One of the primary tenets of osteosynthesis is achieving strong bony fixation using screws or other devices.1,2 Prior to screw placement, the path is drilled. Structures adjacent to the far cortex are at risk for injury when the drill bit continues beyond the edge of the bone (ie, plunging) and during or after insertion of excessively long screws. Proximity of neurovascular structures to common drilling sites has been the subject of numerous publications.3–14 A study by Robinson et al11 used fresh frozen cadavers to evaluate the distance between the clavicle and the subclavian vein. They found that the center of the subclavian vein lumen resided an average of 4.8 mm from the medial aspect of the clavicle.11 Two studies using computed tomography (CT) angiography of live patients' shoulders found the great vessels to be intimately associated with the posterior cortex of the medial aspect of the clavicle,12,13 with a mean distance of 1.7 mm in women and 3.3 mm in men.12 In addition to drilling, inappropriate screw length further jeopardizes local neurovascular structures. Acute or late complications, such as subclavian artery injuries and limb ischemia, have been attributed to drilling or prominent screw placement in the clavicle.15–20
With a standard orthopedic drill, surgeons must rely on tactile and auditory feedback21,22 to determine when the drill has penetrated the second cortex (ie, far cortex). The loss of resistance once the cortex is breached can be appreciated as forward pressure is applied to the drill, and a subtle change in pitch may be heard when the drill bit is about to pass through the cortex. In patients with poor-quality bone, such as those with osteoporosis, these feedback mechanisms may be more difficult to appreciate. In addition, orthopedic trainees may be less adept at recognizing these indicators than more experienced surgeons.
A variety of recommendations have been made to reduce the risk of iatrogenic neurovascular injury during osteosynthesis of the clavicle. One group suggested obtaining a preoperative CT angiogram to assess the relationship between the clavicle and the adjacent neurovascular structures,19 but this practice may not be cost-effective.10 In addition, avoidance of anteroposterior drill/screw trajectories in the medial third of the clavicle has been recommended.13,19
Subperiosteal dissection in the vicinity of the subclavian vein has also been suggested,19 although others have postulated that the more extensive dissection may increase the risk of iatrogenic injury.23 Similarly, some authors have recommended placement of blunt retractors under the clavicle,10,13 whereas others have advised against this technique.19 Galley et al14 recommended using a drill stop. Alternatively, placing a bump posterior to the operative shoulder to increase shoulder protraction has been postulated to increase the distance between the clavicle and the neurovascular structures10; however, other authors recommended keeping the arm by the side without a posterior bump.14 Finally, several reports have recommended avoiding plunging while drilling the far cortex, without suggestion how to accomplish this.9,10,13,16,19 Using sharp drill bits also helps reduce plunge depth10,19,23 because significantly larger plunge depths have been demonstrated with dull drill bits compared with sharp drill bits.24
Recent advances in technology have allowed for automated modulation that stops drill bit rotation when the far cortex has been penetrated.25 Unlike previous methodologies developed to minimize risk to local structures, such as complex image-guided drilling templates for the spine,26,27 the latest drill-sensing technology is relevant to most bone drilling applications. This technology also provides the user with a real-time depth measurement that is displayed on a digital screen (Figure 1).25
The real-time depth measurements are displayed on the controller's digital screen. In this example, the depth is 18.2 mm.
Clavicle fractures account for approximately 3% to 5% of all fractures.28–30 Complications associated with clavicle osteosynthesis are rare but may be devastating due to the close proximity of neurovascular structures.11,12,15–19 Reported complications include subclavian arteriovenous fistula formation,16 subclavian artery injuries including pseudoaneurysm and limb ischemia,15,17–20,31 brachial plexus injury,31,32 pneumothorax,31 and death.33 Although the indications for clavicle osteosynthesis remain controversial,34–38 several recent studies have identified improved outcomes with open reduction and internal fixation.34–37 The purpose of the current study was to quantify the depth of plunge during drilling of the clavicle with traditional drilling technique and drill-sensing technology.
Materials and Methods
The articulated clavicles of one cadaveric upper torso, which included both upper limbs and the thoracic spine, were used for this study. The donor's cause of death was cancer at age 74 years; body mass index was 34 kg/m2. There were no known metastases to bone or previous surgery to the upper extremities or cervical region aside from left thoracic mediport placement and subsequent posthumous removal.
Personnel and Training. Two fellowship-trained, board-certified orthopedic surgeons (J.A.D., M.K.M.) performed the protocol. Neither surgeon had prior experience with the drill-sensing technology. The surgeons were introduced to the IntelliSense Drill Technology (McGinley Orthopaedics) by a representative from the company in a manner consistent with the training a surgeon would receive prior to initial use in the operating room. The surgeons had an opportunity to practice using the drill-sensing technology with composite bones (Sawbones) as many times as necessary to feel comfortable with the device.
Clavicle Drilling. Each surgeon drilled 10 bicortical holes from superior to inferior along the clavicle with the drill in “bicortical mode” (Figure 2), which stops motor rotation after complete penetration of 2 cortices. When the cortex of the bone is breached, there is an inevitable acceleration in the rate of forward progression of the drill bit associated with the loss of resistance that occurs when the cortical bone is penetrated. The drill's rotation is automatically stopped with penetration of the second cortex. The depth measured by the drill-sensing technology's controller was recorded for each hole. The controller monitors the depth measured by the displacement of the sensing arm attached to the drill (Figure 2). The surgeons were blinded to the depth measurements. Each surgeon drilled an additional 10 superior-inferior, bicortical holes with the drill in “freehand mode,” which allows the drill to function as a typical orthopedic drill that stops only when the surgeon releases the trigger. The drill-sensing technology's controller measures depth in real-time while the drill is in use (ie, drill bit spinning), and these data points were recorded for each trial.
View from a superior perspective of the left clavicle. Bicortical holes were drilled along the clavicle in a superior-to-inferior direction (A). The sensing arm (arrow) attached to the drill bit measures displacement as the drill bit is advanced (B).
For holes drilled in freehand mode, the depth at penetration of the far cortex was calculated from the data. The second acceleration of drill bit advancement was identified as the depth of penetration of the far cortex (Figure 3). This depth was recorded for each trial. The depth of drill plunge was determined as the difference between the maximum recorded depth and the depth of penetration of the second cortex. In addition, the minimum distances from the inferior edge of the clavicle to the subclavian artery, subclavian vein, and brachial plexus were measured bilaterally by the surgeons with a wound ruler. New (ie, sharp) drill bits were used for testing.
Graphical view of the data for the drill hole with the largest plunge, which was 15.8 mm (approximately 1.6 cm). The relevant stages of drilling are labeled.
Computed Tomography. Computed tomography scans of each clavicle were performed with 0.75-mm contiguous axial images with pitch less than one. Coronal, sagittal, and 3-dimensional maximum intensity projection reformatted images were obtained. The depth of each hole was determined by measuring the distance between the outer edge of the near cortex and the outer edge of the far cortex along a centerline. Depth measurements were obtained by a senior radiology resident using TeraRecon software (TeraRecon).
The depth of penetration of the second cortex measured by the IntelliSense controller for the bicortical mode drill holes was compared with the CT depth. A difference of 1.35 mm or less was considered acceptable as expected error attributable to the IntelliSense depth measurement is 0.6 mm at 3 standard deviations (according to the manufacturer and its accepted Food and Drug Administration submission25) and the error attributable to reading the CT scans was 0.75 mm (the separation between the CT scan images). The mean plunge depth for each surgeon was calculated and compared using an independent, two-tailed t test (alpha=0.05). The side-to-side mean of the distances from the clavicle to the neurovascular structures was also determined.
The mean difference between the CT measurements and the IntelliSense controller measurements was 0.8 mm (Table 1). In freehand mode, the mean plunge depth for both surgeons was 8.8 mm. For surgeon 1, the range was 5.6 to 15.8 mm, with a mean of 10.9 mm. For surgeon 2, the range was 3.3 to 11.0 mm, with a mean of 6.4 mm. For surgeon 2, the data from 1 hole were not properly recorded by the research team and were excluded from the analysis. The means of the 2 surgeons were significantly different (P=.005). The plunge data for each hole are displayed in Table 2. The bilateral mean distances to the neurovascular structures from the middle third of clavicle were 15.5 mm to subclavian vein, 18.0 mm to subclavian artery, and 8.0 mm to nearest portion of the brachial plexus (Figure 4).
Measured Depths From the Drill-Sensing Technology in Bicortical Mode as Compared With the Depths From the Computed Tomography Scans
Maximum Depths That the Drill Bit Was Advanced, Depth of the Second Cortex Breach (Actual Hole Depth), and Plunge Depths (Maximum Drill Depth Minus Second Cortex Depth) for Each Hole and Surgeon
A pictorial representation of drill bit plunging with respect to the nearby neurovascular structures. The black lines (1–3) represent the minimum, mean, and maximum plunge depths, respectively, observed in this study. The arcs represent the mean distance to the neurovascular structures (yellow [P], brachial plexus; blue [V], subclavian vein; and red [A], subclavian artery).
The drill-sensing technology in bicortical mode reliably stopped with penetration of the second cortex of the clavicle, as indicated by comparison of the drill-sensing technology's controller depth measurements and the CT depth measurements. The information from the manufacturer indicates that the depth measurement is accurate to within 0.6 mm at 3 standard deviations, which was determined by micro CT.25 The current authors' measurements were performed by standard CT imaging, which is less precise than micro CT; therefore, the error measured in this study (0.8 mm) was expected to be larger than the manufacturer's reported data. The error reported here was less than the sum of the error attributed to the drill-sensing technology controller measurement and the CT measurement, which indicates that the IntelliSense controller depth measurement was consistent with the CT measurement. The surgeons anecdotally noted that it is possible for the drill bit to continue to advance after it has stopped spinning if the operator continues to apply substantial forward-directed pressure to the drill, but it was not noted by the surgeons to occur in this study. Although trauma to the surrounding soft tissue may be caused by a nonrotating drill bit, it is expected to be lower risk than a spinning drill bit that tends to wrap adjacent soft tissues around the drill bit.
The plunge depths measured in this study were consistent with the mean plunge depths of surgeons reported in a prior study.39 The plunge depths are concerning given the proximity to neurovascular structures about the clavicle. Even in regions without nearby neurovascular structures, potential trauma to the surrounding tissue (eg, tendon) should be considered. Although the majority of orthopedic procedures are performed without consequence, the potential for iatrogenic injury always needs to be considered, especially when it is potentially preventable. Advances in technology that allow for automated modulation of drilling technique may lessen the incidence or prevent previously inevitable iatrogenic injuries.
The minimum plunge depths for each surgeon were greater than the mean distance between the great vessels and the medial aspect of the clavicle reported by Merrimen et al.12 Both surgeons' mean plunge depths were greater than the distances to the surrounding neurovascular structures from several previous reports11–13 and identified in the current specimen. The soft tissue of the supraclavicular regions of this specimen appeared undisturbed based on gross examination by the participating surgeons. However, it is possible that the distances measured in this study may have been affected by the left mediport placement or posthumous removal of the mediport. The distances were in agreement with previous values in the literature; however, the nearest portion of the brachial plexus was closer to the left clavicle in this specimen than the mean distances reported in prior studies, which range from means of 9.7 to 15.2 mm.8,10,11
There are several reports of injury to neurovascular structures following open reduction and internal fixation of the clavicle. A case report described a 36-year-old man with a right midshaft clavicle fracture treated with compression plating who developed a pulsatile mass and right arm weakness.16 He was found to have a subclavian arteriovenous fistula originating at the end of the most medial screw.16
Pneumothoraces and brachial plexus injuries have also been reported following clavicle osteosynthesis.31 Other reports of subclavian artery injury and limb ischemia have been attributed to long screws.15,17–19 Conversely, short screws may not provide adequate fixation.9 The accuracy of depth measurement with a standard depth gauge is unknown. However, because the depth gauge measurement scale is millimeters, it is expected to be greater than the 0.6-mm measurement error of the IntelliSense drilling technology. Therefore, it is plausible that new measurement techniques may reduce the risk of iatrogenic injury associated with prominent screw placement, although this comparison was outside the scope of the current study.
There were several limitations to the current study. First, data were collected from a single cadaveric specimen; therefore, differences such as the effect of bone mineral density on plunge depth could not be assessed. In addition, this limited the number of holes that could be drilled. The drill-sensing technology depth measurements automatically stop when the drill bit stops rotating. Therefore, any plunge of the drill bit after it stopped rotating in bicortical mode or freehand mode could not be determined. Although soft tissue damage from a nonrotating drill bit is expected to be reduced compared with a rotating drill bit, there is still potential for soft tissue damage from the tip of a sharp drill bit.
In addition, it was not possible to compare freehand and bicortical mode drilling at the same sites along the length of the clavicle. Assessment of surgeon factors that may lead to differences in plunge depths was beyond the scope of this study. Surgeon 2 has been in practice approximately 9 years longer than surgeon 1, which suggests that level of experience may contribute to plunge depth. Both surgeons completed fellowship training time in both orthopedic trauma and sports. It was not possible to reach a definitive conclusion from the small sample of the current study; however, this postulation agrees with a previous report that found increased plunge depths for less experienced surgeons.23 In addition, Leis et al39 found that surgeons of all levels of experience plunge, but that the plunge depths were larger for less experienced surgeons.
These results are relevant given the recent increase in clavicle osteosynthesis among candidates participating in part II of the American Board of Orthopaedic Surgery certification (oral examination).40 Although it is unclear whether this trend also exists among more experienced surgeons,40 the increased rate of clavicle osteosynthesis among early-career surgeons may reflect recent literature that has suggested improved outcomes following clavicle osteosynthesis compared with nonoperative management.34–37,41,42 The reported complication rate among part II American Board of Orthopaedic Surgery certification candidates was low; however, both nerve palsy and vascular injuries were among the reported complications.40 Therefore, it may be especially important for early-career orthopedic surgeons to be aware of the risk of drill bit plunge, the potential for iatrogenic injury, and the techniques to reduce the risk of iatrogenic injury during clavicle osteosynthesis, although the drill bit plunge of the more experienced surgeon in this study also exceeded the distance to local neurovascular structures.
In addition to iatrogenic injuries, there are also cost considerations related to this type of technology. Initial expenses may exceed those of standard operative drills. However, features such as automated depth measurements may save costs associated with operative time and wasted screws. Assessment of cost-effectiveness was beyond the scope of this study but may be beneficial in future investigations. Similarly, although the findings of this study could be extrapolated to other anatomic regions, applications for this technology beyond the clavicle or with a larger sample of surgeons/trainees may warrant future study.
Overall, the drill-sensing technology accurately measured depth and stopped motor rotation with penetration of the second cortex of the clavicle in bicortical mode. With standard orthopedic drilling technique (freehand mode), the mean plunge depths of both surgeons were greater than distances to neurovascular structures previously reported in the literature11–13 and observed in this specimen. In addition, the minimum plunge depths of each surgeon were greater than previously reported mean distances to the great vessels.12 The risk of penetrating soft tissue structures adjacent to the bone with a spinning drill bit is reduced with the bicortical IntelliSense drilling technology. This is of particular importance for bones that reside in close proximity to major neurovascular structures (eg, clavicle, proximal tibia), but should be considered throughout the skeletal system.
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- Post WR, King SS. Neurovascular risk of bicortical tibial drilling for screw and spiked washer fixation of soft-tissue anterior cruciate ligament graft. Arthroscopy. 2001;17(3):244–247. doi:10.1053/jars.2001.21539 [CrossRef] PMID:11239343
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Measured Depths From the Drill-Sensing Technology in Bicortical Mode as Compared With the Depths From the Computed Tomography Scansa
|Drill hole||Measured depth||Computed tomography depth||Differenceb|
Maximum Depths That the Drill Bit Was Advanced, Depth of the Second Cortex Breach (Actual Hole Depth), and Plunge Depths (Maximum Drill Depth Minus Second Cortex Depth) for Each Hole and Surgeona
|Trial||Surgeon 1—right clavicle||Surgeon 2—left clavicle|
|Maximum depth||Second cortex breach||Plunge depth||Maximum depth||Second cortex breach||Plunge depth|