Session XI - Reconstruction
Sun., 10/10/04 Reconstruction, Paper #65, 9:51 am
A Randomized Controlled Prospective Trial of Autologous Bone Graft versus Iliac Crest Bone Graft for Nonunions and Delayed Unions
Purpose: Nonunions and delayed unions are common problems that all orthopaedic surgeons must address. Iliac crest bone graft is the gold standard for treatment of these problems. The complications associated with iliac crest bone graft are well-documented and include pain at the donor site, infection, hematoma, and the need for re-operation. In recent years, a plethora of bone graft substitutes has been introduced, including calcium sulfate and calcium phosphate, demineralized bone matrix, BMP, and other growth factors. The purpose of this study was to report our results of use of conventional iliac crest bone grafting versus the use of autologous growth factor combined with cancellous allograft.
Methods: Patients who were evaluated by one of the three senior authors and who had radiographic and clinical evidence of a nonunion or delayed union were asked to participate in the study. It was approved by the Institutional Review Board, and informed consent was obtained from the subjects. Patients were randomized into group A (iliac crest bone graft) or group B (autologous growth factor). There were 25 patients in group A and 32 patients in group B. There were 37 men and 20 women with an average age of 41.0 years. Of the fractures, 25% were open. The autologous growth factor system used was from Interpore Cross International. Prior to beginning the case, a unit of whole blood was obtained from the patient through a large-bore intravenous tube, and this was processed in the concentrator according to the manufacturer's recommendation. Between 20 cc and 40 cc of platelet-rich product was obtained and was mixed with thrombin and cancellous chips from the bone bank. Iliac crest bone graft was obtained through a 2- to 3-cm incision. Marcaine was instilled in the donor site. The bone defect was prepared by removing all fibrous tissue and then cutting back the end of the fracture to bleeding bone. Bone graft was placed into the defect and compacted with use of a bone tamp.
Results: Three patients were lost to follow-up. Average follow-up was 9.0 months. Major complications occurred in one patient in group A and none of patients in group B. Postoperative pain averaged 7/10 on postoperative day 1 and 6/10 on day 2 in group A compared with 6.4/10 on day 1 and 4.7/10 on day 2 in group B. Radiographic time to union was 194 days in group A and 119 days in group B, though there were outliers which may explain the differences. Three of 20 (15%) patients in group A required re-operation for further nonunion compared with 6 of 31 (19%) of those in group B. The scores for the SF-36 averaged 33 for group A and 32 for group B. Days in the hospital were 2.9 for group A and 2.7 for group B.
Conclusions / Significance: Iliac crest bone graft remains the gold standard for treatment of nonunion. Because of the high complication rate reported in numerous studies, an alternative which has fewer complications but retains the high healing rates of iliac crest bone grafting is desirable. There are few published reports of autologous growth factors in the setting of nonunions. These data suggest that the complication rate, including short- and long-term pain are less with use of autologous growth factor, and the failure rates of the two procedures are similar. Time to healing may be less with use of autologous growth factor.