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Objective Computer-assisted surgery (CAS) and patient-specific instrumentation (PSI) are digital techniques to improve the accuracy of implant positioning in total knee arthroplasty (TKA), but their effects on clinical outcomes are still in dispute. The objective of this trial is to evaluate the efficacy and safety of CAS and PSI compared to conventional instrumentation (CI) in TKA. Methods A prospective randomized controlled trial was conducted. A total of 135 patients undergoing TKA were randomized into CAS group, PSI group and CI group with 45 patients in each group. Primary outcome is the coronal mechanical axis of lower extremity. Secondary outcomes include Femoral Rotation Angle (FRA) of the femoral prosthesis, operation time, perioperative blood loss, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS) and complications. Results Outliers of Hip-Knee-Ankle angle (HKA) were 24.4% in CI group, 17.8% in CAS group and 31.1% in PSI group respectively, and there was no significant difference among these 3 groups ( P  > 0.05). Outliers of FRA were 13.3% in CI group, 26.7% in CAS group and 11.1% in PSI group respectively with no significant difference ( P  > 0.05). Operation time was (66.67 ± 12.85)min, (81.67 ± 12.31)min and (52.78 ± 8.62)min in CI, CAS and PSI group. Operation time in CI was longer than PSI and shorter than CAS with significant difference ( P  < 0.01). There was no significant difference in comparison of blood loss, transfusion rate, postoperative WOMAC and FJS ( P  > 0.05). Conclusion CAS and PSI, compared with CI, did not significantly improve clinical outcomes including lower limb alignment, rotation of femoral prosthesis, blood loss, transfusion rate, and function scores. However, CAS was associated with prolonged operation time, whereas PSI resulted in a reduced operation time. Level of evidence Level II. Trial registration ChiCTR-INR-17,012,881 (registration date: 03/10/2017).

Background Several studies have shown mechanical alignment influences the outcome of TKA. Robotic systems have been developed to improve the precision and accuracy of achieving component position and mechanical alignment. Questions/purposes We determined whether robotic-assisted implantation for TKA (1) improved clinical outcome; (2) improved mechanical axis alignment and implant inclination in the coronal and sagittal planes; (3) improved the balance (flexion and extension gaps); and (4) reduced complications, postoperative drainage, and operative time when compared to conventionally implanted TKA over an intermediate-term (minimum 3-year) followup period. Methods We prospectively randomized 100 patients who underwent unilateral TKA into one of two groups: 50 using a robotic-assisted procedure and 50 using conventional manual techniques. Outcome variables considered were postoperative ROM, WOMAC scores, Hospital for Special Surgery (HSS) knee scores, mechanical axis alignment, flexion/extension gap balance, complications, postoperative drainage, and operative time. Minimum followup was 41 months (mean, 65 months; range, 41–81 months). Results There were no differences in postoperative ROM, WOMAC scores, and HSS knee scores. The robotic-assisted group resulted in no mechanical axis outliers (> ± 3° from neutral) compared to 24% in the conventional group. There were fewer robotic-assisted knees where the flexion gap exceeded the extension gap by 2 mm. The robotic-assisted procedures took an average of 25 minutes longer than the conventional procedures but had less postoperative blood drainage. There were no differences in complications between groups. Conclusions Robotic-assisted TKA appears to reduce the number of mechanical axis alignment outliers and improve the ability to achieve flexion-extension gap balance, without any differences in clinical scores or complications when compared to conventional manual techniques. Level of Evidence Level I, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Intraoperative MRI is increasingly used in neurosurgery, although there is little evidence for its use. We aimed to assess efficacy of intraoperative MRI guidance on extent of resection in patients with glioma. In our prospective, randomised, parallel-group trial, we enrolled adults (≥18 years) with contrast enhancing gliomas amenable to radiologically complete resection who presented to Goethe University (Frankfurt, Germany). We randomly assigned patients (1:1) with computer-generated blocks of four and a sealed-envelope design to undergo intraoperative MRI-guided surgery or conventional microsurgery (control group). Surgeons and patients were unmasked to treatment group allocation, but an independent neuroradiologist was masked during analysis of all preoperative and postoperative imaging data. The primary endpoint was rate of complete resections as established by early postoperative high-field MRI (1·5 T or 3·0 T). Analysis was done per protocol. This study is registered with ClinicalTrials.gov, number NCT01394692. We enrolled 58 patients between Oct 1, 2007, and July 1, 2010. 24 (83%) of 29 patients randomly allocated to the intraoperative MRI group and 25 (86%) of 29 controls were eligible for analysis (four patients in each group had metastasis and one patient in the intraoperative MRI group withdrew consent after randomisation). More patients in the intraoperative MRI group had complete tumour resection (23 [96%] of 24 patients) than did in the control group (17 [68%] of 25, p=0·023). Postoperative rates of new neurological deficits did not differ between patients in the intraoperative MRI group (three [13%] of 24) and controls (two [8%] of 25, p=1·0). No patient for whom use of intraoperative MRI led to continued resection of residual tumour had neurological deterioration. One patient in the control group died before 6 months. Our study provides evidence for the use of intraoperative MRI guidance in glioma surgery: such imaging helps surgeons provide the optimum extent of resection. None.

Objectives This study was a multicenter evaluation of the SAVI SCOUT ® breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal. Methods This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT ® reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT ® handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology. Results SCOUT ® reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision. Conclusions SCOUT ® provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.

Background Patient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components. In contrast, the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation. Depending on the manufacturer, patient-specific instrumentation is based on either MRI or CT scans. However, it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery. Questions/purposes We compared the accuracy of MRI- and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs. The three approaches also were compared with respect to validated outcomes scores and duration of surgery. Methods A randomized clinical trial was conducted in which 90 patients were enrolled and divided into three groups: CT-based, MRI-based patient-specific instrumentation, and conventional instrumentation. The groups were not different regarding age, male/female sex distribution, and BMI. In all groups, coronal and sagittal alignments were measured on postoperative standing long-leg and lateral radiographs. Component rotation was measured on CT scans. Clinical outcomes (Knee Society and WOMAC scores) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient. MRI- and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation, the patient-specific instrumentation groups were compared with each other, and all three approaches were compared for clinical outcome measures and duration of surgery. Results Compared with conventional instrumentation MRI- and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis (MRI versus conventional, 1.0° [range, 0°–4°] versus 4.5° [range, 0°–8°], p < 0.001; CT versus conventional, 3.0° [range, 0°–5°] versus 4.5° [range, 0°–8°], p = 0.02), femoral rotation (MRI versus conventional, 1.0° [range, 0°–2°] versus 4.0° [range, 1°–7°], p < 0.001; CT versus conventional, 1.0° [range, 0°–2°] versus 4.0° [range, 1°–7°], p < 0.001), and tibial slope (MRI versus conventional, 1.0° [range, 0°–2°] versus 3.5° [range, 1°–7°], p < 0.001; CT versus conventional, 1.0° [range, 0°–2°] versus 3.5° [range, 1°–7°], p < 0.001), but the differences were small. Furthermore, MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation (MRI versus CT, 1.0° [range, 0°–4°] versus 3.0° [range, 0°–5°], p = 0.03), while there was no difference in femoral rotation or tibial slope. Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation (MRI versus conventional, 58 minutes [range, 53–67 minutes] versus 76 minutes [range, 57–83 minutes], p < 0.001; CT versus conventional, 63 minutes [range, 59–69 minutes] versus 76 minutes [range, 57–83 minutes], p < .001), there were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups. Conclusions Although this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis, differences are only subtle and of questionable clinical relevance. Because there are no differences in the long-term clinical outcome or survivorship yet available, the widespread use of this technique cannot be recommended. Level of Evidence Level I, therapeutic study. See the Instructions to Authors for a complete description of levels of evidence.

Background Precise insertion of pedicle screws is important to avoid injury to closely adjacent neurovascular structures. The standard method for the insertion of pedicle screws is based on anatomical landmarks (free-hand technique). Head-mounted augmented reality (AR) devices can be used to guide instrumentation and implant placement in spinal surgery. This study evaluates the feasibility and precision of AR technology to improve precision of pedicle screw insertion compared to the current standard technique. Methods Two board-certified orthopedic surgeons specialized in spine surgery and two novice surgeons were each instructed to drill pilot holes for 40 pedicle screws in eighty lumbar vertebra sawbones models in an agar-based gel. One hundred and sixty pedicles were randomized into two groups: the standard free-hand technique (FH) and augmented reality technique (AR). A 3D model of the vertebral body was superimposed over the AR headset. Half of the pedicles were drilled using the FH method, and the other half using the AR method. Results The average minimal distance of the drill axis to the pedicle wall (MAPW) was similar in both groups for expert surgeons (FH 4.8 ± 1.0 mm vs. AR 5.0 ± 1.4 mm, p = 0.389) but for novice surgeons (FH 3.4 mm ± 1.8 mm, AR 4.2 ± 1.8 mm, p = 0.044). Expert surgeons showed 0 primary drill pedicle perforations (PDPP) in both the FH and AR groups. Novices showed 3 (7.5%) PDPP in the FH group and one perforation (2.5%) in the AR group, respectively ( p > 0.005). Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set 6-, 7-, and 8-mm screws ( p > 0.05). Novices showed significant differences of SSPP between most groups: 6-mm screws, 18 (45%) vs. 7 (17.5%), p = 0.006; 7-mm screws, 20 (50%) vs. 10 (25%), p = 0.013; and 8-mm screws, 22 (55%) vs. 15 (37.5%), p = 0.053, in the FH and AR group, respectively. In novices, the average optimal medio-lateral convergent angle (oMLCA) was 3.23° (STD 4.90) and 0.62° (STD 4.56) for the FH and AR set screws ( p = 0.017), respectively. Novices drilled with a higher precision with respect to the cranio-caudal inclination angle (CCIA) category ( p = 0.04) with AR. Conclusion In this study, the additional anatomical information provided by the AR headset superimposed to real-world anatomy improved the precision of drilling pilot holes for pedicle screws in a laboratory setting and decreases the effect of surgeon’s experience. Further technical development and validations studies are currently being performed to investigate potential clinical benefits of the herein described AR-based navigation approach.

Background Aortic aneurysms, a significant cause of mortality, particularly in individuals aged 55 years and older, have witnessed a transformative shift in treatment strategies with the advent of endovascular surgery. Cydar-EV is an innovative image fusion technology that can augment preoperative planning and surgical guidance of endovascular aneurysm repair (EVAR). The ARIA trial aims to evaluate the efficacy of using Cydar-EV with EVAR procedures to reduce operating time while enhancing procedural precision, patient outcomes, and cost-effectiveness. This paper describes the statistical analysis plan for the study. Methods/design The ARIA trial, a phase III, multi-centre, open-label, two-armed, parallel groups randomised controlled surgical trial, seeks to recruit 340 patients diagnosed with abdominal or thoraco-abdominal aortic aneurysms. Participants are randomly assigned to receive either standard endovascular repair or an endovascular repair assisted by Cydar-EV for planning and surgical guidance. Primary and secondary outcomes are assessed at baseline, 4–12 weeks, and 52 weeks. The primary outcome measure is procedure duration at baseline, while additional secondary outcomes are recorded at various time points and include indicators for technical effectiveness, patient outcomes, procedure efficiency, and cost-effectiveness. We plan to analyse the patient outcome data according to the treatment they received regardless of initial allocation. The statistical analysis plan outlines methods for handling missing data, covariates for adjusted analyses, and planned sensitivity analyses to ensure robust evaluation of treatment effects. Trial registration The trial was registered with the ISRCTN register on 03/12/2021, number ISRCTN13832085.

Background For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%). Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. Methods/design This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients ( n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE ( n = 56) or open three-stage transthoracic esophageal resection ( n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien–Dindo classification of surgical complications. Discussion This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. Trial registration Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790

BackgroundLaparoscopic surgery has well-established benefits for patients; however, laparoscopic procedures have a long and difficult learning curve, in large part due to the lack of stereoscopic depth perception. Developments in high-definition and stereoscopic imaging have attempted to overcome this. Three-dimensional high-definition (3D HD) systems are thought to improve operating times compared to two-dimensional high-definition systems. However their performance against new, ultra-high-definition (‘4K’) systems is not known.MethodsPatients undergoing laparoscopic cholecystectomy were randomised to 3D HD or 4K laparoscopy. Operative videos were recorded, and the time from gallbladder exposure to separation from the liver (minus on table cholangiogram) was calculated. Blinded video assessment was performed to calculate intraoperative error scores.ResultsOne hundred and twenty patients were randomised, of which 109 were analysed (3D HD n = 54; 4K n = 55). No reduction in operative time was detected with 3D HD compared to 4K laparoscopy (median [IQR]; 23.41 min [17.00–37.98] vs 20.90 min [17.67–33.03]; p = 0.91); nor was there any decrease observed in error scores (60 [56–62] vs 58 [56–60]; p = 0.27), complications or reattendance. Stone spillage occurred more frequently with 3D HD, but there were no other differences in individual error rates. Gallbladder grade and operating surgeon had significant effects on time to complete the operation. Gallbladder grade also had a significant effect on the error score.ConclusionsA 3D HD laparoscopic system did not reduce operative time or error scores during laparoscopic cholecystectomy compared with a new 4K imaging system.

Background Computer-assisted surgery (CAS) for cup placement has been developed to improve the functional results and to reduce the dislocation rate and wear after total hip arthroplasty (THA). Previously published studies demonstrated radiographic benefits of CAS in terms of implant position, but whether these improvements result in clinically important differences that patients might perceive remains largely unknown. Questions/purposes We hypothesized that THA performed with CAS would improve 10-year patient-reported outcomes measured by validated scoring tools, reduce acetabular polyethylene wear as measured using a validated radiological method, and increase survivorship. Methods Sixty patients operated on for a THA between April 2004 and April 2005 were randomized into two groups using either the CAS technique or a conventional technique for cup placement. All patient candidates for a THA with the diagnosis of primary arthritis or avascular necrosis were eligible for the CAS procedure and randomly assigned to the CAS group by the Hospital Informatics Department with use of a systematic sampling method. The patients assigned to the freehand cup placement group were matched for sex, age within 5 years, pathological condition, operatively treated side, and body mass index within 3 points. All patients were operated on through an anterolateral approach (patient in the supine position) using cementless implants. In the CAS group, a specific surgical procedure using an imageless cup positioning computer-based navigation system was performed. There were 16 men and 14 women in each group; mean age was 62 years (range, 24–80 years), and mean body mass index was 25 ± 3 kg/m 2 . No patient was lost to followup at 10 years, but five patients have died (two in the CAS group and three in the control group). At the 10-year followup, an independent observer blinded to the type of technique performed patients’ evaluation. Cup positioning was evaluated postoperatively using a CT scan in the two groups with results previously published. At 10 years, we assessed subjective functional outcome and quality of life using validated questionnaires (SF-12, Harris hip score [HHS], Hip injury and Osteoarthritis Outcome Score). Wear rate was then evaluated on standardized radiographs using a previously validated semiautomated computer analogic measurement method (dual circle method). Complications and survivorship were compared between groups. With our available sample size, this study had 80% power to detect a difference of 4 points out of 100 on the HHS at the p < 0.05 level. Results With the numbers available, we found we found no differences between groups regarding HSS at last followup 95.3 ± 5.9 points (CAS group) versus 96.2 ± 4.5 points, a mean difference of 0.9 points (95% confidence interval [CI], −4.3 to 4.6; p = 0.6). There was no difference between the groups in terms of the mean (± SD) acetabular linear wear at 10 years. The mean wear was 0.71 ± 0.6 mm in the CAS group versus 0.77 ± 0.52 mm in the control group, a mean difference of 0.06 mm (95% CI, −0.1 to 0.2; p = 0.54). With the numbers available, there was no difference between the CAS group and the conventional THA groups in terms of survivorship free from aseptic loosening (100%; 95% CI, 100%–95%, versus 100%; 95% CI, 100%–94%; p = 0.3). Conclusions Our observations suggest that CAS used for cup placement does not confer any substantial advantage in function, wear rate, or survivorship at 10 years after THA. Because CAS is associated with added costs and surgical time, future studies need to identify what clinically relevant advantages it offers, if any, to justify its continued use in THA. Level of Evidence Level II, therapeutic study.