ArticleJournal of orthopaedics
Evaluation of DIAM™ Spinal Stabilization System for lower lumbar disc degenerative disease: A randomized, prospective, single-site study.
Article in Journal of orthopaedics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed, 4 citations in OpenAlex.
- Biomechanical Effect of Hybrid Dynamic Stabilization Implant on the Segmental Motion and Intradiscal Pressure in Human Lumbar Spine.Bioengineering (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the efficacy of DIAM Spinal Stabilization System compared with nonoperative treatment for patients with low back pain and lower lumbar disc degenerative disease.
methodsA single center collected prospective outcomes data on 38 patients randomized to an interspinous device or non-operative treatment for symptomatic lumbar degenerative disc disease with treatment crossover allowed at 6 months.
resultsAt all postoperative timepoints out to 2-years, statistically significant improvements in ODI and back pain scores were observed with the interspinous device. Clinically significant improvements (ODI >15-point improvement) were seen in 87.5% of DIAM patients at 2-years postoperatively. A high cross-over rate was noted from the non-operative cohort to the operative group (12 of 15) due to continued pain with nonoperative care. Additionally, 80% of patients receiving the DIAM implant reported a >15-point ODI reduction from pre-surgical scores at 2-year follow-up.
conclusionThe DIAM device demonstrates improvement in ODI and Back Pain scores maintained out to a 2-year follow-up timepoint and performed superior to conventional nonoperative treatment regimens commonly used in low back pain.
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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.