How does free rod-sliding affect the posterior instrumentation for a dynamic stabilization using a bovine calf model?

STUDY DESIGN: A biomechanical cadaveric study in lumbar calf spine. OBJECTIVE: Evaluation of the effects of selected degrees of freedom (df) on the dynamic stabilization of the spine in terms of segmental range of motion (RoM), center of rotation (CoR), and implant loadings. SUMMARY OF BACKGROUND DATA: For dorsal stabilization, rigid implant systems are becoming increasingly complemented by numerous dynamic systems based on pedicle screws and varying df. However, it is still unclear which df is most suitable to accomplish a physiologically related dynamic stabilization, and which loadings are induced to the implants. Human and calf specimens are reported to show certain similarities in their biomechanics. Young healthy calf specimens are not degenerated and show less interindividual differences than elderly human specimens. However, the existing differences between species limit the conclusions in a preclinical setting. METHODS: Six calf specimens from level L3-L4 were analyzed in flexion and extension with a 6-df robotic spine simulator. A clinical functional radiological examination tool was used and parameters such as RoM, CoR, and implant loadings were determined for 6 configurations: (1) intact, (2) defect, (3) rigid fixation, (4) free craniocaudal (CC) rod-sliding, (5) free polyaxiality, and (6) combined free rod-sliding and free polyaxiality. The location of the CoR was determined relative to vertebral body dimensions. A CoR repositioning was defined as sufficient when its median differed less than 5% of the vertebral body dimensions. RESULTS: Free rod-sliding in the CC direction restored the CoR from the defect back to the intact condition. The RoM could be significantly reduced to approximately 1/2 of the intact condition. Compared with the rigid condition, the implant bending moments increased from 0.3/-0.8 Nm (flexion/extension) to 1.3/-1.2 Nm for the free CC rod-sliding condition. CONCLUSION: Free CC rod-sliding restores the intact conditions of the tested kinematic parameters most suitably and at the same time reduces the RoM. Stabilization toward the intact condition could decrease the risk of stress shielding and the progress of segment degeneration. LEVEL OF EVIDENCE: N/A.

A method to perform spinal motion analysis from functional X-ray images.

Identifying spinal instability is an important aim for proper surgical treatment. Analysis of functional X-ray images delivers measurements of the range of motion (RoM) and the center of rotation (CoR). In today's practice, CoR determination is often omitted, due to the lack of accurate methods. The aim of this work was to investigate the accuracy of a new analysis software (FXA™) based on an in vitro experiment. Six bovine spinal specimens (L3-4) were mounted in a robot (KR125, Kuka). CoRs were predefined by locking the robot actuator tool center point to the estimated position of the physiologic CoR and taking a baseline X-ray. Specimens were deflected to various RoM(preset) flexion/extension angles about the CoR(preset). Lateral functional radiographs were acquired and specimen movements were recorded using an optical motion tracking system (Optotrak Certus). RoM and CoR errors were calculated from presets for both methods. Prior to the experiment, the FXA™ software was verified with artificially generated images. For the artificial images, FXA™ yielded a mean RoM-error of 0.01 ± 0.03° (bias ± standard deviation). In the experiment, RoM-error of the FXA™-software (deviation from presets) was 0.04 ± 0.13°, and 0.10 ± 0.16° for the Optotrak, respectively. Both correlated with 0.998 (p < 0.001). For RoM < 1.0°, FXA™ determined CoR positions with a bias>20mm. This bias progressively decreased from RoM = 1° (bias = 6.0mm) to RoM = 9° (bias<1.5mm). Under the assumption that CoR location variances <5mm are clinically irrelevant on the lumbar spine, the FXA™ method can accurately determine CoRs for RoMs > 1°. Utilizing FXA™, polysegmental RoMs, CoRs and implant migration measurements could be performed in daily practice.

Determination of the in vivo posterior loading environment of the Coflex interlaminar-interspinous implant.

BACKGROUND CONTEXT: The in vivo loading environment of load-bearing implants is generally largely unknown. Loads are typically approximated from cadaver tests or biomechanical calculations for the preclinical assessment of a device's safety and efficacy. PURPOSE: To determine the actual in vivo loading environment of an elastic interlaminar-interspinous implant (Coflex). STUDY DESIGN: A retrospective radiographic study to noninvasively measure the in vivo implant loads of 176 patients. METHODS: For this study, neutral, flexion, and extension radiographs were quantitatively analyzed using validated image analysis technology. The angle between the Coflex arms was measured for each radiograph and statistically evaluated. Separately, the Coflex implant was characterized using mechanical test data and finite element analysis, which resulted in a load-deformation formula that describes the implant load as a function of its size and elastic deformation. Using the formula and the elastic implant deformation data obtained from the radiographic analysis, the exact implant load was calculated for each patient and each posture. For statistical analysis, the patients were grouped by indication and procedure, which resulted in 12 different groups. The determined loads were compared with the strength of the posterior lumbar spinal elements obtained from the literature and with the static and dynamic mechanical limits of the Coflex interlaminar-interspinous implant. RESULTS: The force data were independent of implant size, diagnosis (with one exception), number of levels of the decompression procedure, number of levels of implantations (one or two), and follow-up time. The median compressive force acting on the Coflex implant was found to be 45.8 N. The maximum load change between flexion and extension was 140 N; the maximum overall load exceeded 239 N in extension. CONCLUSIONS: The average loads exerted by the Coflex implant on the spinous process and lamina are 11.3% and 7.0% of their respective static failure load. The implant fatigue strength is significantly higher than the measured median force, which explains the extremely rare observation of a Coflex fatigue failure.