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Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial
  1. Raine Sihvonen1,2,
  2. Mika Paavola3,4,
  3. Antti Malmivaara5,
  4. Ari Itälä6,
  5. Antti Joukainen7,
  6. Juha Kalske8,
  7. Heikki Nurmi9,
  8. Jaanika Kumm10,
  9. Niko Sillanpää11,
  10. Tommi Kiekara11,
  11. Aleksandra Turkiewicz12,
  12. Pirjo Toivonen2,3,4,
  13. Martin Englund13,
  14. Simo Taimela2,3,4,
  15. Teppo Järvinen2,3,4
  16. for the FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators
    1. 1Department of Orthopaedics and Traumatology, Pihlajalinna Oyj, Tampere, Pirkanmaa, Finland
    2. 2Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland
    3. 3Department of Orthopedics and Traumatology, Töölö Hospital, Helsinki University Hospital, Helsinki, Uusimaa, Finland
    4. 4Department of Orthopedics and Traumatology, University of Helsinki, Helsinki, Finland
    5. 5Centre for Health and Social Economics – CHESS, National Institute for Health and Welfare, Helsinki, Finland
    6. 6Pohjola Hospital, Turku, Finland
    7. 7Department of Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio, Finland
    8. 8Department of Orthopedics and Traumatology, Helsinki University Hospital, Helsinki, Finland
    9. 9Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland
    10. 10Department of Medicine, Tartu Ulikool, Tartu, Tartumaa, Estonia
    11. 11Medical Imaging Center, Tampere University Hospital, Tampere, Finland
    12. 12Department of Orthopedics, Lund University, Lund, Sweden
    13. 13Clinical Epidemiology Unit, Orthopaedics, Lund University, Lund, Sweden
    1. Correspondence to Professor Teppo Järvinen, Department of Orthopaedics and Traumatology, University of Helsinki, Helsinki 00100, Finland; teppo.jarvinen{at}helsinki.fi

    Abstract

    Objectives To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up.

    Design Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial.

    Setting Orthopaedic departments in five public hospitals in Finland.

    Participants 146 adults, mean age 52 years (range 35–65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised.

    Interventions APM or placebo surgery (diagnostic knee arthroscopy).

    Main outcome measures We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale).

    Results There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI −2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), −1.7 (95% CI −7.7 to 4.3) in WOMET, −2.1 (95% CI −6.8 to 2.6) in Lysholm knee score, and −0.04 (95% CI −0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar.

    Conclusions APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.

    Trial registration ClinicalTrials.gov (NCT01052233 and NCT00549172).

    • osteoarthritis
    • meniscus
    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Footnotes

    • Twitter @anttimal, @shamteppo

    • Collaborators FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators: Anna Ikonen, MD (anna.ikonen{at}hus.fi) Department of Orthopedics and Traumatology, Helsinki University Hospital, Töölö hospital, Helsinki, Finland; Timo Järvelä, MD, PhD (Timo.Jarvela{at}sci.fi) Mehiläinen Hospital, Tampere, Finland; Tero AH Järvinen, MD, PhD (tero.jarvinen{at}tuni.fi) Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland; Roope Kalske, MD (roope.kalske{at}helsinki.fi) Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland; Department of Orthopedics and Traumatology, Helsinki University Hospital, Töölö hospital, Helsinki, Finland; Kari Kanto, MD (kari.kanto{at}fimnet.fi)

      Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland; Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland; Janne Karhunen, MD (janne.karhunen{at}mehilainen.fi) Mehiläinen Hospital, Helsinki, Finland; Jani Knifsund, MD (jani.knifsund{at}tyks.fi) Department of Orthopedics and Traumatology, Turku University Hospital, Turku, Finland; Heikki Kröger, MD, PhD (heikki.kroger{at}kuh.fi) Department of Orthopedics and Traumatology, Kuopio University Hospital, Kuopio, Finland; Tommi Kääriäinen, MD (tommi.kaariainen{at}pohjolasairaala.fi) Pohjola Hospital, Kuopio, Finland; Janne Lehtinen, MD, PhD (janne{at}viinitalli.com) Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland; Jukka Nyrhinen, MD (jukka.nyrhinen{at}ksshp.fi); Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland; Juha Paloneva, MD, PhD (juha.paloneva{at}ksshp.fi) Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland; Outi Päiväniemi, MD, PhD (outi.paivaniemi{at}pshp.fi) Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland; Marko Raivio, MD (marko.raivio{at}mehilainen.fi) Mehiläinen Hospital, Tampere, Finland; Janne Sahlman, MD (janne.sahlman{at}pohjolasairaala.fi) Pohjola Hospital, Kuopio, Finland; Roope Sarvilinna, MD, PhD (roope.sarvilinna{at}pihlajalinna.fi) Pihlajalinna-DEXTRA Hospital, Helsinki, Finland; Sikri Tukiainen, MD (sikri.tukiainen{at}mehilainen.fi) Mehiläinen Hospital, Helsinki, Finland; Ville-Valtteri Välimäki, MD, PhD (ville-valtteri.valimaki{at}pohjolasairaala.fi) Pohjola Hospital, Helsinki, Finland; Ville Äärimaa, MD, PhD (ville.aarimaa{at}tyks.fi) Department of Orthopedics and Traumatology, Turku University Hospital, Turku, Finland.

    • Contributors RS, MP, AM and TJ conceived and designed the study. RS, AI, AJ, JK, JK and HN recruited the patients, the FIDELITY Investigators followed up the patients. JK, NS and TK performed the readings of the radiographs. PT, RS and TJ collected the data. AT designed the database and cleaned the data. RS, RK, ME, AT, PT, ST and TJ contributed to the statistical analysis plan (SAP) and data analysis. RS, ME, AT, PT, ST and TJ participated in the analysis and interpretation of the data and drafted the manuscript (Writing Committee). All authors and collaborators approved the final draft of the manuscript. TJ obtained funding and is the guarantor.

    • Funding This study was supported by the Sigrid Juselius Foundation, the State funding for university-level health research (Tampere and Helsinki University Hospitals), the Social Insurance Institution of Finland (KELA), and the Academy of Finland. Professor Englund and Dr Turkiewicz are supported by the Swedish Research Council, the Swedish Rheumatism Association, and Governmental Funding of Clinical Research within National Health Service (ALF), and Dr Sihvonen is supported by the Finnish Medical Foundation and Orion-Pharmos Research Foundation.

    • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. Given that the informed consent forms of the FIDELITY trial did not include a provision for data sharing (trial launched in 2007), the full dataset cannot be shared due to a potential breach of the Finnish Personal Data Act. Scientists with a specific question regarding the trial data are encouraged to contact the corresponding author.

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