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Personalized Robotic-Assisted Total Knee Arthroplasty with Anatomo-Functional Implant Positioning for Varus Knees: A Minimum Follow-Up of 5 Years
No full textInternational audienceBackground/Objectives: Some personalized alignment (PA) concepts have been described with symmetrical gaps in extension and flexion. However, laxity in native knees was significantly greater laterally than medially with respect to both extension and flexion. We hypothesized that a personalized alignment can restore the native knee alignment, keep a satisfying patellar tracking, and obtain physiological ligament balancing, that is, a symmetric gap in extension and an asymmetric gap in flexion. We aimed to assess: (1) the postoperative alignment of TKA and postoperative patellar tracking (primary outcome); (2) the ligament balancing at the end of the surgery; and (3) clinical outcomes and complication rates. Methods: In this single-center, retrospective case series, we evaluated 45 patients in a consecutive series who underwent robotic-assisted primary TKA using PA between January and September 2020 with a minimum follow-up of 5 years. Complication was defined as grade ≥3 according to the Clavien-Dindo classification. Data assessed were: TKA alignment and implant positioning on postoperative radiographs, patellar tracking on the merchant view, and ligament balancing in extension and flexion upon completion of surgery. Results: Mean follow-up was 62.1 ± 2.5 months. The postoperative mean HKA angle was 177.4° ± 2.2. The medial distal femoral angle was restored (91.1° ± 1.5 postoperatively versus 91.3° ± 2). A total of four TKAs had a patellar tilt superior to 5° (8.9%). No significant difference was found in the medial gap laxity—both in extension and in flexion—and the lateral gap laxity in extension. The lateral gap laxity in flexion was significantly higher than extension or medial gap laxity (+2.9 mm). One patient was readmitted for delayed wound healing. Average improvements in Knee Society knee and function scores were 55.86 and 51.84 points, respectively. Conclusions: This personalized alignment technique using anatomo-functional implant positioning allowed restoration of native knee alignment with a “safe zone” (3° varus/valgus) for the tibial implant, maintained satisfying patellar tracking, and restituted the asymmetrical gap laxity in flexion with a higher laxity in the lateral compartment. Being the longest system-specific study to date, the results are encouraging at 5 years with no major complications. However, longer follow-up will be required to confirm the use of this technique
Automated registration of intraoperative optical images with preoperative MRI
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Changes in coronal plane alignment of the knee classification do not significantly influence outcomes after restricted kinematic alignment total knee arthroplasty
No full textInternational audienceAbstract Purpose The coronal plane alignment of the knee (CPAK) classification helps understand knee alignment variability, guiding personalised total knee arthroplasty (TKA) strategies. However, evidence regarding the impact of postoperative CPAK classification changes on patient‐reported functional outcomes after restricted kinematic alignment (rKA) TKA remains limited. This study aimed to investigate whether CPAK classification changes after TKA with rKA influence functional outcomes, measured by the International Knee Society score (IKS). Methods A retrospective cohort study included 464 patients who underwent primary TKA with a posterior stabilised implant (KNEO ® ) between January 2020 and May 2024. The inclusion criteria were primary or secondary osteoarthritis with complete radiographic and clinical follow‐up at 2 years; patients with incomplete data or intraoperative complications requiring implant change were excluded. Pre‐ and postoperative CPAK classifications were compared, and functional outcomes were assessed using IKS knee and function scores at 2 years of follow‐up. Radiographic assessment was performed on standing long‐leg radiographs by a single experienced observer. Results A significant redistribution of CPAK classifications was observed postoperatively ( p < 0.001), with 22.2% of CPAK I changing to CPAK II and 19.1% changing to CPAK V. In total, 33.3% of all knees retained their initial CPAK classification. No significant differences were observed in the postoperative IKS Knee (85.2 ± 12.3 vs. 83.9 ± 11.8; p = 0.62) or IKS Function scores (78.5 ± 13.1 vs. 76.9 ± 12.7; p = 0.54). Given the small sample sizes within certain CPAK subtype transitions, subgroup analyses were not feasible. Conclusions Changes in CPAK classification following rKA‐TKA were common but did not significantly influence functional outcomes at 2 years. These findings suggest that CPAK phenotype transition alone may not be a reliable predictor of clinical success, although larger studies are needed to explore subtype‐specific effects. Level of Evidence Level IV
Orthopedic management in Duchenne muscular dystrophy
No full textInternational audienceThis article provides a comprehensive overview of the orthopedic management strategies in Duchenne muscular dystrophy (DMD). DMD manifests with severe muscle wasting, respiratory insufficiency, and cardiomyopathy, with initial symptoms emerging in early childhood. By the age of 10–12 years, most patients require wheelchairs due to muscle degeneration, which often leads to spinal deformities and joint contractures. The absence of dystrophin causes the breakdown of the dystrophin glycoprotein complex, causing muscle degeneration, necrosis, and fibrosis. Current treatments focus on symptom management, including physical therapy, corticosteroids, orthopedic surgery, ventilatory and nutritional support, and cardiac care. Longterm glucocorticoid therapy can extend mobility and life expectancy, delay the need for ventilation, and reduce the rates of scoliosis surgery. Orthopedic care focuses on prevention to preserve motor function and bone health and involves an interdisciplinary team, early use of orthotic devices, and promotion of proper posture. Common deformities include varus equinus, hip flexor retractions, scoliosis, and pelvic obliquity. Scoliosis management involves posterior fusion surgery extended to the pelvis or limited to the L5 vertebra. Preoperative evaluation should include assessing the risk of hip flexion contracture decompensation following arthrodesis. There now seems to be increasing consensus favoring lower extremity surgery only in exceptional cases. This shift is due to the limited success of surgery, with frequent recurrence of muscle retractions and minimal expected benefits. Fracture management involves bisphosphonate therapy post-fracture, with vertebral compression and lower limb fracture being the most prevalent
Assessment of Liver Graft Viability through Fluorescence-Based Cellular Function Monitoring
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Safety and efficacy of REP 2139-Mg in patients with HDV-related advanced liver disease in an international compassionate access program
No full textInternational audienceBackground & aims: REP 2139-Mg (REP), a nucleic acid polymer, blocks HBV subviral particle assembly and HDV replication. We hereby report results of REP treatment in HDV patients in a compassionate access program (NCT05683548).Methods: Thirty-three HDV patients with advanced chronic liver disease (ACLD) received REP 250mg weekly subcutaneously (SC) plus nucleotide analog for a scheduled 48-weeks duration. Pegylated interferon-α (pegIFN) 45-180ug weekly was added in 20 patients without contraindications. Safety and efficacy were monitored regularly, and intra-hepatic markers performed in one liver explant.Results: Among the 33 patients (age 21-69 years, 21 males), 85% (28/33) had previous treatment failure and 6 had decompensated cirrhosis (ascites n=5). Suboptimal response to REP was rescued with dose modifications [250mg intravenously (IV), or 500mg SC or IV] and/or therapy extension in 21 patients. At the end of therapy (EoT), HDV-RNA declined by >2log10 in 70% (23/33) and was undetectable in 58% (19/33). HBsAg loss occurred in 27% (9/33). In the 28 patients with available follow-up, HDV-RNA and HBsAg remained undetectable in 46% (13/28) and 18% (5/28) respectively. ALT normalized in 50% (14/28). Response was similar with or without pegIFN. Ascites improved in 2/5 patients. Three patients underwent liver transplantation while receiving REP, with no complications. One liver explant analysis showed undetectable HDV-RNA and HDAg and very low levels of intra-hepatic cccDNA activity and HBsAg. No REP-related serious adverse events were reported.Conclusions: REP treatment was safe and effective in HDV patients with ACLD. REP may even induce HDV sustained virological response and HBV functional cure independent of combination with pegIFN. Clinical benefits may also be observed in patients with decompensated cirrhosis.Impact and implications: No antiviral treatment is approved for chronic hepatitis D (CHD) patients with decompensated cirrhosis or in patients who have failed previous bulevirtide and/or pegIFN therapy. In the Replicor Compassionate Access Program including 33 CHD patients with advanced chronic liver disease treated with REP2139-Mg (REP) and nucleotide analog, with or without pegylated interferon, loss of HBsAg was observed in 27% by end of treatment and remained undetectable in 18% after one year follow up, inferring HDV sustained virological response and HBV functional cure for these patients. Among the 6 patients with decompensated cirrhosis, five patients had virological response and two patients presented significant clinical improvement with ascites reduction, with no REP-related serious adverse events. Overall, the efficacy of REP, in this \"difficult to treat\" population, appears promising with acceptable tolerability and no safety issues and should be evaluated in a protocol driven, response-guided clinical trial
Comprehensive mutational profiling and clinical outcome of adults AML with NUP98 rearrangement
No full textInternational audienceAcute myeloid leukemia (AML) harboring NUP98 rearrangements (NUP98r) is recognized as a distinct entity in the 2022 WHO classification; however, it is not as a prognostic factor within the ELN 2022 classification. We report a large cohort of 95 adult patients with NUP98r AML. Patient characteristics included a young age (median 50 years [IQR 38-64]), 20% of therapy-related AML, a high WBC count (median 52×109/L), normal karyotype in 32%, FLT3-ITD in 48% and WT1 mutations in 34%. NUP98::NSD1 fusion was the most common (54%), and these patients were significantly younger (41y vs 61y), had more de novo AML (94% vs 64%), higher rates of normal karyotypes (56% vs 4.5%), FLT3-ITD (76% vs 18%) and WT1 mutations (50% vs 16%) than other NUP98r AML. The median overall survival (OS) for the entire cohort was 14.8 months (95% CI, 11.9–20.8) and event-free survival was 3.3 months (2-7.5). Among patients treated intensively (n=73), age (HR = 1.04) and FLT3 inhibitor therapy (HR = 0.45) influenced OS in univariate analysis, while leukocytosis, partner type, ELN classification, presence of a FLT3-ITD or WT1 mutation or hematopoietic stem cell transplant did not. Compared with NUP98 wild-type (WT) AML, NUP98r patients had a prognosis more similar to that of NUP98 WT ELN adverse patients whether initially classified as intermediate (20.3 months [11.7-30.2]) or adverse (15.7 months [13.5-42.9]). However, treatment with FLT3 inhibitors improved prognosis, with OS approaching that of intermediate-risk AML patients (33.3 months [11.9–not reached])
Induction chemotherapy with a single anthracycline-containing cycle in younger adults with newly diagnosed AML – the french backbone intergroup (BIG)-1 study on behalf of the filo, ALFA, and SFGM-TC study groups
No full textInternational audienceIntroduction The BIG-1 multicenter study was a prospective trial designed for younger AML patients with multiple randomizations at each stage of treatment, including induction, post-induction and hematopoietic stem-cell transplantation. Results of the post-induction randomization (intermediate vs high dose cytarabine) have been already reported (Hunault M et al, NEJM Evid 2025). Here, we report the results of the first randomization that compared high dose idarubicin (IDA, 45 mg/m2 total dose) to high dose daunorubicin (DNR, 270 mg/m2 total dose) during the first and unique induction cycle containing anthracyclines. Methods Patients (pts) aged 18-60 years with newly diagnosed AML, untreated post-MDS AML, or t-AML were eligible if they had an ECOG performance status ≤3, normal cardiac, liver and renal functions, no active infection or neoplasia. Pts with APL, Ph+ AML, CBF AML, or post-MPN AML were not eligible. Pts were randomly assigned to receive either daunorubicin (90 mg/m², d1-3) or idarubicin (9 mg/m², d1-5), combined with cytarabine 200 mg/m² (d1-7). The protocol planned for a single cycle of anthracycline. All patients alive after this first cycle, including those not achieving CR/CRi, underwent a second randomization to compare post-induction IDAC vs HDAC. The primary endpoint was overall survival (OS). Evaluations of treatment effects were adjusted on ELN-2022 risk, post-induction IDAC vs HDAC randomization, and time-dependent HSCT in first CR/CRi. According to French's regulation, no racial or ethnic data were collected. Results 1,159 pts were included from 01/2015 to 05/2018, 578 in the DNR arm and 581 in the IDA arm. Baseline characteristics were well balanced between the two arms. Median age was 50y, 563 pts were female. According to ELN-2022, 308 (27%), 330 (28%), 464 (40%) and favorable, intermediate or adverse risk; 57 pts (5%) were non-classified. With a median follow-up of 5.6y, 5-year OS was 51.8% (95% CI, 47.5-55.9) in the DNR arm vs 50.3% (95% CI, 46.0-54.5) in the IDA arm (adjusted HR, 1.03 [95% CI, 0.87-1.22], p= 0.75). When evaluated in patient subgroups including ELN-2022 risk groups, post-induction IDAC vs HDAC, and allo-HSCT in first remission, no significant interactions with the DNR vs IDA treatment effect were observed for OS. 5y-estimates of EFS (38 vs 38%), RFS (41 vs 44%), and cumulative incidence of relapse (43 vs 41%) did not differ between the two arms. Following induction, there was no difference in remission rate (CR+ CRi, 72.0 vs 73.7%) or early death (2.8 vs 2.8%) in the DNR and IDA arms, respectively. After salvage chemotherapy, the rates of CR/CRi, persistent AML, and early death were 85.6 vs 81.6%, 10.6 vs 13.9%, and 3.8 vs 4.5% in the DNR and IDA arms, respectively. Post-induction CR/CRi (DNR vs IDA) by ELN-2022 groups were: 96 vs 95%, 73 vs 78%, 55 vs 56% in favorable, intermediate and adverse groups respectively, whereas post-salvage CR/CRi were 97 vs 98%, 87 vs 84% and 76 vs 68%. 5y-OS by ELN-2022 groups was 73 vs 74%, 60 vs 58% and 38 vs 38% in favorable, intermediate and adverse groups, respectively. The severity of chemotherapy-induced myelosuppression and the incidences of adverse events were lower after DNR with shorter durations of thrombocytopenia and neutropenia, lower needs for RBC transfusions, number of days on antibiotics, and frequency of fungal infections. The rate of allo-HSCT in first CR/CRi was 43% in the DNR arm and 42% and the IDA arm. The BIG-1 trial enrolled more pts in further phase 2 studies planned in the protocol. Since there was no difference in efficacy and treatment-related mortality between DNR and IDA, we pooled the two arms to build a cohort of 2023 pts included between 01/2015 and 06/2021. To determine the crude contribution of first-line chemotherapy to OS in selected subgroups, we computed the salvage-free, transplantation-free survival (STFS) as the time between the date of inclusion until treatment failure, salvage treatment, morphological or molecular relapse, allo-HSCT or death. 5y-STFS was 52%, 31%, 15%, 11% and 2% in pts with CEBPA-bZIP, NPM1, IDH2, IDH1 mutations or KMT2A rearrangement (except KMT2A-MLLT3), respectively. Conclusions The first two randomizations of the BIG-1 study allowed us to establish a simplified treatment regimen consisting of a single cycle of daunorubicin 90 for induction and IDAC for consolidation. We now consider this regimen as a standard backbone on which new molecules can be added to improve results
Serum Neurofilament Light Chain Correlates With Clinical Severity and Predicts Mortality in Anti-IgLON5 Disease
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Accuracy of an Overnight Axillary-Temperature Sensor for Ovulation Detection: Validation in 194 Cycles
No full textInternational audienceSeveral studies have evaluated the reliability of using temperature sensors placed in different locations on the body to identify the day of ovulation. However, such demonstrations are lacking for axillary temperature wearable devices. This study aimed to evaluate the accuracy with which an axillary temperature armband sensor (Tempdrop) identifies the day of ovulation and the fertile window, using the Clearblue Connected Ovulation Test System as the reference method. A total of 194 cycles were analyzed from 125 women that participated in the study between April 2023 and June 2024. The performance parameters were high: the sensitivity (96.8% (95% CI 95.6; 97.7)), specificity (99.1% (98.8; 99.4)), accuracy (98.6% (98.2; 98.9)), positive predictive value (96.8% (95.6; 97.7)) and negative predictive value (99.1% (98.8; 99.4)). Furthermore, the results revealed a remarkably clear and better-than-expected change in temperature around the time of ovulation. This axillary temperature wearable sensor is an effective alternative to urine ovulation tests for determining the timing of ovulation. Another advantage is that it provides a clear temperature curve that can be used to evaluate the quality of the luteal phase