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 Society2017
Herniectomy versus herniectomy with the DIAM spinal stabilization system in patients with sciatica and concomitant low back pain: results of a prospective randomized controlled multicenter trial.
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, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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
4 citing papers in PubMed.
- 15-year survivorship analysis of an interspinous device in surgery for single-level lumbar disc herniation.BMC musculoskeletal disorders · 2021Article
- Generalizing the results: how can we improve our reports?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 · 2018Article
- 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 · 2018Review
- Finite element simulation and clinical follow-up of lumbar spine biomechanics with dynamic fixations.PloS one · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo investigate the short and medium term efficacy and patient outcomes of DIAM spinal stabilization system on back pain, disability, leg pain and quality of life.
methods165 patients were enrolled; 146 patients with a single level disc herniation (L2 to L5) were randomized: 75 investigational (herniectomy and DIAM) and 71 control (herniectomy alone) treated and followed up for 24 months.
resultsSignificant improvements overtime (P < 0.001) in both groups but not significantly different between groups for visual analog scale (VAS) back pain at 6 months (investigational -3.97 ± 2.55 vs control-3.37 ± 3.15, P = 0.228) and Oswestry Disability Index (ODI) at 12 months (-38.55 ± 20.10 vs -37.19 ± 22.61, P = 0.719). For both outcomes, there was no statistically significant difference between the groups, at all postoperative time points. Although the enrolment ended before the intended sample size (308 patients) was reached, the number of patients reaching the VAS back pain minimally clinically important difference (MCID) of ≥2.2 at 6 months was higher in the investigational (79.4 % vs control 57.1 %, P = 0.008). These results were sustained throughout 24 months (82.8 vs 64.4 %, P < 0.05). In average, surgical duration (P < 0.001), blood loss (P = 0.029) and skin incision (P < 0.001) in the investigational were 10 min longer, 22.5 ml greater and 2.0 cm wider than control group (median values). Improved tertiary outcomes from BL to 24 mo in both groups (investigational vs control): VAS leg pain (mean decrease -6.41 ± 2.57 to -6.41 vs -5.61 ± to -3.30); improved quality of life (SF-36: 20.68 ± 9.44 vs 16.90 ± 10.74); pain medication reduction: 56.7 vs 47.9 %; return to work: 45.7 vs 38.0 %. Adverse event rates: 68.5 % investigational and 66.2 % control.
conclusionsThis is the first randomized controlled trial to report equivalent efficacy and safety of herniectomy with or without DIAM spinal stabilizing device. Leg pain, back pain and the level of disability were not significantly different between groups; however, number of patients reaching the MCID for back pain was significantly higher in the investigational group at 6 through 24 months.
Indexed as
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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.