Introduction

We report a single-centre, prospective, randomised study for pedicle screw insertion, by using a Computer Assisted Surgery (CAS) technique with three dimension (3D) intra-operative images intensifier versus conventional surgical procedure.

In recent years internal fixation of the spine by using posterior approach with minimally invasive and percutaneous technique were increasingly used in trauma. The percutaneous surgery lose information and navigation is supposed to provide better data because the lost information is found again. We hypothesise that a percutaneous minimal invasive dorsal procedure by using 3D intra-operative imaging for vertebral fractures allows short operating times with correct screw positioning and does not increase radiation exposure.

59 patients were included in this prospective, monocentric and randomised study. 29 patients (108 implants) were operated on by using conventional surgical procedure (CP) and 30 patients (72 implants) were operated on by using a 3D fluoroscopy-based navigation system (3D fluo). In the two groups, a percutaneous approach was performed for transpedicular vertebroplasty or percutaneous pedicle screws insertion. In the two groups surgery was done from T4 level to L5 levels. Patients (54 years old on average) suffered trauma fractures, fragility fractures or degenerative instabilities. Evaluation of screw placement was done by using post-operative CT with two independent radiologists that used Youkilis criteria. Operative and radiation running time were also evaluated.

With percutaneous surgery, the 3D fluo technique was less accurate with 13.88% of misplaced pedicle screws (10/72) compared with 11.11% (12/108) observed with CP. The radiation running time for each vertebra level (two screws) reached on average 0.56 mSv with 3D fluo group compared to 1.57 mSv with the CP group. The time required for instrumentation (one vertebra, two screws) with 3D fluo was 19.75 minutes compared with CP group 9.19 minutes. The results were statistically significant in terms of radiation dose and operative running time (p < 0.05), but not in terms of accuracy (p= 0.24).

With percutaneous procedures, 3D fluoroscopy-based navigation (3D fluo) system has no superiority in terms of operative running time and to a lesser degree in terms of accuracy, as compared to 2D conventional procedure (CP), but the benefit in terms of radiation dose is important. Other advantages of the 3D fluo system are twofold: up-to-date image data of patient anatomy and immediate availability to assess the anatomical position of the implanted screws.

Direct arthroscopic cartilage assessment remains the gold standard. It is recommended by the International Cartilage Repair Society (ICRS) to systematically assess cartilage status during arthroscopy but this examination is highly subjective, poorly reproducible, time-consuming and lacks precision. US has shown good potential for cartilage evaluation but is limited in extra-articular conditions. It is also difficult to manually maintain a perfect perpendicularity between the ultrasound beam and the curved surface of the cartilage. Therefore, we have developed a navigated intra-articular US probe (NIAUS). The NIAUS probe could contribute to a more exhaustive and direct intra-articular evaluation of cartilage integrity. Navigation enables control of the US echo pulse perpendicularity and its localisation relative to the joint. Our objectives were (1) to evaluate automatic cartilage thickness measurement with the NIAUS probe in comparison to high definition MRI on cartilage samples, (2) to generate a real-time 3D map of the thickness parameter on samples, and (3) to demonstrate the feasibility of a full NIAUS probe cartilage scan on a specimen distal femur in arthroscopic conditions.

The NIAUS probe is a 4.5mm probe consisting of a 64 element linear array transducer with a central frequency of 13 MHz and a motorised head. The NIAUS probe is navigated. The rotating US head position is controlled by navigation in order to enable constant perpendicular acquisition of cartilage. The NIAUS probe thickness measurement (1) was evaluated on bone and cartilage samples of 9 tibial plateaus. The cartilage thickness was measured via automatic segmentation. Each sample was also scanned in a high resolution MRI (4,7 Tesla) and cartilage thickness was semi-automatically extracted for comparison. During NIAUS scan, (2) a visual 3D map was generated. Finally (3), we scanned two distal femurs with the NIAUS probe in arthroscopic navigated conditions on one specimen and a 3D map of the distal femur thickness was generated in real time.

NIAUS thickness measurement (1) absolute error compared to MRI for 9 plateaus ranged from 0.15mm to 0.32mm in median, p25=0.07 and 0.18, p75=0.28 and 0.5 respectively. 3D maps of the sample cartilage thickness (2) were generated in real time during the NIAUS scan. The cadaveric procedure (3) was conducted without incident via the two anterior portals and a 3D map of the distal femurs cartilage thickness was generated.

A precise US arthroscopic grading and scoring of cartilage during surgery could help for better standardisation, prediction of results and making “live” decisions. Our in vitro experiment shows good results compared to MRI for NAIUS cartilage thickness measurement, and our cadaveric study demonstrate the feasibility of a NIAUS scan in arthroscopic conditions. Our results are encouraging and a clinical trial is currently being designed for preliminary in vivo NIAUS evaluations of cartilage thickness compared to MRI.

Background: A navigated 8 in 1 femoral cutting guide for TKA that does not require primary fixation or intramedullary guides was developed. The hypothesis of our study were twofold: 1) the navigation system allows for precise alignment and adjustment of a new femoral 8 in 1 cutting guide with negligible variance in the initially planned vs. achieved implant position; 2) resulting femoral cuts are very accurate without relevant cutting errors.

Material and Methods: We demonstrate our approach with the Universal Knee Instrument (UKI, Precimed Inc. USA), a versatile 8 in 1 TKA guide designed to perform all femoral cuts with a single jig. We integrated an array of “adjustable constraints” into the UKI by machining four threaded holes directly through the template. Adaptation to a navigation system has been performed by integrating the adjustable constraints protocol on the open platform Surgetics Station (PRAXIM-medivision, France), which uses image-free BoneMorphing technology. Based on navigated bone morphing the required preadjustment of the guide was done mechanically, with depth control by mini screws. Testings on 10 cadavers compared the planned vs. achieved positions of the jig before, after fixation, final implant position and planned vs. achieved cutting procedures.

Results: Results revealed for valgus/varus deviations before fixation −0.1°±0.7°, after 0.0°±0.8° (p=0.51), final implant position 0.9°±1.7° (p=0.93). For flexion before fixation −0.3°±1.3° after −0.3°±1.8° (p=0.44), final position 2.9°±2.5° (p=0.65). Distal cut height before fixation 0.0°±0.4°, after 0.1°±0.3° (p=0.61), final position 0.3°±1.0° (p=0.1). Axial rotation before −0.3°±1.1°, after fixation 0.2°±1.4° (p=0.57), final implant position 0.8°±2.7° (p=0.89). Anterior-posterior positions before fixation 0.7°±1.4°, after 1.0°±1.6° (p=0.27), final position 3.4°±1.3° (p=0.13). Highest deviations in the planned vs. actual cut position was found for the posterior cut −3.1°±2.4° in sagittal and anterior cut 0.8°±1.9° in the coronal plane. The highest mean errors in the final implant position where on the order of 3 degrees/mm in flexion and anterior-posterior positioning.

Conclusion: A novel ‘CAS-enabled 8 in 1 jig’ has been developed and validated. The system allows for direct execution of a complex, multi-planar CAS plan with single navigated device. The instrumentation is considerably simplified and eliminates the problems associated with sequential jigs.