Clinical use of a newly developed calcium phosphate cement (XSB-671D).
BACKGROUND
Several kinds of thermally processed hydroxyapatite have been commonly used for bone defects due to bone diseases or fractures instead of autologous bone grafts. However, these materials do not change in form during surgery and are not absorbed over a long period. To overcome this disadvantage, calcium phosphate bone cements (CPCs) have been developed and are already in use in clinical cases. These materials have merit in that to be formed in situ they are injectable and absorbable, but there are still problems with their handling and their hardening properties. A newly developed CPC called XSB-671D hardens earlier and is more resistant to body fluids than other CPCs. The purpose of this article is to verify the effectiveness, safety and usefulness of this CPC (XSB-671D) as a bone defect filler.


METHODS
We conducted clinical trials at five medical institutions based on a unified protocol in a total of 75 cases (30 males, 45 females). We observed the postoperative constitutional symptoms and local symptoms of the filling sites. The effectiveness of this material was evaluated by radiographs of the filled sites, and blood and urine were examined to evaluate any adverse effects.


RESULTS
The ratio of the cases determined to be "effective" or "better" among the 74 cases we found qualified was 97.3%, and XSB-671D was confirmed to be a highly effective material with beneficial effects of biocompatibility and osteoconduction as a bone defect filler. Additionally, there were no adverse effects caused by XSB-671D except one local skin reaction, which disappeared 2 weeks later; its safety was also thus verified.


CONCLUSIONS
We conclude that effective, safe treatment is possible using XSB-671D in cases requiring filling of a bone defect as well as those with serious osteoporosis.
Department of Orthopedic Surgery, Saitama Medical School, 38 Moro-Hongo, Moroyama-Machi, Iruma, Saitama 350-0495, Japan.
Hiromi
H
Oda
Kozo
K
Nakamura
Takashi
T
Matsushita
Seizo
S
Yamamoto
Hideaki
H
Ishibashi
Takashi
T
Yamazaki
Syuhei
S
Morimoto
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001843:Bone Cements; D002130:Calcium Phosphates / Q000737:chemistry*; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D005592:Fracture Fixation / Q000009:adverse effects / Q000379:methods*; D017102:Fracture Healing / Q000502:physiology; D050723:Fractures, Bone / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D018709:Statistics, Nonparametric; D013718:Tensile Strength
D001843:Bone Cements; D002130:Calcium Phosphates; C020243:calcium phosphate