Session III - Reconstruction

Thurs., 10/5/06 Reconstruction, Paper #15, 4:42 pm

·Bone Morphogenic Proteins Compared to Iliac Crest Bone Graft in Long Bone Nonunions

William T. Obremskey, MD (a-Synthes, EBI);
Philip J. Kregor, MD (a-Synthes, EBI);
Franklin D. Shuler, MD (a-Synthes, EBI);
Marc A. Tressler, DO (*); Alexander R. Vap (*); Fredrick K. Comrie (*);
Vanderbilt University Medical Center, Nashville, Tennessee, USA

Purpose: The aim of this study was to determine the relative efficacy of bone morphogenic proteins (BMP) mixed with cancellous allograft chips to iliac crest autograft.

Methods: After obtaining IRB approval, patients with long bone nonunions treated at a single university medical center from 2000 to 2005 were reviewed. 101 patients with 105 nonunions were identified using applicable CPT codes. To be included in the cohort, patients had to have no radiographic progression of healing on serial radiographs at 6 months, as well as clinical symptoms consistent with nonunion. Cohort analysis included treating surgeon, nonunion gap, graft type, complication rate, union rate, and effect of confounding factors such as diabetes and smoking. Nonunion revision success was radiographically determined by an independent orthopaedic surgeon, not involved in any of the surgeries. Finally, analysis of effects was were evaluated statistically.

Results: Overall nonunion healing after surgical intervention was 88/105 (83.8%). 71/83 (85.5%) patients treated with iliac crest autograft healed their nonunion. 17/22 (77.3%) patients treated with BMP and cancellous autograft chips healed. The odds of a BMP procedure healing is about 0.6 times the odds of an autograft healing. The odds of a complication resulting from a BMP procedure were 0.9 times the odds of an autograft procedure. Adjusting for all covariables, only pre-existing infection rate increased the odds of a complication by a factor of 4. Surgeon, diabetes, nicotine, and infection did not significantly affect union rate.

Conclusions: Although the odds of iliac crest bone graft leading to union in long bone nonunion surgery is higher, this is not statistically significant. This effect is not impacted by the presence of pre-existing infection, diabetes, or nicotine use. Not surprisingly, preoperative infection was a strong predictor of complications.

Significance: Bone morphogenic proteins with cancellous allograft chips are equally effective in healing long bone nonunions with no increased risk of complications.

If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
· The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an "off label" use). · · FDA information not available at time of printing.