall (LPW), hooded, or offset reorientating) influences the risk of revision total hip arthroplasty (THA) for instability or loosening.

Methods

The National Joint Registry (NJR) dataset was analyzed for primary THAs performed between 2003 and 2017. A cohort of 224,874 cemented acetabular components were included. The effect of acetabular component geometry on the risk of revision for instability or for loosening was investigated using log-binomial regression adjusting for age, sex, American Society of Anesthesiologists grade, indication, side, institution type, operating surgeon grade, surgical approach, polyethylene crosslinking, and prosthetic head size. A competing risk survival analysis was performed with the competing risks being revision for other indications or death.


The Bone & Joint Journal
Vol. 104-B, Issue 3 | Pages 376 - 385
1 Mar 2022
Gramlich Y Hofmann L Kress S Ruckes C Kemmerer M Klug A Hoffmann R Kremer M

Aims. This study compared the cobalt and chromium serum ion concentration of patients treated with two different metal-on-metal (MoM) hinged total knee arthroplasty (TKA) systems, as well as a titanium nitride (TiN)-coated variant. Methods. A total of 63 patients (65 implants) were treated using either a MoM-coated (n = 29) or TiN-coated (n = 7) hinged TKA (GenuX mobile bearing, MUTARS; Implantcast, Germany) versus the BPKS (Brehm, Germany) hinged TKA (n = 27), in which the weight placed on the MoM hinge is diffused through a polyethylene (PE) inlay, reducing the direct load on the MoM hinge. Serum cobalt and chromium ion concentrations were assessed after minimum follow-up of 12 months, as well as functional outcome and quality of life. Results. No differences in mean age (69 years, 40 to 86), mean age adapted Charlson Comorbidity Index (3.1 (SD 1.4)), mean BMI (29.2 kg/m. 2. (SD 5.8)), or number of other implants were observed between groups. Significant improvements in outcome scores and pain levels were achieved for all groups, and there was no difference in quality of life (12-Item Short-Form Health Survey questionnaire (SF-12)). Mean cobalt and chromium ion levels were significantly higher for the GenuX versus the BPKS hinged TKA (GenuX vs BPKS: cobalt: 16.3 vs 9.4 µg/l; chromium: 9.5 vs 5.2 µg/l). The TiN-coated implants did not appear to confer improvement in the metal ion levels. Metal ion concentrations above 7 µg/l were detected in 81%(29/36) of GenuX patients versus 41% (11/27) in the BPKS group. No GenuX patients had normal levels under 2 µg/l, versus 22% of BPKS patients. No significant reduction in outcome scores was observed regardless of the metal ion levels, whereas higher work-related activity was correlated with higher chromium concentrations. Conclusion. Hinged TKA, using MoM hinges, resulted in critically high cobalt and chromium ion concentrations. The BPKS hinged TKA showed significantly lower metal ion concentrations compared with the GenuX TKA. No benefits were observed using TiN coating. The different weightbearing mechanics might influence the wear of the component materials. Higher workloads and physical activity could influence chromium levels. Cite this article: Bone Joint J 2022;104-B(3):376–385


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1192 - 1198
1 Oct 2019
Sköldenberg OG Rysinska AD Chammout G Salemyr M Mukka SS Bodén H Eisler T

Aims. Radiostereometric analysis (RSA) studies of vitamin E-doped, highly crosslinked polyethylene (VEPE) liners show low head penetration rates in cementless acetabular components. There is, however, currently no data on cemented VEPE acetabular components in total hip arthroplasty (THA). The aim of this study was to evaluate the safety of a new cemented VEPE component, compared with a conventional polyethylene (PE) component regarding migration, head penetration, and clinical results. Patients and Methods. We enrolled 42 patients (21 male, 21 female) with osteoarthritis and a mean age of 67 years (. sd. 5), in a double-blinded, noninferiority, randomized controlled trial. The subjects were randomized in a 1:1 ratio to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or VEPE, with identical geometry. The primary endpoint was proximal implant migration of the component at two years postoperatively measured with RSA. Secondary endpoints included total migration of the component, penetration of the femoral head into the component, and patient-reported outcome measurements. Results. In total, 19 control implants and 18 implants in the VEPE group were analyzed for the primary endpoint. We found a continuous proximal migration of the component in the VEPE group that was significantly higher with a difference at two years of a mean 0.21 mm (95% confidence interval (CI) 0.05 to 0.37; p = 0.013). The total migration was also significantly higher in the VEPE group, but femoral head penetration was lower. We found no difference in clinical outcomes between the groups. Conclusion. At two years, this cemented VEPE component, although having a low head penetration and excellent clinical results, failed to meet noninferiority compared with the conventional implant by a proximal migration above the proposed safety threshold of RSA. The early proximal migration pattern of the VEPE component is a reason for continued monitoring, although a specific threshold for proximal migration and risk for later failure cannot be defined and needs further study. Cite this article: Bone Joint J 2019;101-B:1192–1198


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1348 - 1355
1 Nov 2019
Gascoyne T Parashin S Teeter M Bohm E Laende E Dunbar M Turgeon T

Aims. A retrospective study was conducted to measure short-term in vivo linear and volumetric wear of polyethylene (PE) inserts in 101 total knee arthroplasty (TKA) patients using model-based radiostereometric analysis (MBRSA). Patients and Methods. Nonweightbearing supine RSA exams were performed postoperatively and at six, 12, and 24 months. Weightbearing standing RSA exams were performed on select patients at 12 and 24 months. Wear was measured both linearly (joint space) and volumetrically (digital model overlap) at each available follow-up. Precision of both methods was assessed by comparing double RSA exams. Patient age, sex, body mass index, and Oxford Knee Scores were analyzed for any association with PE wear. Results. Linear wear occurred at 0.015 mm/year (supine) and 0.220 mm/year (standing). Volumetric wear occurred at 10.3 mm. 3. /year (supine) and 39.3 mm. 3. /year (standing). Wear occurred primarily on the medial side of the joint. Weightbearing imaging greatly improved the reliability of measurement. Clinical precision of volumetric wear was 34 mm. 3. No significant associations were found between patient demographics or function scores and measured wear. Conclusion. In vivo volumetric wear of TKAs can be assessed at short-term follow-up using MBRSA. Cite this article: Bone Joint J 2019;101-B:1348–1355


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 996 - 1002
1 Aug 2017
Brown TS Van Citters DW Berry DJ Abdel MP

Advances in polyethylene (PE) in total hip arthroplasty have led to interest and increased use of highly crosslinked PE (HXLPE) in total knee arthroplasty (TKA). Biomechanical data suggest improved wear characteristics for HXLPE inserts over conventional PE in TKA. Short-term results from registry data and few clinical trials are promising. Our aim is to present a review of the history of HXLPEs, the use of HXLPE inserts in TKA, concerns regarding potential mechanical complications, and a thorough review of the available biomechanical and clinical data. Cite this article: Bone Joint J 2017;99-B:996–1002


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 6 | Pages 915 - 919
1 Aug 2002
Bechtold JE Kubic V Søballe K

We have investigated whether the presence of polyethylene (PE) alone is sufficient to cause an aggressive periprosthetic tissue response, or whether certain mechanical interface conditions can allow bone to grow while in the presence of PE. An experimental implant was loaded in the presence and absence of particulate PE under stable and unstable conditions. Bone with a thin, discontinuous fibrous membrane formed in both groups of stable implants, either in the presence or absence of PE. By contrast, a continuous fibrous membrane consistently formed in both groups of unstable implants. The membrane consisted of loose fibrous connective tissue when PE was absent, and dense connective tissue with macrophages and a synovial lining when PE was present. In this model, if the interface was stable, the presence of PE was not sufficient to prevent the formation of bone or to produce a phagocytic tissue response. Only when the interface was unstable did a fibrous membrane form, and only then in the presence of PE


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 4 | Pages 593 - 597
1 May 2001
Kamikawa K Harada Y Nagata K Moriya H

Sterilisation by gamma irradiation in the presence of air causes free radicals generated in polyethylene (PE) to react with oxygen, which could lead to loss of physical properties and reduction in fatigue strength. Tissue retrieved from failed total hip replacements often has large quantities of particulate PE and most particles associated with peri-implant osteolysis are oxidised. Consequently, an understanding of the cellular responses of oxidised PE particles may lead to clarification of the pathogenesis of osteolysis and aseptic loosening. We have used the agarose system to demonstrate the differential effects of oxidised and non-oxidised PE particles on the release of proinflammatory products such as interleukin-1β (IL-1β), IL-6, and tumour necrosis factor-α (TNF-α) from monocytes/ macrophages (M/M). Oxidised PE particles were shown to stimulate human M/M to phagocytose and to release cytokines. Oxidation may alter the surface chemistry of the particles and enhance the response to specific membrane receptors on macrophages, such as scavenger-type receptors


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 3 | Pages 441 - 447
1 Apr 2001
Rahbek O Overgaard S Lind M Bendix K Bünger C Søballe K

We have studied the beneficial effects of a hydroxyapatite (HA) coating on the prevention of the migration of wear debris along the implant-bone interface. We implanted a loaded HA-coated implant and a non-coated grit-blasted titanium alloy (Ti) implant in each distal femoral condyle of eight Labrador dogs. The test implant was surrounded by a gap communicating with the joint space and allowing access of joint fluid to the implant-bone interface. We injected polyethylene (PE) particles into the right knee three weeks after surgery and repeated this weekly for the following five weeks. The left knee received sham injections. The animals were killed eight weeks after surgery. Specimens from the implant-bone interface were examined under plain and polarised light. Only a few particles were found around HA-coated implants, but around Ti implants there was a large amount of particles. HA-coated implants had approximately 35% bone ingrowth, whereas Ti implants had virtually no bone ingrowth and were surrounded by a fibrous membrane. Our findings suggest that HA coating of implants is able to inhibit peri-implant migration of PE particles by creating a seal of tightly-bonded bone on the surface of the implant


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1126 - 1131
1 Oct 2022
Hannon CP Kruckeberg BM Pagnano MW Berry DJ Hanssen AD Abdel MP

Aims

We have previously reported the mid-term outcomes of revision total knee arthroplasty (TKA) for flexion instability. At a mean of four years, there were no re-revisions for instability. The aim of this study was to report the implant survivorship and clinical and radiological outcomes of the same cohort of of patients at a mean follow-up of ten years.

Methods

The original publication included 60 revision TKAs in 60 patients which were undertaken between 2000 and 2010. The mean age of the patients at the time of revision TKA was 65 years, and 33 (55%) were female. Since that time, 21 patients died, leaving 39 patients (65%) available for analysis. The cumulative incidence of any re-revision with death as a competing risk was calculated. Knee Society Scores (KSSs) were also recorded, and updated radiographs were reviewed.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 635 - 640
1 Jun 2023
Karczewski D Siljander MP Larson DR Taunton MJ Lewallen DG Abdel MP

Aims

Knowledge on total knee arthroplasties (TKAs) in patients with a history of poliomyelitis is limited. This study compared implant survivorship and clinical outcomes among affected and unaffected limbs in patients with sequelae of poliomyelitis undergoing TKAs.

Methods

A retrospective review of our total joint registry identified 94 patients with post-polio syndrome undergoing 116 primary TKAs between January 2000 and December 2019. The mean age was 70 years (33 to 86) with 56% males (n = 65) and a mean BMI of 31 kg/m2 (18 to 49). Rotating hinge TKAs were used in 14 of 63 affected limbs (22%), but not in any of the 53 unaffected limbs. Kaplan-Meier survivorship analyses were completed. The mean follow-up was eight years (2 to 19).


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 475 - 481
1 May 2024
Lee M Lee G Lee K

Aims

The purpose of this study was to assess the success rate and functional outcomes of bone grafting for periprosthetic bone cysts following total ankle arthroplasty (TAA). Additionally, we evaluated the rate of graft incorporation and identified associated predisposing factors using CT scan.

Methods

We reviewed a total of 37 ankles (34 patients) that had undergone bone grafting for periprosthetic bone cysts. A CT scan was performed one year after bone grafting to check the status of graft incorporation. For accurate analysis of cyst volumes and their postoperative changes, 3D-reconstructed CT scan processed with 3D software was used. For functional outcomes, variables such as the Ankle Osteoarthritis Scale score and the visual analogue scale for pain were measured.


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 29 - 34
1 Jan 2023
Fransen BL Bengoa FJ Neufeld ME Sheridan GA Garbuz DS Howard LC

Aims

Several short- and mid-term studies have shown minimal liner wear of highly cross-linked polyethylene (HXLPE) in total hip arthroplasty (THA), but the safety of using thinner HXLPE liners to maximize femoral head size remains uncertain. The objective of this study was to analyze clinical survival and radiological wear rates of patients with HXLPE liners, a 36 mm femoral head, and a small acetabular component with a minimum of ten years’ follow-up.

Methods

We retrospectively identified 55 patients who underwent primary THA performed at a single centre, using HXLPE liners with 36 mm cobalt-chrome heads in acetabular components with an outer diameter of 52 mm or smaller. Patient demographic details, implant details, death, and all-cause revisions were recorded. Cox regression and Kaplan-Meier survival was used to determine all-cause and liner-specific revision. Of these 55 patients, 22 had a minimum radiological follow-up of seven years and were assessed radiologically for linear and volumetric wear.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 136 - 143
1 Feb 2024
van der Lelij TJN Marang-van de Mheen PJ Kaptein BL Koster LA Ljung P Nelissen RGHH Toksvig-Larsen S

Aims

The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface.

Methods

Overall, 87 patients undergoing total hip arthroplasty (THA) were randomized to either a Trident II HA or Trident HA shell, each cementless with clusterholes and HA-coating. All components were used in combination with a cemented Exeter V40 femoral stem. Implant migration was measured using radiostereometric analysis (RSA), with radiographs taken within two days of surgery (baseline), and at three, 12, and 24 months postoperatively. Proximal acetabular component migration was the primary outcome measure. Clinical scores and patient-reported outcome measures (PROMs) were collected at each follow-up.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1052 - 1059
1 Oct 2023
El-Sahoury JAN Kjærgaard K Ovesen O Hofbauer C Overgaard S Ding M

Aims

The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA).

Methods

A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.