Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial
| Autor: | Fidelity Investigators, Sihvonen, Raine, Kalske, Roope, Englund, Martin, Turkiewicz, Aleksandra, Toivonen, Pirjo, Taimela, Simo, Järvinen, Teppo L.N., Kanto, Kari, Järvelä, Timo, Lehtinen, Janne, Päiväniemi, Outi, Raivio, Marko, Järvinen, Tero, Sillanpää, Niko |
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| Přispěvatelé: | Tampere University, Department of TAYS Division 8, Department of Musculoskeletal Diseases, BioMediTech, Department of Radiology, Clinical Medicine, I kirurgian klinikka (Töölö), University of Helsinki, HUS Musculoskeletal and Plastic Surgery, Clinicum, Department of Surgery, FICEBO |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Statistical analysis plan SURGERY Statistics as Topic Medicine (miscellaneous) Osteoarthritis Meniscus (anatomy) Menisci Tibial law.invention Study Protocol 0302 clinical medicine Statistical Analysis Plan Randomized controlled trial law Pharmacology (medical) 030212 general & internal medicine Finland lcsh:R5-920 medicine.diagnostic_test Middle Aged Osteoarthritis Knee musculoskeletal system Magnetic Resonance Imaging Torn meniscus Treatment Outcome medicine.anatomical_structure KNEE Female lcsh:Medicine (General) Medial meniscus Adult medicine.medical_specialty 03 medical and health sciences medicine Humans Arthroscopic partial meniscectomy Aged Meniscectomy 030203 arthritis & rheumatology business.industry Arthroscopy DEGENERATIVE MENISCUS TEAR Placebo Effect medicine.disease 3126 Surgery anesthesiology intensive care radiology Radiography Case-Control Studies Orthopedic surgery Physical therapy business Follow-Up Studies |
| Zdroj: | Trials Trials, Vol 21, Iss 1, Pp 1-7 (2020) |
| Popis: | 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. published version peerReviewed |
| Databáze: | OpenAIRE |
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