Evidence map›Paper›PMID 33054780›Full record

ArticleJournal of orthopaedic surgery and research2020

Flexible versus standard intramedullary rod in posterior stabilized primary total knee arthroplasty: protocol for a randomized controlled trial.

M R Bénard, R F M van Doremalen, A B Wymenga, P J C Heesterbeek

Abstract readComparative StudyClinical Trial Protocol
In one paragraph

Article in Journal of orthopaedic surgery and research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

4 authors.

M R BénardSint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands.
R F M van DoremalenRobotics and Mechatronics, University of Twente, Enschede, The Netherlands.
A B WymengaSint Maartenskliniek Orthopaedics, Sint Maartenskliniek, Nijmegen, The Netherlands.
P J C HeesterbeekSint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands. p.heesterbeek@maartenskliniek.nl.ORCID http://orcid.org/0000-0003-2873-8907

Funding

Stryker n/a
6 · The paper itself

Abstract

backgroundIn total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur. Although patients report better post-operative functional outcome when the flexible rod was used, it is unknown how the use of the flexible rod affects the placement of the femoral TKA component, and how this relates to activities of daily living. It is expected that the use of the flexible rod will result in a more flexed femoral component, a larger patellar tendon moment arm, and consequently in better functional outcome. The goal of this study is to compare the flexible rod to the standard intramedullary rod in primary TKA in terms of fit of the TKA, functional outcome, and sizing of the femoral component.

methodsA single-blind randomized controlled trial with two groups (flexible vs standard rod), with patients blinded for group allocation, and 2 years post-operative follow-up. The fit of the TKA is quantified by two parameters: (1) the flexion angle of the TKA in the sagittal plane and (2) the sagittal profile of the distal femur compared between the pre-operative bone and the TKA. Both parameters are calculated in 3D volume images obtained using fluoroscopy. Functional outcome will be measured using (1) the timed Get-up and Go test (2), the stair climbing test (3), knee power output, and (4) patient and clinician reported outcomes. Different parameters will be measured during the TKA procedure to account for the invisibility of cartilage in the 3D volumes and to study if the amount of bone removed during the procedure is affected by group allocation. DISCUSSION: The sagittal fit of TKA is not a standardized outcome measure. We discuss our choice of parameters to define the sagittal fit (i.e., flexion angle and sagittal profile), our choice for the parameters we measure during the TKA procedure to account for the lack of cartilage thickness in fluoroscopy, and our choice for the parameters to study if the amount of bone removed during the procedure is affected by group allocation. Lastly, we discuss the merits of this planned trial.

trial registrationNetherlands Trial Register, 4888 , registered 30 March 2015. https://www.trialregister.nl/trial/4888.

Indexed as

Internal FixatorsPliabilityActivities of Daily LivingAdultAftercareAgedArthroplasty, Replacement, KneeFemaleFemurHumansKnee ProsthesisMaleMiddle AgedOsteoarthritis, KneePatient Outcome AssessmentPatient SatisfactionFemoral bowingFunctional outcomeIntramedullary rodSagittal fitTotal knee arthroplasty

Identifiers

PMID33054780
PMCPMC7557004

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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.