Evidence map›Paper›PMID 42163296›Full record

ArticleTrials2026

The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing: a pragmatic multicentre randomised controlled Trial with blinding (PART) - statistical analysis plan.

R N Evans, A Judge, G S Matharu, M J Petrie, A W Blom, K Pike

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

R N EvansBristol Medical School, Bristol Trials Centre, University of Bristol, Bristol, UK. becci.evans@bristol.ac.uk.ORCID http://orcid.org/0000-0002-7119-8187
A JudgeNational Institute for Health and care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
G S MatharuMusculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.
M J PetrieSheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
A W BlomSchool of Biological Sciences, The University of Manchester, Manchester, UK.
K PikeBristol Medical School, Bristol Trials Centre, University of Bristol, Bristol, UK.

Funding

Health Technology Assessment Programme 15/180/55
6 · The paper itself

Abstract

backgroundThe PAtellar Resurfacing compared to selective patellar resurfacing Trial (PART) is a randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of selective patellar resurfacing (intraoperative decision by surgeon) compared to always patellar resurfacing in patients undergoing elective primary total knee replacement (TKR). This paper presents the PART statistical analysis plan, detailing the trial analysis and presentation plan. The proposed analysis follows recommendations from the International Council for Harmonisation guideline on Good Clinical Practice and "Guidelines for the Content of Statistical Analysis Plans in Clinical trials" and are in line with the Consolidated Standards of Reporting Trials. METHODS/

designPART is a multi-centre, randomised, blinded, pragmatic parallel two-group superiority RCT aiming to recruit 990 patients undergoing primary TKR. The primary outcome is the Oxford Knee Score (OKS) 12 months after TKR surgery. The planned statistical analyses of the trial primary and secondary outcomes are described in detail, including approaches to deal with the following: missing data, multiple testing, violation of model assumptions, withdrawals from the trial, non-adherence with the treatment and other protocol deviations. DISCUSSION: This manuscript prospectively describes, prior to the completion of data collection and database lock, the analyses to be undertaken for the PART trial to reduce the risk of reporting bias and data-driven analyses.

trial registrationThe trial was registered as ISRCTN33276681 on 27 Feb 2023, before recruitment began.

Indexed as

Arthroplasty, Replacement, KneeKnee JointOsteoarthritis, KneePatellaCost-Benefit AnalysisCost-Effectiveness AnalysisElective Surgical ProceduresEquivalence Trials as TopicHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomePatellar resurfacingStatistical analysis planTotal knee replacement

Identifiers

PMID42163296
PMCPMC13366729

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.