Ethics approval and consent to participate
Central ethical approval was confirmed from the Pirkanmaa Hospital District’s committee of ethics (ref approval no. R06157) and we did not begin recruiting at other centres in the trial until local ethical approval was obtained. Informed consent was obtained from all study participants at trial entry.
Consent for publication
Availability of data and material
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 (TLNJ).
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 three years; no other relationships or activities that could appear to have influenced the submitted work.
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. Dr. Sihvonen is supported also by the Finnish Medical Foundation and Orion-Pharmos Research Foundation. The funding sources had no role in the collection, analysis and interpretation of data; in the writing of the report and in the decision to submit the article for publication.
Department of Orthopedics and Traumatology, Tays Hatanpää, Tampere University Hospital, Tampere, Finland
Raine Sihvonen, MD, PhD
Kari Kanto, MD
Timo Järvelä, MD, PhD
Janne Lehtinen, MD, PhD
Outi Päiväniemi, MD, PhD
Marko Raivio, MD
Pirjo Toivonen, PT
Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Mika Paavola, MD, PhD
Juha Kalske, MD
Anna Ikonen, MD
Janne Karhunen, MD
Roope Sarvilinna, MD, PhD
Sikri Tukiainen, MD
Ville-Valtteri Välimäki, MD, PhD
Roope Kalske, MD
Simo Taimela, MD, PhD
Teppo LN Järvinen, MD, PhD
Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland
Tero Järvinen, MD, PhD
Center for Health and Social Economics, National Institute for Health and Welfare, Helsinki, Finland
Antti Malmivaara, MD, PhD
Department of Orthopedics and Traumatology, Turku University Hospital, Turku, Finland
Ari Itälä, MD, PhD
Jani Knifsund, MD
Ville Äärimaa, MD, PhD
Department of Orthopedics and Traumatology, Kuopio University Hospital, Kuopio, Finland
Antti Joukainen, MD, PhD
Tommi Kääriäinen, MD
Heikki Kröger, MD, PhD, Professor
Janne Sahlman, MD
Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland
Heikki Nurmi, MD
Jukka Nyrhinen, MD
Juha Paloneva, MD, PhD
Department of Radiology, University of Tartu, Tartu, Estonia
Jaanika Kumm, MD, PhD
Clinical Epidemiology Unit, Orthopedics, Department of Clinical Sciences, Lund University, Lund, Sweden
Martin Englund, MD, PhD
Aleksandra Turkiewicz, MSc
Writing committee: R. Sihvonen, R. Kalske, S. Taimela, P. Toivonen, A. Turkiewicz, M. Englund and T.L.N. Järvinen.
Trial concept and design: R. Sihvonen, A. Malmivaara, M. Paavola and T.L.N. Järvinen.
Provision of study materials or patients: T.L.N. Järvinen.
Statistical and epidemiological expertise: A. Turkiewicz and M. Englund
Obtaining of funding: T.L.N. Järvinen.
Administrative, technical, or logistic support: T.L.N. Järvinen and S. Taimela.
Patient enrollment: R. Sihvonen, A. Itälä, A. Joukainen, H. Nurmi, J. Kalske and J. Karhunen.
Acquisition, collection and assembly of data, responsibility of participants’ follow-up:
2-year follow-up: T. Järvelä, T.A.H. Järvinen, J. Lehtinen, O. Päiväniemi, and M. Raivio (Hatanpää Hospital, Tampere, Finland); J. Nyrhinen and J. Paloneva, (Central Finland Central Hospital, Jyväskylä, Finland); S. Tukiainen and A. Ikonen (Helsinki University Central Hospital, Helsinki, Finland); H. Kröger and J. Sahlman (Kuopio University Hospital, Kuopio, Finland); J. Knifsund and V. Äärimaa (Turku University Hospital, Turku, Finland), and P. Toivonen (all sites).
5-year follow–up: K. Kanto (Hatanpää Hospital), T. Kääriäinen, (Kuopio University Hospital); V-V. Välimäki (Helsinki University Hospital); Ville Äärimaa, MD, PhD (Turku University Hospital) , and P. Toivonen (all sites).
Radiographic readings: J. Kumm (Tartu University, Tartu, Estonia)
Research coordination: P. Toivonen.
We thank the patients for their participation. We would like to thank research nurses Marja-Liisa Sutinen, Sari Karesvuori, Pekka Karppi, Saara-Maija Hinkkanen, Johanna Koivistoinen, Kirsi Saarioja, Elina Jalava, Ina Fagerlund and Marketta Rautanen for their vital role in the implementation of the study.