Trial reportThe Journal of bone and joint surgery. American volume2016
OP-1 Compared with Iliac Crest Autograft in Instrumented Posterolateral Fusion: A Randomized, Multicenter Non-Inferiority Trial.
Trial report in The Journal of bone and joint surgery. American volume, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 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
20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Pooled it
- Efficacy and safety of bone substitutes in lumbar spinal fusion: a systematic review and network 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 · 2020Pooled it
- A meta-analysis of bone morphogenetic protein-2 versus iliac crest bone graft for the posterolateral fusion of the lumbar spine.Journal of bone and mineral metabolism · 2020Pooled it
- rhBMP in lumber fusion for lumbar spondylolisthesis: A systematic review and meta-analysis.Chinese journal of traumatology = Zhonghua chuang shang za zhi · 2019Pooled it
- Comparison of the use of rhBMP-7 versus iliac crest autograft in single-level lumbar fusion: a meta-analysis of randomized controlled trials.Journal of bone and mineral metabolism · 2018Pooled it
- Long-term (> 10 years) clinical outcomes of instrumented posterolateral fusion for spondylolisthesis.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 · 2021Trial
- Trial
- Comparative Efficacy and Safety of Osteobiologics in Posterior Lumbar Fusion: A Network Meta-Analysis of Randomized Controlled Trials.Global spine journal · 2026Review
- Bone Grafts: Everything You Need to Know.Journal of periodontal research · 2026Review
- Intervertebral disc degeneration.Nature reviews. Disease primers · 2026Review
- Comparative Effectiveness of Microdecompression Alone vs Decompression Plus Instrumented Fusion in Lumbar Degenerative Spondylolisthesis.JAMA network open · 2020Article
- Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.Global spine journal · 2020Article
- Xeno-Hybrid Bone Graft Releasing Biomimetic Proteins Promotes Osteogenic Differentiation of hMSCs.Frontiers in cell and developmental biology · 2020Article
- Harvest of Iliac Crest Autograft Not Associated With Localized Pain.International journal of spine surgery · 2019Article
- Bone marrow aspirate concentrate with cancellous allograft versus iliac crest bone graft in the treatment of long bone nonunions.OTA international : the open access journal of orthopaedic trauma · 2019Article
- Bone morphogenic proteins are a good choice for select spinal surgeries and merit further research.Journal of spine surgery (Hong Kong) · 2017Article
- Osseous differentiation of human fat tissue grafts: From tissue engineering to tissue differentiation.Scientific reports · 2017Article
- Use of OP-1 (rhBMP-7) in posterolateral lumbar arthrodesis.Journal of spine surgery (Hong Kong) · 2016Article
- Bio-augmented spinal fusion-the best is yet to come.Journal of spine surgery (Hong Kong) · 2016Article
- Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies.International journal of spine surgery · 2016Article
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Authors and funding
14 authors at 11 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpinal fusion with the use of autograft is a commonly performed procedure. However, harvesting of bone from the iliac crest is associated with complications. Bone morphogenetic proteins (BMPs) are extensively used as alternatives, often without sufficient evidence of safety and efficacy. The purpose of this study was to investigate non-inferiority of osteogenic protein-1 (OP-1, also known as BMP-7) in comparison with iliac crest bone graft in posterolateral fusions.
methodsThis study was a randomized, controlled multicenter trial. Patients who underwent a single-level instrumented posterolateral fusion of the lumbar spine for degenerative or isthmic spondylolisthesis with symptoms of neurological compression were randomized to receive OP-1 combined with local bone (OP-1 group) or autologous bone graft from the iliac crest combined with local bone (autograft group). The primary outcome was overall success, defined as a combination of clinical success and evidence of fusion on computed tomography (CT) scans, at one year postoperatively.
resultsOne hundred and nineteen patients were included in the study, and analysis of the overall outcome was performed for 113. Non-inferiority of OP-1 compared with iliac crest autograft was not found at one year, with a success rate of 40% in the OP-1 group versus 54% in the autograft group (risk difference = -13.3%, 90% confidence interval [CI] = -28.6% to +2.10%). This was due to the lower rate of fusion (the primary aim of OP-1 application) seen on the CT scans in the OP-1 group (54% versus 74% in the autograft group, p = 0.03). There were no adverse events that could be directly related to the use of OP-1.
conclusionsOP-1 with a collagen carrier was not as effective as autologous iliac crest bone for achieving fusion and cannot be recommended in instrumented posterolateral lumbar fusion procedures. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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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.