Abstract
Pegs are often used in cementless total knee replacement (TKR) to improve fixation strength. Studies have demonstrated that interference fit, surface properties, bone mineral density (BMD) and viscoelasticity affect the performance of press-fit designs. These parameters also affect the insertion force and the bone damage occurring during insertion. We aimed to quantify the effect of the aforementioned parameters on the short-term fixation strength of cementless pegs.
6 mm holes were drilled in twenty-four human femora. BMD was measured using calibrated CT-scans, and randomly assigned to samples. Pegs were produced to investigate the effect of interference fit (diameters 6.5 and 7.6 mm), surface treatment (smooth and rough- porous-coating [friction coefficient: 1.4]) and bone relaxation (relaxation time 0 and 30 min) and interactions were studied using a DOE method. Two additional rough surfaced peg designs (diameters 6.2 and 7.3 mm) were included to scrutinize interference. Further, a peg based on the LCS Porocoat® (DePuy Synthes Joint Reconstruction, Leeds, UK) was added as a clinical baseline. In total seven designs were used (n = 10 for all groups). Pegs were inserted and extracted using an MTS machine (Figure 1), while recording force and displacement. Bone damage was defined as the difference between the cross-sectional hole area prior to and after the test.
BMD and interference fit were significant factors for insertion force. BMD had a significant positive correlation with pull-out force and subsequent analyses were therefore normalised for BMD.
Pull-out force increased significantly with interference for both surface coatings at time 0 (p < 0.05). However, after 30 minutes the effect remained significant for rough pegs only (p < 0.05-Figure 2A).
Pull-out force reduced significantly with roughness for both peg diameters at time 0 (p < 0.001). However, after 30 minutes the effect remained significant for small pegs only (p < 0.05-Figure 2A).
The time dependant interaction was only significant for smooth pegs in both diameters (p < 0.05-Figure 2A).
Additionally, the pull-out force increased with diameter in a non-linear manner for the rough pegs (Figure 2B). The two surface treatments were not significantly different to the clinical comparator. Interference fit was the only significant factor for bone damage.
BMD was significant for insertion and pull-out forces, reinforcing the need to account for this factor in biomechanical studies and clinical practice. This study also highlights the importance of time in studying bone interactions, with surface treatment and interference showing different interaction effects with relaxation time. Although smooth pegs initially have a higher pull-out force, this effect reduces over time whereas the pullout force for rough pegs is maintained. Smooth pegs also show time sensitivity in relation to interference and the benefit of increased interference reduces over time, whereas it is maintained in rough pegs. This may be explained by different damage (compressive and abrasive) mechanisms associated with different surface treatments.
In conclusion, BMD and interference fit are significant factors for initial fixation. Bone relaxation plays an important role as it reduces the initial differences between groups. Therefore, these findings should be strongly considered in the design development of cementless TKR.
