Does the use of dynamic surgical guidance assist accurate pedicle screw placement in patients with osteoporosis or osteopenia? / O uso do guia cirúrgico dinâmico auxilia a acurácia do posicionamento dos parafusos pediculares em pacientes com osteoporose ou osteopenia? / ¿el uso de guía quirúrgica dinámica ayuda a colocar con precisión los tornillos pediculares en pacientes con osteoporosis u osteopenia?

ABSTRACT Objective To compare the use of a dynamic surgical guide (PediGuard®) and pilot hole preparation, with the use of a probe and the aid of fluoroscopy in osteoporotic or osteopenic patients undergoing pedicular fixation of the thoracic or lumbar spine. Methods One hundred and eight patients were randomized. A pilot hole was prepared with the dynamic surgical guide (PediGuard®), or with a probe with the aid of fluoroscopy. A total of 657 vertebral pedicles (120 thoracic and 180 lumbar) were included in the study. The parameters used for the comparison were: accuracy of the pedicular screw, number of fluoroscopic shots, and change in intraoperative trajectory of the perforation after detecting pedicle wall rupture. Results In the group with use of the dynamic surgical guide, malpositioning of the pedicle screws was observed in 8 (2.6%) patients and intraoperative change of perforation trajectory in 12 (4%) patients, and there were 52 fluoroscopic shots. In the group without use of the dynamic surgical guide (PediGuard®), misplacement of the pedicle screws was observed in 33 (11%) patients and intraoperative change of perforation trajectory in 47 (13.2%) patients, and there were 136 fluoroscopic shots. Conclusion The use of the dynamic surgical guide (PediGuard®) in patients with osteoporosis or osteopenia enabled more accurate placement of pedicular screws, with less change in the intraoperative course of the perforation and less intraoperative radiation. Level of Evidence II; Randomized clinical trial of lesser quality.

RESUMO Objetivo Comparar o uso de um guia cirúrgico dinâmico (PediGuard®) e o preparo de orifício piloto com uma sonda e o auxílio de fluoroscopia em pacientes com osteopenia ou osteoporose submetidos à fixação pedicular da coluna torácica ou lombar. Métodos Cento e oito pacientes foram randomizados. Um orifício piloto foi preparado com o guia cirúrgico dinâmico (PediGuard®) ou com uma sonda com auxílio de fluoroscopia. Foram incluídos no estudo 657 pedículos vertebrais (120 torácicos e 180 lombares). Os parâmetros usados para a comparação foram: acurácia da colocação do parafuso pedicular, número de disparos fluoroscópicos e mudança da trajetória intraoperatória da perfuração depois da detecção de ruptura da parede do pedículo. Resultados No grupo de pacientes em que se usou o guia cirúrgico dinâmico, observou-se mau posicionamento dos parafusos pediculares em oito (2,6%) pacientes e alteração da trajetória intraoperatória da perfuração em 12 (4%) pacientes, com 52 disparos fluoroscópicos. No grupo de pacientes em que o guia cirúrgico dinâmico (PediGuard®) não foi usado o mau posicionamento dos parafusos pediculares foi observado em 33 (11%) pacientes, a mudança intraoperatória da trajetória da perfuração foi vista em 47 (13,2%) pacientes, com 136 disparos fluoroscópicos. Conclusão O uso do guia cirúrgico dinâmico (PediGuard®) em pacientes com osteoporose ou osteopenia permitiu a colocação de parafusos pediculares com maior acurácia, com menor alteração da trajetória intraoperatória da perfuração e menor dose de radiação intraoperatória. Nível de Evidência II; Estudo clínico randomizado de menor qualidade.

RESUMEN Objetivo Comparar el uso de una guía quirúrgica dinámica (PediGuard®) y la preparación del orificio piloto con una sonda y la ayuda de fluoroscopia en pacientes con osteopenia u osteoporosis sometidos a fijación pedicular de la columna torácica o lumbar. Métodos Ciento ocho pacientes fueron asignados aleatoriamente. Se preparó un orificio piloto preparado con la guía quirúrgica dinámica (PediGuard®) o con una sonda con ayuda de fluoroscopia. Se incluyeron en el estudio 657 pedículos vertebrales (120 torácicos y 180 lumbares). Los parámetros utilizados para la comparación fueron: precisión de la colocación del tornillo pedicular, número de disparos del dispositivo de fluoroscopia y cambio en la trayectoria intraoperatoria de la perforación después de la detección de ruptura de la pared del pedículo. Resultados En el grupo de pacientes en el que se utilizó la guía quirúrgica dinámica, se observó mal posicionamiento de los tornillos pediculares en 8 (2,6%) pacientes y cambios de la trayectoria intraoperatoria de la perforación en 12 (4%) pacientes, con 52 disparos del aparato de fluoroscopia. En el grupo de pacientes en los que no se utilizó la guía quirúrgica dinámica (PediGuard®), se observó un mal posicionamiento de los tornillos pediculares en 33 (11%) pacientes, el cambio intraoperatorio de la trayectoria de perforación se observó en 47 (13,2%) pacientes, con 136 disparos fluoroscópicos. Conclusión El uso de la guía quirúrgica dinámica (PediGuard®) en pacientes con osteoporosis u osteopenia permitió la colocación de tornillos pediculares con mayor precisión, menos cambios en la trayectoria intraoperatoria de la perforación y dosis más baja de radiación intraoperatoria. Nivel de Evidencia II; Ensayo clínico aleatorizado de menor calidad.

Maintenance of graft compression in the adult cervical spine.

It is generally advised that the graft inserted in adult cervical spine should be pre-loaded with a compressive force or that the screws are inserted in a divergent orientation, in order to maximise compression and the chance of graft incorporation (Truumees et al. in Spine 28:1097-1102, 2003). However, there is little evidence that a compressive force is maintained once the force applicator has been removed, or that the divergent screws enhance compression. This study compared the maintenance of applied pre-load force, across cervical spine graft, between standard anterior plating technique with pre-load and divergent screws and a novel plate technique, which allows its application prior to removal of the force applicator. Six intact adult cadaveric human cervical spines were exposed by standard surgical technique. A Casper type distracter was inserted across the disc space of interest, the disc was removed. In 14 experiments, following the disc removal, an autologous iliac crest bone graft was inserted under distraction, together with a strain gauge pressure transducer. A resting output from the transducer was recorded. The voltage output has a linear relationship with compressive force. A standardised compressive force was applied across the graft through the "Casper type" distracter/compressor (7.5 kg, torque). The pre-load compressive force was measured using a torque drill. Then two different procedures were used in order to compare the final applied strain on the bone graft. In eight experiments (procedure 1), the "Casper type" distracter/compressor was removed and a standard anterior cervical plate with four divergent screws was inserted. In six experiments (procedure 2), a novel plate design was inserted prior to removal of the distracter/compressor, which is not possible with the standard plate design. A final compressive force across the graft was measured. For the standard plate construct (procedure 1), the applied compression force is significantly greater than resting (SO/SC)--P=0.01, but the compression force is not maintained once the compressor is removed (SO/SR)--P=0.27. Final bone graft compression after plate insertion is not significantly different to the resting state (SO/SF)--P=0.16 (Wilcoxon's sign test for paired observation). Application of the plate tended to offload the graft; the final compressive force is 170+/-100% less than the resting force. None of the applied force was maintained (mean 9.5+/-8.8%). For the new plate (procedure 2), the end compressive force (SF) measured across the graft was greater than the resting force (SO) (P<0.001). Further, the novel plate application increased the compressive force on the graft by 712+/-484%. The final bone graft compression using a novel plate, which allows its application prior to removal of the force applicator, is significant (SO/SF)--P=0.01. Here, 77+/-10% of the applied pre-load was maintained. The difference between the plates is significant (P<0.001). Conclusions are as follows: (1) Applied pre-load is not maintained across a graft once the force applicator is removed. (2) Divergent screws with a plate do not compress graft and rather tend to offload it. (3) Compressive force may be maintained if the plate is applied prior to the force applicator removal.

A preliminary study of reliability of impedance measurement to detect iatrogenic initial pedicle perforation (in the porcine model).

Accidental perforation of the vertebral pedicle wall is a well-known complication associated with standard approach of pedicle screw insertion. Depending on detection criteria, more than 20% of screws are reported misplaced. Serious clinical consequences, from dysesthesia to paraplegia, although not common, may result from these misplaced screws. Many techniques have been described to address this issue such as somatosensory evoked potentials, electromyography, surgical navigation, etc. Each of these techniques presents advantages and drawbacks, none is simple and ergonomic. A new drilling tool was evaluated which allows for instant detection of pedicle perforation by emission of variable beeps. This new device is based on two original principles: the device is integrated in the drilling or screwing tool, the technology allows real-time detection of perforation through two independent parameters, impedance variation and evoked muscular contractions. A preliminary animal study was conducted to assess the safety and efficacy of this system based upon electrical conductivity. A total of 168 manual pedicle drillings followed by insertion of implants were performed in 11 young porcine lumbar and thoracic spines. The presence or absence of perforation detection, which defines the reliability of the device, was correlated with necropsic examination of the spines. Using this protocol the device demonstrated 100% positive predictive value, 96% negative predictive value, 100% specificity, and 97% sensitivity. Of 168 drillings there were three (1.79%) false-negatives, leading to a minor effraction, cranially in the intervertebral disks, nine (5.36%) screw threads breaching the vertebral cortex when inserting screws, although preparation of the holes did not indicate any perforation, 34 (36%) breaches detected by the instrument and not detected by the surgeon. These results confirm that the impedance variation detection capability of this device offers a simple and effective means to detect perforation in vertebral pedicle, prior to insertion of pedicle screws. Due to the porcine nerve root anatomy, it was not possible to evaluate the added benefit of cross-linking impedance and EMG detection. A future clinical study may further explore the subject of current study.