Evidence map›Paper›PMID 33485345›Full record

ArticleBMC musculoskeletal disorders2021

The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up.

Yama Afghanyar, Sebastian Joser, Jonas Tecle, Philipp Drees, Jens Dargel, Philipp Rehbein, Karl Philipp Kutzner

Registry-linked trialAbstract read
In one paragraph

Article in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04322916 (Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04322916 unknown statusnot on this map

Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem

TypeobservationalSponsorMathys Ltd BettlachRan2009 to 2022Enrolled675ConditionsArthropathy of Hip, Hip ReplacementArmsRM Pressfit vitamys
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Review
  4. Review
  5. Review
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  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Yama AfghanyarDepartment of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany. yafghanyar@joho.de.ORCID http://orcid.org/0000-0002-2361-3067
Sebastian JoserDepartment of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany.
Jonas TecleDepartment of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany.
Philipp DreesDepartment of Orthopaedics and Traumatology, University Medical Centre of the Johannes Gutenberg-University of Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.
Jens DargelDepartment of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany.
Philipp RehbeinDepartment of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany.
Karl Philipp KutznerDepartment of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany.ORCID http://orcid.org/0000-0001-6363-8165

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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).

Indexed as

Arthroplasty, Replacement, HipHip ProsthesisAcetabulumFollow-Up StudiesHumansPolyethyleneProspective StudiesProsthesis DesignProsthesis FailureVitamin EPolyethyleneVitamin ECementless acetabular cupEBRAMigrationTotal hip arthroplastyVitamysWear

Identifiers

PMID33485345
PMCPMC7827971

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.