BACKGROUND: There are numerous autograft alternatives promoted. Although most have laboratory or animal data, few have evaluations of clinical performance. We performed an evaluation of a new calcium sulfate-demineralized bone matrix/Allomatrix in the treatment of nonunions. METHODS: A consecutive series of patients requiring bone grafting for atrophic/avascular nonunions were retrospectively studied. Patients were monitored for healing and adverse effects, which included local or systemic reactions, wound problems, infection, and any secondary surgery caused by graft complications. RESULTS: Over half of the patients (51%) developed postoperative drainage. Of the 41 patients, 13 (32%) had drainage that required surgical intervention and 14 (34%) developed a deep infection. Eleven patients with deep infections also required surgical treatment of drainage. Also, 19 (46%) patients did not heal and required secondary surgical intervention. Using chi it was found that there were correlations between infection and a history of previously treated infection (p < 0.007), as well as wound drainage (p < 0.001). Failure of treatment correlated to the presence of a postoperative infection (p < 0.001). Other analyses were not performed because of the small sample size, which was because of early termination of the study. CONCLUSIONS: The use of Allomatrix/demineralized bone matrix as an alternative for autogenous bone graft in the treatment of nonunions resulted in an unacceptably high rate of complications. Although we recommend further study, we do not recommend the use of Allomatrix for the treatment of nonunions, especially if there is a large volumetric defect or a history of any prior contamination of the tissue bed.
BACKGROUND: There are numerous autograft alternatives promoted. Although most have laboratory or animal data, few have evaluations of clinical performance. We performed an evaluation of a new calcium sulfate-demineralized bone matrix/Allomatrix in the treatment of nonunions. METHODS: A consecutive series of patients requiring bone grafting for atrophic/avascular nonunions were retrospectively studied. Patients were monitored for healing and adverse effects, which included local or systemic reactions, wound problems, infection, and any secondary surgery caused by graft complications. RESULTS: Over half of the patients (51%) developed postoperative drainage. Of the 41 patients, 13 (32%) had drainage that required surgical intervention and 14 (34%) developed a deep infection. Eleven patients with deep infections also required surgical treatment of drainage. Also, 19 (46%) patients did not heal and required secondary surgical intervention. Using chi it was found that there were correlations between infection and a history of previously treated infection (p < 0.007), as well as wound drainage (p < 0.001). Failure of treatment correlated to the presence of a postoperative infection (p < 0.001). Other analyses were not performed because of the small sample size, which was because of early termination of the study. CONCLUSIONS: The use of Allomatrix/demineralized bone matrix as an alternative for autogenous bone graft in the treatment of nonunions resulted in an unacceptably high rate of complications. Although we recommend further study, we do not recommend the use of Allomatrix for the treatment of nonunions, especially if there is a large volumetric defect or a history of any prior contamination of the tissue bed.
Authors: Oliver Pieske; Alexandra Wittmann; Johannes Zaspel; Thomas Löffler; Bianka Rubenbauer; Heiko Trentzsch; Stefan Piltz Journal: J Trauma Manag Outcomes Date: 2009-12-15