Reducing residual forces in spinal fusion using a custom-built rod bending machine.

BACKGROUND AND OBJECTIVE: As part of spinal fusion surgery, shaping the rod implant to align with the anatomy is a tedious, error-prone, and time-consuming manual process. Inadequately contoured rod implants introduce stress on the screw-bone interface of the pedicle screws, potentially leading to screw loosening or even pull-out. METHODS: We propose the first fully automated solution to the rod bending problem by leveraging the advantages of augmented reality and robotics. Augmented reality not only enables the surgeons to intraoperatively digitize the screw positions but also provides a human-computer interface to the wirelessly integrated custom-built rod bending machine. Furthermore, we introduce custom-built test rigs to quantify per screw absolute tensile/compressive residual forces on the screw-bone interface. Besides residual forces, we have evaluated the required bending times and reducer engagements, and compared our method to the freehand gold standard. RESULTS: We achieved a significant reduction of the average absolute residual forces from for the freehand gold standard to (p=0.0015) using the bending machine. Moreover, our bending machine reduced the average time to instrumentation per screw from to . Reducer engagements per rod were significantly decreased from an average of 1.00±1.14 to 0.11±0.32 (p=0.0037). CONCLUSION: The combination of augmented reality and robotics has the potential to improve surgical outcomes while minimizing the dependency on individual surgeon skill and dexterity.

Second Metatarsal Length and Transfer Ulcers After First Metatarsal Amputation in Diabetic Foot Infections.

BACKGROUND: Plantar transfer ulcers (TUs) underneath the second metatarsal head are frequent after first metatarsal ray amputations due to diabetic foot infections. Whether the second metatarsal length (2ML) is associated with TU occurrence in these patients is unclear. This study evaluated whether 2ML is associated with TU occurrence after first-ray amputations and whether ulcer-free survival is shorter in patients with "excess" 2ML. METHODS: Forty-two patients with a mean age of 67 (range 33-93) years, diabetes, and first metatarsal ray amputation (first amputation at the affected foot) were included. Two independent readers measured the 2ML using the Coughlin method. A protrusion of more than 4.0 mm of the second metatarsal was defined as "excess" 2ML. The effect of 2ML on ulcer occurrence was analyzed using a multivariate Cox regression model. A Kaplan-Meier curve for TU-free survival was constructed comparing the 2 groups of "normal" (n = 21) and "excess" 2ML (n = 21). RESULTS: Interrater reliability was excellent. TUs underneath the second metatarsal occurred in 15 (36%) patients. In agreement with our hypothesis, 2ML was nonsignificantly different in patients with TUs, recording a mean of 5.3 (SD 2.5) mm, compared to patients without 4.0 (SD 2.3) mm (hazard ratio [HR] 1.12, 95% CI 0.89-1.41), whereas insulin dependence was associated with ulcer occurrence (HR 0.33, 95% CI 0.11-0.99). CONCLUSION: In our relatively small study population with a cutoff level of 4 mm for excess 2ML, ulcer-free survival was similar in patients with "normal" and "excess" 2ML. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Automatic registration with continuous pose updates for marker-less surgical navigation in spine surgery.

Established surgical navigation systems for pedicle screw placement have been proven to be accurate, but still reveal limitations in registration or surgical guidance. Registration of preoperative data to the intraoperative anatomy remains a time-consuming, error-prone task that includes exposure to harmful radiation. Surgical guidance through conventional displays has well-known drawbacks, as information cannot be presented in-situ and from the surgeon's perspective. Consequently, radiation-free and more automatic registration methods with subsequent surgeon-centric navigation feedback are desirable. In this work, we present a marker-less approach that automatically solves the registration problem for lumbar spinal fusion surgery in a radiation-free manner. A deep neural network was trained to segment the lumbar spine and simultaneously predict its orientation, yielding an initial pose for preoperative models, which then is refined for each vertebra individually and updated in real-time with GPU acceleration while handling surgeon occlusions. An intuitive surgical guidance is provided thanks to the integration into an augmented reality based navigation system. The registration method was verified on a public dataset with a median of 100% successful registrations, a median target registration error of 2.7 mm, a median screw trajectory error of 1.6°and a median screw entry point error of 2.3 mm. Additionally, the whole pipeline was validated in an ex-vivo surgery, yielding a 100% screw accuracy and a median target registration error of 1.0 mm. Our results meet clinical demands and emphasize the potential of RGB-D data for fully automatic registration approaches in combination with augmented reality guidance.

Development and evaluation of robot-assisted ultrasound navigation system for pedicle screw placement: An ex-vivo animal validation.

PURPOSE: Spinal instrumentation with pedicle screw placement (PSP) is an important surgical technique for spinal diseases. Accurate screw trajectory is a prerequisite for PSP. Ultrasound (US) imaging with robot-assisted system forms a non-radiative alternative to provide precise screw trajectory. This study reports on the development and assessment of US navigation for this application. METHODS: A robot-assisted US reconstruction was proposed and an automatic CT-to-US registration algorithm was investigated, allowing the registration of screw trajectories. Experiments were conducted on ex-vivo lamb spines to evaluate system performance. RESULTS: In total, 72 screw trajectories are measured, displaying an average position accuracy of 2.80 ± 1.14 mm and orientation accuracy of 1.38 ± 0.61°. CONCLUSION: The experimental results demonstrate the feasibility of proposed US system. This work, although restricted to laboratory settings, encourages further exploration of the potential of this technology in clinical practice.

Automatic breach detection during spine pedicle drilling based on vibroacoustic sensing.

Pedicle drilling is a complex and critical spinal surgery task. Detecting breach or penetration of the surgical tool to the cortical wall during pilot-hole drilling is essential to avoid damage to vital anatomical structures adjacent to the pedicle, such as the spinal cord, blood vessels, and nerves. Currently, the guidance of pedicle drilling is done using image-guided methods that are radiation intensive and limited to the preoperative information. This work proposes a new radiation-free breach detection algorithm leveraging a non-visual sensor setup in combination with deep learning approach. Multiple vibroacoustic sensors, such as a contact microphone, a free-field microphone, a tri-axial accelerometer, a uni-axial accelerometer, and an optical tracking system were integrated into the setup. Data were collected on four cadaveric human spines, ranging from L5 to T10. An experienced spine surgeon drilled the pedicles relying on optical navigation. A new automatic labeling method based on the tracking data was introduced. Labeled data was subsequently fed to the network in mel-spectrograms, classifying the data into breach and non-breach. Different sensor types, sensor positioning, and their combinations were evaluated. The best results in breach recall for individual sensors could be achieved using contact microphones attached to the dorsal skin (85.8%) and uni-axial accelerometers clamped to the spinous process of the drilled vertebra (81.0%). The best-performing data fusion model combined the latter two sensors with a breach recall of 98%. The proposed method shows the great potential of non-visual sensor fusion for avoiding screw misplacement and accidental bone breaches during pedicle drilling and could be extended to further surgical applications.

Synthetic white balancing for intra-operative hyperspectral imaging.

Purpose: Hyperspectral imaging shows promise for surgical applications to non-invasively provide spatially resolved, spectral information. For calibration purposes, a white reference image of a highly reflective Lambertian surface should be obtained under the same imaging conditions. Standard white references are not sterilizable and so are unsuitable for surgical environments. We demonstrate the necessity for in situ white references and address this by proposing a novel, sterile, synthetic reference construction algorithm. Approach: The use of references obtained at different distances and lighting conditions to the subject were examined. Spectral and color reconstructions were compared with standard measurements qualitatively and quantitatively, using ΔE and normalized RMSE, respectively. The algorithm forms a composite image from a video of a standard sterile ruler, whose imperfect reflectivity is compensated for. The reference is modeled as the product of independent spatial and spectral components, and a scalar factor accounting for gain, exposure, and light intensity. Evaluation of synthetic references against ideal but non-sterile references is performed using the same metrics alongside pixel-by-pixel errors. Finally, intraoperative integration is assessed though cadaveric experiments. Results: Improper white balancing leads to increases in all quantitative and qualitative errors. Synthetic references achieve median pixel-by-pixel errors lower than 6.5% and produce similar reconstructions and errors to an ideal reference. The algorithm integrated well into surgical workflow, achieving median pixel-by-pixel errors of 4.77% while maintaining good spectral and color reconstruction. Conclusions: We demonstrate the importance of in situ white referencing and present a novel synthetic referencing algorithm. This algorithm is suitable for surgery while maintaining the quality of classical data reconstruction.

Robot-assisted ultrasound reconstruction for spine surgery: from bench-top to pre-clinical study.

PURPOSE: Robot-assisted ultrasound (rUS) systems have already been used to provide non-radiative three-dimensional (3D) reconstructions that form the basis for guiding spine surgical procedures. Despite promising studies on this technology, there are few studies that offer insight into the robustness and generality of the approach by verifying performance in various testing scenarios. Therefore, this study aims at providing an assessment of a rUS system, with technical details from experiments starting at the bench-top to the pre-clinical study. METHODS: A semi-automatic control strategy was proposed to ensure continuous and smooth robotic scanning. Next, a U-Net-based segmentation approach was developed to automatically process the anatomic features and derive a high-quality 3D US reconstruction. Experiments were conducted on synthetic phantoms and human cadavers to validate the proposed approach. RESULTS: Average deviations of scanning force were found to be 2.84±0.45 N on synthetic phantoms and to be 5.64±1.10 N on human cadavers. The anatomic features could be reliably reconstructed at mean accuracy of 1.28±0.87 mm for the synthetic phantoms and of 1.74±0.89 mm for the human cadavers. CONCLUSION: The results and experiments demonstrate the feasibility of the proposed system in a pre-clinical setting. This work is complementary to previous work, encouraging further exploration of the potential of this technology in in vivo studies.

The Relationship between Frontal, Axial Leg Alignment, and Ankle Joint Line Orientation-a Radiographic Analysis of Healthy Subjects.

OBJECTIVE: Ankle joint line orientation (AJLO) is influenced by the subtalar foot and frontal leg alignment. However, the influence of axial leg alignment on AJLO remains unclear. The study aimed to analyze the influence of frontal, axial leg alignment on AJLO in healthy subjects. METHODS: Thirty healthy subjects (60 legs) without prior surgery underwent standing biplanar long leg radiograph (LLR) between 2016 and 2020. AJLO was measured in standing long-leg radiographs relative to the ground. Meary's angle and calcaneal pitch were measured. Hip-knee-ankle angle (HKA), femoral antetorsion, and tibial torsion were assessed with SterEOS software (EOS Imaging, Paris, France). LLR was acquired with the feet directing straight anteriorly, which corresponds to a neutral foot progression angle (FPA). The influence of subtalar, frontal, and axial alignment on AJLO was analyzed in a multiple regression model. RESULTS: An increase in knee valgus increased relative valgus AJLO by 0.5° (95% CI: 0.2° to 0.7°) per 1° (P < 0.001). A decrease in femoral antetorsion increased relative valgus AJLO by 0.2° (95% CI: 0.1° to 0.2°) per 1° (P < 0.001), whereas Meary's angle and calcaneal pitch did not influence AJLO. CONCLUSION: A link between frontal, axial leg alignment, and AJLO could be demonstrated, indicating that a valgus leg alignment and relative femoral retrotorsion are associated with an increase of valgus AJLO in healthy subjects when placing their feet in a neutral position. Alteration of the frontal, or rotational profile after realignment surgery or by implant positioning might influence the AJLO, when the FPA is kept constant.

Arthroscopic and open treatment of cartilage lesions with BST-CARGEL scaffold and microfracture: A cohort study of consecutive patients.

BACKGROUND: CARGEL (Smith & Nephew Inc.), a chitosan-based polymer scaffolding biomaterial, has been used since 2012 for treating articular cartilage lesions. Limited data are available on patient outcomes following CARGEL treatment. This study aimed to describe short-term clinical and radiographic outcomes in a cohort of patients treated with CARGEL and microfracture surgery for articular cartilage defects in the knee. METHODS: A retrospective cohort study was conducted of consecutive patients with articular cartilage defects who had undergone microfracture surgery with CARGEL, or in patellar lesions microfracture and CARGEL plus Chondro-Gide (at SportsClinic Zurich). Study outcomes included reoperations, infections, allergic reactions, pain, swelling, range of motion, and tissue quality and quantity. Ethics approval was obtained from the local ethics committee on 05/09/2017 (Basec. Nr: 2017-01441). RESULTS: A total of 91 participants, with 93 treated lesions, consenting to chart review were included. No participants required reoperation due to complications on the index lesion. Fifteen participants had second-look surgery on the index knee for other reasons, allowing for visual confirmation of cartilage repair. No study participants experienced a post-surgical infection or suffered an allergic reaction. No significant changes in range of motion or T2 values were observed from pre-treatment to post-treatment follow-up. However, significant decreases were found in pain (P < 0.001) and swelling (P < 0.001), along with significant increases in MOCART II scores (P < 0.001). Similar results were found in a subgroup of patients with patellar lesions. CONCLUSIONS: Patients treated with CARGEL experienced few postoperative complications and reported promising reductions in pain and swelling after treatment. LEVEL OF EVIDENCE: IV.