FDA-approved bone grafts and bone graft substitute devices in bone regeneration

CE Gillman, AC Jayasuriya - Materials Science and Engineering: C, 2021 - Elsevier
To induce bone regeneration there is a complex cascade of growth factors. Growth factors
such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone …

[HTML][HTML] Commercial bone grafts claimed as an alternative to autografts: Current trends for clinical applications in orthopaedics

M Govoni, L Vivarelli, A Mazzotta, C Stagni, A Maso… - Materials, 2021 - mdpi.com
In the last twenty years, due to an increasing medical and market demand for orthopaedic
implants, several grafting options have been developed. However, when alternative bone …

Management and outcomes of surgical site tuberculosis infection due to infected bone graft in spine surgery: a single-institution experience and 1-year postoperative …

LG McVeigh, MA Zaazoue, BC Lane… - … of Neurosurgery: Spine, 2022 - thejns.org
OBJECTIVE In 2021, several patients across the United States received bone allograft
contaminated with Mycobacterium tuberculosis (TB). TB is typically a pulmonary infection …

Investigating the efficacy of allograft cellular bone matrix for spinal fusion: a systematic review of the literature

RR Diaz, AR Savardekar, JR Brougham, D Terrell… - Neurosurgical …, 2021 - thejns.org
OBJECTIVE The use of allograft cellular bone matrices (ACBMs) in spinal fusion has
expanded rapidly over the last decade. Despite little objective data on its effectiveness …

[HTML][HTML] Histological evaluation of the incorporation and remodeling of structural allografts in critical size metaphyseal femur defects in rats of different ages

N Ashukina, V Maltseva, P Vorontsov… - Romanian Journal of …, 2022 - ncbi.nlm.nih.gov
Insufficient bone regeneration is a common issue for patients with extensive bone damage,
therefore the use of allografts is required. With increasing life expectancy, there is a higher …

Achieving value in spine surgery: 10 major cost contributors

LR Philipp, A Leibold, A Mahtabfar… - Global Spine …, 2021 - journals.sagepub.com
Study Design: Narrative Review. Objectives: The increasing cost of healthcare overall and
for spine surgery, coupled with the growing burden of spine-related disease and rising …

Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy …

PM Arnold, AR Vaccaro, RC Sasso, B Goulet… - …, 2023 - journals.lww.com
BACKGROUND: Previous analyses of the US Food and Drug Administration (FDA)
Investigational Device Exemption study demonstrated the superiority of i-FACTOR …

Truss implant technology™ for interbody fusion in spinal degenerative disorders: profile of advanced structural design, mechanobiologic and performance …

JP Hunt, MR Begley, JE Block - Expert review of medical devices, 2021 - Taylor & Francis
Introduction: Interbody fusion devices are customarily used in fusion of the anterior spinal
column for treatment of degenerative disc disease. Their traditional role is to reestablish and …

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products

RP Dickson, DA Dingell - JAMA, 2024 - jamanetwork.com
When Shandra Eisenga underwent an elective spine surgery in April 2023, her hope was
that it would let her spend more quality time with her grandchildren. A 57-year-old resident of …

[HTML][HTML] Bone Mineralization and Spinal Fusion Evaluation of a Truss-based Interbody Fusion Device: Ovine Finite Element Analysis with Confirmatory: In Vivo …

A Kiapour, HB Seim III, BL Atkinson, PA Lalor, JE Block - Spine, 2022 - journals.lww.com
Study Design. Finite element analysis (FEA) and in vivo ovine spinal interbody fusion study.
Objective. To determine comparative load-induced strain amplitudes, bone mineralization …