Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion

Arnold, Paul M.; Sasso, Rick C.; Janssen, Michael; Fehlings, Michael G.; Smucker, Joseph D.; Vaccaro, Alexander R.; Heary, Robert F.; Patel, Ashvin I.; Goulet, Benoît; Kalfas, Iain H.; Kopjar, Branko

doi:10.1097/brs.0000000000001466

Cited by 62 publications

(32 citation statements)

References 39 publications

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“…Fusion status was also frequently assessed using dynamic lateral radiographs. Using this imaging technique, authors measured ISM (22 of 39, 56.4%) [ 10 , 13 , 14 , 16 , 19 - 22 , 25 , 28 , 29 , 31 , 33 - 39 , 41 - 43 ] or used the Cobb angle method (12 of 39, 30.8%) [ 11 , 15 , 17 , 27 , 32 , 34 , 37 , 42 - 46 ] to assess cervical fusion. No consensus was reached regarding the amount of motion for evaluation of cervical fusion on dynamic lateral radiographs.…”

Section: Resultsmentioning

confidence: 99%

“…No consensus was reached regarding the amount of motion for evaluation of cervical fusion on dynamic lateral radiographs. For the interspinous process method, no motion (9 of 22, 40.9%) [ 13 , 14 , 17 , 21 , 24 , 26 , 29 , 33 , 37 ], under 1 millimeter (mm) (7 of 22, 31.8%) [ 10 , 20 , 28 , 31 , 32 , 41 , 42 ], under 2 mm (2 of 22, 9.1%) [ 12 , 35 ], and under 3 mm of motion (4 of 22, 18.2%) [ 27 , 30 , 40 , 43 ] between spinous process were all used as cutoff values for a definition of fusion. Using the Cobb angle method, changes of 1 degree (1 of 12, 8.3%) [ 38 ], 1.5 degrees (1 of 12, 8.3%) [ 42 ], 2 degrees (5 of 12, 41.7%) [ 19 , 25 , 36 , 44 , 46 ], 4 degrees (4 of 12, 25.0%) [ 11 , 43 , 45 ], and 5 degrees (2 of 12, 16.7%) [ 27 , 30 ] were all used in various studies.…”

Section: Resultsmentioning

confidence: 99%

“…The dynamic flexion-extension films can also assess for the change in Cobb angle between the adjacent fused vertebrae to determine postoperative fusion status. Recent literature frequently employed the change in Cobb angle as a criteria to confirm fusion (30.8%) [ 11 , 15 , 17 , 27 , 32 , 34 , 37 , 42 - 46 ], but the radiographic parameters ranged from 1.5 to 5 degrees. Cannada et al [ 4 ] showed that changes in Cobb angle of 2 degrees lead to a sensitivity of 82% and specificity of 39%.…”

Section: Discussionmentioning

confidence: 99%

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Diagnosing Pseudoarthrosis After Anterior Cervical Discectomy and Fusion

Lin

Boddapati

et al. 2018

Neurospine

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Radiographic confirmation of fusion after anterior cervical discectomy and fusion (ACDF) surgery is a critical aspect of determining surgical success. However, there is a lack of established diagnostic radiographic parameters for pseudoarthrosis. The purpose of this study is to summarize the findings of previous studies, review the advantages and disadvantages of frequently employed diagnostic criteria, and present our recommended protocol of fusion assessment. This study identified randomized controlled trials, case-control studies, and prospective and retrospective cohort studies reporting on spinal fusion and how successful fusion after ACDF. Among the 39 articles reviewed, bridging bone across the operated levels on static radiographs was the most commonly used criteria to confirm fusion (31 of 39, 79%). Dynamic flexion-extension radiographs were used to assess for interspinous movement (ISM) (22 of 39, 56.4%) and change in Cobb angle (12 of 39, 30.8%). Computed tomography (CT) based findings (21 of 39, 53.8%) were employed in ambiguous cases with improved sensitivity and specificity. Reconstructed CT scans were used to assess for intragraft bridging bone and extragraft bridging bone (ExGBB). ExGBB were proved to have the highest diagnostic sensitivity and specificity for pseudoarthrosis detection when compared to all other radiographic criteria. The ISM <1 mm on dynamic flexion-extension radiographs had high diagnostic sensitivity and specificity as well. After our reviewing, we recommend using dynamic lateral flexion-extension cervical spine radiographs at 150% magnificationin which the interspinous motion <1 mm and superjacent interspinous motion ≥4 mm confirms fusion. In ambiguous cases, we recommend using reconstructed CT scans to evaluate for ExGBB.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Diagnosing Pseudoarthrosis After Anterior Cervical Discectomy and Fusion

Lin

Boddapati

et al. 2018

Neurospine

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“…This FDA-approved trial was prospective, randomized, blinded, controlled, and statistically powered, and thus represents level 1 study data. 73 In this 319-patient trial, i-FACTOR successfully met the predefined noninferiority criteria for radiologic fusion (88.9% versus 85.8% for control), neck disability index (28.8% change versus 27.4% for control), neurological success (93.7% versus 93% for control), and safety (97.5% versus 95.4% for control.) More importantly, a FDAmandated, prospectively designed statistical analysis of the overall clinical success, defined in the as individual patients who were successful for all 4 of the primary outcomes, demonstrated statistical superiority to local autograft in overall clinical success (68.8% versus 56.9%) at 12 months.…”

Section: Clinical Trials Of Rhbmp-2mentioning

confidence: 85%

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

et al. 2018

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Autologous bone graft remains the gold standard by which bone graft substitutes are compared in spine fusion surgery. The utilization of bone graft substitutes, either as (1) an extender for spinal fusion constructs or (2) an alternative to minimize morbidity while maximizing outcomes, is changing. Moreover, current procedural technology (CPT) code 20939 became effective in 2018 defining bone marrow aspirate for bone grafting, spine surgery only. Changes in the complex landscape of grafting materials have prompted ISASS to provide category guidance for bone graft substitutes by comparing and contrasting US regulatory pathways, mechanisms of action, and supportive clinical evidence for these bone grafting materials. Testing & Regulatory Affairs

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“…Cerapedics initiated an IDE trial for single level ACDF in an allograft ring in 2006, which culminated in PMA approval in 2015. This FDA-approved trial was prospective, randomized, blinded, controlled and statistically-powered, thus represents Level I study data [35]. In this 319-patient trial, i-FACTOR bone graft successfully met the predefined noninferiority criteria for radiologic fusion (88.9 vs. 85.8% for control), neck disability index (28.8 change vs. 27.4% for control), neurological success (93.7 vs. 93% for control), and safety (97.5 vs. 95.4% for control).…”

Section: I-factor™: P-15 Peptidementioning

confidence: 99%

Class III Spine Grafts

Marx¹,

Lorio²

2021

Clinical Implementation of Bone Regeneration and Maintenance

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This chapter is focused on the USFDA regulation and the related efficacy evidence of bone graft materials, especially Class III drug-device combination products for use in the spine. Nonstructural allograft and cellular allograft products that do not rely on the metabolic activity of living cells are HCT/P products, which require no premarket review for safety and efficacy. Synthetic bone grafts and demineralized bone matrices (DBMs) fall under Class II and require a 510(k) for market clearance, generally on the basis of an animal study. Drug-device combination bone grafts are Class III and require an investigational device exemption (IDE) clinical trial followed by a premarket approval (PMA) application with the FDA to review safety and effectiveness. Currently, there are only two PMA-supported Class III drug-device bone graft substitutes with Level I data that demonstrate equivalence to autograft for safety and effectiveness in spine: Infuse ® (rhBMP-2) and i-FACTOR (P-15 peptide). Both of these products have been shown to be effective autograft replacement options, vs. the other technologies, which are autograft extenders. The OP-1 Implant (rhBMP-7) was marketed for a period of time, but it has been removed from the market. This chapter will discuss these products along with their supporting clinical data.

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Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion

Abstract: 1.

Cited by 62 publications

References 39 publications

Diagnosing Pseudoarthrosis After Anterior Cervical Discectomy and Fusion

Diagnosing Pseudoarthrosis After Anterior Cervical Discectomy and Fusion

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

Class III Spine Grafts

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