Evidence map›Paper›PMID 33372080›Full record

ArticleBMJ open2020

Clinical outcomes and cost-utility of rotator cuff repair surgery by open and arthroscopic techniques: study protocol for a randomised clinical trial.

Rafael Pierami, Eliane Antonioli, Isadora Oliveira, Isabela Queirós Castro, Felipe Manente, Paula Fairbanks, Eduardo da Frota Carrera, Bruno Akio Matsumura, Mario Lenza

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04146987 (Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 41% 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.

NCT04146987 naunknown statusnot on this map

Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2020 to 2022Enrolled100ConditionsRotator Cuff Injuries, Shoulder Pain, Shoulder Impingement, Shoulder InjuriesArmsRotator cuff repair surgery
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

9 authors at 1 institution in 1 country.

Rafael PieramiDepartamento de Ortopedia, Grupo de Ombro e Cotovelo do Hospital Alvorada Moema, Sao Paulo, Sao Paulo, Brazil rafael_pierami@hotmail.com.ORCID 0000-0002-1745-4362
Eliane AntonioliPrograma Locomotor, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.ORCID 0000-0002-8563-877X
Isadora OliveiraPrograma Locomotor, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Isabela Queirós CastroPrograma Locomotor, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Felipe ManenteFaculdade Israelita de Ciências da Saúde Albert Einstein, Sao Paulo, SP, Brazil.
Paula FairbanksFaculdade Israelita de Ciências da Saúde Albert Einstein, Sao Paulo, SP, Brazil.
Eduardo da Frota CarreraDepartamento de Ortopedia, Grupo de Ombro e Cotovelo do Hospital Alvorada Moema, Sao Paulo, Sao Paulo, Brazil.
Bruno Akio MatsumuraDepartamento de Ortopedia, Grupo de Ombro e Cotovelo do Hospital Alvorada Moema, Sao Paulo, Sao Paulo, Brazil.
Mario LenzaPrograma Locomotor, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Hospital Israelita Albert Einstein · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRotator cuff injuries account for up to 70% of pain in the shoulder. However, there remains no consensus on the best surgical treatment for patients with rotator cuff injuries, in terms of the cost-effectiveness and cost-utility of open and arthroscopic methods for rotator cuff repair. The objective of this trial is to compare the efficacy, cost-effectiveness and cost-utility of open and arthroscopic procedures for rotator cuff repair. METHODS AND ANALYSIS: The trial is a two-group, parallel-design, randomised controlled trial. A total of 100 patients with symptomatic rotator cuff lesions will be allocated in either open or arthroscopic technique in a 1:1 ratio, considering smoking (yes or no), lesion size (≤3 cm or >3 cm) and diabetes (present or absent) as stratification factors. All patients will be included in the same rehabilitation programme after the intervention. The primary outcome measure will be the Constant-Murley Score and the EuroQol-5D-3L score at 48 weeks postsurgery. Secondary outcomes include cost-effectiveness, cost-utility, pain, complications and clinical analysis, using the Simple Shoulder Test, Visual Analogue Pain Scale (VAS), integrity of the repair evaluated through MRI, and complications and failures of the proposed methods. For the cost-effectiveness analysis, we will use the VAS and the Constant-Murley Score as measures of effectiveness. For the cost-utility analysis, we will use the EuroQol-5D-3L as a measure of utility in terms of incremental cost per quality-adjusted life-years. ETHICS AND DISSEMINATION: The study has been approved by the local research ethics committee of both institutions: Hospital Israelita Albert Einstein and Hospital Alvorada Moema/Hospital Pró-Cardíaco. The results will be published in a peer-reviewed, open access journal. TRIAL REGISTRATION NUMBER: NCT04146987.

Indexed as

Rotator CuffRotator Cuff InjuriesArthroscopyHumansQuality-Adjusted Life YearsRandomized Controlled Trials as TopicShoulderTreatment Outcomeadult orthopaedicselbow & shouldermusculoskeletal disordersorthopaedic sports traumashoulder

Identifiers

PMID33372080
PMCPMC7772301
OpenAlexW3114107454

What OpenQuestion holds

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LicenceCC BY-NC
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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.