Evidence map›Paper›PMID 33941155›Full record

Trial reportBMC musculoskeletal disorders2021

Despite higher revision rate, MoM large-head THA offers better clinical scores than HR: 14-year results from a randomized controlled trial involving 48 patients.

Lazaros Kostretzis, Martin Lavigne, Marc-Olivier Kiss, Maged Shahin, Janie Barry, Pascal-André Vendittoli

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 NCT04516239 (Prospective Double-blind Randomized Clinical Trial Comparing Gait Analysis and Clinical Function After Metal on Metal Total Hip Arthroplasty With Large Diameter Femoral Head and Metal on Metal Total Hip Resurfacing.), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 21% of its field
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.

NCT04516239 phase4completednot on this map

Prospective Double-blind Randomized Clinical Trial Comparing Gait Analysis and Clinical Function After Metal on Metal Total Hip Arthroplasty With Large Diameter Femoral Head and Metal on Metal Total Hip Resurfacing.

TypeinterventionalSponsorCiusss de L'Est de l'Île de MontréalRan2005 to 2020Enrolled48ConditionsArthroplasty, Replacement, HipArmsTHA, HR
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Complications and mid to long term outcomes for hip resurfacing versus total hip replacement: a systematic review and meta-analysis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2023
    Pooled it
  4. Review
  5. Review
  6. Review
  7. Article
  8. 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

6 authors at 1 institution in 1 country.

Lazaros KostretzisSurgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, 5415 Boulevard de l'Assomption, Montréal, Québec, H1T 2M4, Canada.
Martin LavigneSurgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, 5415 Boulevard de l'Assomption, Montréal, Québec, H1T 2M4, Canada.
Marc-Olivier KissSurgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, 5415 Boulevard de l'Assomption, Montréal, Québec, H1T 2M4, Canada.
Maged ShahinSurgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, 5415 Boulevard de l'Assomption, Montréal, Québec, H1T 2M4, Canada.
Janie BarrySurgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, 5415 Boulevard de l'Assomption, Montréal, Québec, H1T 2M4, Canada.
Pascal-André VendittoliSurgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, 5415 Boulevard de l'Assomption, Montréal, Québec, H1T 2M4, Canada. pa.vendittoli@me.com.ORCID http://orcid.org/0000-0003-4652-6238
Hôpital Maisonneuve-Rosemont · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe high failure rates of metal on metal (MoM) large diameter head total hip arthroplasty (LDH THA) and hip resurfacing (HR) prevented their long-term comparisons with regards to clinical outcome. Such knowledge would be important as ceramic LDH bearing is now available. With long-term follow-up, we investigated the difference in 1) patient-reported outcome measures (PROMs); 2) revision and adverse events rates, and 3) metal ion levels between MoM LDH THA and HR.

methodsForty-eight patients were randomized for LDH THA (24) or HR (24) with the same MoM articulation. At a mean follow-up of 14 years, we compared between groups different PROMs, the number of revisions and adverse events, whole blood Cobalt (Co) and Chromium (Cr) ion levels, and radiographic signs of implant dysfunction.

resultsLDH THA (all cases: revised and well-functioning) had significantly better WOMAC (94 versus 85, p = 0.04), and more frequently reported having no limitation (p = 0.04). LDH THA revision rate was 20.8% (5/24) versus 8.3% (2/24) for HR (p = 0.4). Mean Co and Cr ion levels were higher in LDH THA compared to the HR (Co: 3.8 μg/L vs 1.7 μg/L; p = 0.04 and Cr: 1.9 μg/L vs 1.4 μg/L, p = 0.1). On radiographic analyses, 2 LDH THAs showed signs of adverse reaction to metal debris, whereas 1 loose femoral HR component was documented.

conclusionIn the long-term, MoM LDH THA had a high trunnion related revision rate but nonetheless showed better PROMs compared to HR. Provided with a well-functioning modular junction, non-MoM LDH THA would offer an appealing option.

trial registrationClinicalTrials.gov ( NCT04516239 ), August 18, 2020. Retrospectively registered.

Indexed as

Arthroplasty, Replacement, HipHip ProsthesisMetal-on-Metal Joint ProsthesesChromiumCobaltHumansProsthesis DesignReoperationChromiumCobaltHip resurfacingLarge diameterMetal ionsMetal on metalPatient reported outcome measuresRadiographicRevision rateTotal hip arthroplasty

Identifiers

PMID33941155
PMCPMC8091753
OpenAlexW3159180461

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.