Evidence map›Paper›PMID 41069331›Full record

ArticleHaemophilia : the official journal of the World Federation of Hemophilia2025

Orthopaedic Surgery Outcomes in Patients With Haemophilia A or B Treated With Extended Half-Life Recombinant Factor VIII and IX Fc Fusion Proteins: A Multicentre Prospective Study.

Luigi Piero Solimeno, Roberta Gualtierotti, Emanuele Guido, Jacopo Acquati Lozej, Enrica Cristini, Alessandro Ciavarella, Sara Arcudi, Christian Carulli, Lisa Pieri, Simona Maria Siboni and 1 more

Abstract readMulticenter Study
In one paragraph

Article in Haemophilia : the official journal of the World Federation of Hemophilia, 2025. 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

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

1 citing paper in PubMed.

  1. 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

11 authors.

Luigi Piero SolimenoDivision of Orthopaedic Surgery and Traumatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0002-4130-3601
Roberta GualtierottiAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0001-6465-7624
Emanuele GuidoDepartment of Oncology and Hematology-Oncology, Università degli Studi di Milano, Milan, Italy.ORCID https://orcid.org/0009-0009-8073-0284
Jacopo Acquati LozejDivision of Orthopaedic Surgery and Traumatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0002-2615-1048
Enrica CristiniDivision of Orthopaedic Surgery and Traumatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Alessandro CiavarellaAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0003-2297-5231
Sara ArcudiAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0001-5743-9098
Christian CarulliOrthopaedic Clinic, University of Florence, Firenze, Italy.ORCID https://orcid.org/0000-0002-0845-7940
Lisa PieriCenter for Bleeding Disorders and Coagulation, Department of Oncology, Careggi University Hospital, Florence, Italy.ORCID https://orcid.org/0000-0003-1812-8072
Simona Maria SiboniAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0002-8456-7519
Flora PeyvandiAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0001-7423-9864

Funding

Italian Ministry of Education and Research-MUR ('Dipartimenti di Eccellenza' Programme 2023-27-Department of Pathophysiology and Transplantation, Università degli Studi di Milano)Italian Ministry of Health-Bando Ricerca CorrenteSobi
6 · The paper itself

Abstract

introductionHaemophilia A and B are hereditary bleeding disorders that require multidisciplinary perioperative management. Data on orthopaedic surgery outcomes with extended-half-life (EHL) recombinant Fc-fusion factor VIII (rFVIIIFc) and factor IX (rFIXFc) products remain limited.

aimsTo evaluate the efficacy of EHL rFVIIIFc or rFIXFc in major orthopaedic surgery, focusing on haemostasis, safety and factor consumption.

methodsThis prospective study involved persons with haemophilia A or B treated with rFVIIIFc or rFIXFc undergoing orthopaedic surgery.

resultsTwenty major orthopaedic surgeries (2018-2023) were included in 19 persons with severe or moderate haemophilia A (n = 14) or B (n = 5), median age 46 years (range 26-60). Procedures included arthroplasty, arthrodesis, arthroscopic synovectomy, prosthetic revision of the knee or ankle, and removal of a femur fracture fixation device. Median hospital stay was 7 days (range 2-18). Median cumulative factor consumption was 300 and 388 IU/kg for haemophilia A and B, respectively. Haemostatic efficacy was rated as 'good' in 95% (n = 18) of cases, 'poor' in 5% (n = 1), and not documented in one case. Median haemoglobin (Hb) change was -2.0 g/dL (range -4.6 to +0.5); no transfusions were required. Complications were reported in 45% (n = 9) of cases (anaemia 40%; blood loss 5%) and managed with oral supplementation of iron and folates. No adverse events related to rFVIIIFc or rFIXFc administration were observed.

conclusionRFVIIIFc and rFIXFc provide effective haemostasis during orthopaedic surgery in patients with haemophilia A and B, with a favourable safety profile. Further multicentre studies are warranted to confirm these results and refine perioperative management guidelines.

Indexed as

Factor IXFactor VIIIHemophilia AHemophilia BImmunoglobulin Fc FragmentsOrthopedic ProceduresRecombinant Fusion ProteinsAdultFemaleHalf-LifeHumansMaleMiddle AgedProspective StudiesTreatment OutcomeFactor IXFactor VIIIfactor VIII-Fc fusion proteinImmunoglobulin Fc FragmentsRecombinant Fusion Proteinsfactor IX Fc fusion proteinfactor VIII Fc fusion proteinhaemophiliajoint diseasesorthopaedic surgerytotal joint replacements

Identifiers

PMID41069331
PMCPMC12612362

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LicenceCC BY
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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.