ArticleJournal of orthopaedic surgery and research2019
Comparison of synthetic bone graft ABM/P-15 and allograft on uninstrumented posterior lumbar spine fusion in sheep.
Article in Journal of orthopaedic surgery and research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05038527 (ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial), which is not on this map. Cited by 17 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.
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial
Who cites it
17 citing papers in PubMed, 26 citations in OpenAlex.
- Occurrence of ectopic ossification around the surgical site after using of ABM/P-15 in anterior cervical discectomy and fusion.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 · 2026Article
- A novel growth factor bioavailability-enhanced allograft for use in craniomaxillofacial bone regeneration.Frontiers in bioengineering and biotechnology · 2026Article
- Orthobiologics in spine surgery: a narrative review.Journal of spine surgery (Hong Kong) · 2025Review
- Transforming spinal surgery with innovations in biologics and additive manufacturing.Materials today. Bio · 2025Review
- First steps in the development of an ovine proximal phalanx fracture and bone defect model: a study of animal welfare and bone healing.Frontiers in veterinary science · 2025Article
- Biomimetic Porous Ti6Al4V Implants: A Novel Interbody Fusion Cage via Gel-Casting Technique to Promote Spine Fusion.Advanced healthcare materials · 2024Article
- Article
- The Osteogenic Peptide P-15 for Bone Regeneration: A Narrative Review of the Evidence for a Mechanism of Action.Bioengineering (Basel, Switzerland) · 2024Review
- Efficacy and Outcome Measurement of iFactor/ABM/P-15 in Lumbar Spine Surgery: A Systematic Review.Global spine journal · 2024Review
- 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.Global spine journal · 2024Article
- Advances in Synthetic Grafts in Spinal Fusion Surgery.International journal of spine surgery · 2023Article
- A Pre-clinical Standard Operating Procedure for Evaluating Orthobiologics in anJournal of orthopaedics and sports medicine · 2022Article
- Is a Block of the Femoral and Sciatic Nerves an Alternative to Epidural Analgesia in Sheep Undergoing Orthopaedic Hind Limb Surgery? A Prospective, Randomized, Double Blinded Experimental Trial.Animals : an open access journal from MDPI · 2021Article
- Clinical and radiographic outcomes of hybrid graft in patients with Modic changes undergoing transforaminal lumbar interbody fusion.Journal of orthopaedic surgery and research · 2021Article
- Three Decades of Research on Recombinant Collagens: Reinventing the Wheel or Developing New Biomedical Products?Bioengineering (Basel, Switzerland) · 2020Review
- Ceramic Biologics for Bony Fusion-a Journey from First to Third Generations.Current reviews in musculoskeletal medicine · 2020Review
- Pre-Clinical Evaluation of Biological Bone Substitute Materials for Application in Highly Loaded Skeletal Sites.Biomolecules · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpinal fusion is a commonly used procedure in spinal surgery. To ensure stable fusion, bone graft materials are used. ABM/P-15 (commercial name i-Factor™ Flex) is an available synthetic bone graft material that has CE approval in Europe. This peptide has been shown to improve bone formation when used in devices with fixation or on bone defects. However, the lack of external stability and large graft size make posterolateral lumbar fusion (PLF) a most challenging grafting procedure. This prospective randomized study was designed to evaluate early spinal fusion rates using an anorganic bovine-derived hydroxyapatite matrix (ABM) combined with a synthetic 15 amino acid sequence (P-15)-ABM/P-15 bone graft, and compared with allograft in an uninstrumented PLF model in sheep. The objective of this study was to assess fusion rates when using ABM/P-15 in uninstrumented posterolateral fusion in sheep.
methodsTwelve Texas/Gotland mixed breed sheep underwent open PLF at 2 levels L2/L3 and L4/L5 without fixation instruments. The levels were randomized so that sheep received an ABM graft either with or without P15 coating. Sheep were euthanized after 4.5 months and levels were harvested and evaluated with a micro-CT scanner and qualitative histology. Fusion rates were assessed by 2D sections and 3D reconstruction images and fusion was defined as intertransverse bridging.
resultsThere was 68% fusion rate in the allograft group and an extensive migration of graft material was noticed with a fusion rate of just 37% in the ABM/P-15 group. Qualitative histology showed positive osteointegration of the material and good correlation to scanning results.
conclusionsIn this PLF fusion model, ABM/P15 demonstrated the ability to migrate when lacking external stability. Due to this migration, reported fusion rates were significantly lower than in the allograft group. The use of ABM/P15 as i-Factor™ Flex may be limited to devices with fixation and bone defects.
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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.