A767. PRE-CLINICAL RESULTS OF POROUS TITANIUM PARTICLES IN CEMENTED IMPACTION GRAFTING HIP REVISION ARTHROPLASTY

Abstract

Bone impaction grafting (BIG) is a surgical technique for the restoration of bone stock loss with impaction of autograft or allograft bone particles (BoP). The goal of a series in-vitro and in-vivo experiments was to assess the suitability of deformable pure Ti (titanium) particles (TiP, FONDEL MEDICAL BV, Rotterdam, The Netherlands) for application as a full bone graft substitute in cemented revision total hip arthroplasty. TiP are highly porous (interconnective porosity before impaction 85 to 90%). In-vitro acetabular reconstructions were made in Sawbones (SAWBONES EUROPE, Malmö, Sweden) to evaluate migration by roentgen stereo photogrammetric analysis and shear force resistance by a lever out experiment. In-vitro femoral TiP reconstructions (SAWBONES, Malmö, Sweden) were used to evaluate micro-particle release and subsidence. Mature Dutch milk goats were used for two in-vivo experiments.

1. A non-loaded femoral defect model was used to compare osteoconduction of bioceramic coated TiP with BoP and ceramic particles (CeP).

2. Acetabular defects (AAOS type 3) were reconstructed in 10 goats using a metal mesh with impacted TiP acting as a full bone graft substitute in combination with a cemented polyethylene cup and a downsized cemented Exeter femoral stem (STRYKER BENOIST, Girard, France).

Blood samples were taken for toxicological analysis.

In-vitro: TiP were as deformable as BoP and created an entangled graft layer (porosity after impaction 70 to 75%). Acetabular TiP reconstructions were more stable and resistant to subsidence and shear force than BoP reconstructions (lever-out moment 56 ± 12 Nm respectively 12 ± 4 Nm, p < 0.001). After initial setting, femoral subsidence rates were smaller than seen in femoral bone impaction grafting (0.45 ± 0.04 mm after 300 000 loading cycles). Impaction generated 1.3 mg particles/g TiP (particle Ø 0.7–2 000 μm, tri-modal size distribution). In-vivo: Bioceramic coated (10 −40 μm) TiP showed bone ingrowth rates comparable to BoP and CeP. Reconstructed acetabular defects showed rapid bone ingrowth into the layer of TiP. Serum titanium concentrations slowly increased from 0.60 ± 0.28 parts per billion (ppb) preoperatively to 1.06 ± 0.70 ppb at fifteen weeks postoperatively (p = 0.04).

Mechanical studies showed very good initial mechanical properties of TiP reconstructed defects. The in-vitro study showed micro-particle generation, but in the short-term goat studies, histology showed very few particles and no negative biological effects were found. The in-vivo acetabular study showed very favorable bone ingrowth characteristics into the TiP layer and a much thinner interface with the cement layer compared to similar defects reconstructed with BoP or mixtures of BoP with CeP. Further analysis in a human pilot study should proof that TiP is an attractive and safe alternative for allograft bone in impaction grafting revision arthroplasty.