Evidence map›Paper›PMID 26050106›Full record

Observational studyEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2015

Maverick total disc replacement in a real-world patient population: a prospective, multicentre, observational study.

Richard Assaker, Karsten Ritter-Lang, Dominique Vardon, Stéphane Litrico, Stéphane Fuentes, Michael Putzier, Jörg Franke, Peter Jarzem, Pierre Guigui, Gérard Nakach and 1 more

Open access · hybridAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study 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, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Lumbar total disc arthroplasty: outdated surgery or here to stay procedure?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
  2. [Long-Term Functional and Radiological Outcomes of Maverick].Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca · 2026
    Observational
  3. Review
  4. Review
  5. [A review on the current state of ball-on-socket type artificial lumbar disc prosthesis].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2020
    Review
  6. We Need to Talk about Lumbar Total Disc Replacement.International journal of spine surgery · 2018
    Article
  7. The Michel Benoist and Robert Mulholland yearly European Spine Journal Review: a survey of the "surgical and research" articles in the European Spine Journal, 2017.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
    Review
  8. The Michel Benoist and Robert Mulholland yearly European Spine Journal review: a survey of the "medical" articles in the European Spine Journal, 2015.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
    Article
  9. The Michel Benoist and Robert Mulholland yearly European spine journal review: a survey of the "surgical and research" articles in the European spine journal, 2015.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
    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

11 authors at 9 institutions in 3 countries.

Richard AssakerService de Neurochirurgie, Centre Hospitalier Régional Universitaire, Hôpital Roger Salengro, 2 Avenue Oscar Lambret, 59037, Lille Cedex, France, richardassaker@gmail.com.
Karsten Ritter-Lang
Dominique Vardon
Stéphane Litrico
Stéphane Fuentes
Michael Putzier
Jörg Franke
Peter Jarzem
Pierre Guigui
Gérard Nakach
Jean-Charles Le Huec
Assistance Publique – Hôpitaux de Paris · FRCharité - Universitätsmedizin Berlin · DEClinique Pasteur · FRHôpital de la Timone · FRHôpital Pasteur · FRHôpital Pellegrin · FRHôpital Roger Salengro · FRKlinikum Dortmund · DEMontreal General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeControlled trials have shown that total disc replacement (TDR) can provide pain and disability relief to patients with degenerative disc disease; however, whether these outcomes can also be achieved for patients treated in normal surgical practice has not been well documented.

methodsThis prospective, international study observed changes in disability and back pain in 134 patients who were implanted with Maverick TDR within the framework of routine clinical practice and followed for 2 years post-surgery. Primary and secondary outcomes were the differences from baseline to 6 months post-surgery in the means of the Oswestry Disability Index and the change in back pain intensity assessed on a 10-cm visual analogue scale, respectively. Mean patient age at surgery was 43 years, but ranged up to 65 years.

resultsOne hundred twenty-three patients had an implant at one level, 10 patients at two levels, and one patient at three levels. Statistically significant improvements in mean disability (-25.4) and low back pain intensity (-4.0) scores were observed at 6 months postoperatively (P < 0.0001 for both) in the hands of experienced surgeons (>10 TDRs per centre). During the study, 56 patients (42 %) experienced a complication or adverse event.

conclusionsThis is the first international observational study to report outcomes of TDR in real-world clinical settings. We showed statistically significant improvements in disability and pain scores at 6 months following Maverick TDR, which were maintained for 2 years alongside an acceptable rate of perioperative complications. The safety and tolerability shown in this observational study were comparable to those from controlled trials.

Indexed as

RegistriesAdultAgedFemaleHumansIntervertebral Disc DegenerationJoint ProsthesisLow Back PainLumbar VertebraeMaleMiddle AgedPain MeasurementPostoperative ComplicationsProspective StudiesRadiculopathyRecurrence

Identifiers

PMID26050106
OpenAlexW656268471

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.