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

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

SUBMITTER: Sihvonen R 

PROVIDER: S-EPMC6961384 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature