Evidence map›Paper›PMID 27061727›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 Society2016

Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT).

Jarle Sundseth, Eva Astrid Jacobsen, Frode Kolstad, Ruth O Sletteberg, Oystein P Nygaard, Lars Gunnar Johnsen, Are Hugo Pripp, Hege Andresen, Oddrun Anita Fredriksli, Erling Myrseth and 1 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled 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, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00735176 (Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT00735176 nacompletednot on this map

Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2008 to 2017Enrolled136ConditionsRadiculopathy, CervicalArmsCervical arthroplasty, Anterior cervical discectomy and fusion (ACDF)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.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 · 2017
    Trial
  4. Article
  5. Unintended fusion in cervical artificial disk replacement: a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up.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 · 2021
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Heterotopic ossification is related to change in disc space angle after Prestige-LP cervical disc arthroplasty.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 · 2019
    Article
  12. Review
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Jarle SundsethDepartment of Neurosurgery, Oslo University Hospital Rikshospitalet, Postboks 4950, Nydalen, 0424, Oslo, Norway. jsundset@ous-hf.no.
Eva Astrid JacobsenDepartment of Neuroradiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Frode KolstadDepartment of Neurosurgery, Oslo University Hospital Rikshospitalet, Postboks 4950, Nydalen, 0424, Oslo, Norway.
Ruth O SlettebergDepartment of Neuroradiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Oystein P NygaardNational Advisory Unit of Spinal Disorders, University Hospital of Trondheim (St Olavs Hospital HF), Trondheim, Norway.
Lars Gunnar JohnsenNational Advisory Unit of Spinal Disorders and Department of Orthopaedic Surgery, Clinic of Orthopaedics and Rheumatology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Are Hugo PrippDepartment of Biostatistics, Epidemiology and Health Economics, Oslo University Hospital, Oslo, Norway.
Hege AndresenNational Advisory Unit of Spinal Disorders, University Hospital of Trondheim (St Olavs Hospital HF), Trondheim, Norway.
Oddrun Anita FredriksliDepartment of Neurosurgery, University Hospital of Trondheim (St Olavs Hospital HF), Trondheim, Norway.
Erling MyrsethDepartment of Neurosurgery, Haukeland University Hospital, Bergen, Norway.
John A ZwartDepartment of Neuroradiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Oslo University Hospital · NOSt Olav's University Hospital · NOHaukeland University Hospital · NONorwegian University of Science and Technology · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHeterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery.

methodsThirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0-4). The patients were divided by level of ossification, low grade (0-2) or high grade (3-4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures.

resultsHeterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3-4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification.

conclusionHigh-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.

Indexed as

AdultArthroplastyCervical VertebraeFemaleFollow-Up StudiesHumansMaleMiddle AgedNeck PainOssification, HeterotopicProstheses and ImplantsProsthesis DesignQuality of LifeRadiculopathySeverity of Illness IndexSingle-Blind MethodArthroplastyCervicalFusionHeterotopic ossificationOutcome

Identifiers

PMID27061727
OpenAlexW2326387656

What OpenQuestion holds

Textmetadata
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.