Testing of primary stability of the Activ® L intervertebral disc prosthesis in cadaver bone and comparison of the two different anchoring concepts – keel and spike anchoring

2020 ◽  
Author(s):  
Christoph von Schulze Pellengahr ◽  
Wolfram Teske ◽  
Saurabh Kapoor ◽  
Alexander Klein ◽  
Bernd Wegener ◽  
...  

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.

2021 ◽  
Author(s):  
Christoph von Schulze Pellengahr ◽  
Wolfram Teske ◽  
Saurabh Kapoor ◽  
Alexander Klein ◽  
Bernd Wegener ◽  
...  

Abstract Background: High primary stability is the key 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 ActivL intervertebral disc prosthesis (5 x keel anchoring, 5 x spike anchoring) implanted in human cadaver lumbar spine specimens were tested in a spine movement simulator. Under axial load 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. Micromotion of the implants covering every single movement axis were measured for both anchor types and compared using Student’s T-test for significance after calculating 95% confidence intervals. Results: In the transverse axis, the keel anchoring concept showed lower statistically significant (p<0.05) mean values of micromotion compared to spike anchoring concept. The highest micromotion values for both types were observed in the longitudinal axis. The data achieved the threshold of primary stability (150-200 μm).Conclusions: Both fixation systems fulfil the required criteria of primary stability. Independent of the selected anchorage type an immediate postoperative active mobilization doesn’t compromise the stability of the prostheses.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Christoph von Schulze Pellengahr ◽  
Wolfram Teske ◽  
Saurabh Kapoor ◽  
Alexander Klein ◽  
Bernd Wegener ◽  
...  

Abstract Background High primary stability is the key prerequisite for safe osseointegration of cementless intervertebral disc prostheses. The aim of our study was to determine the primary stability of intervertebral disc prostheses with two different anchoring concepts – keel and spike anchoring. Methods Ten ActivL intervertebral disc prostheses (5 x keel anchoring, 5 x spike anchoring) implanted in human cadaver lumbar spine specimens were tested in a spine movement simulator. Axial load flexion, extension, left and right bending and axial rotation motions were applied on the lumbar spine specimens through a defined three-dimensional movement program following ISO 2631 and ISO/CD 18192-1.3 standards. Tri-dimensional micromotions of the implants were measured for both anchor types and compared using Student’s T-test for significance after calculating 95 % confidence intervals. Results In the transverse axis, the keel anchoring concept showed statistically significant (p < 0.05) lower mean values of micromotions compared to the spike anchoring concept. The highest micromotion values for both types were observed in the longitudinal axis. In no case the threshold of 200 micrometers was exceeded. Conclusions Both fixation systems fulfill the required criteria of primary stability. Independent of the selected anchorage type an immediate postoperative active mobilization doesn’t compromise the stability of the prostheses.


2014 ◽  
Vol 73 ◽  
pp. 273-281 ◽  
Author(s):  
Francisco García Vacas ◽  
Francisco Ezquerro Juanco ◽  
Ana Pérez de la Blanca ◽  
María Prado Novoa ◽  
Sergio Postigo Pozo

2004 ◽  
Vol 13 (5) ◽  
pp. 464-467 ◽  
Author(s):  
S. Aunoble ◽  
P. Donkersloot ◽  
J. C. Le Huec

2018 ◽  
Vol 12 ◽  
pp. 274-280
Author(s):  
Guido La Rosa ◽  
Graziano Basile ◽  
Giovanna Fargione ◽  
Fabio Giudice

2013 ◽  
Vol 13 (11) ◽  
pp. 1640-1649 ◽  
Author(s):  
Kyle O. Colle ◽  
John B. Butler ◽  
Phillip M. Reyes ◽  
Anna G.U.S. Newcomb ◽  
Nicholas Theodore ◽  
...  

2020 ◽  
Author(s):  
Liangliang Cao ◽  
Yumei Liu ◽  
Wei Mei ◽  
Jian-guang Xu ◽  
Shi Zhan

Abstract Background : Previous studies have revealed positive effect of Topping-off technique on upper adjacent segment after fusion surgery, while for the cases with fusion surgery on L5-S1 segment, owning maximal range of motion, and preexisting degenerated upper adjacent disc, it is necessary to clarify the superiority of Topping-ff technique and the effect exerted on the lumbar spine. Methods: A young healthy male volunteer was selected for thin-slice CT scanning. Then the image information was imported into the computer to establish the whole lumbar spine model as the health model. The medium degeneration model of intervertebral disc was established by changing the material properties of L4-S1 disc on the basis of the health model, and the fusion model and Topping-off model were respectively established on the basis of the degenerated model. The variation trend of ROM of L2-L5 and the stress changes of L4-L5 intervertebral disc, nucleus pulposus and facet joints were calculated respectively. Results: The L4-L5 ROM of fusion model increased significantly but the ROM of L2-L3 and L3-L4 segments did not change significantly. Compared with the degenerated model, L4-L5 activity of the Topping-off model decreased, and ROM of the L2-L3 and L3-L4 increased to some extent in the flexion and extension positions. the stress on the disc, nucleus pulposus and facet joint of the fusion model L4-L5 increased in four positions of flexion, extension, rotation and bending compared with the degenerated model, while the fiber stress on the Topping-off model decreased significantly in all four positions. Conclusion: Topping-off technology can decrease the stress and ROM of the adjacent upper degenerated segment, and increase the ROM of other upper segments, thereby protecting the degenerated upper adjacent segments and compensating the lumbar spine mobility.


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