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 Society2012
Influence of lumbar intervertebral disc degeneration on the outcome of total lumbar disc replacement: a prospective clinical, histological, X-ray and MRI investigation.
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, 2012. 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.
What it found
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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.
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.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Lumbar total disc arthroplasty: outdated surgery or here to stay procedure?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 · 2017Pooled it
- Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers.Journal of pain research · 2023Trial
- Optimizing success with lumbar 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 · 2014Trial
- A Self-Polymerizing Mesh of Nano-Tethers for the Mechanical Constraint of Degraded Intervertebral Discs-A Review of 25 Years of Pre-Clinical and Early Clinical Research.Bioengineering (Basel, Switzerland) · 2024Review
- Single-Level Total Disc Replacement: Index-Level and Adjacent-Level Revision Surgery Incidence, Characteristics, and Outcomes.International journal of spine surgery · 2022Article
- Validation of Pre-operative Templating for Total Disc Replacement Surgery.International journal of spine surgery · 2019Article
- We Need to Talk about Lumbar Total Disc Replacement.International journal of spine surgery · 2018Article
- ISASS Policy Statement - Lumbar Artificial Disc.International journal of spine surgery · 2015Article
- Parameters influencing the outcome after total disc replacement at the lumbosacral junction. Part 2: distraction and posterior translation lead to clinical failure after a mean follow-up of 5 years.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 · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe role of fusion of lumbar motion segments for the treatment of axial low back pain (LBP) from lumbar degenerative disc disease (DDD) without any true deformities or instabilities remains controversially debated. In an attempt to avoid previously published and fusion-related negative side effects, motion preserving technologies such as total lumbar disc replacement (TDR) have been introduced. The adequate extent of preoperative DDD for TDR remains unknown, the number of previously published studies is scarce and the limited data available reveal contradictory results. The goal of this current analysis was to perform a prospective histological, X-ray and MRI investigation of the index-segment's degree of DDD and to correlate these data with each patient's pre- and postoperative clinical outcome parameters from an ongoing prospective clinical trial with ProDisc II (Synthes, Paoli, U.S.A.). MATERIALS AND
methodsNucleus pulposus (NP) and annulus fibrosus (AF) changes were evaluated according to a previously validated quantitative histological degeneration score (HDS). X-ray evaluation included assessment of the mean, anterior and posterior disc space height (DSH). MRI investigation of DDD was performed on a 5-scale grading system. The prospective clinical outcome assessment included visual analogue scale (VAS), Oswestry Disability Index (ODI) scores as well as the patient's subjective satisfaction rates.
resultsData from 51 patients with an average follow-up of 50.5 months (range 6.1-91.9 months) were included in the study. Postoperative VAS and ODI scores improved significantly in comparison to preoperative levels (p < 0.002). A significant correlation and interdependence was established between various parameters of DDD preoperatively (p < 0.05). Degenerative changes of NP tissue samples were significantly more pronounced in comparison to those of AF material (p < 0.001) with no significant correlation between each other (p > 0.05). Preoperatively, the extent of DDD was not significantly correlated with the patient's symptomatology (p > 0.05). No negative influence was associated with increasing stages of DDD on the postoperative clinical outcome parameters following TDR (p > 0.05). Increasing stages of DDD in terms of lower DSH scores were not associated with inferior clinical results as outlined by postoperative VAS or ODI scores or the patient's subjective outcome evaluation at the last FU examination (p > 0.05). Conversely, some potential positive effects on the postoperative outcome were observed in patients with advanced stages of preoperative DDD. Patients with more severe preoperative HDS scores of NP samples demonstrated significantly lower VAS scores during the early postoperative course (p = 0.02).
conclusionIncreasing stages of DDD did not negatively impact on the outcome following TDR in a highly selected patient population. In particular, no preoperative DDD threshold value was identified from which an inferior postoperative outcome could have been deduced. Conversely, some positive effects on the postoperative outcome were detected in patients with advanced stages of DDD. Combined advantageous effects of progressive morphological structural rigidity of the index segment and restabilizing effects from larger distraction in degenerated segments may compensate for increasing axial rotational instability, one of TDR's perceived disadvantages. Our data reveal a "therapeutic window" for TDR in a cohort of patients with various stages of DDD as long as preoperative facet joint complaints or degenerative facet arthropathies can be excluded and stringent preoperative decision making criteria are adhered to. Previously published absolute DSH values as contraindication against TDR should be reconsidered.
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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.