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Platelet-derived growth factor comparable to bone graft for ankle and hindfoot fusion

At 24 weeks, two out of 20 PDGF patients had delayed unions, attributable to comorbidity or 'overpacking.'

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TORONTO — Platelet-derived growth factor may be as effective as autologous bone graft for achieving bone union in ankle and hindfoot fusion, according to the preliminary results of a study presented here.

Sheldon Lin, MD, and colleagues are evaluating the efficacy of recombinant platelet-derived growth factor (rhPDGF) in a prospective, randomized, feasibility trial involving 20 patients being followed for 9 months postop. Lin discussed the 24-week results of this U.S. study, along with results from a 60-patient Canadian trial, at the American Orthopaedic Foot and Ankle Society 23rd Annual Summer Meeting held here.

This is the first study investigating the potential orthopedic applications of rhPDGF, which is a biosynthetic bone graft substitute shown to aid bone formation in periodontal disease, according to the study.

In the U.S. study, Lin and colleagues randomly assigned patients 2:1 to receive either rhPDGF in a tricalcium phosphate carrier or autologous bone graft.

At 6 weeks follow-up, both groups achieved comparable union values, Lin said.

"At 12 weeks, osseous bridging seen in the autograft group was 50%, 69% for the U.S. [rhPDGF] and 70% for the Canadian [rhPDGF]. Complete union was seen in 100% of the autograft group and 85% of the U.S. [rhPDGF] at 24 weeks," Lin said, noting that two symptomatic delayed unions remained in the U.S. rhPDGF group.

"Possible factors for these delayed unions are either comorbidity ... and possibly overpacking the joint with the material," he said.

AOFAS scores were comparable between the three groups at 6 and 12 weeks, Lin said. "There were no device-related adverse events or severe adverse events," he noted.

For more information:

• Sheldon Lin, MD, can be reached at New Jersey Medical School, 90 Bergen St., Ortho DOC Suite 7300, Newark, NJ 07103; 973-972-2184; e-mail: linss@umdnj.edu. He receives research or institutional support from BioMimetics.
• Lin S, DiGiovanni C, Baumhauer J, et al. A prospective, randomized, controlled, multi-center human clinical feasibility trial to evaluate the preliminary safety and efficacy of rhPDGF vs. autologous bone graft as a bone regeneration device. Presented at the American Orthopaedic Foot and Ankle Society 23rd Annual Summer Meeting. July 13-15, 2007. Toronto.