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

Trials

for the Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators¹  Martin Englund²  Aleksandra Turkiewicz²  Raine Sihvonen³  Roope Kalske⁴  Pirjo Toivonen⁴  Simo Taimela⁴  Teppo L. N. Järvinen⁴ 

[1] ;Clinical Epidemiology Unit, Orthopedics, Department of Clinical Sciences Lund, Lund University;Department of Orthopedics and Traumatology, Tampere University Hospital;Finnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital;

关键词: Statistical analysis plan;    Randomized controlled trial;    Arthroscopic partial meniscectomy;    Osteoarthritis;   

DOI  :  10.1186/s13063-019-3833-2

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown