Evidence map›Paper›PMID 36040510›Full record

Trial reportKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2023

Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial.

Michele Ulivi, Valentina Meroni, Marco Viganò, Alessandra Colombini, Michele D M Lombardo, Nicolò Rossi, Luca Orlandini, Carmelo Messina, Luca M Sconfienza, Giuseppe M Peretti and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06040957 (Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis), which is not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
6.6field-weighted citation impact, top 2% 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.

NCT06040957 narecruitingnot on this mapstarted 2024, after this paper: background citation

Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial

TypeinterventionalSponsorIstituto Ortopedico RizzoliRan2024 to 2027Enrolled204ConditionsKnee OsteoarthritisArmsBone marrow aspirate concentrate injection, intra-articular injection of Minimally manipulated adipose tissue
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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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

12 authors at 2 institutions in 1 country.

Michele UliviIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Valentina MeroniIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Marco ViganòIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Alessandra ColombiniIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Michele D M LombardoResidency Program in Orthopedics and Traumatology, University of Milan, via Festa del Perdono 7, 20122, Milan, Italy.
Nicolò RossiResidency Program in Orthopedics and Traumatology, University of Milan, via Festa del Perdono 7, 20122, Milan, Italy.
Luca OrlandiniIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Carmelo MessinaIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Luca M SconfienzaIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Giuseppe M PerettiIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Laura MangiaviniIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy. laura.mangiavini@unimi.it.ORCID http://orcid.org/0000-0003-1892-1249
Laura de GirolamoIRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Istituto Ortopedico Galeazzi · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCurrent conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing.

methodsThis study is a prospective, randomized controlled clinical trial. 78 patients affected by knee OA grade 3-4 according to KL classification were randomly assigned to AD or AD + mFAT treatment groups. Clinical, radiological and serological assessments were performed at 6 months after treatment. Additional clinical evaluation was performed at the end of the study with an average follow-up of 26.1 ± 9.5 months. VAS, KOOS, WOMAC and SF-12 were also collected at both timepoints, KSS only at 6 months.

resultsTreatment with AD + mFAT improved functional scores at both 6 months (KOOS-PS: + 11.7 ± 20.2 vs + 24.4 ± 22.5, in AD and AD + mFAT, respectively, p = 0.024; KSS: + 14.9 ± 15.9 vs + 24.8 ± 23.5, in AD and AD + mFAT, respectively, p = 0.046) and 24-month follow-ups (KOOS-PS Functional subscale: - 2.0 ± 3.5 vs - 4.7 ± 4.2, in AD and AD + mFAT, respectively, p = 0.012). Lower T2-mapping scores were obtained in AD + mFAT-treated group in medial and lateral condyle compartments (p < 0.001). Slight increase was observed in the levels of a serum biomarker of cartilage deposition (PIIINP) in both groups at 6-month follow-up (p = 0.037).

conclusionmFAT improves functional outcome and MRI appearance when used in association with AD, therefore supporting its use in the treatment of knee OA in an arthroscopic setting.

Indexed as

Osteoarthritis, KneeAdipose TissueDebridementHumansKnee JointProspective StudiesTreatment OutcomeArthroscopic debridementCartilage biomarkersKnee osteoarthritisMicro-fragmented adipose tissueRegenerative medicine

Identifiers

PMID36040510
PMCPMC9424810
OpenAlexW4293661162

What Socratic holds

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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 Socratic graph.