Adverse reactions to OsteoSet bone graft substitute, the incidence in a consecutive series.
BACKGROUND
The purpose of this study was to identify factors that may be associated with the development of a sterile inflammatory reaction to OsteoSet (Wright Medical Technology) bone graft substitute. We report on a series of 58 consecutive cases of patients with benign bone lesions who developed an adverse reaction to Osteoset. All procedures were performed by a single orthopaedic oncology surgeon.


METHODS
Patients who exhibited an adverse reaction to OsteoSet and those who did not were analyzed for statistical differences with respect to age, sex, volume of graft material used, size of pellet, use of alcohol washes, mixing of OsteoSet with allograft, medications, drug allergies, and smoking history. Comparisons were made between the reaction group and the non-reaction group with respect to the these variables.


RESULTS
Eight definite (13.8%) and 3 probable (5.2%) reactions were identified. Symptoms developed an average of 38.9 days after the operation. There was no statistically significant difference (p>0.05) in the volume of Osteoset used, size of pellet, use of alcohol washes, mixing of OsteoSet with allograft, patient age, sex, drug allergies, or smoking history. Reported use of at least one medication was statistically significant between groups when probable reactions were included with the non-reaction group (p < 0.05), but not when probables were analyzed with the definite reaction group ( p < 0.10). A review of our patients' medication lists did not reveal any single or combination of medications likely to be responsible for this difference. Type and location of tumor also did not appear to differ significantly between the two groups.


CONCLUSIONS
Although we report a 13.8%-19.0% incidence of adverse reaction to OsteoSet, we are unable to identify any statistically significant factors that might predict the development of a reaction. Fortunately, the reaction is essentially self limited and fairly benign requiring only anti-inflammatories and observation.
Northwestern University Medical School, Chicago, IL 60611, USA.
Gregory H
GH
Lee
Joseph G
JG
Khoury
John-Erik
JE
Bell
Joseph A
JA
Buckwalter
D000293:Adolescent; D000328:Adult; D000368:Aged; D018786:Bone Substitutes / Q000009:adverse effects*; D002133:Calcium Sulfate / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007249:Inflammation / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged
D018786:Bone Substitutes; D002133:Calcium Sulfate