ArticleGlobal spine journal2024
Safety and Reoperation Rates in Non-instrumented Lumbar Fusion Surgery: Secondary Report From a Randomized Controlled Trial of ABM/P-15 vs Allograft With Minimum 5 years Follow-Up.
Article in Global spine journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed, 5 citations in OpenAlex.
- Trial
- Comparative Efficacy and Safety of Osteobiologics in Posterior Lumbar Fusion: A Network Meta-Analysis of Randomized Controlled Trials.Global spine journal · 2026Review
- Article
- Two-Year Radiological Fusion Outcomes Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion Using Banana-Shaped Interbody Cages.Journal of clinical medicine · 2025Article
- Efficacy and Outcome Measurement of iFactor/ABM/P-15 in Lumbar Spine Surgery: A Systematic Review.Global spine journal · 2024Review
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
designRandomized controlled trial with minimum of 5-years follow-up.
objectiveThe purpose of this study is to evaluate the peri- and postoperative complications rates, ectopic bone migration, and reoperation rates, and secondly evaluate the 5-year patient reported outcomes (PROs), in patients treated with decompression and non-instrumented posterolateral fusion with ABM/P-15 or allograft.
methodsPatients with degenerative spondylolisthesis were enrolled in a Randomized Clinical Trial and randomized 1:1 to either ABM/P-15 or allograft bone. Patient Reported Outcomes were collected at 5-year follow-up, and patients were invited to a clinical follow-up including a computed tomography scan (CT) to evaluate signs of osteolysis, ectopic bone formation, and bone migration.
resultsOf 101 subjects enrolled in the primary study, 83 patients were available for the 5-year follow-up. We found a statistically significant difference in back pain and Oswestry Disability Index between groups. Fifty-eight patients agreed to participate in the CT study. Sixty percentage in the ABM/P-15 group vs 30% in the allograft group was classified as fused (
conclusionOur study indicated that complication rates are no higher in patients treated with ABM/P-15 than allograft. We found significantly higher fusion rates in the AMB/P-15 group than in the allograft group, and patients in the ABM/P-15 group reported less back pain and lower disability score at 5-year follow-up.
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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.