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Evaluation of a new...
Evaluation of a new cemented highly cross-linked all-polyethylene cup : a prospective and randomised study assessing wear and fixation characteristics using radiostereometric analysis
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- Otten, Volker, 1973- (author)
- Umeå universitet,Ortopedi
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- Wästerlund, Daniel (author)
- Umeå universitet,Ortopedi
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- Lindbjörn, John (author)
- Umeå universitet,Ortopedi
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- Mertens, Carl (author)
- Umeå universitet,Ortopedi
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- Mukka, Sebastian (author)
- Umeå universitet,Ortopedi
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- Crnalic, Sead (author)
- Umeå universitet,Ortopedi
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- Nilsson, Kjell G. (author)
- Umeå universitet,Ortopedi
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(creator_code:org_t)
- 2021-02-10
- 2022
- English.
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In: HIP International. - : Sage Publications. - 1120-7000 .- 1724-6067. ; 32:6, s. 779-786
- Related links:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Ortopedi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Orthopaedics (hsv//eng)
Keyword
- Highly cross-linked polyethylene
- RCT
- RSA
- migration
- wear
Publication and Content Type
- ref (subject category)
- art (subject category)
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