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.

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

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.

We investigated the feasibility of using porous titanium particles (TiP) to reconstruct femoral bone defects in revision hip replacement surgery in stead of using morzelised bone grafts. Questions regarding handling, initial stability and titanium particle release were addressed.

Seven composite femurs (Sawbones) were reamed and filled, stepwise, with 32 grams of large (Ø 3.15 – 4 mm) and 9 grams of smaller (Ø 2.8 – 3.15 mm) pure, 85% porous TiP. Subsequently an Exeter stem was cemented into the graft layer. All reconstructions were loaded axially (0–3000 N) for 300,000 loading cycles at 2 Hz. Subsidence of the stem was measured with radio stereometric analysis (RSA) and possible titanium particle release was measured using the laser diffraction technique.

The TiP were impacted into a > 3 mm (SD 1.43 mm) thick, highly entangled, graft layer. An average cement mantle of > 2 mm (SD 0.86 mm) was measured and little cement penetration was observed. The average subsidence of only 0.45 mm (SD 0.04 mm) was measured after 300 000 loading cycles. Most titanium particles were found directly after impaction. Most of these particles (87%) were smaller than 10 μm and could therefore be potentially harmful since they can induce osteolysis.

We can conclude that:

A graft layer of impacted TiP can be constructed,

These data warrant further animal tests to assess the biological response to these released impaction particles. Also, animal tests should clarify possible particle release upon loading and its effects.