Fri., 10/17/08 Geriatrics/Reconstruction, Paper #42, 4:59 pm OTA-2008
A Prospective Trial of Autologous Growth Factor versus Iliac Crest Bone Graft
David A. Volgas, MD (a-Biomet (Interport-Cross), Smith + Nephew, Synthes, Pfizer);
James P. Stannard, MD (a-Smith + Nephew, Synthes);
Rena L. Stewart, MD (a-Synthes, Wyeth); Benton Emblom, MD (n);
Jorge Alonso, MD (e-Synthes);
University of Alabama at Birmingham, Birmingham, Alabama, USA
Introduction: Iliac crest bone graft is the gold standard for bone defects in the extremities caused by trauma. However, complications are frequent and pain at the hip fracture can be severe. An alternative that provides growth factors (platelet-derived growth factor, transforming growth factor-β, insulin-like growth factor) and a suitable scaffold is a combination of platelet gel and cancellous allograft.
Methods: 101 patients who required a bone graft for nonunion or traumatic bone defect were enrolled in this prospective, observational study. After standardized counseling for risks and benefits of iliac crest bone graft and autologous growth factor (AGF; Interpore Cross International, Irvine, CA) mixed with cancellous allograft, patients were allowed to self-select their treatment. There were 26 patients in group A (iliac crest bone graft) and 47 patients in group B (AGF/cancellous allograft). The mean age was 41.4 years for group A and 40.5 for group B. In group A, 47% were smokers and in group B, 56% were smokers (P = 0.54). Fractures were considered healed when there was radiographic evidence of at least three cortices in continuity and the patient was able to bear load on the extremity without pain at the fracture site and there was no radiographic evidence of hardware failure. Postoperative pain was measured during each hospital day and each clinic visit using a visual analog scale. Mean follow-up was 20.3 months.
Results: There were three failures (11.5%) in group A and seven failures (14.9%) in group B (P = 0.49). The mean time to healing was 240 days in group A and 169 days in group B (P = 0.28). There were three patients (11.5%) with positive cultures at the time of the bone graft in group A and nine patients (19.2%) in group B (P = 0.52). Late infection occurred at the fracture site in one patient in group A and nine patients in group B (P = 0.08). Pain was not significantly different between groups during the hospital stay, though the mean pain level was less in group B for each day in the hospital. At final follow-up, one patient still complained of hip pain in group A. There were no cases of hematoma or seroma and no surgical-site infections at the iliac crest donor site.
Clinical Significance: AGF combined with cancellous bone graft may offer a reasonable alternative to iliac crest bone graft with less donor-site morbidity. However, there may be more recipient-site infections with AGF.
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. Δ OTA Grant.