Evidence map›Paper›PMID 34706757›Full record

ArticleTrials2021

Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial.

Rasmus Kramer Mikkelsen, Lars Blønd, Lisbeth Rosenkrantz Hölmich, Cecilie Mølgaard, Anders Troelsen, Per Hölmich, Kristoffer Weisskirchner Barfod

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05465096 (Interventional Pilot Study on the Treatment of Osteoarthritis of the Hip Joint With Intra-articular Ultrasound-guided Infiltration of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% 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.

NCT05465096 nacompletednot on this mapstarted 2022, after this paper: background citation

Interventional Pilot Study on the Treatment of Osteoarthritis of the Hip Joint With Intra-articular Ultrasound-guided Infiltration of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells

TypeinterventionalSponsorIstituto Ortopedico RizzoliRan2022 to 2025Enrolled30ConditionsHip Osteoarthritis, Hip DiseaseArmsMicro-fragmented adipose tissue injection
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Stem cell injections for osteoarthritis of the knee.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
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

7 authors at 5 institutions in 1 country.

Rasmus Kramer MikkelsenDepartment of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650, Hvidovre, Denmark. rasmus.kramer.mikkelsen.02@regionh.dk.
Lars BløndDepartment of Orthopedic Surgery, University Hospital Zealand, Lykkebækvej 1, 4600, Køge, Denmark.
Lisbeth Rosenkrantz HölmichDepartment of Plastic Surgery, Copenhagen University Herlev and Gentofte Hospital, Borgmester Ib Juuls Vej 1, 2730, Herlev, Denmark.
Cecilie MølgaardDepartment of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650, Hvidovre, Denmark.
Anders TroelsenDepartment of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650, Hvidovre, Denmark.
Per HölmichDepartment of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650, Hvidovre, Denmark.
Kristoffer Weisskirchner BarfodDepartment of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, 2650, Hvidovre, Denmark.
Copenhagen University Hospital · DKHvidovre Hospital · DKGentofte Hospital · DKUniversity of Copenhagen · DKZealand University Hospital Køge · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. METHODS/

designThe study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2-3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. DISCUSSION: This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient's opinion about their knee and associated problems when suffering from osteoarthritis.

Indexed as

Osteoarthritis, KneeAdipose TissueHumansInjections, Intra-ArticularKnee JointRandomized Controlled Trials as TopicTreatment OutcomeBiologic treatmentKnee osteoarthritisMicro-fragmented adipose tissueMSCsPericyteRandomized controlled trialStemcell

Identifiers

PMID34706757
PMCPMC8549306
OpenAlexW3182676713

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.