Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery

Jacobsen, Mikkel; Andresen, Andreas Duch Killerich; Jespersen, Annette Bennedsgaard; Støttrup, Christian; Carreon, Leah Y.; Overgaard, Søren; Andersen, Mikkel

doi:10.1016/j.spinee.2020.01.009

Cited by 20 publications

(21 citation statements)

References 32 publications

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“…On the other hand, Jacobsen et al [ 14 ] conducted a randomised controlled trial comparing the fusion rates in elderly Scandinavian population treated with non-instrumented ALIF using allografts and ABM/P-15. They found that at 1 year post surgery, the rate of fusion in the ABM/P-15 group was 50% while that in the allograft group was 20%.…”

Section: Discussionmentioning

confidence: 99%

Comparative Analysis of ABM/P-15, Bone Morphogenic Protein and Demineralized Bone Matrix after Instrumented Lumbar Interbody Fusion

Sathe

Lee

Kim

et al. 2022

J Korean Neurosurg Soc

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Objective : ABM/P-15 (anorganic bone matrix/15-amino acid peptide fragment) is a commercially available synthetically manufactured P-15 collagen peptide fragment, that is adsorbed on ABM. This study was done to investigate the efficacy of ABM/ P-15 in achieving fusion in the lumbar spine and comparing it with that of recombinant bone morphogenic protein-2 (rhBMP-2) and demineralized bone matrix (DBM).Methods : A retrospective observational study of prospectively collected data of 140 patients who underwent lumbar spinal fusion surgeries in a single specialty spine hospital between 2016 and 2020, with a minimum 6-month follow-up was conducted. Based on the material used for the augmentation of the bone graft at the fusion site, the patients were divided into three categories namely ABM/P-15, rhBMP-2, and DBM group.Results : ABM/P-15, rhBMP-2, and DBM were used in 46, 44, and 50 patients, respectively. Patient characteristics like age, gender, bone mineral density, smoking history, and presence of diabetes mellitus were comparable amongst the three groups. Average follow-up was 16.0±5.2, 17.9±9.8, and 26.2±14.9 months, respectively in ABM/P-15, rhBMP-2, and DBM groups. The fusion was achieved in 97.9%, 93.2%, and 98% patients while the average time-to-union was 4.05±2.01, 10±4.28, and 9.44±3.49 months (p<0.001), respectively for ABM/P-15, rhBMP-2, and DBM groups. The average pre-operative Visual analogue scale score was 6.93±2.42, 7.14±1.97, 7.01±2.14 (p=0.900) for ABM/P-15, rhBMP-2 and DBM groups, respectively, which reduced to 1.02±0.80, 1.21±0.96, and 0.54±0.70 (p=0.112), respectively at the last follow up. Pre-operative Oswestry disability index scores were 52.7±18.02, 55.4±16.8, and 53.56±19.6 (p=0.751) in ABM/P-15, rhBMP-2, and DBM groups, which post-operatively reduced to 33.77±15.52, 39.42±16.47, and 38.3±15.89 (p=0.412) and further to 15.74±8.3, 17.41±10.45, and 16.76±9.81 (p=0.603), respectively at the last follow-up.Conclusion : ABM/P-15 appears to achieve union significantly earlier than rhBMP-2 and DBM in lumbar spinal fusion cases while maintaining a comparable clinical and complication profile.

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Section: Discussionmentioning

confidence: 99%

Comparative Analysis of ABM/P-15, Bone Morphogenic Protein and Demineralized Bone Matrix after Instrumented Lumbar Interbody Fusion

Sathe

Lee

Kim

et al. 2022

J Korean Neurosurg Soc

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“…i-FACTOR has already demonstrated safety and improved outcomes compared to local autograft. 11,[13][14][15] This comprehensive cost-effective analysis was the critical next and necessary step, providing clear support for a better alternative to autograft. The evolution of ACDF has been remarkable.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery

Thaçi¹,

Yee²,

Kim³

et al. 2021

CEOR

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We conducted decision analytical modeling using a Markov model to determine the ICER of i-factor compared to autograft in ACDF surgery. Objective: The efficacy and safety of traditional anterior cervical discectomy and fusion (ACDF) surgery has improved with the introduction of new implants and compounds. Costeffectiveness of these innovations remains an often-overlooked aspect of this effort. To evaluate the cost-effectiveness of i-FACTOR compared to autograft for patients undergoing ACDF surgery. Methods: The patient cohort was extracted from a prospective, multicenter randomized control trial (RCT) from twenty-two North American centers. Patients randomly received either autograft (N = 154) or i-Factor (N = 165). We analyzed various real-world scenarios, including inpatient and outpatient surgical settings as well as private versus public insurances. Two primary outcome measures were assessed: cost and utility. In the base-case analysis, both health and societal system costs were evaluated. Health-related utility outcome was expressed in quality-adjusted life years (QALYs). Cost-effectiveness was expressed as an incremental cost-effectiveness ratio (ICER). Results: In all scenarios, i-FACTOR reduced costs within the first year by 1.4% to 2.1%. The savings proved to be incremental over time, increasing to 3.7% over an extrapolated 10 years. The ICER at 90 days was $13,333 per QALY and became negative ("dominated") relative to the control group within one year and onwards. In a threshold sensitivity analysis, the cost of i-FACTOR could theoretically be increased 70-fold and still remain cost-effective. Conclusion:The novel i-FACTOR is not only cost-effective compared to autograft in ACDF surgery but is the dominant economic strategy.

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“…Scientists also used recombinant and chemical methods to synthesize short collagen-derived peptides for research and tissue repair applications. In one example, a synthetic 15-mer peptide derived from the α1(I) chain serves as an ingredient in a material for bone repair [66,67]. Although chemical synthesis is an attractive method to produce collagen fragments, these fragments lack crucial collagen characteristics, including triple-helical conformation, modifications of proline and lysine residues, and resistance to enzymatic degradation.…”

Section: Collagen Expression Systemsmentioning

confidence: 99%

Three Decades of Research on Recombinant Collagens: Reinventing the Wheel or Developing New Biomedical Products?

Fertala

2020

Bioengineering

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Collagens provide the building blocks for diverse tissues and organs. Furthermore, these proteins act as signaling molecules that control cell behavior during organ development, growth, and repair. Their long half-life, mechanical strength, ability to assemble into fibrils and networks, biocompatibility, and abundance from readily available discarded animal tissues make collagens an attractive material in biomedicine, drug and food industries, and cosmetic products. About three decades ago, pioneering experiments led to recombinant human collagens’ expression, thereby initiating studies on the potential use of these proteins as substitutes for the animal-derived collagens. Since then, scientists have utilized various systems to produce native-like recombinant collagens and their fragments. They also tested these collagens as materials to repair tissues, deliver drugs, and serve as therapeutics. Although many tests demonstrated that recombinant collagens perform as well as their native counterparts, the recombinant collagen technology has not yet been adopted by the biomedical, pharmaceutical, or food industry. This paper highlights recent technologies to produce and utilize recombinant collagens, and it contemplates their prospects and limitations.

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Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery

Cited by 20 publications

References 32 publications

Comparative Analysis of ABM/P-15, Bone Morphogenic Protein and Demineralized Bone Matrix after Instrumented Lumbar Interbody Fusion

Comparative Analysis of ABM/P-15, Bone Morphogenic Protein and Demineralized Bone Matrix after Instrumented Lumbar Interbody Fusion

Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery

Three Decades of Research on Recombinant Collagens: Reinventing the Wheel or Developing New Biomedical Products?

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