Autograft Is The "Gold Standard",
MIS Makes It Even Better

Autograft is undeniably considered the best bone graft for fusion. Clinical research demonstrates iliac crest graft is superior to allograft, DBM, TCPs, BMAs, and other bone graft substitutes. The proof is in the science.

$3B+ is spent annually in the US on bone graft substitutes with deficient or invalidated data; especially clinical evidence. Autograft is undeniably considered the best bone graft for fusion. Clinical research demonstrates iliac crest graft is superior to allograft, DBM, TCPs, BMAs, and other bone graft substitutes. LEVEL-1 evidence shows ICBG had identical fusion success to BMP-2 with fewer complications & adverse events.

The proof is in the independent science below.

(note: the inclusion of the studies and authors below are independent sources not intended to be an endorsement of Paradigm BioDevices' products.)

Dr. Radcliff Discusses Iliac Crest Bone Grafting

The Trephine Technique for ICBG Harvest Study published in Spine January 2021 found...

"Our results show that a trephine harvest technique provides ample autograft without complications and with no significant pain at the harvest site...the technique is not time-consuming and significantly less expensive than biological alternatives."

(McLain, Robert F. MDa; Techy, Fernando MD, FAAOSb Trephine Technique for Iliac Crest Bone Graft Harvest, SPINE: January 1, 2021 - Volume 46 - Issue 1 - p 41-47 doi: 10.1097/BRS.0000000000003702)

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Dr. McLain Discusses Minimally Invasive Iliac Crest Bone Graft Harvest in Spine Fusion

The SPORT Study published in JBJS September 2012 found...

"no difference in post-operative pain scores for patients with or without autograft harvests."

(K. Radcliff, "The Effect of Iliac Crest Autograft on the Outcome of Fusion in the Setting of Degenerative Spondylolisthesis" JBJS Am 9/2012)

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An independent study conducted with the QuickDraw found that pain with our MIS bone harvester was "non-existent" or "mild enough" that patients didn't know they had a bone graft taken..."

"non-existent" or "mild enough" that patients didn't know they had a bone graft taken..."

(S. Pirris, Southern Neuro Society 5/2014)

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Dr. Carragee on Autogenous Bone Graft vs BMP

Co-Author E. Carragee summarized four (4) separate FDA regulated, randomized, non-blinded investigational device trials of rhBMP-2 and OP-1 use compared to ICBG for spinal fusion. The study cited:

"...no significant increase in back pain scores or functional disability at any time after surgery for those subjects undergoing the ICBG harvesting..."

"...(ICBG) did not appear to affect post-operative pain, function, or occupational activities in the best comparative trials we have."

(E. Carragee, "Pseudomorbidity in iliac crest bone harvesting: the rise of rhBMP-2 in short segment posterior lumbar fusion" The Spine Journal 9 (2009) 873-879)

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