Evidence map›Paper›PMID 31937344›Full record

Trial reportTrials2020

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

Raine Sihvonen, Roope Kalske, Martin Englund, Aleksandra Turkiewicz, Pirjo Toivonen, Simo Taimela, Teppo L N Järvinen, Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00549172 nacompletednot on this map

Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee

TypeinterventionalSponsorTampere UniversityRan2007 to 2013Enrolled146ConditionsOsteoarthritis, KneeArmsOperative (partial arthroscopy), Conservative (diagnostic arthroscopy)
NCT01052233 phase4unknown statusnot on this map

Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?

TypeinterventionalSponsorTampere UniversityRan2010 to 2024Enrolled160ConditionsOsteoarthritis of the Knee, Arthroscopy, Meniscal TearArmsArthroscopic partial meniscectomy, Arthroscopy (diagnostic)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Raine SihvonenDepartment of Orthopedics and Traumatology, Tampere University Hospital, Hatanpää, Tampere, Finland.
Roope KalskeFinnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland.
Martin EnglundClinical Epidemiology Unit, Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
Aleksandra TurkiewiczClinical Epidemiology Unit, Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
Pirjo ToivonenFinnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland.
Simo TaimelaFinnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland.
Teppo L N JärvinenFinnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland. teppo.jarvinen@helsinki.fi.ORCID http://orcid.org/0000-0003-3713-956X
Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators
University of Helsinki · FIBoston University · USTampere University Hospital · FITöölö Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 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.

Indexed as

AdultAgedCase-Control StudiesFemaleFinlandFollow-Up StudiesHumansMagnetic Resonance ImagingMaleMeniscectomyMenisci, TibialMiddle AgedOsteoarthritis, KneePlacebo EffectRadiographyStatistics as TopicArthroscopic partial meniscectomyOsteoarthritisRandomized controlled trialStatistical analysis plan

Identifiers

PMID31937344
PMCPMC6961384
OpenAlexW3004070498

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.