Evidence map›Paper›PMID 39013643›Full record

ArticleBMJ open2024

Adolescent idiopathic scoliosis: a prospective randomised trial protocol comparing clinical and radiological outcomes in minimally invasive surgery versus standard posterior spinal fusion in a single-centre, the Rizzoli Orthopaedic Institute, Bologna, Italy.

Bruna Maccaferri, Giuseppe Filardo, Chiara Cini, Alessandro Gasbarrini, Francesco Vommaro

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05860673 (Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT05860673 narecruitingnot on this map

Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.

TypeinterventionalSponsorIstituto Ortopedico RizzoliRan2023 to 2032Enrolled126ConditionsAdolescent Idiopathic ScoliosisArmsmini invasive scoliosis surgery, posterior spinal fusion technique
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

5 authors.

Bruna MaccaferriSpine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy bruna.maccaferri@ior.it.ORCID 0000-0002-7224-3314
Giuseppe FilardoApplied and Translational Research Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Chiara CiniSpine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Alessandro GasbarriniSpine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Francesco VommaroSpine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMinimally invasive spine surgery (MISS) has been shown to be safe and effective in adolescent idiopathic scoliosis (AIS) correction, even though there is no consensus on which treatment provides the best results. METHODS AND ANALYSIS: The present study will be a randomised controlled trial with allocation 1:1. We will enrol 126 patients with Cobb≤70° undergoing AIS surgery. Patients will be divided into two groups, according to a randomisation list unknown to the surgeons. Group 1 will be treated with posterior spine fusion and group 2 with MISS. MISS technique: two midline noncontiguous skin incisions of 3 cm in length, 3-4 segments (6-8 pedicles screws) instrumented per skin incision, uniplanar and polyaxial pedicle screws inserted bilaterally on each side of the proximal and distal levels, rod translation manoeuvre and C-D manoeuvre performed on the distal part. Clinical and radiological follow-ups will be performed for 5 years. Values of Cobb angles degrees will be collected to study the correction rate of the structural major curve. Postoperative and preoperative anterior-posterior (AP) direct radiography will be compared with the last follow-up examination. Operative time, preoperative haemoglobin (Hb) and second postoperative day Hb, full length of hospitalisation, time to achieve verticalisation and time to remove the drainage will be recorded. Numeric Rating Scale (NRS) medium score will be assessed immediately after surgery and during the whole postoperative rehabilitation treatment to estimate pain reduction. Complications will be collected postoperatively and throughout the whole follow-up period.Moreover, questionnaires will be administered at follow-up (NRS, Scoliosis Research Society-22 and Oswestry Disability Index) for the clinical assessment. ETHICS AND DISSEMINATION: The study protocol has been approved by the local ethic committee Area Vasta Emilia Romagna Centro. Written informed consent will be collected for all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05860673.

Indexed as

Minimally Invasive Surgical ProceduresScoliosisSpinal FusionAdolescentFemaleHumansItalyMalePedicle ScrewsProspective StudiesRadiographyRandomized Controlled Trials as TopicTreatment OutcomeAdolescentScoliosisSpine

Identifiers

PMID39013643
PMCPMC11253742

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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.