Evidence map›Paper›PMID 30894146›Full record

ArticleBMC musculoskeletal disorders2019

Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol.

Jacob Fyhring Mortensen, Lasse Enkebølle Rasmussen, Svend Erik Østgaard, Andreas Kappel, Frank Madsen, Henrik Morville Schrøder, Anders Odgaard

Registry-linked trialOpen access · goldAbstract readComparative StudyClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03396640 (Randomized Clinical Trial of Medial Unicompartmentel Versus Total Arthroplasty for Medial Tibio-femoral OA.), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 35% 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.

NCT03396640 naactive not recruitingnot on this map

Randomized Clinical Trial of Medial Unicompartmentel Versus Total Arthroplasty for Medial Tibio-femoral OA.

TypeinterventionalSponsorUniversity Hospital, Gentofte, CopenhagenRan2017 to 2041Enrolled350ConditionsOsteoarthritis, KneeArmsUnicondylar Knee Arthroplasty, Total Knee Arthroplasty
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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 at 5 institutions in 1 country.

Jacob Fyhring MortensenDepartment of Orthopedic Surgery, Copenhagen University Hospital Herlev-Gentofte, Kildegårdsvej 28, DK-2900, Hellerup, Denmark. mortensen.jacob.f@gmail.com.ORCID http://orcid.org/0000-0002-7642-0664
Lasse Enkebølle RasmussenDepartment of Orthopedic Surgery, Vejle Hospital, Kabbeltoft 25, DK-7100, Vejle, Denmark.
Svend Erik ØstgaardDepartment of Orthopedic Surgery, Aalborg University Hospital, Hobrovej 18-22, DK-9100, Aalborg, Denmark.
Andreas KappelDepartment of Orthopedic Surgery, Aalborg University Hospital, Hobrovej 18-22, DK-9100, Aalborg, Denmark.
Frank MadsenDepartment of Orthopedic Surgery, Århus University Hospital, Tage-Hansens Gade 2, DK-8000, Aarhus, Denmark.
Henrik Morville SchrøderDepartment of Orthopedic Surgery, Næstved Hospital, Ringstedgade 61, DK-4700, Næstved, Denmark.
Anders OdgaardDepartment of Orthopedic Surgery, Gentofte Hospital, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.
Aalborg University Hospital · DKGentofte Hospital · DKAarhus University Hospital · DKNæstved Sygehus · DKVejle Sygehus · DK

Funding

Region Hovedstaden (DK) part 1 from Forskningsfonden 2015
6 · The paper itself

Abstract

backgroundIn treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic.

methodsA double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years. DISCUSSION: Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded. PROMS: OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT.

trial registrationClinicalTrials.gov ID: NCT03396640 . Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.

Indexed as

AdolescentArthroplasty, Replacement, KneeChildChild, PreschoolDouble-Blind MethodFemaleFemurFollow-Up StudiesHumansInfantInfant, NewbornMaleMulticenter Studies as TopicOsteoarthritis, KneeProspective StudiesRandomized Controlled Trials as TopicAnteromedial osteoarthritisKnee replacementMedial Unicondylar knee arthroplastyOKSTotal knee arthroplasty

Identifiers

PMID30894146
PMCPMC6425587
OpenAlexW2944181759

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.