Use of demineralized bone matrix in spinal fusion

Table 1 Clinical studies of demineralized bone matrix used in spinal fusion

Ref.	Study design	Diagnosis/procedures	Type of graft	Main outcomes	Level of evidence
Cervical spine
An et al[48]	2-Center randomized prospective control trial	Patients undergone anterior cervical fusion for degenerative disc disease, n = 77	Freeze-dried allograft augmented with DBM (Grafton®), n = 39. Iliac Crest Autograft, n = 38	Pseudarthrosis rate was 46.2% in DBM-allograft Group vs 26.3% in autograft group, but with no significant differences. Graft collapse ≥ 2 mm occurred in 39.7% in DBM-allograft group than 24.4% in autograft group (P = 0.09)	II
Vaidya et al[49]	Retrospective comparative study	Patients treated with anterior cervical discectomy and fusion, n = 46	PEEK cages + morphogenetic protein-2 (rhBMP-2), n = 22 Allograft spacers + DBM, n = 24	No significant difference in pain scores between groups. Probable fusion at latest follow up in 23/24 of DBM group vs 22/22 in rhBMP-2 group. 85% of rhBMP-2 and 56% of DBM reported difficulty in swallowing. The cost of implants in patients treated with rhBMP-2 and PEEK spacers was more than three times the cost of the other group	III
Park et al[52]	Prospective, case series study	Patients undergoing anterior cervical discectomy and fusion	PEEK cages and DBM (Grafton®), n = 31	97% fusion rate (41/42 levels), neck and arm pain improved after surgery and significanly improved in 12/12 follow-up, P < 0.05	IV
Topuz et al[50]	Retrospective, case series study	Patients underwent 2-level contiguousanterior cervical discectomy and fusion	PEEK cages and DBM (Grafton®) and autologous blood, n = 79	87.3% "excellent" and "good" clinical outcomes, final fusion rate 91.7% (145/158 levels)	IV
Moon et al[51]	Retrospective case series	Patients undergone 2-level, non-instrumented cervical fusion for degenerative disk disease, n = 27 (54 levels)	PEEK cages and DBM	Fusion rate was 88.9% of levels. All patients showed improvements in clinical outcomes (VAS score, neurologic pain and JOA myelopathy score)	IV
Demircan et al[53]	Prospective case series	Patients undergone non-instrumented anterior cervical fusion for degenerative disk disease, n = 16 (42 levels)	Polyetheretherketone cages packed with autologous blood, curettage microchip material, and DBM (Grafton®)	Fusion rate was 90.5% of levels, at 18 mo after surgery with improved clinical outcomes using JOA score (P = 0.004)	IV
Lumbar spine
Kang et al[54]	Prospective multicenter randomized clinical trail	Patients undergoing single-level posterior lumbar fusion	DBM (Grafton®) + local bone, n = 30. Autologous iliac crest bone graft, n = 16	Fusion rates were 86% (Grafton®) vs 92% (autologous graft). Grafton showed consistently higher physical function scores at 24 mo. There was a greater mean intraoperative blood loss in the autologous group.	I
Cammisa et al[3]	Prospective multicenter control trial	Patients undergone posterolateral lumbar, instrumented fusion, n = 120	Iliac Crest Autograft on one side DBM (Grafton®) + Iliac crest autograft on contralateral side of same patient	Radiographic fusion rates at 24 mo after surgery in Grafton DBM side was 52% and in Iliac Crest Bone Autograft side was 54%	II
Vaccaro et al[55]	Prospective, comparative study	Patients undergone instrumented posterolateral lumbosacral spinal fusion	DBM (Grafton®) + Bone Marrow, n = 19, DBM + Iliac crest autograft, n = 27 Autograft, n = 27	Fusion rates were 63% with DBM + Bone Marrow, 70% DBM + autograft and 67% with autograft	III
Sassard et al[56]	Retrospective comparative study	Instrumented posterolateral lumbar spinal fusion with rigid pedicle screw fixation (n = 108)	Iliac crest bone graft (n = 52). Local autograft-Grafton® (n = 56)	Fusion rates at 24 mo after surgery: In Iliac crest bone graft group: 56% and in local autograft-Grafton group: 60%	III
Schizas et al[57]	Retrospective case control study	Patients undergone posterolateral, one or two-level, instrumented, lumbar fusion, n = 59 (78 levels)	DBM (Accell Connexus® putty) with Iliac crest autograft or local decompression material, n = 33. Iliac crest autograft or local decompression material, n = 26	Fusion rate was 69.7% with DBM vs 76.9% without DBM. There were no differences in complication rates, ODI or VAS pain score	III
Epstein et al[58]	Prospective, clinical study	Patients undergone multilevel lumbar laminectomies, 1-level (n = 95) and 2-levels (n = 45)	Lamina autograft + DBM (Osteofil), n = 140	1-level fusion rates: 98%, 2-levels fusion rates: 96%. Revealed essentially comparable outcomes on 6 of 8 Health Scales of SF-36	IV
Thalgott et al[61]	Prospective case series study	Patients undergone lumbar interbody fusion (n = 50)	Titanium mesh cages filled with coralline hydroxyapatite (ProOsteon™ 500R) and DBM (Grafton®)	96% fusion rate, decrease in mean pain scores by 60% from baseline	IV
Girardi et al[60]	Retrospective case series study	Instrumented lumbar spinal fusion for various diagnoses (n = 65)	Combination of autologous bone graft and allograft DBM (AlloMatrix® Injectable Putty)	Gradual and constant improvement based on radiographic measurements taken 1, 3, 6 and 12 mo after surgery	IV
Thalgott et al[62]	Retrospective case series	Patients undergone instrumented posterolateral lumbar fusion, n = 40	Coralline hydroxyapatite (Pro Osteon™ 500) + DBM (Grafton®), n = 28 Pro Osteon™ 500 alone, n = 12	Radiographic fusion rates was 100% with coralline hydroxyapatite alone, than 89.3% with Grafton added.	IV
Epstein[59]	Prospective case series	Geriatric patients undergone posterolateral non-instrumented lumbar fusion, n = 75	Lamina autograft mixed with DBM (Osteofil) in 1:1 ratio	Fusion rate was 82.7% of levels. Improved clinical outcomes using SF-36 score.	IV
Idiopathic scoliosis
Weinzapfel et al[63]	Retrospective comparative study	Anterior thoracic discectomies with video Assisted thoracoscopic surgery in idiopathic scoliosis	Morselized allograft bone, n = 12. DBM (Grafton®), n = 28	Curve correction was similar for both groups (68% vs 67%). Radiological fusion fusion: 82% in allograft group vs 92% in DBM group	III

DBM: Demineralized bone matrix; PEEK: Polyetheretherketone; JOA: Japanese-orthopaedic-association; BMP: Bone morphogenetic protein; ODI: Oswestry disability index; VAS: Visual analogue scale.