Evidence map›Paper›PMID 28776134›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2018

A randomized double-blinded clinical trial to evaluate the safety and efficacy of a novel superelastic nickel-titanium spinal rod in adolescent idiopathic scoliosis: 5-year follow-up.

Jason Pui Yin Cheung, Dino Samartzis, Kelvin Yeung, Michael To, Keith Dip Kei Luk, Kenneth Man-Chee Cheung

Abstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Contactless treatment for scoliosis by electromagnetically controlled shape-memory alloy rods: a preliminary study in rabbits.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2020
    Article
  9. Review
  10. 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

6 authors.

Jason Pui Yin CheungDepartment of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.ORCID 0000-0002-7052-0875
Dino SamartzisDepartment of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.
Kelvin YeungDepartment of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.
Michael ToDepartment of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.
Keith Dip Kei LukDepartment of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.
Kenneth Man-Chee CheungDepartment of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China. cheungmc@hku.hk.

Funding

Hong Kong Innovation Technology Fund Tier 2 Grant GHP 019/05Hong Kong Research Grants Council HKU 7283/00MScoliosis Research Society 9667002
6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of a superelastic shape-memory alloy (SNT) rod used in the treatment of adolescent idiopathic scoliosis (AIS).

methodsAIS Patients with Lenke 1 curves undergoing fusion surgery were randomized (1:1) at the time of surgery to receive either the SNT or a conventional titanium alloy (CTA) rod. Radiographs were obtained preoperatively and postoperatively up to 5 years of follow-up. Parameters assessed included coronal and sagittal Cobb angles, and overall truncal and shoulder balance. Sagittal profiles were subcategorized into Types A (<20°), B (20-40°), and C (>40°).

resultsTwenty-four patients with mean age of 15 years were recruited. A total of 87.0% of subjects were followed up till postoperative 5 years, but all patients had minimum 2 years of follow-up. The fulcrum-bending correction index for the SNT group was 113% at postoperative day 4 and 127% at half-year, while the CTA group was 112% at postoperative day 4 and only 106% at half-year. In terms of sagittal profile, the SNT group moved toward type B profile at half-year follow-up with a mean correction of 7.6°, while no significant change was observed in the CTA group (-0.7°). Nickel levels remained normal, and there were no complications.

conclusionsThis is the first randomized clinical trial of a novel SNT rod for treating patients with AIS, noting it to be safe and has potential to gradually correct scoliosis over time. This study serves as a pilot and platform to properly power future large-scale studies to demonstrate efficacy and superiority.

Indexed as

Bone NailsAdolescentAlloysDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleNickelPostoperative PeriodProsthesis DesignRadiographyResearch DesignScoliosisSpinal FusionThoracic VertebraeAlloysNickelTitaniumtitanium nickelideAdolescent idiopathic scoliosisNickelRodSuperelasticTitanium

Identifiers

PMID28776134

What OpenQuestion holds

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Registered trials

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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.