Evidence map›Paper›PMID 37586862›Full record

ArticleBMJ open2023

Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK).

Laurens Jan Houterman Allaart, James Lech, Arno Alexander Macken, Agathe Kling, Laurent Lafosse, Thibault Lafosse, Michel P J van den Bekerom, Geert Alexander Buijze

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04618484 (Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04618484 naunknown statusnot on this map

Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?

TypeinterventionalSponsorClinique Générale dAnnecyRan2021 to 2024Enrolled146ConditionsRotator Cuff TearsArmsBiomodulation (non-pharmacological)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

8 authors.

Laurens Jan Houterman Allaart *Division of Orthopaedics and Trauma Surgery, Clinique Générale Annecy, Annecy, France laurensallaart@gmail.com.ORCID 0000-0002-7211-183X
James Lech *Radiology, Universiteit van Amsterdam, Amsterdam, The Netherlands.
Arno Alexander MackenDivision of Orthopaedics and Trauma Surgery, Clinique Générale Annecy, Annecy, France.ORCID 0000-0002-7513-7437
Agathe KlingDivision of Orthopaedics and Trauma Surgery, Clinique Générale Annecy, Annecy, France.
Laurent LafosseDivision of Orthopaedics and Trauma Surgery, Clinique Générale Annecy, Annecy, France.
Thibault LafosseDivision of Orthopaedics and Trauma Surgery, Clinique Générale Annecy, Annecy, France.
Michel P J van den BekeromDepartment of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-5146-6148
Geert Alexander BuijzeDivision of Orthopaedics and Trauma Surgery, Clinique Générale Annecy, Annecy, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PURPOSE/

introductionOver the last decades, there has been increasing interest in biological stimulation or bioaugmentation after rotator cuff repair. So far, there is no consensus on the appropriate composition of biologicals or which patients would benefit most, and moreover, these biologicals are often expensive. However, there are other, non-pharmacological strategies that are also believed to achieve biological stimulation. This randomised controlled trial evaluates the possible cumulative effect of pragmatic application of cryobiomodulation, photobiomodulation and electrobiomodulation-collectively called biomodulation-on the bone-to-tendon healing process after rotator cuff repair.

methodsIn this randomised, controlled proof of concept study, 146 patients undergoing arthroscopic repair of a full thickness posterosuperior or anterosuperior rotator cuff tear will be 1:1 randomly assigned to either a control group or to the additional biomodulation protocol group. The adjuvant biomodulation protocol consists of seven self-applicable therapies and will be administered during the first 6 weeks after surgery. Primary outcome will be healing of the rotator cuff as evaluated by the Sugaya classification on MRI at 1-year postoperatively. ETHICS AND DISSEMINATION: This study has been accepted by the National Ethical Review Board CPP Sud-Est IV in France and has been registered at Clinicaltrials.gov. The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04618484.

Indexed as

Biological ProductsRotator CuffArthroplastyConsensusHumansPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRotator Cuff InjuriesBiological ProductsOrthopaedic sports traumaORTHOPAEDIC & TRAUMA SURGERYREHABILITATION MEDICINE

Identifiers

PMID37586862
PMCPMC10432644

What OpenQuestion holds

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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.