Abstract
Background: High primary stability is the fundamental prerequisite for safe osseointegration of cementless intervertebral disc prosthesis. The aim of our study was to determine the primary stability of intervertebral disc prosthesis with two different anchoring concepts – keel and spike anchoring. Methods: 10 human cadaveric lumbar spine specimens with an ActivL intervertebral disc prosthesis (5 x keel anchoring, 5 x spike anchoring) were tested on a spine simulator. Under axial load, moments of flexion, extension, left and right bending and axial rotation were applied on the lumbar spine specimens through a defined three-dimensional movement program as per ISO 2631 and ISO/CD 18192-1.3 standards. Micro-motion of the implant was measured in every axis for both anchor types and compared using statistical test for significance after calculating 95% confidence intervals. Results: In the transverse axis, the keel anchoring concept showed lower mean values of micro-motion , which was statistically significant (p<0.05) compared to spike anchoring concept. In the sagittal axis, the results were again in favour of the keel anchoring, but did not reach statistical significance (p>0.05). The highest micro-motion values were observed in the longitudinal axis. Both concepts showed values around the threshold of primary stability (150 μm) with the spike concept showing lower mean values, but without a statistically significant difference.Conclusions: Both types of anchors met the criteria of primary stability. The keel anchoring shows a slight advantage compared to anchoring with spikes. Direct postoperative active mobilization doesn’t seem to compromise the primary stability of the prosthesis.