Evidence map›Paper›PMID 38658012›Full record

Observational studyBMJ open2024

Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty.

Luma Mahmoud Issa, Henrik Kehlet, Sten Madsbad, Martin Lindberg-Larsen, Claus Varnum, Thomas Jakobsen, Mikkel Rathsach Andersen, Manuel Josef Bieder, Søren Overgaard, Torben Bæk Hansen and 2 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05613439 (The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications), 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
–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.

NCT05613439 completednot on this map

The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications

Typeobservational_patient_registrySponsorRigshospitalet, DenmarkRan2022 to 2025Enrolled45,000ConditionsHip, Knee, Fast-track Surgery, Enhanced Recovery After SurgeryArmsDay-surgery, High-risk patient, Main Group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Luma Mahmoud IssaAnæstesiologisk afd, Hvidovre Hospital, Hvidovre, Denmark lumaissa@gmail.com.ORCID 0000-0002-0288-0916
Henrik KehletSection for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.
Sten MadsbadDepartment of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.
Martin Lindberg-LarsenOrthopaedic Surgery and Traumatology, University of Southern Denmark, Odense, Denmark.
Claus VarnumDepartment of Orthopaedic Surgery, Lillebaelt Hospital-University Hospital of Southern Denmark, Vejle, Denmark.
Thomas JakobsenDepartment of Orthopaedic Surgery, Aalborg University Hospital, Aalborg, Denmark.
Mikkel Rathsach AndersenDepartment for Orthopaedic Surgery, Gentofte University Hospital, Hellerup, Denmark.
Manuel Josef BiederDepartment of Orthopaedic Surgery, Næstved Sygehus Ortopædkirurgi, Nastved, Denmark.
Søren OvergaardDepartment of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital Orthopedic Surgery Department M, Kobenhavn, Denmark.
Torben Bæk HansenUniversity Clinic for Hand, Hip and Knee Surgery, Hospital Unit West Jutland, Aarhus Universitetshospital, Herning, Denmark.
Kirill GromovHvidovre Hospital Department of Orthopaedic Surgery, Hvidovre, Denmark.
Christoffer Calov JørgensenDepartment of Anaesthesia, Hillerød Hospital, Hillerød, Denmark.ORCID 0000-0001-6902-8181

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPerioperative glycaemic control is important. However, the complexity of guidelines for perioperative diabetes management is complicated due to different and novel antihyperglycaemic medications, limited procedure-specific data and lack of data from implemented fast-track regimens which otherwise are known to reduce morbidity and glucose homeostasis disturbances. Consequently, outcome in patients with diabetes mellitus (DM) after surgery and the influence of perioperative diabetes management on postoperative recovery remains poorly understood. METHODS AND ANALYSIS: A prospective observational multicentre study involving 8 arthroplasty centres across Denmark with a documented implemented fast-track programme (median length of hospitalisation (LOS) 1 day). We will collect detailed perioperative data including preoperative haemoglobin A1c and antidiabetic treatment in 1400 unselected consecutive patients with DM undergoing hip and knee arthroplasty from September 2022 to December 2025, enrolled after consent. Follow-up duration is 90 days after surgery. The primary outcome is the proportion of patients with DM with LOS >4 days and 90-day readmission rate after fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). The secondary outcome is the association between perioperative diabetes treatment and LOS >2 days, 90-day readmission rate, other patient demographics and Comprehensive Complication Index for patients with DM after THA/TKA/UKA in a fast-track regimen. ETHICS AND DISSEMINATION: The study will follow the principles of the Declaration of Helsinki and ICH-Good Clinical Practice guideline. Ethical approval was not necessary as this is a non-interventional observational study on current practice. The trial is registered in the Region of Southern Denmark and on ClinicalTrials.gov. The main results and all substudies of this trial will be published in peer-reviewed international medical journals. TRIAL REGISTRATION NUMBER: NCT05613439.

Indexed as

Arthroplasty, Replacement, HipArthroplasty, Replacement, KneeDenmarkDiabetes MellitusGlycated HemoglobinHumansHypoglycemic AgentsLength of StayMulticenter Studies as TopicObservational Studies as TopicPatient ReadmissionPostoperative ComplicationsProspective StudiesRisk FactorsGlycated HemoglobinHypoglycemic Agentsadult anaesthesiageneral diabetesorthopaedic & trauma surgery

Identifiers

PMID38658012
PMCPMC11043738

What OpenQuestion holds

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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.