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 Society2014
A prospective randomised controlled trial to assess the efficacy of dynamic stabilisation of the lumbar spine with the Wallis ligament.
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, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 5 of them syntheses that pooled 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.
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
12 citing papers in PubMed, 5 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Surgical interventions for degenerative lumbar spinal stenosis: a systematic review with network meta-analysis.BMC medicine · 2024Pooled it
- Is the interspinous process device safe and effective in elderly patients with lumbar degeneration? A systematic review and meta-analysis of randomized controlled trials.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 · 2024Pooled it
- Interspinous process devices for treatment of degenerative lumbar spine stenosis: A systematic review and meta-analysis.PloS one · 2018Pooled it
- Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials.Neurosurgical review · 2017Pooled it
- Surgical options for lumbar spinal stenosis.The Cochrane database of systematic reviews · 2016Pooled it
- Efficacy and Safety of the Use of Interspinous Spacers in the Treatment of Lumbar Spinal Stenosis: Mapping Gap and Scoping Review.Pain practice : the official journal of World Institute of Pain · 2026Article
- Analysis of Long-Term Results of Lumbar Discectomy With and Without an Interspinous Device.International journal of spine surgery · 2022Article
- Application of the IntraSPINE® interlaminar device in patients with osteoporosis and spinal stenosis: two case reports.The Journal of international medical research · 2021Article
- Decompression Surgery versus Interspinous Devices for Lumbar Spinal Stenosis: A Systematic Review of the Literature.Asian spine journal · 2020Article
- Interspinous implants: are the new implants better than the last generation? A review.Current reviews in musculoskeletal medicine · 2017Review
- Change of sagittal spinal alignment and its association with pain and function after lumbar surgery augmented with an interspinous implant.Scoliosis and spinal disorders · 2017Article
- Interspinous process spacers versus traditional decompression for lumbar spinal stenosis: systematic review and meta-analysis.Journal of spine surgery (Hong Kong) · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis prospective randomised control study is to demonstrate whether or not there is a clinical benefit from inserting a Wallis implant on the functional recovery of patients who have undergone lumbar decompression surgery.
methodSixty consecutive patients with an average age of 58 years (34-81) who were selected for primary lumbosacral decompression were randomly assigned into two groups with equal number of patients, decompression alone or decompression with Wallis implant. The patients had an average follow-up of 40 months. Patients were assessed by visual analogue scale (VAS) (Boonstra et al., Int J Rehabil Res 31:165-169, 2008; Price et al., Pain 17:45-56, 1983) pain score for back and leg pain, and the Oswestry Disability Index questionnaire (ODI) (Smeets et al., Arthritis Care Res (Hoboken) 63:S158-S173, 2011).
resultsThe results in both the groups did not reveal a significant difference in the clinical outcome assessment of back pain score or ODI. With the Wilcoxon two-sample test, no difference in median values was achieved (p value 0.0787 for ODI and p value 0.1926 for back pain). The average ODI in the Wallis group dropped from 50.93 to 29.11. The average VAS for the Wallis group back pain dropped from 7.79 to 4.22.
conclusionThe Wallis implant is a safe medical device. This study revealed a reduction in pain and functional disability in patients treated with decompression surgery for lumbar stenosis, with or without Wallis. The Wallis group improved more, but it was not statistically significant. The risk of complications is lower than other interspinous devices.
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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.