Use of demineralized bone matrix in the extremities

Table 1 Clinical studies of demineralized bone matrix use in extremities

Ref.	Design	Diagnosis/procedures	Type of graft	Main outcomes	Level of evidence
Clinical studies of DBM used in fractures
Lindsey et al[33]	Prospective, randomized pilot study	Patients treated for long bone fractures	DBM (Grafton®) + bone marrow n = 10 Iliac crest autograft n = 8	Full bone formation in 90% with DBM + marrow and 75% with autograft at 12/12 Totally 100% healed with DBM + marrow and 63% heal with autograft	II
Cheung et al[34]	Retrospective comparative study	Periarticular fractures (n = 28)	Allograft conductive cancellous chips + DBM Grafton® (n = 13) Allograft conductive cancellous chips + DBM Orthoblast (n = 15)	Healing on the first graft attempt without complications DBM Grafton®: 69% DBM Orthoblast: 100%	III
Bibbo et al[35]	Retrospective comparative study	Patients treated for displaced intra-articular calcaneal fractures	DBM + CaSO4 + vancomycin n = 33 Control group n = 11	Union in 8.2 wk with graft, while 10.4 wk in control group P < 0.05 Wound problems in 15% in graft group	III
Clinical studies of DBM used in nonunions
Hierholzer et al[36]	Retrospective consecutive cohort study	Patients with an aseptic, atrophic delayed union or nonunion of a humeral shaft fracture were treated with ORIF and graft	Autologous iliac crest bone graft n = 45 DBM (Grafton®) n = 33	Union in 100% with autologous graft vs 97% in DBM group Union in 4.5 mo with autologous graft vs 4.2 mo in DBM group 44% of the autologous graft group had donor site morbidity	III
Wilkins et al[37]	Prospective clinical study	Patients with stiff nonunions of long bones (n = 66)	Percutaneous use of a mixture of autologous bone marrow and allograft DBM (AlloMatrix)	61 of 69 patients with stiff nonunion went on to union in an average of 8.1 mo; 7 more healed after a second procedure	IV
Wilkins et al[39]	Retrospective clinical study	Patients undergoing surgical intervention for removal of benign tumors (n = 41) or treatement of nonunions in multiple bone types (n = 35)	AlloMatrix Injectable Putty	38 of 41 patients with benign tumors healed within an average of 4.8 mo, and 30 of 35 patients with nonunion went on to union in an average of 3.5 mo	IV
Ziran et al[38]	Consecutive patients	Patients required bone grafting for atrophic/avascular nonunions	AlloMatrix + morselized cancellous allograft chips (1:1 ratio) n = 41	51% developed postoperative drainage, 34% developed deep infection, 32% required surgical intervention	IV
Clinical studies of DBM used in bone cysts
Park et al[40]	Retrospective comparative study	Calcaneal unicameral cysts were treated with graft	Lyophilized irradiated CAB + bone marrow n = 13 DBM + bone marrow n = 10	Complete healing in 9/13 in CAB group vs 5/9 in DBM group Healed with defect in 4/13 in CAB group and 3/9 in DBM group No infections or pathologic fractures during 48/12 follow up	III
Di Bella et al[41]	Retrospective comparative study	184 patients treated for unicameral bone cysts with cortical erosion	Multiple injection of corticosteroid Single injection of DBM + bone marrow concentrate	38% healed with steroids at 48/12 and 71% healed with DBM + BMC at 20/12 Failure rate after 1 steroid injection was 63% vs 24% with DBM + BMC	III
Rougraff et al[42]	Consecutive patients	Active unicameral bone cyst (n = 23)	Trephination and percutaneous injection of a mixture of demineralized bone matrix (Grafton) and autologous bone marrow	Healing on the first graft attempt: 78%	IV
Kanellopoulos et al[43]	Consecutive patients	Active unicameral bone cyst (n = 19)	Combination of percutaneous reaming, injection of a mixture of allogenic DBM (AlloMatrix) and autologous bone marrow	Healing on the first graft attempt: 89.5%	IV
Hass et al[44]	Retrospective case series	Treatment of juvenile bone cysts at all sites with DBM	Juvenile bone cysts packed with DBM (n = 9)	Totally osteodense images after an average of 8 mo, with no other significant changes in 2 yr follow-up	IV
Sung et al[45]	Retrospective comparative study	Patients, younger than 20, treated for humeral and femoral unicameral bone cysts	Corticosteroid injection n = 94, curretage + bone graft n = 39, Steroids + DBM + bone marrow aspirate n = 34	Failure rate was 84% with steroids, 64% with curretage and 50% with SDB P < 0.001. Retreatment in 76% with steroids, 63% with curretage and 71% with SDB	III
Clinical studies of DBM used in tumor surgery
Kim et al[46]	Retrospective comparative study	Bony defects after tumor surgery of various bone tumors	ICS n = 28 DBM n = 28	ICS and DBM success rate = 85.7% (24/28) and 88.9% (24/27) P < 0.05 Average healing time for ICS and DBM was 17.3 wk and 14.9 wk P < 0.05	III
Wilkins et al[39]	Retrospective clinical study	Patients undergoing surgical intervention for removal of benign tumors (n = 41) or treatment of nonunions in multiple bone types (n = 35)	AlloMatrix injectable putty	38 of 41 patients with benign tumors healed within an average of 4.8 mo, and 30 of 35 patients with nonunion went on to union in an average of 3.5 mo	IV
Clinical studies of DBM used in various long bone applications
Dallari et al[47]	Prospective, randomized control trial	High tibial osteotomy for genu varus	DBSint® (Mg-hydroxyapatite + DBM) n = 9 SINTlife®n = 13 Lyophilised bone chips n = 9	6/52 DBSint® showed higher osseointegration rate than lyophilized bone chips (P < 0.01) 52/52 DBSint® was demonstrated as effective and safe as SINTlife® and bone chips	II
Hatzokos et al[48]	Retrospective comparative study	Patients were managed with bone transport for the treatment of a tibial bone defect, with 3 types of docking procedures (n = 43)	Group A: closed compression Group B: autologous iliac graft Group C: BMC + DBM	Healing time was significantly longer in the compression group as compared with the BMC + DBM P < 0.05, no significant difference among the groups in terms of complication rates	III
Wilkins et al[49]	Prospective clinical study	Patients requiring bone grafting procedures (n = 50)	Combination product of bioassayed DBM (AlloGro®) and calcium sulfate pellets	Healing rate of 98% within an average period of 11.8 wk	IV
Clinical studies of DBM used in osteonecrosis of femoral head
Feng et al[50]	Retrospective comparative study	Treatment of large osteonecrotic lesions of the femoral head with graft	OsteoSet®2 DBM + free vasculated fibular graft n = 2, Free vasculated fibular graft + autologous cancellous bone n = 24	Improvement in the mean Harris hip score was noted in both groups P < 0.001, no significant differences in Harris hip score and clinical outcomes between groups	III
Clinical studies of DBM used in acetabular revision
Etienne et al[51]	Retrospective clinical study	Acetabular revision surgery (n = 20)	Acetabular reconstruction using a mixture of DBM (ALLOMATRIX™ C Bone Putty) and cancellous allograft chips	Successful graft incorporation in 18 of 20 patients (90%)	IV
Clinical studies of DBM used in fusion
Thordarson et al[52]	Retrospective Comparative Study	Complex ankle or hindfoot fusion with commercially available DBM formulations that did or did not contain crushed cancellous allograft bone (n = 63)	Grafton® + allograft cancellous bone chips n = 37 Orthoblast + allograft cancellous bone chips n = 26	Clinical and radiological fusion In DBM Grafton: 86% In DBM Orthoblast: 92%	III

DBM: Demineralized bone matrix; CAB: Chip allogenic bone; ICS: Injectable calcium sulfate; SDB: Steroids and demineralized bone matrix and bone marrow aspirate; BMC: Bone marrow concentrate.