Feasibility, technique and accuracy of ultrasound-guided transurethral injections into the urinary sphincter of female cadavers: proof of concept

Background The injection of muscle precursor cells (MPC) into the external urinary sphincter muscle (EUS) is a promising therapeutic option for regenerative treatment of stress urinary incontinence (SUI). The objective of the present project was to conduct a pre-clinical trial to investigate the feasibility and accuracy of ultrasound (US) guided, transurethral injections into the EUS of female cadavers. Methods This is a prospective, anatomical, interventional and radiological cadaveric laboratory investigation. Two urologists performed transurethral US-guided injections to deliver nano-iron particles into the EUS. The intervention was performed in three unfixed, fresh female cadavers. Each cadaver received MRI before and CT as well as MRI of the pelvis after the injections. Results The precision and accumulation of nano-iron particles in the EUS was compared using a rating scale to evaluate left versus right and anterior versus posterior distribution in axial and sagittal orientation with US, MRI and CT. The accuracy of our US-guided injections into the anterior target region yielded 4 points on the rating scale. Adequate precision and accumulation of particles in the left versus right EUS were also demonstrated (3 vs. 3.33 points, respectively). Signal intensity in MRI revealed a mean ratio of 0.33 before and after injection. CT scans showed no relevant artefacts impairing the assessment. Conclusion US-guided, transurethral injection into the EUS is feasible and imaging reveals a precise accumulation in the target region. Our method provides an appropriate approach to deliver MPC in the EUS muscle for a regenerative treatment of SUI in the near future.

Spinopelvic Parameters Do Not Predict the Sagittal Orientation of the Acetabulum

Background: The orientation of the acetabulum has a fundamental role in impingement and instability of the hip, and the spinopelvic parameters are thought to predict the sagittal orientation of the acetabulum (SOA). However, similar to the acetabular version (axial orientation) and inclination (coronal orientation), the cephalic or caudal orientation of the acetabulum in the sagittal plane, or SOA, may primarily be an intrinsic feature of the acetabulum itself. Purpose: To determine whether the spinopelvic parameters predict the sagittal orientation of the acetabulum in individuals without lumbar deformity. Study Design: Cross-sectional study; Level of evidence, 4. Methods: A retrospective analysis was performed in 89 patients (94 hips; 62 female, 27 male; mean ± SD age, 45.9 ± 15.4 years) without lumbosacral deformity who underwent magnetic resonance arthrogram (MRA) for assessment of hip pain. The SOA was determined in the sagittal cut MRA. A line was drawn at the distal limit of the anterior and posterior acetabular horns longitudinally to the transverse ligament, and the angle between this line and the axial plane represented the SOA. The sacral slope, pelvic incidence, and spinopelvic tilt were determined using a 3-dimensional cursor and the axial, sagittal, and coronal cuts. All MRA studies were performed with the patient in the supine position. Results: The SOA had a mean ± SD cephalic orientation of 18° ± 6.6°. No significant correlation was observed between the SOA and the sacral slope ( r = –0.03; P = .77). A weak correlation was observed between the SOA and the pelvic incidence ( r = 0.22; P = .03) and between the SOA and the spinopelvic tilt ( r = 0.41; P < .01). Conclusion: The SOA cannot be presumed based on the spinopelvic parameter. Similar to the well-known parameters to assess the axial and coronal orientation of the acetabulum, the assessment of the SOA demands acetabular-specific parameters. Additional studies are necessary to assess the SOA in asymptomatic hips, including disparities between genders. Clinically significant values for abnormal SOA of the acetabulum remain to be defined.

Preoperative factors improving the prediction of the postoperative sagittal orientation of the pelvis in standing position after total hip arthroplasty

The aims of this study were to investigate if the sagittal orientation of the pelvis (SOP) in the standing position changes after total hip arthroplasty (THA) and evaluate what preoperative factors may improve the prediction of the postoperative standing SOP in the context of a patient-specific functional cup orientation. 196 primary THA patients from Japan were retrospectively selected for this study. Computed tomography imaging of the pelvis, EOS imaging of the lower body and lateral radiographs of the lumbar spine in the standing position were taken preoperatively. Common biometrics and preoperative Harris Hip Score were recorded. The EOS imaging in the standing position was repeated three months following THA. A 3D/2.5D registration process was used to determine the standing SOP. Thirty-three preoperative biometric, morphological and functional parameters were measured. Important preoperative parameters were identified that significantly improve the prediction of the postoperative standing SOP by using multiple linear LASSO regression. On average, the SOP changed significantly (p < 0.001) between the preoperative and postoperative standing position three months after THA by 3° ± 4° in the posterior direction. The age, standing lumbar lordosis angle (LLA) and preoperative supine and standing SOP significantly (p < 0.001) improve the prediction of the postoperative standing SOP. The linear regression model for the prediction of the postoperative standing SOP is significantly (p < 0.001) improved by adding the parameters preoperative standing SOP and LLA, in addition to the preoperative supine SOP, reducing the root mean square error derived from a leave-one-out cross-validation by more than 1°. The mean standing SOP in Japanese patients changes already three months after THA in comparison to the preoperative value. The preoperative factors age, LLA, supine and standing SOP can significantly improve the prediction of the postoperative standing SOP and should be considered within the preoperative planning process of a patient-specific functional cup orientation.

Fusion iENA Scholar Study: Sensor-Navigated I-124-PET/US Fusion Imaging versus Conventional Diagnostics for Retrospective Functional Assessment of Thyroid Nodules by Medical Students

In conventional thyroid diagnostics, the topographical correlation between thyroid nodules (TN) depicted on ultrasound (US) in axial or sagittal orientation and coronally displayed scintigraphy images can be challenging. Sensor-navigated I-124-PET/US fusion imaging has been introduced as a problem-solving tool for ambiguous cases. The purpose of this study was to investigate the results of multiple unexperienced medical students (MS) versus multiple nuclear medicine physicians (MD) regarding the overvalue of I-124-PET/US in comparison to conventional diagnostics (CD) for the functional assessment of TN. Methods: Out of clinical routine, cases with ambiguous findings on CD were selected for I-124-PET/US fusion imaging. Sixty-eight digital patient case files (PCF) of 34 patients (CDonly and CD+PET/US PCF) comprising 66 TN were provided to be retrospectively evaluated by 70 MD and 70 MS, respectively. A total of 2174 ratings (32.9 per TN) were carried out: 555 ratings (8.4 per TN) for CDonly and 532 ratings (8.1 per TN) for CD+PET/US by each MD and MS. Results: Functional assessment revealed 8.5%/11.7% (n.s.) (16.4%/25.8% (p = 0.0002)), 41.8%/28.5% (p < 0.0001) (23.9%/17.9% (p = 0.0193)), 36.0%/30.5% (n.s.) (57.3%/53.9% (n.s.)), and 13.7%/29.4% (p < 0.0001) (2.4%/2.4% (n.s.)) hyperfunctioning, indifferent, hypofunctioning, and not rateable TNs for CDonly (CD+PET/US) and MD/MS, respectively. The respective rating confidence was indicated as absolute certain, quite certain, equivocal, uncertain, and not rateable in 11.7/3.4% (p < 0.0001) (44.9%/38.9% (p = 0.0541), 51.9%/26.7% (p < 0.0001) (46.2%/41.5% (n.s.)), 21.6%/29.0% (p = 0.0051) (6.2%/14.8% (p < 0.0001)), 1.1%/11.5% (p < 0.0001) (0.2%/2.3% (p = 0.0032)), and 13.7%/29.4% (p < 0.0001) (2.4%/2.4% (n.s.)) by MD/MS, respectively. There was a significant difference in the diversity of the observers’ functional assessment of TN (MD 0.84 vs. MS 1.02, p = 0.0006) and the respective confidence in functional assessment (MD 0.93 vs. MS 1.16, p < 0.0001) between MD and MS on CDonly, whereas CD+PET/US revealed weaker differences for both groups (MD 0.48 vs. MS 0.47, p = 0.57; and MD 0.66 vs. MS 0.83, p = 0.0437). With the additional application of I-124-PET/US, the rating diversity of both MD and MS markedly tends towards more consistency (p < 0.0001 in each case). Conclusion: The additional application of sensor-navigated I-124-PET/US fusion imaging significantly influenced the functional assessment of TN positively, especially for unexperienced observers.

Changes in Cross-sectional Area and Signal Intensity of Healing Anterior Cruciate Ligaments and Grafts in the First 2 Years After Surgery

Background: The quality of a repaired anterior cruciate ligament (ACL) or reconstructed graft is typically quantified in clinical studies by evaluating knee, lower extremity, or patient performance. However, magnetic resonance imaging of the healing ACL or graft may provide a more direct measure of tissue quality (ie, signal intensity) and quantity (ie, cross-sectional area). Hypotheses: (1) Average cross-sectional area or signal intensity of a healing ACL after bridge-enhanced ACL repair (BEAR) or a hamstring autograft (ACL reconstruction) will change postoperatively from 3 to 24 months. (2) The average cross-sectional area and signal intensity of the healing ligament or graft will correlate with anatomic features of the knee associated with ACL injury. Study Design: Cohort study; Level of evidence, 2. Methods: Patients with a complete midsubstance ACL tear who were treated with either BEAR (n = 10) or ACL reconstruction (n = 10) underwent magnetic resonance imaging at 3, 6, 12, and 24 months after surgery. Images were analyzed to determine the average cross-sectional area and signal intensity of the ACL or graft at each time point. ACL orientation, stump length, and bony anatomy were also assessed. Results: Mean cross-sectional area of the grafts was 48% to 98% larger than the contralateral intact ACLs at all time points ( P < .01). The BEAR ACLs were 23% to 28% greater in cross-sectional area than the contralateral intact ACLs at 3 and 6 months ( P < .02) but similar at 12 and 24 months. The BEAR ACLs were similar in sagittal orientation to the contralateral ACLs, while the grafts were 6.5° more vertical ( P = .005). For the BEAR ACLs, a bigger notch correlated with a bigger cross-sectional area, while a shorter ACL femoral stump, steeper lateral tibial slope, and shallower medial tibial depth were associated with higher signal intensity ( R2 > .40, P < .05). Performance of notchplasty resulted in an increased ACL cross-sectional area after the BEAR procedure ( P = .007). No anatomic features were correlated with ACL graft size or signal intensity. Conclusion: Hamstring autografts were larger in cross-sectional area and more vertically oriented than the native ACLs at 24 months after surgery. BEAR ACLs had a cross-sectional area, signal intensity, and sagittal orientation similar to the contralateral ACLs at 24 months. The early signal intensity and cross-sectional area of the repaired ACL may be affected by specific anatomic features, including lateral tibial slope and notch width—observations that deserve further study in a larger cohort of patients. Registration: NCT02292004 (ClinicalTrials.gov identifier)

Patient-specific instrumentation for total knee arthroplasty

Purpose: To assess the accuracy of total knee replacements (TKRs) performed using CT-based patient-specific instrumentation by postoperative CT scan. Method: Approval from the Ethics Committee was granted prior to commencement of this study. Fifty prospective and consecutive patients who had undergone TKR (Evolis, Medacta International) using CT-based patient-specific instrumentation (MY KNEE, Medacta International) were assessed postoperatively using a CT scan and the validated Perth protocol measurement technique. The hip-knee-ankle (HKA) angle of the lower limb in the coronal plane; the coronal, sagittal, and rotational orientation of the femoral component; and the coronal and sagittal orientation of the tibial component were measured. These results were then compared to each patient’s preoperative planning. The percentage of patients found to be less than or equal to 3° of planned alignment was calculated. One patient was excluded as the femoral cutting block did not fit the femur as predicted by planning and therefore underwent a conventional TKR. Results: Ninety-eight percent of patients were within 3° of planned alignment in the coronal plane reproducing the predicted HKA angle. Predicted coronal plane orientation of the tibial and femoral component was achieved in 100% and 96% of patients, respectively. The sagittal orientation of the femoral component was within 3° in 98% of patients. The planned sagittal positioning of the tibial component was achieved in 92% of patients. Furthermore, 90% of patients were found to have a femoral rotation within 3° of planning. Eighty-six percent of patients achieved good-to-excellent outcome at 12 months (Oxford Knee Score > 34). Conclusion: We have found that TKR using this patient-specific instrumentation accurately reproduces preoperative planning in all six of the parameters measured in this study.