Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses.
BACKGROUND
Augment Bone Graft, a fully synthetic bone graft material composed of recombinant human PDGF and a calcium phosphate matrix (rhPDGF/TCP), has been considered as a possible alternative to autogenous bone graft. Before proceeding with randomized control studies comparing rhPDGF/TCP to autograft bone, a human trial to assess efficacy and safety was required.


METHODS
The current study was a prospective, open-label, multi-center trial designed to evaluate rhPDGF in a calcium phosphate matrix (Augment Bone Graft). Sixty patients requiring hindfoot or midfoot fusion were prospectively followed for 36 weeks. All patients received 0.9 to 2.7 mg of rhPDGF at the fusion sites and returned for clinical and radiographic review at Day 7 to 14 and Weeks 6, 9, 12, 16, 24, and 36. Computerized tomography (CT) scans of the fusion site were obtained at the 6- and 12-week postoperative appointment, with an additional CT scan at 16 weeks if required.


RESULTS
No patients suffered a serious adverse event caused by rhPDGF. CT scan evaluation at 12- to 16-week time periods revealed moderate or complete osseous bridging of 75% (44/59) at 36 weeks.


CONCLUSIONS
These results indicate that rhPDGF is a safe product and provides clinical/radiographic outcomes that justify the pursuit of randomized controlled studies comparing rhPDGF/TCP to autograft.
Daniels
Timothy
T
St. Michael's Hospital, University of Toronto, 55 Queen Street East, Suite 800, Toronto, Ontario M5C 1R6, Canada. danielst@smh.toronto.on.ca
DiGiovanni
Christopher
C
Lau
Johnny T C
JT
Wing
Kevin
K
Younger
Alastair
A
D000328:Adult; D000368:Aged; D001174:Arthrodesis; D018786:Bone Substitutes / Q000627:therapeutic use*; D002130:Calcium Phosphates / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005529:Foot Bones / Q000000981:diagnostic imaging / Q000601:surgery; D033023:Foot Joints / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010982:Platelet-Derived Growth Factor / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed
D018786:Bone Substitutes; D002130:Calcium Phosphates; D010982:Platelet-Derived Growth Factor; D011994:Recombinant Proteins