Abstract
BackgroundThe 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 designFIDELITY 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.DiscussionTo 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 registrationClinicalTrials.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.
Highlights
IntroductionTrial overview and purpose of the statistical analysis plan The Finnish degenerative meniscal lesion study (FIDELITY) is a trial to assess the efficacy of arthroscopic partial meniscectomy (APM) in patients with a degenerative meniscus tear
To assess the long-term efficacy of arthroscopic partial meniscectomy (APM) on knee symptoms and function we are carrying out a longterm (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document
Trial overview and purpose of the statistical analysis plan The Finnish degenerative meniscal lesion study (FIDELITY) is a trial to assess the efficacy of arthroscopic partial meniscectomy (APM) in patients with a degenerative meniscus tear
Summary
Trial overview and purpose of the statistical analysis plan The Finnish degenerative meniscal lesion study (FIDELITY) is a trial to assess the efficacy of arthroscopic partial meniscectomy (APM) in patients with a degenerative meniscus tear. The original study protocol [1] provides more details on the trial rationale, eligibility criteria, interventions, data management, and methods for limiting bias This SAP follows the guidelines for writing SAPs provided by Gamble et al [5] and describes the overall principles for analysis of long-term outcomes There is mounting evidence to suggest that APM is associated with increased risk of accelerated progression of knee osteoarthritis (OA) and earlier need for “corrective” surgery (high tibial osteotomy (HTO) or total knee replacement (TKR)) in middle-aged to older patients [14, 15] It still remains unclear whether the increased risk is due to the meniscus tear per se, the surgical procedure (APM), or if there is an interaction between the two. The biological rationale behind these studies is that resection of the torn meniscus (APM) has an effect on the progression of degenerative knee disease: some argue that APM cures symptoms and slows down the development of OA while others assert the contrary
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