ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery

Abjornson, Celeste; Brecevich, Antonio T.; Callanan, Tucker C.; Dowe, Christina; Cammisa, Frank P.; Lorio, Morgan P.

doi:10.14444/5095

Cited by 19 publications

(22 citation statements)

References 76 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The lack of a carrier for the demineralized bone matrix implant made manipulation of the biomaterial difficult during surgical implantation and some tissue may have lost into the marrow cavity 5,23 . Pure particulate biomaterial was used to preserve the characteristics of the demineralized bone matrix, since the addition of carrier substances may alter activity 24 . Since there are no reports in the current literature on the implantation of caprine demineralized bone matrix in bone defects, we needed to avoid use of any materials that may increase implant rejection.…”

Section: ■ Discussionmentioning

confidence: 99%

Caprine demineralized bone matrix (DBMc) in the repair of non-critical bone defects in rabbit tibias. A new bone xenograft

et al. 2020

View full text Add to dashboard Cite

To evaluate the use of demineralized bone matrix of caprine origin in experimental bone defects of the tibia in New Zealand rabbits. Methods: Fragments of the tibia diaphysis were collected aseptically from clinically healthy goats. The bones were sectioned into 1 cm fragments and stored at-20°C for subsequent hydrochloric acid (HCL) demineralization. A 70 mg portion of DBMc was used to fill the experimental bone defects. Twenty-four female adult New Zealand rabbits were divided into 2 groups: the MG (matrix group, left tibia) and CG (control group, right tibia). Additionally, they were separated into 4 groups with 6 animals, according to the period of analysis (15, 30, 60 and 90 days postoperatively). Using microCT, volumetric parameters were evaluated: bone volume, relationship between bone volume and total volume, bone surface area, relationship between bone surface area and total volume, number of trabeculae, trabecular thickness and trabecular separation. Results: There was a statistically significant difference (P<0.05) between groups considering bone volume (BV) and bone:total volume (BV/TV), on 15, 30 and 90 days postoperatively. Control group showed a statistically significant superiority (P < 0.05) considering the mean of the variables bone surface (BS), number of trabeculae (Tb.N) and between bone surface and total volume (BS/TV) at 15 and 90 days. Conclusions: Caprine demineralized bone matrix was safe and tolerable. No signs of material rejection were seen macroscopically. It is an alternative for the treatment of bone defects when autologous graft is not available or in insufficient quantities.

show abstract

Section: ■ Discussionmentioning

confidence: 99%

Caprine demineralized bone matrix (DBMc) in the repair of non-critical bone defects in rabbit tibias. A new bone xenograft

et al. 2020

View full text Add to dashboard Cite

show abstract

“…There are no required studies or evaluations outside of these criteria prior to reaching the market. 9 In contrast, some products, such as DBM BGEs, can be approved under the 501(k) section of the Food, Drug, and Cosmetic Act. Under this section of the act, a device can get FDA approval if it is found to have similar safety and effectiveness profiles to another marketed device, according to the following criteria: 1) it has the same intended use as the predicate, and 2) it has the same technological characteristics as the predicate; or 1) it has the same intended use as the predicate, and 2) it has different technological characteristics and does not raise different questions of safety and effectiveness, and 3) the information submitted to the FDA demonstrates that the device is as safe and effective as the legally marketed device.…”

Section: Regulatory Processes Involved In Clearance For Acbmsmentioning

confidence: 99%

“…Today, it has gained an approximately 10% share of the spine biologics market, which was estimated as $2.4 billion in 2020. 9 As evidenced by this rapid market capture, there exists significant enthusiasm for ACBMs in spine fusion; however, the clinical efficacy of this group of novel bone graft expanders (BGEs) in comparison to the gold standard ICBG or to other BGEs such as demineralized bone matrices (DBMs) remains elusive even 7-8 years after their FDA approval and continued use in clinical settings. 9 This systematic review provides a snapshot of the existing literature on the level of evidence for efficacy of ACBMs in spinal fusion.…”

mentioning

confidence: 99%

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

Diaz¹,

Savardekar²,

Brougham³

et al. 2021

Neurosurgical Focus

View full text Add to dashboard Cite

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, ACBM use has replaced the use of traditional autograft techniques, namely iliac crest bone graft (ICBG), in many centers. METHODS In accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic review was conducted of the PubMed, Cochrane Library, Scopus, and Web of Science databases of English-language articles over the time period from January 2001 to December 2020 to objectively assess the effectiveness of ACBMs, with an emphasis on the level of industry involvement in the current body of literature. RESULTS Limited animal studies (n = 5) demonstrate the efficacy of ACBMs in spinal fusion, with either equivalent or increased rates of fusion compared to autograft. Clinical human studies utilizing ACBMs as bone graft expanders or bone graft substitutes (n = 5 for the cervical spine and n = 8 for the lumbar spine) demonstrate the safety of ACBMs in spinal fusion, but fail to provide conclusive level I, II, or III evidence for its efficacy. Additionally, human studies are plagued with several limiting factors, such as small sample size, lack of prospective design, lack of randomization, absence of standardized assessment of fusion, and presence of industry support/relevant conflict of interest. CONCLUSIONS There exist very few objective, unbiased human clinical studies demonstrating ACBM effectiveness or superiority in spinal fusion. Impartial, well-designed prospective studies are needed to offer evidence-based best practices to patients in this domain.

show abstract

“…Predicated on the principles of osteogenesis, osteoinduction and osteoconduction, the effectiveness of graft choice should be balanced with cost to ultimately yield greater value. 81 …”

Section: Introductionmentioning

confidence: 99%

Achieving Value in Spine Surgery: 10 Major Cost Contributors

Philipp

Leibold

Mahtabfar

et al. 2021

Global Spine Journal

View full text Add to dashboard Cite

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 demand have necessitated a shift in practice standards with a new emphasis on value-based care. Despite multiple attempts to reconcile the discrepancy between national recommendations for appropriate use and the patterns of use employed in clinical practice, resources continue to be overused—often in the absence of any demonstrable clinical benefit. The following discussion illustrates 10 areas for further research and quality improvement. Methods: We present a narrative review of the literature regarding 10 features in spine surgery which are characterized by substantial disproportionate costs and minimal—if any—clear benefit. Discussion items were generated from a service-wide poll; topics mentioned with great frequency or emphasis were considered. Items are not listed in hierarchical order, nor is the list comprehensive. Results: We describe the cost and clinical data for the following 10 items: Over-referral, Over-imaging & Overdiagnosis; Advanced Imaging for Low Back Pain; Advanced imaging for C-Spine Clearance; Advanced Imaging for Other Spinal Trauma; Neuromonitoring for Cervical Spine; Neuromonitoring for Lumbar Spine/Single-Level Surgery; Bracing & Spinal Orthotics; Biologics; Robotic Assistance; Unnecessary perioperative testing. Conclusions: In the pursuit of value in spine surgery we must define what quality is, and what costs we are willing to pay for each theoretical unit of quality. We illustrate 10 areas for future research and quality improvement initiatives, which are at present overpriced and underbeneficial.

show abstract

ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery

Cited by 19 publications

References 76 publications

Caprine demineralized bone matrix (DBMc) in the repair of non-critical bone defects in rabbit tibias. A new bone xenograft

Caprine demineralized bone matrix (DBMc) in the repair of non-critical bone defects in rabbit tibias. A new bone xenograft

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

Achieving Value in Spine Surgery: 10 Major Cost Contributors

Contact Info

Product

Resources

About