To evaluate the clinical safety and efficacy of using a biologic technology known as preparation rich in growth factors (PRGF) for the treatment of nonhypertrophic nonunion.
The design of the study was a retrospective case series.
The private practice was in 2 centers.
There were 15 patients with a total of 16 aseptic nonunions, 12 diaphyseal and 4 supracondylar, diagnosed as nonhypertrophic. The mean time since prior surgical treatment was 21 months (9-46 months).
Supracondylar and diaphyseal nonunions followed surgical fixation with condylar plating or intramedullary nailing, whereas a composite biomaterial created by mixing PRGF with bone allograft was applied. The area was then covered with autologous fibrin membranes. Stable nonunions were treated with repeated percutaneous injections of PRGF; this minimally invasive procedure was also applied if delayed healing was suspected after surgical treatment.
Main Outcome Measurements:
Radiographic union using radiographic views was taken in 2 planes. Clinical outcome evaluated pain, motion at the fracture site upon manual stress testing, and recovery of range of motion.
All nonunions treated operatively healed after a single procedure, even though additional PRGF had to be injected in 2 patients. Two of 3 stable nonunions achieved healing only after repeated percutaneous PRGF injections. The mean time from surgery and/or PRGF application to union was 4.9 months (2-8 months). Complications associated with the described procedure were not observed.
This study, although uncontrolled, shows that PRGF technology is clinically safe and can enhance the healing of nonhypertrophic nonunions.