Evaluation of a new cemented highly cross-linked all-polyethylene cup: a prospective and randomised study assessing wear and fixation characteristics using radiostereometric analysis

2021 ◽  
pp. 112070002198999
Author(s):  
Volker Otten ◽  
Daniel Wästerlund ◽  
John Lindbjörn ◽  
Carl Mertens ◽  
Sebastian Mukka ◽  
...  

Background and purpose: The aim of this prospective, randomised and controlled study was to evaluate the wear and fixation properties of a new cemented highly cross-linked all-polyethylene (HXLPE) cup in comparison with a conventional cemented ultra-high molecular weight polyethylene (ConvPE) cup using radiostereometric analysis (RSA). Patients and methods: A total of 58 patients (58 hips) with primary osteoarthritis (OA) were enrolled in a randomised controlled trial to receive either a ConvPE cup (control) or HXLPE cup (intervention) with identical geometry. The subjects were randomised in a 1:1 ratio. The primary endpoint was proximal wear measured as femoral head penetration into the cup, secondary outcomes were 3D-wear and annual proximal wear from 1 to 5 years. Cup fixation was measured as movement of the cup in relation to the acetabular bone with proximal migration being the primary outcome measure, 3D-migration and change in inclination as secondary outcomes. The patients were followed for 5 years with RSA performed postoperatively, at 3, 12, 24, and 60 months. Results: The HXLPE displayed a lower median proximal femoral head penetration compared to ConvPE, with a median difference at 2 years of –0.07 mm (95% CI, –0.10 to –0.04 mm), and –0.19 mm (95% CI, –0.27 to –0.15 mm) at 5 years. Annual proximal wear between 1 and 5 years was 0.03 mm/year for HXLPE and 0.06 mm/year for ConvPE (mean difference 0.05 mm, [95% CI, 0.03–0.07 mm]). Proximal migration, 3D migration and change in inclination was numerically slightly higher for HXLPE, albeit not statistically significant. Conclusions: Compared to ConvPE, the HXLPE cup displayed significantly lower polyethylene wear. Cup migration was not statistically significant different. ClinicalTrials.gov Identifier: NCT04322799.

2019 ◽  
Vol 101-B (7) ◽  
pp. 760-767 ◽  
Author(s):  
V. P. Galea ◽  
P. Rojanasopondist ◽  
M. Laursen ◽  
O. K. Muratoglu ◽  
H. Malchau ◽  
...  

Aims Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years. Patients and Methods A total of 89 patients were enrolled into a prospective study. All patients received a PTC shell and were randomized to receive a VEPE liner (n = 44) or a moderately crosslinked polyethylene (ModXLPE) liner (n = 45). Radiostereometric analysis (RSA) was used to measure polyethylene wear and component migration. Differences in wear were assessed while adjusting for body mass index, activity level, acetabular inclination, anteversion, and head size. Plain radiographs were assessed for radiolucency and patient-reported outcome measures (PROMs) were administered at each follow-up. Results In total, 73 patients (82%) completed the seven-year visit. Mean seven-year linear proximal penetration was -0.07 mm (sd 0.16) and 0.00 mm (sd 0.22) for the VEPE and ModXLPE cohorts, respectively (p = 0.116). PROMs (p = 0.310 to 0.807) and radiolucency incidence (p = 0.330) were not different between the polyethylene cohorts. The mean proximal shell migration rate was 0.04 mm per year (sd 0.09). At seven years, patients with radiolucency (34%) demonstrated greater migration (mean difference: 0.6 mm (sd 0.2); p < 0.001). PROMs were lower for patients with radiolucency and greater proximal migration (p = 0.009 to p = 0.045). No implants were revised for aseptic loosening. Conclusion This is the first randomized controlled trial to report seven-year RSA results for VEPE. All wear rates were below the previously reported osteolysis threshold (0.1 mm per year). PTC shells demonstrated acceptable primary stability through seven years, as indicated by low migration and lack of aseptic loosening. However, patients with acetabular radiolucency were associated with higher shell migration and lower PROM scores. Cite this article: Bone Joint J 2019;101-B:760–767.


2006 ◽  
Vol 448 ◽  
pp. 46-51 ◽  
Author(s):  
Charles R Bragdon ◽  
Jonas Thanner ◽  
Meridith E Greene ◽  
Henrik Malchau ◽  
Georgios Digas ◽  
...  

2012 ◽  
Vol 529-530 ◽  
pp. 279-284 ◽  
Author(s):  
Taishi Sato ◽  
Yasuharu Nakashima ◽  
Mio Akiyama ◽  
Takuaki Yamamoto ◽  
Taro Mawatari ◽  
...  

The purpose of this study was to examine the effects of ceramic femoral head material on the wear of annealed, crosslinked ultra-high molecular weight polyethylene (UHMWPE) (XLPE) in total hip arthroplasty compared to non-crosslinked conventional UHMWPE (CPE). XLPE was fabricated by crosslinking with 60 kGy irradiation and annealing. Femoral heads made from zirconia and alumina ceramics, and cobalt-chrome (CoCr) of 22 mm or 26 mm diameter were used. In this study, the femoral head penetration into the cup was measured digitally on radiographs of 70 hips with XLPE and 50 hips with CPE. The average follow-up periods were 6.1 and 12.7 years, respectively. The steady wear rate of XLPE was significantly lower than those of CPE (0.002 versus 0.08 mm/year, respectively). Zirconia displayed increased wear rates compared to alumina in CPE; however, there was no difference among head materials in XLPE (0.0028, 0.011 and 0.009 mm/year for zirconia, alumina and CoCr, respectively). Neither head size or implantation period impacted XLPE wear. In contrast to CPE, XLPE displayed low wear rates surpassing the effects of varying femoral head material, size, implantation period and patient demographics.


2000 ◽  
Vol 82 (8) ◽  
pp. 1102-1107 ◽  
Author(s):  
JAMES E. DOWD ◽  
CHRISTI J. SYCHTERZ ◽  
ANTHONY M. YOUNG ◽  
CHARLES A. ENGH

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