Evidence map›Paper›PMID 32093769›Full record

ArticleTrials2020

CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial.

Celia Clarke, Valerie Pomeroy, Allan Clark, Graham Creelman, Nicola Hancock, Simon Horton, Anne Killett, Charles Mann, Estelle Payerne, Andoni Toms and 4 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  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

14 authors.

Celia ClarkeSchool of Health Sciences, University of East Anglia, Norwich, UK. Celia.Clarke@uea.ac.uk.ORCID http://orcid.org/0000-0001-6584-9601
Valerie PomeroySchool of Health Sciences, University of East Anglia, Norwich, UK.
Allan ClarkNorwich Medical School, University of East Anglia, Norwich, UK.
Graham CreelmanPatient and Public Involvement, Norwich, UK.
Nicola HancockSchool of Health Sciences, University of East Anglia, Norwich, UK.
Simon HortonSchool of Health Sciences, University of East Anglia, Norwich, UK.
Anne KillettSchool of Health Sciences, University of East Anglia, Norwich, UK.
Charles MannDepartment of Trauma and Orthopaedics, Norfolk and Norwich University Hospital, Norwich, UK.
Estelle PayerneNorwich Clinical Trials Unit, UEA, Norwich, UK.
Andoni TomsNorwich Medical School, University of East Anglia, Norwich, UK.
Gareth RobertsPatient and Public Involvement, Norwich, UK.
Toby SmithSchool of Health Sciences, University of East Anglia, Norwich, UK.
Ann Marie SwartNorwich Medical School, University of East Anglia, Norwich, UK.
Iain McNamaraNorwich Medical School, University of East Anglia, Norwich, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKRs; the JOURNEY II Bi-Cruciate Stabilised knee arthroplasty, a newer knee prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee, and the GENESIS II, a proven existing design.

aimTo compare the change in Patient-reported Outcome Measures (PROMs) scores of the JOURNEY II BCS and the GENESIS II from pre-operation to 6 months post operation.

methodsCAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n = 80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at 1 week, 6 to 8 weeks and 6 months post-operatively. The primary outcome is the Oxford Knee Score (OKS) at 6 months post-operatively. Secondary outcomes include: other PROMs, biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients' perspectives via interview pre and post surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n = 30) will have additional in-depth interviews to explore the themes identified. The surgeons' perspectives on the operation will be investigated by a group interview after all participants have undergone surgery. DISCUSSION: This trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.

trial registrationInternational Standard Randomised Controlled Trials Number Registration, ID: ISRCTN32315753. Registered on 12 December 2017.

Indexed as

Arthroplasty, Replacement, KneeBiomechanical PhenomenaHumansKnee JointOsteoarthritis, KneePatient Reported Outcome MeasuresPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRange of Motion, ArticularFunctional abilityKinematicsKnee prosthesisKnee replacementPrimary osteoarthritisTotal knee arthroplasty

Identifiers

PMID32093769
PMCPMC7041243

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Registered trials

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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.