Evidence map›Paper›PMID 35354310›Full record

Trial reportCartilage

Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial.

P Niemeyer, M Hanus, J Belickas, T László, R Gudas, M Fiodorovas, A Cebatorius, M Pastucha, P Hoza, K Magos and 13 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Cartilage. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03319797 (Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject Plus in the Treatment of Cartilage Defects of the Knee), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
8.0field-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.

NCT03319797 phase3completednot on this map

Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject Plus in the Treatment of Cartilage Defects of the Knee

TypeinterventionalSponsorTetec AGRan2017 to 2024Enrolled100ConditionsCartilage Defects of the KneeArmsNOVOCART® Inject plus
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Treatment Options for Focal Cartilage Lesions of the Knee.Deutsches Arzteblatt international · 2026
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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

23 authors at 12 institutions in 7 countries.

P NiemeyerOCM Clinic, Munich, Germany.
M HanusDepartment of Orthopaedics and Traumatology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic.
J BelickasLithuanian University of Health Sciences, Kaunas, Lithuania.
T LászlóClinic of Traumatology, Jász-Nagykun-Szolnok County Hetényi Géza Hospital, Szolnok, Hungary.
R GudasHospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, Lithuania.
M FiodorovasKlaipeda University Hospital, Klaipeda, Lithuania.
A CebatoriusKlaipeda University Hospital, Klaipeda, Lithuania.
M PastuchaDepartment of Orthopaedics, Hořovice Hospital, Hořovice, Czech Republic.
P HozaDepartment of Orthopaedics, Pardubice Hospital, Pardubice, Czech Republic.
K MagosKastélypark Clinic, Tata, Hungary.
K IzadpanahDepartment of Orthopedics and Trauma Surgery, Medical Center, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.
L PašaClinic of Traumatology, Faculty of Medicine, Masaryk Univerzity Brno and Úrazová Nemocnice, Brno, Czech Republic.
G VásárhelyiDepartment of Orthopaedics and Traumatology, Uzsoki Hospital, Budapest, Hungary.
K SisákDepartment of Orthopaedics, University of Szeged, Szeged, Hungary.
M MohylaDepartment of Orthopaedics, University Hospital in Ostrava, Ostrava-Poruba, Czech Republic.
C FarkasDepartment of Orthopaedics, Szabolcs-Szatmár-Bereg County Hospitals, University Teaching Hospital, Nyíregyháza, Hungary.
O KesslerCenter for Orthopedics & Sports, Zürich, Switzerland.
S KybalOrthopaedics Department of Hospital Benešov, Benešov, Czech Republic.
R SpiroAesculap Biologics, LLC, Breinigsville, PA, USA.
A KöhlerTETEC-Tissue Engineering Technologies AG, Reutlingen, Germany.
A KirnerTETEC-Tissue Engineering Technologies AG, Reutlingen, Germany.ORCID 0000-0001-8687-8284
S TrattnigThe High Field MR Centre, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
C GaissmaierTETEC-Tissue Engineering Technologies AG, Reutlingen, Germany.
TETEC Tissue Engineering Technologies (Germany) · DEKlaipėda University · LTAesculap (United States) · USCenter for Pediatric Endocrinology Zurich · CHCharles University · CZHospital of Lithuanian University of Health Sciences Kaunas Clinics · LTLithuanian University of Health Sciences · LTMedical University of Vienna · ATUniversity Hospital Ostrava · CZUniversity of Freiburg · DEUniversity of Szeged · HUUzsoki Hospital · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the clinical outcome of a hydrogel-based autologous chondrocyte implantation (ACI) for large articular cartilage defects in the knee joint.

designProspective, multicenter, single-arm, phase III clinical trial. ACI was performed in 100 patients with focal full-thickness cartilage defects ranging from 4 to 12 cm

resultsTwo years after ACI treatment, 93% of patients were KOOS responders having improved by ≥10 points compared with their pre-operative level. The primary endpoint of the study was met and demonstrated that the KOOS response rate is markedly greater than 40% with a lower 95% CI (confidence interval) of 86.1, more than twice the pre-specified no-effect level. KOOS improvement (least squares mean) was 42.0 ± 1.8 points (95% CI between 38.4 and 45.7). Mean changes from baseline were significant in the overall KOOS and in all 5 KOOS subscores from Month 3 (first measurement) to Month 24 (inclusive) (

conclusionsOverall, hydrogel-based ACI proved to be a valuable treatment option for patients with large cartilage defects in the knee as demonstrated by early, statistically significant, and clinically meaningful improvement up to 2 years follow-up. Parallel to the clinical improvements, MRI analyses suggested increasing maturation, re-organization, and integration of the repair tissue.

trial registrationNCT03319797; EudraCT No.: 2016-002817-22.

Indexed as

Cartilage, ArticularChondrocytesHumansHydrogelsKnee JointProspective StudiesTransplantation, AutologousHydrogelsautologous chondrocyte implantationcartilage repairhydrogelkneelarge defects

Identifiers

PMID35354310
PMCPMC9137299
OpenAlexW4221080905

What OpenQuestion holds

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LicenceCC BY-NC
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.