Abstract
We have investigated the use of a conically-shaped cement plug made of Polyactive (PA), a biodegradable copolymer. The flexibility and hydrogel properties were thought to facilitate occlusion of the femoral canal even when it was oval or irregular in shape. The function of the plug was first compared with that of the Thackray polyethylene model in 16 artificial plastic femora.
The maximum intramedullary pressure achieved during cementing was ten times higher with the biodegradable model. Migration or leakage of cement did not occur when the diameter of the femoral canal was equal to or smaller than the diameter of the plug. We also showed that the biodegradable properties of this implant were such that it did not require removal during revision.
The new plug was tested in a pilot clinical trial. At two years only two out of 21 patients had evidence of migration or leakage of cement, probably due to a mismatch in the size of plug and femoral canal. There were no local changes in the femur.