Musculoskeletal Cancer
Table 3: Comparative Pre-clinical and Clinical Studies of Mineral Bone Graft Substitutes in the Treatment of Bone Defects
Study (Reference) Vehicle
Uchida et al., 198463
Saini et al., 200675
(Trade Name) CP, HA, CAl (NS)
β-TCP
(FormPutty, Vitoss)
Design
Pre-clinical rabbit/rat
Condition: Comparison
Calvarial defect: CP versus HA versus CAl
Pre-clinical Humeral defect: canine
FormPutty versus Vitoss versus ICBG versus sham
Level Number N/A NS N/A 26
Mean FU (Months)
6 6 Findings
All 3 had ingrowth, ‘considerably lower- density ingrowth in CAl group’; no adverse reactions
Both synthetics had increased tissue reaction scores at 12 weeks compared with ICBG and sham as well as themselves at 6 weeks; both
had significantly decreased residual implant at 12 weeks compared with 6 weeks; no difference in yield force, stiffness or failure force at 12 or 24 weeks
Urban et al., 200799
Hing et al., 200795
CS (Osteoset), Pre-clinical Humeral defect: CS/CP cement canine (Prodense)
CS (Osteoset), Pre-clinical Femoral defect: β-TCP (Vitoss), rabbit Si-CP (Actifuse)
Habibovic et al., HA/β-TCP, 2008106
Pre-clinical Bone defect:
HA/β-TCP + PLA, goat CA, HA (NS)
Ogose et al., HA (Bonfil), 200571
β-TCP (OSferion)
Bucholz et al., HA blocks 198955
HA/β-TCP versus HA/β-TCP +
PLA versus CA versus HA
Retrospective Benign bone case series
tumors:
Bonfil versus OSferion
(Pro Osteon)
Petruskevicius CS pellets et al., 200243
Prospective Tibial palteau controlled
fractures: Pro Osteon versus ICBG
(Osteoset)
Dickson et al., HA cement 200256
Cassidy et al., CP cement 200381
Sanchez-Sotelo CP cement et al., 200082
Prospective BTB defects: controlled
I
Osteoset versus nothing
Prospective Metaphyseal (BoneSource) controlled (Norian SRS) (Norian SRS)
fractures: BoneSource versus ICBG
Prospective Distal radius controlled
Prospective Distal radius controlled
I
fractures: Norian SRS versus nothing
I
fractures: Norian SRS versus nothing
Mattsson et al., CP cement 200487
(Norian SRS)
Mattsson et al., CP cement 200586
Mattsson et al., CP cement 200388
(Norian SRS) (Norian SRS)
Prospective Intertrochanteric controlled
I
fractures: Norian SRS versus nothing
Prospective Intertrochanteric controlled
Prospective Femoral neck controlled
I
fractures: Norian SRS versus nothing
I
fractures: Norian SRS versus nothing
44 40 1.5 112 6 26 6 110 12 297 12 I 44 6 20 6 I 40 25 III 53 26 N/A
Osteoset versus Prodense
N/A NS
Osteoset versus Vitoss versus Actifuse
N/A 11 3 3 10 6
Prodense showed statisticaly increased compressive strength, modulus of elasticity closer to bone, and slower resorption Rapid resolution of CS with inflammatory reaction; β-TCP also had inflammatory phase; Si-CP was more stable scaffold, had faster
angiogenesis, and had denser/more mature bone apposition
At 3 months: β-TCP/HA showed new bone formation; HA, CA, HA/β-TCP + PLA, and deactivated HA/β-TCP showed no bone formation
4% overall patholgic fracture; HA showed no resorption; β-TCP had quicker time to
incorporation (10 versus 17 weeks); HA group
had subsidence (2 versus 0%): not statistically significant
Unable to find any differences; 7 cases
underwent biopsy, which showed 25–47% bone ingrowth, 25–39% residual HA; no cases of complete HA resorption
CT evaluation: significantly increased bone in control group from 6 to 12 weeks but not in
graft group, no differences found between two groups at any time interval
83 versus 67% improved reduction maintenance in HA group; ‘success’ increased at 6 and 12 months: not statistically signficant
Norian: allowed earlier motion, statistically improved function at 6–8 weeks; No difference in function or reduction/healing at 1 year Norian: allowed earlier motion, statistically improved function and range of motion at earlier
time interval; improved statisfactory results (82 versus 56%) and improved maintenance of reduction at 1 year in Norian group (42 versus 18%) Norian: statistically decreased translation and varus angulation in first 6 months
Norian: statistically increased blood loss, improved function at 6 weeks, improved SF-36 scores at 6 months
Norian: statistically decreased translation and varus angulation in first 6 weeks
US ONCOLOGY & HEMATOLOGY
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