Evidence map›Paper›PMID 31897548›Full record

Trial reportKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2020

Safety and efficacy of matrix-associated autologous chondrocyte implantation with spheroid technology is independent of spheroid dose after 4 years.

Philipp Niemeyer, Volker Laute, Wolfgang Zinser, Thilo John, Christoph Becher, Peter Diehl, Thomas Kolombe, Jakob Fay, Rainer Siebold, Stefan Fickert

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 4% 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.

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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
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  12. Review
  13. Limited evidence for biological treatment measures for cartilage and tendon injuries of the shoulder.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2022
    Review
  14. Article
  15. Progress of Platelet Derivatives for Cartilage Tissue Engineering.Frontiers in bioengineering and biotechnology · 2022
    Review
  16. Article
  17. Review
  18. 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

10 authors at 5 institutions in 1 country.

Philipp NiemeyerDepartment of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Munich, Germany. phniemeyer@gmail.com.
Volker LauteJoint and Spine Centre Berlin, Berlin, Germany.
Wolfgang ZinserDepartment of Orthopedic Surgery and Traumatology, St. Vinzenz-Hospital Dinslaken, Dinslaken, Germany.
Thilo JohnClinic for Traumatology and Orthopedic Surgery, DRK Hospital Westend Berlin, Berlin, Germany.
Christoph BecherDepartment of Orthopedic Surgery, Medical University Annastift Hanover, Hanover, Germany.
Peter DiehlDepartment of Orthopedic Surgery and Traumatology, Orthopedic Center Munich East, Munich, Germany.
Thomas KolombeTraumatology and Reconstructive Surgery, DRK Hospital Luckenwalde, Luckenwalde, Germany.
Jakob FayDepartment of Traumatology and Arthroscopic Surgery, Lubinus Clinicum Kiel, Kiel, Germany.
Rainer SieboldCenter for Hip, Knee and Foot Surgery, ATOS Clinic Heidelberg, Heidelberg, Germany.
Stefan FickertSporthopaedicum Straubing, Straubing, Germany.
Clinical Research Center Kiel · DEDRK Kliniken Berlin · DEHeidelberg University · DEMedizinische Hochschule Hannover · DEUniversity Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this study was to investigate the effect of product dose in autologous chondrocyte implantation (ACI) for the treatment of full-thickness cartilage defects of the knee and to assess its influence on clinical and morphological mid-term outcome.

methodsSeventy-five patients were included in this single-blind, randomised, prospective, controlled clinical trial. Patients were assigned randomly to three different dose groups [low (3-7 spheroids/cm

resultsThe analysis population comprised 75 patients (22 women, 53 men) aged 34 ± 9 years. Defect sizes ranged from 2 to 10 cm

conclusionsResults of this study confirm the efficacy and safety of the applied "advanced therapy medicinal product"; no dose dependence was found either for the incidence or for the severity of any adverse reactions. All doses applied in the present study led to significant clinical improvement over time and can therefore be regarded as effective doses. The influence of product doses in the range investigated seems to be low and can be neglected. Thus, the authorised dose range of 10-70 spheroids/cm LEVEL OF EVIDENCE: I.

Indexed as

AdolescentAdultCartilage, ArticularCartilage DiseasesChondrocytesFemaleHumansKnee JointMaleMiddle AgedOrthopedic ProceduresPostoperative ComplicationsProspective StudiesSingle-Blind MethodTransplantation, AutologousYoung AdultAutologous chondrocyte implantationCartilage lesionKnee surgeryPatellaRandomised clinical trial

Identifiers

PMID31897548
OpenAlexW2998411704

What OpenQuestion holds

Textmetadata
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.