Evidence map›Paper›PMID 19506919›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 Society2009

Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up.

Svante Berg, Tycho Tullberg, Björn Branth, Claes Olerud, Hans Tropp

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
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, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06989632 (Total Lumbar Disc Prosthesis and Subsequent Work Activity 5 Years After Total Lumbar Disc Replacement), which is not on this map. Cited by 58 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 13 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.

NCT06989632 completednot on this map

Total Lumbar Disc Prosthesis and Subsequent Work Activity 5 Years After Total Lumbar Disc Replacement

TypeobservationalSponsorUniversity of ValenciaRan2008 to 2025Enrolled130ConditionsLumbar Disc Degeneration, Lumbar Disc Disease, Sciatica, Lumbar Disc HerniationArmsTotal lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 13 syntheses or guidelines pooled it.

  1. Advanced meta-analyses comparing the three surgical techniques total disc replacement, anterior stand-alone fusion and circumferential fusion regarding pain, function and complications up to 3 years to treat lumbar degenerative disc disease.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
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Lumbar total disc arthroplasty: outdated surgery or here to stay procedure? A systematic review of current literature.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2017
    Pooled it
  5. Pooled it
  6. Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses.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
    Pooled it
  7. Adjacent segment degeneration after lumbar spinal fusion compared with motion-preservation procedures: a meta-analysis.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
    Pooled it
  8. Pooled it
  9. Adjacent segment degeneration and disease after lumbar fusion compared with motion-preserving procedures: a meta-analysis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2014
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Low back pain (chronic).BMJ clinical evidence · 2010
    Pooled it
  13. A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease.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 · 2010
    Pooled it
  14. Trial
  15. Trial
  16. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial.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 · 2013
    Trial
  17. Predictors of outcome after surgery with disc prosthesis and rehabilitation in patients with chronic low back pain and degenerative disc: 2-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 · 2012
    Trial
  18. Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-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 · 2011
    Trial
  19. Trial
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Svante BergStockholm Spine Center, Löwenströmska Hospital, 19489, Upplands Väsby, Sweden. svante.berg@spinecenter.se
Tycho Tullberg
Björn Branth
Claes Olerud
Hans Tropp

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined.

Indexed as

AdultDisability EvaluationDiskectomyFemaleFollow-Up StudiesHumansIntervertebral DiscLow Back PainLumbar VertebraeMaleMiddle AgedOutcome Assessment, Health CarePostoperative ComplicationsProspective StudiesReoperationSciatica

Identifiers

PMID19506919
PMCPMC2899375

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.