From the view of the potential risks of allogeneic bone products in clinical use. the key aspects of risk control and quality management for these products are discussed, as well as the general problems existing in the quality management system of their production enterprises in China are briefly introduced.
Bone Transplantation ; instrumentation ; methods ; Humans ; Quality Control ; Risk Assessment ; Transplantation, Homologous ; adverse effects ; instrumentation ; methods

BACKGROUND: Vertebroplasty is not free from cement related complications. If an allograft is used as a filler, most of them can be averted. METHODS: Forty consecutive cases of osteoporotic vertebral fracture were divided into two groups by self-selection. The study and the control groups underwent vertebroplasty with fresh frozen allogeneic bone chips and bone cement, respectively. Clinical results were assessed at preoperation, postoperative day 1 and months 3, 6, and 12 by 10-grade visual analog scale (VAS), and radiological results were assessed at the same time by vertebral kyphotic angle (VKA) and local kyphotic angle (LKA). The results were compared within and between the groups. Survival function was analyzed. The criteria of an event were clinical or radiological deterioration versus pre-index surgery state. RESULTS: VAS was improved in the study group from 8.4 +/- 0.8 to 5.2 +/- 1.4, 6.4 +/- 1.2, 5.5 +/- 2.7, and 3.7 +/- 1.4 at postoperative day 1 and months 3, 6, and 12, respectively, and in the control group from 8.4 +/- 1.2 to 3.2 +/- 1.1, 3.2 +/- 1.7, 3.2 +/- 2.7, and 2.5 +/- 1.7, respectively (within group, p < 0.001; between groups, p < 0.001). VKA was improved in the study group from 18.9degrees +/- 8.0degrees to 15.2degrees +/- 6.1degrees (p = 0.046) and in the control group from 14.7degrees +/- 5.2degrees to 10.3degrees +/- 4.7degrees (p < 0.001) at postoperative day 1. LKA was not improved in the study group but was improved in the control group from 16.8degrees +/- 11.7degrees to 14.3degrees +/- 9.6degrees (p = 0.015). Correction angle was 2.7degrees +/- 4.6degrees, -7.9degrees +/- 5.3degrees, -7.2degrees +/- 5.2degrees, and -7.4degrees +/- 6.3degrees at postoperative day 1 and months 3, 6, and 12, respectively, in the study group and 4.3degrees +/- 3.7degrees, 0.7degrees +/- 3.6degrees, 0.7degrees +/- 4.2degrees, and 0.1degrees +/- 4.4degrees, respectively, in the control group. Correction loss was significant in both groups (p < 0.001) and more serious in the study group (p < 0.001). The 6-month survival rate was 16.7% in the study group and 64.3% in the control group (p = 0.003; odds ratio, 5.250). CONCLUSIONS: In treatment of osteoporotic vertebral fracture, fresh frozen allogeneic bone chips are not recommendable as a filler for its worse results than bone cement.
Aged ; Bone Cements/adverse effects ; Bone Substitutes/adverse effects ; Case-Control Studies ; Female ; Humans ; Male ; Osteoporotic Fractures/epidemiology/*surgery ; Pain Measurement ; Transplantation, Homologous/adverse effects/instrumentation/*methods ; Vertebroplasty/adverse effects/instrumentation/*methods