Evidence map›Paper›PMID 31092226›Full record

ArticleBMC musculoskeletal disorders2019

The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure.

Alan Getgood, Dianne Bryant, Andrew Firth, Stability Group

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02018354 (Multicenter Randomized Clinical Trial Comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure.), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
6.0field-weighted citation impact, top 3% 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.

NCT02018354 naunknown statusnot on this map

Multicenter Randomized Clinical Trial Comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure.

TypeinterventionalSponsorUniversity of Western Ontario, CanadaRan2014 to 2025Enrolled624ConditionsAnterior Cruciate Ligament ReconstructionArmsLateral Extra-Articular Tenodesis (LET), ACL Reconstruction
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 59 citations in OpenAlex.

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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

4 authors at 2 institutions in 1 country.

Alan GetgoodOrthopaedic Sport Medicine Fellowship Director, Fowler Kennedy Sport Medicine Clinic, 3M Centre, University of Western Ontario, 1151 Richmond St., London, ON, N6A 3K7, Canada.
Dianne BryantFaculty of Health Sciences, Elborn College, University of Western Ontario, Room 1438, 1201 Western Rd, London, ON, N6C 1H1, Canada.
Andrew FirthFowler Kennedy Sport Medicine Clinic, 3M Centre, University of Western Ontario, 1151 Richmond St, London, ON, N6A 3K7, Canada. afirth5@uwo.ca.ORCID http://orcid.org/0000-0002-8502-6204
Stability Group
Western University · CAFowler Kennedy Sport Medicine Clinic · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of anterior cruciate ligament reconstruction (ACLR) is to restore stability to the knee. Persistent rotational laxity following ACLR has been correlated with poor outcome and graft failure. We hypothesize that anterolateral complex reconstruction by way of a Modified Lemaire Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. We will conduct a pragmatic, multicenter, randomized clinical trial comparing standard single bundle hamstring ACLR with combined ACLR and LET.

methodsSix-hundred patients (300 per group) aged 25 years or less with an ACL deficient knee that meet two of the following three criteria will be included: 1) Grade 2 pivot shift or greater; 2) Returning to high risk cutting or pivoting sports; 3) Generalized ligamentous laxity. Participants will be seen at 3-months, 6-months, 12-months and 24-months post-operatively. The primary outcome measure is graft failure requiring revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift indicating persistent rotational laxity. Patients will complete secondary outcome measures at each follow-up visit including patient-reported outcome measures, functional and biomechanical testing, and magnetic resonance imaging. DISCUSSION: This protocol is the first adequately powered randomized clinical trial investigating the effects of augmenting ACLR with an LET in patients at high-risk of graft failure. The successful completion of this trial has the potential to change surgical practice and provide evidence for the role of the LET in ACLR.

trial registrationThe trial is registered at ClinicalTrials.gov: NCT02018354 , 23-12-2013.

Indexed as

AdolescentAdultAnterior Cruciate LigamentAnterior Cruciate Ligament InjuriesAnterior Cruciate Ligament ReconstructionFemaleHamstring TendonsHumansMaleMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTenodesisTransplantation, AutologousTreatment FailureYoung AdultAnterior cruciate ligament (ACL) repairAnterolateral ligamentOrthopaedicsTenodesis

Identifiers

PMID31092226
PMCPMC6521537
OpenAlexW2947670564

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.