Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial

Fidelity Investigators, Raine Sihvonen, Roope Kalske, Martin Englund, Aleksandra Turkiewicz, Pirjo Toivonen, Simo Taimela, Teppo L.N. Järvinen, Kari Kanto, Timo Järvelä, Janne Lehtinen, Outi Päiväniemi, Marko Raivio, Tero Järvinen, Niko Sillanpää

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    Abstract

    Background: The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and design: FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion: To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out. Trial registration: ClinicalTrials.gov, NCT00549172 (Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear). Registered on 25 October 2007 (NCT00549172). ClinicalTrials.gov, NCT01052233 (Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear). Registered on 20 January 2010.

    Original languageEnglish
    Article number76
    JournalTrials
    Volume21
    Issue number1
    DOIs
    Publication statusPublished - 2020
    Publication typeA1 Journal article-refereed

    Keywords

    • Arthroscopic partial meniscectomy
    • Osteoarthritis
    • Randomized controlled trial
    • Statistical analysis plan

    Publication forum classification

    • Publication forum level 1

    ASJC Scopus subject areas

    • Medicine (miscellaneous)
    • Pharmacology (medical)

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