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29 نتائج ل "Schotanus, Martijn G. M."
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Improved accuracy of implant placement with an imageless handheld robotic system compared to conventional instrumentation in patients undergoing total knee arthroplasty: a prospective randomized controlled trial using CT-based assessment of radiological outcomes
Purpose Image-free handheld robotic-assisted total knee arthroplasty (RATKA) has shown to achieve desired limb alignment compared to conventional jig-based instrumented total knee arthroplasty (CTKA). The aim of this prospective randomized controlled trial (RCT) was to evaluate the accuracy of a semi-autonomous imageless handheld RATKA compared to CTKA in order to achieve the perioperative planned target alignment of the knee postoperatively. Methods Fifty-two patients with knee osteoarthritis were randomized in 1:1 ratio to undergo unilateral CTKA or an imageless handheld RATKA. A full-length lower limb CT-scan was obtained pre- and 6-week postoperative. The primary outcomes were radiologic measurements of achieved target hip–knee–ankle axis (HKA-axis) and implant component position including varus and external rotation and flexion of the femur component, and posterior tibial slope. The proportion of outliers in above radiographic outcomes, defined as > 3° deviation in postoperative CT measurements as compared to perioperative planned target, were also noted. Knee phenotypes were compared with use of the Coronal Plane Alignment of the Knee (CPAK) classification. Results Baseline conditions were comparable between both groups. The overall proportion and percentage of outliers ( n  = 38, 24.4% vs n  = 9, 5.8%) was statistically significant ( p  < 0.001) in favor of RATKA. The achieved varus–valgus of the femoral component (varus 1.3° ± 1.7° vs valgus − 0.1° ± 1.9°, p  < 0.05) with statistically significant less outliers (0% vs 88.5%, p  < 0.01), the achieved HKA-axis (varus 0.4° ± 2.1° vs valgus − 1.2° ± 2.1°, p  < 0.05) and the posterior tibial slope (1.4° ± 1.1° vs 3.2° ± 1.8°, p  < 0.05) were more accurate with RATKA. The most common postoperative CPAK categories were type II (50% CTKA vs 61.5% RATKA), type I (3.8% CTKA vs 23.1% RATKA) and type V (26.9% CTKA vs 15.4% RATKA). CPAK classification III was only found in CTKA (19.2%). Type VI, VII, VIII, and IX were rare in both populations. Conclusions The present trial demonstrates that an imageless handheld RATKA system can be used to accurately perioperatively plan the desired individual component implant positions with less alignment outliers whilst aiming for a constitutional alignment. Level of evidence I.
Double-center observational study of minimally invasive sacroiliac joint fusion for sacroiliac joint dysfunction: one-year results
Background For a substantial part of patients with chronic low back pain, the origin is located in the sacroiliac joint (SIJ). Minimally invasive sacroiliac joint fusion (MISJF) is increasingly being implemented as a treatment option in SIJ dysfunction. Despite remaining controversy, evidence continues to increase. This study evaluates the clinical results and safety of MISJF in a double-center consecutive case series in patients with SIJ dysfunction over a one-year observation period. Methods SIJ complaints were diagnosed after history taking, physical examination and least a 50% reduction of SIJ pain 30–60 min following image-guided injection. Primary outcome measures were patient reported outcome measurements (PROMs), consisting of Visual Analogue Scale (VAS) pain score and EuroQol 5-dimensions 3-levels (EQ-5D-3L). Patients’ perspectives on the effects of surgery were collected through questionnaires. Secondary outcome measures were implant positioning and (serious) adverse events ((S)AE’s). Results A total of 29 patients were included. In 44.8% of patients, SIJ dysfunction was of postpartum origin. The mean VAS-pain score improved from 7.83 (± 1.71) to 4.97 (± 2.63) postoperatively ( p  < 0.001). EQ-5D-3L score improved from 0.266 (± 0.129) to 0.499 (± 0.260) postoperatively ( p  < 0.001). Opioid consumption decreased from 44.8 to 24.1% postoperatively ( p  = 0.026). In 13.7% of patients, an (S)AE occurred. Conclusion MISJF appears to be an effective and safe procedure in this cohort. Statistically significant and clinically relevant improvements in pain and quality of life were observed one-year postoperatively. Future studies should focus on the long-term outcomes to further evaluate the safety and effectiveness of MISJF.
No radiographic difference between patient-specific guiding and conventional Oxford UKA surgery
Purpose Implant position is an important factor in unicompartmental knee arthroplasty (UKA) surgery. Results on conventional UKA alignment are commonly described in literature. Patient-specific guiding (PSG) is a new technique for positioning the Oxford UKA. Our hypothesis is that PSG improves component position without affecting the HKA angle. Methods This prospective study compares the results of our first thirty cases of cementless Oxford UKA using PSG with thirty cases using conventional outlining. Baseline characteristics for both groups were identical. Details on handling of the guide, estimated blood loss and operation time were recorded. Postoperative screened radiographs and standing long-leg radiographs of both groups were compared. Results Median AP position of the femoral component was 3 degrees varus (−5 to 9) using PSG versus 2 degrees varus (−10 to 8) for the conventional group. For the femoral flexion, this was 9 degrees flexion (0–16) using PSG versus 12 degrees flexion (0–20). The tibial median AP position was 1 degree varus (−3 to 7) using PSG versus 2 degrees varus (−5 to 10). The median tibial posterior slope was 5 degrees (1–10) using PSG versus 5 degrees (0–12). All guides aligned well. No conversion to conventional outlining was performed, and no significant changes had to be made to the original approved plan. Operation time, estimated blood loss and postoperative haemoglobin drop were not significantly different between both groups. Discussion Implant position was not different between both groups, even in the early phase of the learning curve. Perioperative results were not different between both groups. Level of evidence III.
Image-free handheld robotic-assisted technology improved the accuracy of implant positioning compared to conventional instrumentation in patients undergoing simultaneous bilateral total knee arthroplasty, without additional benefits in improvement of clinical outcomes
Purpose The purpose of this study was to compare the clinical and radiological outcomes in patients who underwent simultaneous bilateral total knee arthroplasty (SB-TKA) using either robotic-assisted TKA (RA-TKA) or conventional TKA (C-TKA). Methods Included were the patients who underwent SB-TKA between January 2018 and January 2020 and had a minimum follow-up of 2 years. Of 151 patients included, 117 patients were operated using an image-free handheld robotic sculpting system (RA-TKA group) and 34 patients operated using conventional instrumentation (C-TKA group). The key outcomes noted were multiple patient-reported outcomes (PROs), adverse events, and radiological outcomes. Two investigators independently measured the radiological outcomes on pre- and post-operative radiographs in coronal plane (medial proximal tibial angle [MPTA] and anatomic lateral distal femoral angle [aLDFA]) and sagittal plane (posterior tibial slope [PTS] and posterior condylar offset [PCO]). The chi-square test was used to examine categorical variables. Student’s t test was used to analyze the continuous variables. Results Patients in both groups were similar in baseline characteristics (gender, body mass index, incidence of comorbidities, and length of hospital stay) except that RA-TKA group patients younger (66.7 ± 8.9 vs 70.4 ± 10.5, P =  0.037) than C-TKA group. The operative time was longer in RA-TKA group as compared to C-TKA (189.3 ± 37.1 vs 175.0 ± 28.2, P =  0.040). The final PROs at each were similar between the two groups ( P >  0.05). The values of PROs at final follow-up in RA-TKA compared to C-TKA were VAS pain (0.4 ± 0.9 vs 0.4 ± 0.5), KOOS-JR (89.3 ± 5.8 vs 87.1 ± 5.3), and physical (55.9 ± 2.8 vs 55.4 ± 3.2), mental (61.1 ± 4.4 vs 60.2 ± 4.7) component of VR-12 scores, and KSS satisfaction (37.5 ± 1.1 vs 37.1 ± 2.2) (all P >  0.50 or non-significant [n.s.]). While one patient in RA-TKA required revision of femoral component for peri-prosthetic fracture, none of the patient in conventional group were revised (0.85% vs 0%, P =  n.s.). The proportion of patients with outliers in RA-TKA group was lower for aLDFA (2.6% vs 22.1%, P <  0.01) and PTS (0% vs 35%, P <  0.01). Conclusion This comparative study in patients undergoing SB-TKA found reduction of outliers in femoral and tibial implant positioning with RA-TKA as compared to C-TKA. There were no differences in both groups for pain, function, and satisfaction at a minimum of 2 years of follow-up. Level of evidence III Therapeutic Study.
Achieving functional alignment in total knee arthroplasty: early experience using a second-generation imageless semi-autonomous handheld robotic sculpting system
Purpose In order to minimize errors during achieving the targeted alignment of the total knee arthroplasty (TKA) components, robotic-assisted surgery has been introduced with the aim to help surgeons to improve implant survival, clinical outcomes, and patient satisfaction. The primary goal of this paper is to highlight surgical tips and tricks on how to achieve functional alignment (FA) through intra-operative boney mapping, numeric gap, and alignment data, using the next generation of imageless robotic surgical systems. Method This retrospective case-series contains planned and achieved data on the FA and joint gap data obtained from 526 patients captured and assessed with use of a semi-autonomous imageless handheld robotic sculpting systems. All patients were operated upon by two experienced TKA surgeons. Results The mean difference between planned and achieved alignment was 1.46° (≥ 7° varus group), 1.02° (< 7° varus group), 1.16° (< 7° valgus group), and 1.43° (≥ 7° valgus group). The mean observed planned and achieved extension and flexion gaps were below 1.47 mm for medial extension gaps, 1.12 mm for the lateral extension gaps, 1.4 mm for the medial flexion gaps, and 1.16 mm for the lateral flexion gaps. Conclusion Analysis of these first cases highlights the capability of the next generation of imageless robotic-assisted total knee replacement using a semi-autonomous handheld robotic sculpting to maintain accuracy of the desired alignment. The system allows the surgeon to choose freely their own alignment philosophy while maintaining efficiency.
Outpatient surgery for unicompartmental knee arthroplasty is effective and safe
Purpose There has been increasing interest in accelerated programs for knee arthroplasty. We examined the efficacy and safety of an outpatient surgery (OS) pathway in patients undergoing unicompartmental knee arthroplasty (UKA). Methods This case–controlled study evaluates patients operated for UKA in an OS pathway ( n  = 20) compared to rapid recovery (RR), the current standard ( n  = 20). We investigated whether patients could be discharged on the day of surgery, resulting in comparable or better outcome by means of adverse events (AEs) in terms of pain (numerical rating scale, NRS), incidences of postoperative nausea and vomiting (PONV) and opiate use (<48 h postoperatively), complication and readmission rates (<3 months postoperatively). Patient-reported outcome measures (PROMS) were obtained preoperatively and 3 months postoperatively. Results Postoperative pain (NRS > 5) was the most common reason for prolonged hospital stay in the OS pathway. Eighty-five per cent of the patients were discharged on the day of surgery, whereas 95 % of the patients were discharged on postoperative day 3 in the RR pathway. Overall, median pain scores in both pathways did not exceed a NRS score of 5, without significant differences (RR vs. OS) in the number of patients with PONV (4 vs. 2) and opiate use (11 vs. 9) <48 h postoperatively. At 3 months postoperatively, no significant differences were found for AEs and PROMS between both pathways. Conclusion The results of this study illustrates that an OS pathway for UKA is effective and safe with acceptable clinical outcome. Well-established and adequate standardized protocols, inclusion and exclusion criteria and a change in mindset for both the patient and the multidisciplinary team are the key factors for the implementation of an OS pathway. Level of evidence Case–control study, Level III.
Patient selection criteria for outpatient joint arthroplasty
Purpose General consensus of patient selection criteria for outpatient joint arthroplasty is lacking, which is paramount to prevent prolonged hospital stay, adverse events and/or readmissions. This review highlights patient selection criteria for OJA based on the current literature and expert opinion. Methods A search of the English and International electronic healthcare databases including MEDLINE/PubMed, EMBASE, AMED and the Cochrane library was performed in November 2015 to include studies published during the last 10 years. Furthermore, a survey of physicians from different specialties was performed. Results Fourteen studies described results regarding outpatient joint arthroplasty. Studies on outpatient hip and/or knee arthroplasty resulted in similar outcome in preselected patients. Patients who are able and willing to participate, with a low ASA classification (II), bleeding disorders, poorly controlled and/or severe cardiac (e.g. heart failure, arrhythmia) or pulmonary (e.g. embolism, respiratory failure) comorbidities, uncontrolled DM (type I or II), a high BMI (>30 m 2 /kg), chronic opioid consumption, functional neurological impairments, dependent functional status, chronic/end-stage renal disease and/or reduced preoperative cognitive capacity should be excluded from outpatient joint arthroplasty. The expert opinion-based selection criteria were comparable to literature with a further extension of exclusion for patients with practical issue’s, urologic medical history and/or severe mobility disorders. Conclusion Based on the current literature, the presented patient selection criteria provide a basis for outpatient joint arthroplasty and can be useful when selecting patients. Together with a change in mindset, a multidisciplinary approach and literature-based protocols, outpatient joint arthroplasty can be applied in daily orthopaedic practice while ensuring patients’ safety. Level of evidence Clinical review, Level III.
Measurement of lower limb alignment: there are within-person differences between weight-bearing and non-weight-bearing measurement modalities
Purpose Previous studies have compared weight-bearing mechanical leg axis (MLA) measurements to non-weight-bearing measurement modalities. Most of these studies compared mean or median values and did not analyse within-person differences between measurements. This study evaluates the within-person agreement of MLA measurements between weight-bearing full-length radiographs (FLR) and non-weight-bearing measurement modalities (computer-assisted surgery (CAS) navigation or MRI). Materials and methods Two independent observers measured the MLA on pre- and postoperative weight-bearing FLR in 168 patients. These measurements were compared to non-weight-bearing measurements obtained by CAS navigation or MRI. Absolute differences in individual subjects were calculated to determine the agreement between measurement modalities. Linear regression was used to evaluate the possibility that other independent variables impact the differences in measurements. Results A difference was found in preoperative measurements between FLR and CAS navigation (mean of 2.5° with limit of agreement (1.96 SD) of 6.4°), as well as between FLR and MRI measurements (mean of 2.4° with limit of agreement (1.96 SD) of 6.9°). Postoperatively, the mean difference between MLA measured on FLR compared to CAS navigation was 1.5° (limit of agreement (1.96 SD) of 4.6°). Linear regression analysis showed that weight-bearing MLA measurements vary significantly from non-weight-bearing MLA measurements. Differences were more severe in patients with mediolateral instability ( p  = 0.010), age ( p  = 0.049) and ≥3° varus or valgus alignment ( p  = 0.008). Conclusion The clinical importance of this study lies in the finding that there are within-person differences between weight-bearing and non-weight-bearing measurement modalities. This has implications for preoperative planning, performing total knee arthroplasty (TKA), and clinical follow-up after TKA surgery using CAS navigation or patient-specific instrumentation. Level of evidence III.
No advantage of adrenaline in the local infiltration analgesia mixture during total knee arthroplasty
Purpose Local infiltration analgesia (LIA) is widely applied in patients undergoing total knee arthroplasty (TKA). In daily practice, adrenaline is added to the LIA mixture to achieve vasoconstriction. However, adrenaline has some possible negative side effects (e.g. tissue necrosis). This trial investigated whether ropivacaine alone is at least as effective for postoperative pain relief after LIA. Methods Fifty patients scheduled for primary TKA were included in this prospective randomized, double-blind, controlled pilot study receiving high-volume (150 mL) single-shot intra-capsular LIA with ropivacaine (2 %) with (Ropi+) or without (Ropi−) adrenaline (0.01 %). All patients received the same pre-, peri- and postoperative care with multimodal oral pain protocol. Postoperative pain was assessed before and after the first mobilization and during the first 48 h postoperative using the visual analogue scale (VAS). Secondary outcomes were rescue medication use, early mobilization, length of hospital stay, adverse events (AE’s) and readmission rates. Patient reported outcomes measures (PROMS); Oxford Knee Score and WOMAC, were obtained preoperative and 3 months postoperative. Results VAS scores were not significantly different before (n.s.) and after the first mobilization (n.s.), neither over the first 48 h postoperative (n.s.). Patients who needed rescue medication (n.s.), who mobilized <6 h postoperative (n.s.), who were discharged before postoperative day 3 (n.s.), AE’s and readmission rate (n.s.) were comparable between both groups. At 3-month follow-up, PROMS significantly improved within both groups. Conclusion To prevent possible negative side effects (e.g. tissue necrosis), adrenaline should be omitted from the LIA mixture. Single-shot LIA with ropivacaine alone results in clinical acceptable adequate pain control and can be used in daily TKA practice. Level of evidence Randomized, double-blind, prospective clinical trial, Level I.
Patient-specific positioning guides for total knee arthroplasty: no significant difference between final component alignment and pre-operative digital plan except for tibial rotation
Purpose To assess whether there is a significant difference between the alignment of the individual femoral and tibial components (in the frontal, sagittal and horizontal planes) as calculated pre-operatively (digital plan) and the actually achieved alignment in vivo obtained with the use of patient-specific positioning guides (PSPGs) for TKA. It was hypothesised that there would be no difference between post-op implant position and pre-op digital plan. Methods Twenty-six patients were included in this non-inferiority trial. Software permitted matching of the pre-operative MRI scan (and therefore calculated prosthesis position) to a pre-operative CT scan and then to a post-operative full-leg CT scan to determine deviations from pre-op planning in all three anatomical planes. Results For the femoral component, mean absolute deviations from planning were 1.8° (SD 1.3), 2.5° (SD 1.6) and 1.6° (SD 1.4) in the frontal, sagittal and transverse planes, respectively. For the tibial component, mean absolute deviations from planning were 1.7° (SD 1.2), 1.7° (SD 1.5) and 3.2° (SD 3.6) in the frontal, sagittal and transverse planes, respectively. Absolute mean deviation from planned mechanical axis was 1.9°. The a priori specified null hypothesis for equivalence testing: the difference from planning is >3 or <−3 was rejected for all comparisons except for the tibial transverse plane. Conclusion PSPG was able to adequately reproduce the pre-op plan in all planes, except for the tibial rotation in the transverse plane. Possible explanations for outliers are discussed and highlight the importance for adequate training surgeons before they start using PSPG in their day-by-day practise. Level of evidence Prospective cohort study, Level II.