Evidence map›Paper›PMID 22571284›Full record

Trial reportBMC musculoskeletal disorders2012

Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study).

Soren T Skou, Ewa M Roos, Mogens B Laursen, Michael S Rathleff, Lars Arendt-Nielsen, Ole H Simonsen, Sten Rasmussen

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01410409 (Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.5field-weighted citation impact, top 8% 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.

NCT01410409 nacompletednot on this map

Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

TypeinterventionalSponsorNorthern Orthopaedic Division, DenmarkRan2011 to 2015Enrolled100ConditionsOsteoarthritis of the KneeArmsNeuromuscular training (NEMEX-TJR), Paracetamol, Burana, Pantoprazol, Dietary counseling
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
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  8. Translation and validation of 'The Knee Society Clinical Rating System' into Spanish.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2013
    Article
  9. Article
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

7 authors at 4 institutions in 2 countries.

Soren T SkouOrthopaedic Surgery Research Unit, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark. sots@rn.dk
Ewa M Roos
Mogens B Laursen
Michael S Rathleff
Lars Arendt-Nielsen
Ole H Simonsen
Sten Rasmussen
Aalborg University Hospital · DKAalborg University · DKAarhus University Hospital · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain. METHODS/

designThe study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0-100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)(4) defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength. DISCUSSION: This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.

trial registrationClinicaltrials.gov reference: NCT01410409.

Indexed as

Arthroplasty, Replacement, KneeExercise TherapyPhysical Therapy ModalitiesWeight LossActivities of Daily LivingAdolescentAdultAgedAged, 80 and overCombined Modality TherapyFemaleHumansKnee JointMaleMiddle AgedOsteoarthritis, Knee

Identifiers

PMID22571284
PMCPMC3461437
OpenAlexW2128487796

What Socratic holds

Textmetadata
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 Socratic graph.