Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Otten V

PROVIDER: S-EPMC9726741 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Otten Volker V Wästerlund Daniel D Lindbjörn John J Mertens Carl C Mukka Sebastian S Crnalic Sead S Nilsson Kjell G KG

Hip international : the journal of clinical and experimental research on hip pathology and therapy 20210210 6

<h4>Background and purpose</h4>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).<h4>Patients and methods</h4>A total of 58 patients (58 hips) with primary osteoarthritis (OA) were enrolled in a randomised controlled trial to receive eit ...[more]

PMID: 33566703

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Project description:BackgroundThe newest generation of cementless titanium-coated, isoelastic monoblock cup with vitamin E-blended highly cross-linked polyethylene (HXLPE) was introduced to the market in 2009. The aim of the present study was to obtain mid-term follow-up data including migration and wear analyses.MethodsThis prospective study investigated 101 primary total hip arthroplasty (THA) cases in 96 patients treated at a single institution. Patients were allowed full weight-bearing on the first day postoperatively. Harris hip score (HHS) and pain and satisfication on a visual analogue scale (VAS) were assessed at a mean follow-up of 79.0 months. Migration and wear were assessed using Einzel-Bild-Roentgen-Analyse (EBRA) software. Radiological acetabular bone alterations and complications were documented.ResultsAt mid-term follow-up (mean 79.0 months, range: 51.8-101.7), 81 cases with complete clinical and radiological data were analyzed. Utilisable EBRA measurements were obtained for 42 hips. The mean HHS was 91.1 (range 38.0-100.0), VAS satisfaction was 9.6 (range 6.0-10.0), VAS rest pain was 0.2 (range 0.0-4.0), and VAS load pain was 0.6 (range 0.0-9.0). Mean migration was 0.86 mm (range: 0.0-2.56) at 24 months and 1.34 mm (range: 0.09-3.14) at 5 years, and the mean annual migration rate was 0.22 (range: - 0.24-1.34). The mean total wear was 0.4 mm (range: 0.03-1.0), corresponding to a mean annual wear rate of 0.06 mm per year (range: 0.0-0.17). Radiographic analysis did not reveal any cases of osteolysis, and no revision surgeries had to be performed.ConclusionsAfter using vitamin-E blended HXLPE in cementless isoelastic monoblock cups, there were no obvious signs of osteolysis or aseptic loosening occurred. No patients required revision surgery after mid-term follow-up. Cup migration and wear values were well below the benchmarks considered predictive for potential future failure.Trial registrationThe trial registration number on ClinicalTrials.gov : NCT04322916 (retrospectively registered at 26.03.2020).

Dataset Information

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

Background and purpose

Patients and methods

Results

Conclusions

Clinicaltrials.gov identifier

Publications

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

Similar Datasets

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