Evidence map›Paper›PMID 36336744›Full record

ArticleKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2023

The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study.

T G van Tienen, B van Minnen, K C Defoort, P J Emans, S A W van de Groes, N Verdonschot, L M Jutten, R W E Pikaart, P J C Heesterbeek

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In one paragraph

Article 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. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. The Current State of Meniscus Replacements.Current reviews in musculoskeletal medicine · 2024
    Review
  5. 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

9 authors at 4 institutions in 1 country.

T G van TienenRadboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. tony.vantienen@radboudumc.nl.ORCID http://orcid.org/0000-0003-2005-0550
B van MinnenATRO Medical BV, Liessentstraat 9-A, 5405 AH, Uden, The Netherlands.
K C DefoortSint Maartenskliniek Nijmegen, Hengstdal 3, 6574 NA, Ubbergen, The Netherlands.
P J EmansJoint-Preserving Clinic, Department of Orthopaedic Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
S A W van de GroesRadboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
N VerdonschotRadboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
L M JuttenJoint-Preserving Clinic, Department of Orthopaedic Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
R W E PikaartATRO Medical BV, Liessentstraat 9-A, 5405 AH, Uden, The Netherlands.
P J C HeesterbeekSint Maartenskliniek Nijmegen, Hengstdal 3, 6574 NA, Ubbergen, The Netherlands.
Radboud University Nijmegen · NLMaastricht University Medical Centre · NLNederlandse Vereniging voor Heelkunde · NLSint Maartenskliniek · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome.

methodsEleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.

resultsThe surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.

conclusionThis first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising. LEVEL OF EVIDENCE: Level II.

Indexed as

Joint ProsthesisMenisci, TibialHumansKnee JointPainQuality of LifeTreatment OutcomeArtificial meniscusMeniscectomyMeniscus prosthesisMeniscus replacementPost-meniscectomy pain syndrome

Identifiers

PMID36336744
PMCPMC10183417
OpenAlexW4308314692

What OpenQuestion holds

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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.