2-year Time Point Research Articles

Perioperative Losartan is Associated with Similar Rates of Additional Surgical Procedures For Postoperative Shoulder Stiffness Following Primary Arthroscopic Rotator Cuff Repair But Lower Rates of Secondary Debridement and Repair

PurposeThe purpose of this study is to compare the rate of additional shoulder surgery related to postoperative stiffness or tendon healing following primary rotator cuff repair between patients with a losartan prescription and without a losartan prescription. MethodsThe Tenth Revision International Classification of Diseases code (ICD-10 M75.1) was used to identify all patients in the TriNetX Research Network with a rotator cuff tear diagnosis who underwent arthroscopic rotator cuff repair between January 1, 2015 and December 31, 2021. Patients were stratified into the losartan group (LG) and non-losartan group (NLG) based on whether or not they had a coded prescription for losartan within 1 year prior to surgery or 3 months following surgery. The two cohorts were propensity scored and matched to reduce confounding biases. Specifically, cohorts were matched based on age, sex, obesity, nicotine use, hyperlipidemia, diabetes, hypertensive diseases, ischemic heart disease, heart failure and valvular disease, and peripheral arterial disease. The incidence of additional shoulder surgeries associated with stiffness and rotator cuff healing were analyzed and compared at the 1-year and 2-year timepoints. ResultsAfter propensity score matching, both the LG and NLG contained 3,970 patients. There was no difference in the rate of lysis of adhesions or manipulation under anesthesia at 1 or 2 years postoperatively between patients in the LG and LG. Patients in the LG were less likely undergo arthroscopic debridement (OR=0.71; CI: 0.56-0.91; P=0.006) and rotator cuff repair (OR=0.71; CI: 0.58-0.87; P=0.001) at 1 year post operatively when compared to patients I the NLG. At 1 year postoperatively, there was no difference in the rate of arthroplasty, arthroscopic synovectomy, and diagnostic arthroscopy between group. At 2 years postoperatively, there was no difference in the rate of rotator cuff repair, arthroplasty, arthroscopic debridement, synovectomy, and diagnostic arthroscopy between groups. ConclusionPatients undergoing arthroscopic rotator cuff repair with or without a perioperative prescription for losartan had no significant difference in the rate of LOA or MUA at 1 or 2 years postoperatively, indicating that the antifibrotic properties of losartan may not have a clinically significant impact on shoulder stiffness after arthroscopic rotator cuff repair. However, patients with a prescription for losartan were less likely to undergo additional arthroscopic debridement and rotator cuff repair at 1 year postoperatively when compared to a matched cohort of patients without a losartan prescription.

Minimally Invasive Transforaminal Versus Lateral Lumbar Interbody Fusion for Degenerative Spinal Pathology: Clinical Outcome Comparison in Patients With Predominant Back Pain.

Retrospective review. To compare perioperative and postoperative clinical outcomes between minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and lateral lumbar interbody fusion (LLIF) in patients presenting with predominant back pain. Two popular techniques utilized for lumbar arthrodesis are MIS-TLIF and LLIF. Both techniques have reported high fusion rates and suitable postoperative clinical outcomes. Scarce literature exists, however, comparing these 2 common fusion techniques in a subset population of patients presenting with predominant back pain preoperatively. A retrospective review of lumbar procedures performed between November 2005 and December 2021 was conducted using a prospectively maintained single-surgeon database. Inclusion criteria were set as primary, elective, single, or multilevel MIS-TLIF or LLIF procedures for degenerative spinal pathology in patients with predominant preoperative back pain [visual analog scale (VAS) back pain preoperative score > VAS leg preoperative score]. Patients undergoing a revision procedure, single-level procedure at L5-S1, or surgery indicated for infectious, malignant, or traumatic etiologies were excluded. In addition, patients with VAS leg preoperative scores ≥ to VAS back preoperative scores were excluded. Patient demographics, perioperative characteristics, postoperative complications, and patient-reported outcome measures (PROMs) were collected. PROMs included VAS for back and leg pain, Oswestry Disability Index (ODI), and Short Form-12 (SF-12) Item Survey Mental (MCS) and Physical (PCS) Composite Scores with all values collected at the preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year follow-up time point. Patients were grouped into 2 cohorts, depending on whether a patient underwent a MIS-TLIF or LLIF. Demographic and perioperative characteristics were compared between groups using χ 2 and Student t test for categorical and continuous variables, respectively. Mean PROM scores were compared between cohorts at each time point utilizing an unpaired Student t test. Postoperative improvement from preoperative baseline within each cohort was assessed with paired samples t test. Achievement of minimum clinical important difference (MCID) was determined by comparing ΔPROM scores to previously established threshold values. MCID achievement rates were compared between groups with χ 2 analysis. Statistical significance was noted as a P value <0.05. Eligible study cohort included 153 patients, split into 106 patients in the MIS-TLIF cohort and 47 patients in the LLIF cohort. The mean age was 55.9 years, the majority (57.5%) of patients were males, the mean body mass index was 30.8kg/m 2 , and the majority of the included cohort were nondiabetic and nonhypertensive. No significant demographic differences were noted between cohorts. The MIS-TLIF cohort had a significantly greater proportion of patients with preoperative spinal pathology of recurrent herniated nucleus pulposus, whereas a significantly greater proportion of patients in the LLIF cohort demonstrated isthmic spondylolisthesis ( P < 0.046, all). No significant differences were noted between cohorts for operative duration, estimated blood loss, 1-year rate of arthrodesis, postoperative length of stay, postoperative VAS pain scores on postoperative day 0 or 1, and postoperative narcotic consumption on postoperative day 0 or 1. Patients in the LLIF cohort showed greater rates of postoperative ileus (4.3% vs 0.0%). No other significant differences were noted between cohorts for postoperative complications. Between cohorts, preoperative PROM scores did not significantly differ. The following significant postoperative mean PROM scores were demonstrated: VAS back at 12 weeks and ODI at 12 weeks with both mean scores favoring the LLIF cohort. The MIS-TLIF cohort reported significant improvement from preoperative baseline to the 2-year time point for all PROMs collected at all individual postoperative time points except SF-12 MCS at 6 weeks ( P < 0.0, all). LLIF cohort reported significant improvement from preoperative baseline to the 1-year time point for all PROMs collected at all individual postoperative time points except for ODI at 6 weeks, 1 year, and 2 years, SF-12 MCS at 6 weeks and 2 years, and SF-12 PCS at 2 years( P < 0.042, all). The majority of patients in both cohorts achieved overall MCID for VAS back, VAS leg, ODI, and SF-12 PCS. A significantly greater proportion of patients in the LLIF cohort achieved MCID for SF-12 PCS at 12 weeks (94.4% vs 61.1%; P < 0.008). Patients with predominant back pain undergoing MIS-TLIF or LLIF for degenerative spinal pathology demonstrated similar 2-year mean clinical outcomes for physical function, disability, leg pain, and back pain. At the 12-week time point, mean outcome scores for back pain and disability favored the lateral approach with concurrent higher rates of MCID achievement for physical function at that time point.

Predictors of time to achieve clinically significant improvements following lateral lumbar interbody fusion

BackgroundAs lateral lumbar interbody fusions (LLIF) are increasingly performed, our understanding of postoperative clinical trajectories is important in informing preoperative patient expectations. While minimum clinically important difference (MCID) rates are widely utilized in spine surgery literature, there is less published on how long it takes for patients to achieve MCID following LLIF. ObjectiveTo evaluate the length of time it takes for patients to report MCID achievement for back pain, leg pain, disability, and physical function and evaluate predictors of time to achieve MCID. MethodsPatients undergoing elective LLIF by the senior author with baseline and postoperative patient-reported outcomes (PROs) recorded were retrospectively identified. Data on potential predictors of time to MCID achievement were gathered including demographics, comorbidities, diagnostic information, and baseline PROs. MCID achievement rates for Oswestry Disability Index (ODI), Visual Analog Scale-Back (VAS-Back), VAS-Leg, and Patient-Reported Outcome Measurement Information System-Physical Function (PROMIS-PF) were calculated at six-, twelve, 6 month- 1 year- and 2-year postoperative timepoints. A Kaplan-Meier survival analysis was conducted to determine the proportion of patients achieving MCID at each time point. A multivariate Cox regression determined predictors of time to MCID achievement. ResultsOne hundred-five patients were included in the analysis. The mean time to achieve MCID for PROMIS-PF was 44.7 weeks, for VAS-Back was 38.5 weeks, for VAS-Leg was 36.7 weeks, and for ODI was 38.3 weeks. Worse baseline VAS-Back significantly predicted earlier MCID achievement for VAS-Back (HR: 1.55), while diabetes was predictive of later MCID achievement (HR: 0.21). Higher body mass index and worse preoperative ODI predicted earlier MCID achievement for ODI (HR: 1.04–1.08), and higher VAS-Leg score and two-level fusion were predictive of later MCID achievement for ODI, (HR:0.26–0.81). Worse preoperative VAS-Leg, isthmic spondylolisthesis, and three-level fusion were predictors of earlier achievement of MCID for VAS-Leg (HR: 1.27–6.47). Herniated nucleus pulposus and foraminal stenosis were early predictors (HR: 2.92–3.23) and workers’ compensation was a late predictor of MCID attainment for PROMIS-PF (HR: 0.13). ConclusionSelect demographic variables, comorbidities, spinal pathology, and preoperative PROs influenced the time it took for patients to report clinically significant improvements in pain, disability, and physical function scores. These findings can be used to prognosticate outcomes for patients undergoing LLIF and inform patient expectations of postoperative recovery.

Comparison of Minimally Invasive and Open Bunion Surgery in Older Patients

Category: Bunion Introduction/ Purpose: Hallux valgus deformity affects more than 35% of people over 65 years old. Surgical correction in this population can be more complicated due to the likelihood of poor bone quality, worse deformity, and post-operative recovery challenges associated with weight bearing restrictions. There is no consensus on which surgical option is the best in this age-group. Minimally invasive bunionectomy (MIS) has gained popularity, namely due to evidence showing reduced recovery time, earlier weight-bearing, and less post-operative pain which can eliminate the need for opioids, all of which are beneficial to older surgical patients. The purpose of this study was to compare the radiographic and clinical outcomes of patients age 65 and older who underwent either open Lapidus or minimally invasive chevron akin osteotomy for bunion correction. Methods: A retrospective review of prospectively collected data within an institutional registry was performed. We identified 62 patients age 65 or older who were treated surgically for hallux valgus (open Lapidus or minimally invasive chevron akin osteotomy) between January 2017 and August 2022 with at least 1-year post-operative PROMIS scores. Chart review was performed to obtain demographic information and to confirm the surgical procedures completed. Pre- and at least 6-month post-operative radiographs were measured to obtain the hallux valgus angle (HVA) and intermetatarsal angle (IMA). PROMIS scores were obtained pre-operatively and at one and/or two years post-operatively. Differences in demographic, clinical, and radiographic outcomes between cohorts were assessed using the Mann Whitney U test and p-values were adjusted for a false discovery rate of 5%. Results: Both the MIS and open cohorts showed significant improvement in radiographic measurements between pre- and post-operative radiographs (p &lt; 0.001), though there was no significant difference between groups (p &gt; 0.05). There was a clinically and statistically significant improvement within the PROMIS domain of Pain Interference for the open and MIS groups and Physical Function for the MIS group at 1 and 2-years post-operatively, however, there was only a significant difference at 2-years for the PROMIS Physical Function domain in the open group. No difference was noted in Physical Function at 1-year post-operatively for the open group or between groups (Table 1). Within the MIS and open groups, there was an overall complication rate of 26% in each group (p &gt; 0.05). Conclusion: Patients in both the MIS and open surgical groups had improvement in radiographic measurements and PROMIS scores, though there was no clinical or statistical difference found between groups. Additionally, patients in the open group may take longer to improve as there was not a significant improvement in the PROMIS Physical Function domain until the 2-year post-operative time point. Further investigation of recovery metrics between techniques in the earlier post-operative time-point is warranted. Given the results, both MIS and open surgical techniques appear to be safe and effective in correcting hallux valgus in older patients.

Correlation of PROMIS Scores with the Various Classes of the New Classification System of Progressive Collapsing Foot Deformity

Category: Other; Hindfoot Introduction/Purpose: The current classification system of progressive collapsing foot deformity (PCFD) is comprised of 5 classes that can occur simultaneously. Classes A-E indicate various deformities: hindfoot valgus, midfoot/forefoot abduction, forefoot varus/medial column instability, and ankle joint instability/valgus tilting in the ankle mortise, respectively. While the relationship between each of the PCFD deformities in the classification system to one another has been studied, to our knowledge, the correlation between the various classes and patient-reported outcomes has not been assessed. The purpose of this study was to evaluate whether the PCFD classification system is predictive of patient-reported outcomes and overall prognosis following surgery. The hypothesis was that patients with more severe deformity would have worse patient-reported outcomes. Methods: A retrospective review of prospectively collected data within an institutional registry was performed. We identified 74 patients aged 18 or older who were treated surgically for PCFD between October 2018 and October 2021 with preoperative, 1-year, and 2-year postoperative PROMIS scores. Chart review was performed to obtain demographic information and to confirm the surgical procedures completed. Using radiographs, weight-bearing computed tomography (WBCT), and office notes, patients were classified using the PCFD classification system. Patients were divided into two groups depending on whether subclasses D and/or E were present, indicating more severe deformity. Linear mixed models were used to assess longitudinal change in PROMIS scores between groups over time. Results: Patient demographic and classification characteristics are presented in Table 1. 47 patients were allocated to the Class D/E group and 27 patients were allocated to the No Class D/E group. Patients in the Class D/E group had worse pre-operative Global Physical Health (GPH) (p=0.018) and depression scores (p=0.012); however, post-operatively, there was only a difference in the PROMIS domain of Physical Function (PF) at both 1-Year (p=0.019) and 2-Year (p=0.038) time points (Table 2). There were no statistical differences between the two groups for any other domain at any timepoint (Table 2). Conclusion: Patients with more severe PCFD had clinically significant improvement in physical function at both 1- and 2-years post-operatively, but had worse outcomes compared to those with less severe deformity. The findings regarding preoperative GPH and depression suggest that while Class D/E patients did not perform as well functionally, they may be satisfied with their overall quality of life due to the similar scores postoperatively when compared to the patients with less severe deformity. Future studies are needed to better determine if the novel PCFD classification system is predictive of overall prognosis following surgery based on the various deformities present.

Rule breakers achieve successful shoulder balance: unraveling the myth of upper instrumented vertebrae selection criteria

PurposeThis study compared shoulder balance outcomes in “rule breakers” (RB) vs. “rule followers” (RF) based on commonly utilized upper instrumented vertebrae (UIV) selection guidelines.MethodsAdolescent idiopathic scoliosis (AIS) patients (Lenke 1–4) who underwent posterior spine fusion (PSF) with minimum 2-year follow-up had radiographic measurement of shoulder balance including first rib angle (FRA), T1 tilt, coracoid process height difference (CPHD), and clavicle angle (CA) at preop, postop, 6-month, 1-year, and 2-year timepoints. Postoperative outcomes were compared between RB and RF groups defined based on the UIV selection guidelines of Rose and Lenke.ResultsAmong 88 patients (43 RF, 45 RB), age, gender, preoperative T1 tilt, FRA, CA, and CPHD were not significantly different between groups (p > 0.05). Immediately post-surgery, the RF group had more balanced shoulders (CPHD: 11.6 mm vs. 15.7 mm, p = 0.033; CA: 2.8° vs. 3.6°, p = 0.045; FRA: 3.4° vs. 5.1°, p = 0.009; T1 tilt: 4.7° vs. 6.1°, p = 0.045). At 2 years, no difference was observed between RF vs. RB in CA (2.3 vs. 2.2°, p = 0.857) and CPHD (8.5 vs. 8.1 mm, p = 0.791). FRA and T1 tilt were higher in RB vs. RF (FRA: 4.6 vs. 2.9°, p = 0.002; T1 tilt: 5.6 vs. 3.9, p = 0.008). Shoulder balance (CPHD < 1 cm) was achieved in 73.1% of RB and 69.9% of RF at 2-year follow-up (p = 0.216).ConclusionAdherence to commonly accepted UIV selection guidelines did not predict better shoulder balance. The RB group had worse shoulder balance immediately post-surgery, but also improved more over time. These results suggest the need to refine current UIV selection and management.Level of evidenceIII.

Higher Rate of Spontaneous Bacterial Peritonitis Recurrence With Secondary Spontaneous Bacterial Peritonitis Prophylaxis Compared With No Prophylaxis in 2 National Cirrhosis Cohorts.

Spontaneous bacterial peritonitis (SBP) bacteriology has changed over time. Reappraisal of primary SBP prophylaxis showed an increased rate of resistance in patients on primary prophylaxis with resultant discontinuation of this prophylaxis throughout the Veterans Affairs (VA). We aimed to re-evaluate the risk-benefit ratio of secondary SBP prophylaxis (SecSBPPr). Using validated International Classification of Diseases-9/10 codes, we used the VA Corporate Data Warehouse and the Non-VA National TriNetX database to identify patients in 2 different large US systems who survived their first SBP diagnosis (with chart review from 2 VA centers) between 2009 and 2019. We evaluated the prevalence of SecSBPPr and compared outcomes between those who started on SecSBPPr vs not. We identified 4,673 veterans who survived their index SBP episode; 54.3% of whom were prescribed SecSBPPr. Multivariable analysis showed higher SBP recurrence risk in those on vs off SecSBPPr (hazards ratio 1.63 [1.40-1.91], P < 0.001). This was accompanied by higher fluoroquinolone resistance odds in SecSBPPr patients (odds ratio = 4.32 [1.36-15.83], P = 0.03). In TriNetX, we identified 6,708 patients who survived their index SBP episode; 48.6% were on SecSBPPr. Multivariable analysis similarly showed SecSBPPr increased SBP recurrence risk (hazards ratio 1.68 [1.33-1.80], P < 0.001). Both data sets showed higher SBP recurrence trends over time in SecSBPPr patients. Results remained consistent at 6-month and 2-year timepoints. In 2 national data sets of >11,000 patients with SBP, we found that SecSBPPr was prescribed in roughly half of patients. When initiated, SecSBPPr, compared with no prophylaxis after SBP, increased the risk of SBP recurrence in multivariable analysis by 63%-68%, and this trend worsened over time. SecSBPPr should be reconsidered in cirrhosis.

Antibody persistence and safety of a live-attenuated chikungunya virus vaccine up to 2 years after single-dose administration in adults in the USA: a single-arm, multicentre, phase 3b study

Chikungunya virus infection can lead to long-term debilitating symptoms. A precursor phase 3 clinical study showed high seroprotection (defined as a 50% plaque reduction of chikungunya virus-specific neutralising antibodies on a micro plaque reduction neutralisation test [μPRNT] titre of ≥150 in baseline seronegative participants) up to 6 months after a single vaccination of the chikungunya virus vaccine VLA1553 (Valneva Austria, Vienna, Austria) and a good safety profile. Here we report antibody persistence and safety up to 2 years. In this single-arm, multicentre, phase 3b study, we recruited participants from the precursor phase 3 trial from professional vaccine trial sites in the USA. Participants (aged ≥18 years) were eligible if they had completed the previous study and received VLA1553. Chikungunya virus-specific neutralising antibodies were evaluated at 28 days, 6 months, and 1 year and 2 years after vaccination. The primary outcome was the proportion of seroprotected participants (ie, μPRNT50 titre of ≥150) at 1 and 2 years, assessed in all eligible participants who had at least one post-vaccination immunogenicity sample available, overall and by age group at the time of vaccination (18-64 years and ≥65 years). Adverse events of special interest at the time of transition from the previous study to the current study (ie, at 6 months) and serious adverse events during the current study were recorded (ie, between 6 months and 2 years). All analyses were descriptive. This study is registered with ClinicalTrials.gov, NCT04838444, and immunogenicity follow-up is ongoing. In the precursor study, participants were screened between Sept 17, 2020, and April 10, 2021; data cutoff for this analysis was March 31, 2023. Of 2724 participants in the precursor study who received one dose of VLA1553, 363 participants were analysed in this study (310 [85%] aged 18-64 years and 53 [15%] aged ≥65 years at enrolment in the precursor study; mean age 47·7 years [SD 14·2], 207 [57%] of 363 participants were female, 156 [43%] were male, 280 [77%] were White, and 314 [87%] were not Hispanic or Latino). Strong seroprotection was observed at 1 year (98·9% [356 of 360 assessable participants; 97·2-99·7]) and 2 years (96·8% [306 of 316; 94·3-98·5]) after vaccination, and was very similar between those aged 18-64 years (at 1 year: 98·7% [303 of 307; 96·7-99·6]; at 2 years: 96·6% [256 of 265; 93·7-98·4]) and those aged 65 years and older (at 1 year: 100% [53 of 53; 93·3-100]; at 2 years: 98·0% [50 of 51; 89·6-100]) at each timepoint. No adverse events of special interest were ongoing at the time of transition. Ten serious adverse events occurred in nine (2%) participants between the 6-month and 2-year timepoints, including one death (due to drug overdose) that was determined to not be related to VLA1553. After a single VLA1553 vaccination, chikungunya virus-neutralising antibodies above the threshold considered to be protective persisted up to 2 years and there were no long-term serious adverse events related to vaccination. VLA1553 is an efficient and safe intervention that offers high seroprotection against chikungunya virus infection, a virus likely to spread globally with an urgent demand for long-lasting prophylaxis. Valneva Austria, Coalition for Epidemic Preparedness Innovation, and EU Horizon 2020.

Comparison of short- and midterm outcomes in patients following ream-and-run and anatomic total shoulder arthroplasties

Anatomic total shoulder arthroplasty (aTSA) may not be an ideal treatment option for young and active patients because of potential activity restriction and concerns about glenoid loosening. The ream-and-run procedure (RnR) allows for the continuance of high-level activity without concerns of a glenoid component failure. Initial RnR publications are promising, although more outcomes studies are needed. Therefore, our primary purpose was to compare outcomes at multiple time points between matched aTSA and RnR cohorts. Second, we sought to examine relationships between patient-reported outcomes and preoperative glenoid pathoanatomy in our RnR cohort Last, we examined postoperative radiographs to determine if the RnR successfully corrected glenoid pathoanatomy and humeral head decentering. We performed a retrospective matched-cohort study comparing patients who underwent an RnR vs. patients who underwent the aTSA procedure between 2017 and 2019. All patients had primary diagnoses of shoulder osteoarthritis and a minimum of 2-year follow-up. Simple Shoulder Test, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and daily and worst pain outcomes were compared between groups at 3 and 6 months, and 1 and 2 years postarthroplasty. Pre- and postoperative glenoid anatomy and humeral decentering were measured radiographically, and correlation analyses were conducted to explore relationships between these factors and 2-year pain and function scores. Forty-six shoulders (23 RnR and 23aTSA) belonging to 43 male patients with an average age of 56.2±8.3 years were included. Eighteen matched pairs were available at 3 and 6 months, 21 matched pairs at 1 year, and all 23 matched pairs at the 2-year time point. RnR patients reported significantly higher daily pain ratings (P=.047) and lower ASES scores (P=.031) compared with the aTSA group 3 months after arthroplasty but reported similar outcomes at 6 months and beyond. Preoperative pathoanatomy outcomes were not directly related to final reported pain or function in the RnR group. Additionally, the RnR was able to correct posterior humeral head decentering in our cohort. Young male patients undergoing RnR can likely expect similar short-term results as young male patients who undergo aTSA. Additionally, the RnR outcomes were not affected by preoperative glenoid wear or humeral head decentering. Our findings support the RnR as a viable surgical alternative for young, active patients with shoulder arthritis.

Poster 387: Application of Survival Machine Learning Methodology to Predict Time-Dependent Risk of Revision ACLR Graft Failure in the MARS Cohort

Objectives: Previous machine learning (ML) analysis has shown that a novel ML model built using the Multicenter Anterior Cruciate Ligament (ACL) Revision Study (MARS) cohort data can predict graft failure at 6 years postoperatively as a binary outcome with moderate ability. However, binary classification does not consider the time-to-event component of graft failure as an outcome. In contrast, survival models can factor the time-to-event component of an outcome, incorporate time-dependent variables, and appropriately process censored data to deliver more clinically meaningful outcome predictions. While the previous binary classifier can provide information about whether the primary outcome graft failure will occur at 6 years, survival analysis models are able to provide information on when graft failure occurs (for example, within 2, 4, or 6 years). Therefore, this study sought to apply ML survival analysis methodology to the MARS cohort data to produce a model that can most accurately estimate the probability of revision ACL reconstruction (rACLR) graft failure within 2, 4, and 6 years postoperatively, and identify factors that impact probability estimates at each of these time horizons. Methods: rACLR patients were prospectively recruited by the MARS group. Preoperative radiographs, surgeon-reported intraoperative findings, and 2 and 6-year follow-up data on patient-reported outcomes (PROs), subsequent knee surgeries, and graft failure were obtained. ML models including Cox Proportional Hazards (CoxPH), XGBoost Survival Embeddings (XGBoost), Random Survival Forest (RSF), Extra Survival Tree (EST), and CoxBoost, were built to predict the probability of graft failure within 2, 4, and 6 years postoperatively. Validated performance metrics and feature importance measures were used to evaluate model performance. Results: The cohort included 1142 patients, of which 4.8% (n = 55) experienced documented graft failure during the 6-year postoperative period. CoxBoost demonstrated the highest discriminative power across all studied time points (Timepoint: Time Dependent C-index | 2-year: 0.725 ± 0.127 | 4-year: 0.669 ± 0.057 | 6-year: 0.645 ± 0.054), with well-calibrated scores (Timepoint: Time dependent Brier Score | 2-year: 0.023 ± 0.012 | 4-year: 0.035 ± 0.010 | 6-year: 0.046 ± 0.012) as listed in Table 1 and Table 2 respectively. Based on the Kaplan Meier survival plot, the survival probability (probability of not tearing the ACL graft) at 2, 4, 6 years was 0.977, 0.965, and 0.954 respectively. Within the context of the predictive models, features deemed important for CoxBoost differed from those deemed important for CoxPH predictive ability. Conclusions: Survival machine learning models can predict the risk of rACLR graft failure up to 6 years postoperatively, with the most robust predictions at the 2-year postoperative timepoint. While external validation with further combined registry datasets is required, this present study builds on prior ML analyses towards the development of a bedside calculator for rACLR outcome prediction and risk stratification.

Characterization of Retinal Microvascular Abnormalities in Birdshot Chorioretinopathy Using OCT Angiography

To characterize changes in the retinal microvasculature in eyes with birdshot chorioretinopathy (BCR) using OCT angiography (OCTA). Retrospective, observational, single center. Twenty-eight patients (53 eyes) with BCR and 59 age-matched controls (110 eyes). En face OCTA images of the superficial capillary plexus (SCP) and deep capillary plexus (DCP) of each eye were assessed for the presence of microvascular abnormalities and used to measure the vessel and foveal avascular zone (FAZ) areas. A longitudinal analysis was performed with a representative cohort of 23 BCR eyes (16 patients) at baseline and at a 2-year time point. Whole-image vessel density (VD, %), extrafoveal avascular zone (extra-FAZ) VD (%), and FAZ area (%) were calculated and compared between control and BCR eyes. The frequency of microvascular abnormalities in BCR eyes was recorded. In the SCP, increased intercapillary space and capillary loops were common features present on OCTA images. Whole-image and extra-FAZ VD were lower in the BCR group compared with controls (P < 0.0001 [SCP and DCP]). Foveal avascular zone area was enlarged in BCR eyes (P= 0.0008 [DCP]). Worsening best-corrected visual acuity was associated with a decrease in whole-image and extra-FAZ VD in the SCP (P<0.0001 for both) and the DCP (P < 0.005 for both). Multivariable analysis, with vessel analysis parameters as outcomes, demonstrated that increasing age, increasing disease duration, lower central subfield thickness, and treatment-naive eyes (compared with those on only biologics) were associated with a significant decrease in both DCP whole-image and extra-FAZ VD. Increasing disease duration was associated with a significant decrease in both SCP whole-image and extra-FAZ VD. Longitudinal analysis demonstrated no significant difference in any vessel analysis parameters except for an increase in DCP FAZ area. Our results demonstrate a significant a decrease in VD in BCR eyes and an association on multivariable analysis with disease duration. Quantifying VD in the retinal microvasculature may be a useful biomarker for monitoring disease severity and progression in patients with BCR. Further studies with extended longitudinal follow-up are needed to characterize its utility in monitoring disease progression and treatment response. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Comparison of the efficacy of ROI-C cage with Zero-P device in anterior cervical discectomy and fusion of cervical degenerative disc disease: a two-year follow-up study.

This study aimed to compare the clinical outcomes of Zero-P and ROI-C devices applied to anterior cervical discectomy and fusion (ACDF) surgery of cervical degenerative disc disease (CDDD). From January 2020 and December 2020, 56 patients with CDDD who underwent ACDF using Zero-P or ROI-C were included in this retrospective study. The outcomes included visual analogue scale (VAS) score, Japanese Orthopedic Association (JOA) score, neck disability index (NDI) score, Cobb angle, dysphagia, and bone fusion rate. Dysphagia was assessed using the Bazaz grading system. The comparison of outcomes between the two groups was based on the 2-year follow-up time point, which was defined as the last follow-up visit. The Zero-P group included 16 males and 14 females, with a mean age of 56.2 (range, 35-65) years. The ROI-C group included 11 males and 15 females, with a mean age of 57.4 (range, 36-67) years. There was no significant difference in gender and mean age between the two groups. There were no significant differences in VAS score, JOA score, NDI score, Cobb angle, dysphagia, and bone fusion rate between two groups at the last follow up visit. In the Zero-P group, the duration of surgeries involving C3-4 or C6-7 segments was significantly longer than those including C4-5 or C5-6 segments (135.0 ± 19.0 vs. 105.6 ± 17.5 min, P < 0.05). In surgeries involving C3-4 or C6-7 segments, the operation time of ROI-C was significantly shorter than that of Zero-P (106.5 ± 19.5 vs.112.2 ± 20.5 min, P < 0.05). There were no significant differences in the dysphagia or cage subsidence rates between the Zero-P and ROI-C groups (P > 0.05). The Cobb angle in the last follow-up visit in the Zero-P group (24.4 ± 4.5°) was significantly higher than that in the ROI-C group (18.1 ± 2.3°) (P < 0.05). ACDF using ROI-C device showed an efficacy similar to the Zero-P device, as well as a shorter operation time for surgeries involving C3-4 or C6-7 segments. However, ROI-C could cause more loss of Cobb angle over time, which could lead to uncomfortable symptoms.

Predicting the risk of neurocognitive decline after brain irradiation in adult patients with a primary brain tumor.

Deterioration of neurocognitive function in adult patients with a primary brain tumor is the most concerning side effect of radiotherapy. This study aimed to develop and evaluate normal-tissue complication probability (NTCP) models using clinical and dose-volume measures for 6-month, 1-year, and 2-year Neurocognitive Decline (ND) postradiotherapy. A total of 219 patients with a primary brain tumor treated with radical photon and/or proton radiotherapy (RT) between 2019 and 2022 were included. Controlled oral word association test, Hopkins verbal learning test-revised, and trail making test were used to objectively measure ND. A comprehensive set of potential clinical and dose-volume measures on several brain structures were considered for statistical modeling. Clinical, dose-volume and combined models were constructed and internally tested in terms of discrimination (area under the curve, AUC), calibration (mean absolute error, MAE), and net benefit. Fifty percent, 44.5%, and 42.7% of the patients developed ND at 6-month, 1-year, and 2-year time points, respectively. The following predictors were included in the combined model for 6-month ND: age at radiotherapy > 56 years (OR = 5.71), overweight (OR = 0.49), obesity (OR = 0.35), chemotherapy (OR = 2.23), brain V20 Gy ≥ 20% (OR = 3.53), brainstem volume ≥ 26 cc (OR = 0.39), and hypothalamus volume ≥ 0.5 cc (OR = 0.4). Decision curve analysis showed that the combined models had the highest net benefits at 6-month (AUC = 0.79, MAE = 0.021), 1-year (AUC = 0.72, MAE = 0.027), and 2-year (AUC = 0.69, MAE = 0.038) time points. The proposed NTCP models use easy-to-obtain predictors to identify patients at high risk of ND after brain RT. These models can potentially provide a base for RT-related decisions and post-therapy neurocognitive rehabilitation interventions.

Differences in presurgical MMPI-3 scores across trajectories of recovery from spine surgery.

Approximately 30% of patients who undergo spinal surgery for chronic back pain continue to experience significant pain and disability up to 2 months following surgery. Prior studies have identified mental health variables including depression and anxiety as predictors of poorer postsurgical outcomes using screening instruments, but no studies have examined long-term outcomes using the Minnesota Multiphasic Personality Inventory-3 (MMPI-3), a commonly used tool used in presurgical psychological evaluations (PPE). Using group-based trajectory modeling and a sample of 404 spine surgery evaluees, the present study examined the trajectories of changes in disability scores from presurgery through 3, 12, and 24 months postsurgery. We then compared scores on MMPI-3 scales between trajectory groups. We identified three trajectory groups of change in disability over time: a rapid-remitting group (8%), characterized by moderate presurgical disability that rapidly and substantially remitted by 12 and 24 months; a steady-recovering group (68%), characterized by moderate presurgical disability, slower change over time, and mild levels of disability at the 2-year time point; and a persisting disability group (24%), characterized by severe presurgical disability that continued into long-term follow-ups. Participants in the persisting pain group produced higher presurgical scores on somatic/cognitive and internalizing MMPI-3 scales than participants in the rapid-remitting and steady-recovering groups. Our results support the clinical utility of the MMPI-3 in PPEs and highlight the importance of evaluating somatic/cognitive concerns and internalizing dysfunction to identify patients who are likely to have poorer postsurgical outcomes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Calipered kinematic alignment restored the arithmetic hip-knee-ankle angle, achieved high satisfaction and improved clinical outcomes.

The purpose of this study was to determine whether unrestricted calipered kinematic alignment (KA), coupled with a medial-stabilised (MS) implant system, can reproduce the patient's constitutional alignment as per the arithmetic hip-knee-ankle (aHKA) and improve clinical outcomes. One-hundred and ninety-three patients received total knee arthroplastyby the senior author. To determine whether the constitutional alignment was achieved, the postoperative hip-knee-ankle (HKA) alignment was compared against the aHKA. Range of motion (ROM) was determined preoperative and postoperatively at 6 months and 2 years by measuring the active flexion and extension. Patient-Reported Outcomes Measures (PROMs) including Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score (KOOS), Forgotten Joint Score (FJS) and Visual Analogue Scalefor Satisfaction were also completed. The Sports and Recreation component of KOOS was used to assess the patient's ability to return to sports and daily activities. There was a strong correlation between postoperative HKA and aHKA (r = 0.7, p < 0.05). There was a significant improvement in both extension and flexion seen from as early as 6 months postoperatively, with a mean flexion of 123° ± 11° and extension of 1° ± 3° at 2 years. PROMs had significant improvements with a mean score of 42.8 ± 6.0 for the OKS and all KOOS subscales consisting of Symptoms (88.0 ± 11.7), Pain (91.4 ± 11.6), Activities of Daily Living(91.1 ± 12.4), Sports (76.8 ± 22.1) and Quality of Life(83.0 ± 19.1). The FJS had significant improvements from 6 months to 2 years of 19.9 (p < 0.05), with a mean score of 69.2 ± 26.6 at 2 years. Ninety-three percent (180 patients) were classified as 'satisfied' at the 2-year timepoint. The KOOS Sports component was completed by 64% (124 patients), whereby the mean age was younger than the noncompliant patients (67.7 ± 9.4vs. 71.7 ± 8.2 years). Unrestricted calipered KA can result in an alignment that closely resembles the patient's constitutional alignment, as per the aHKA. This resulted in improved knee ROM and patient satisfaction, as well as assisting younger patients to return to sports and daily activities. Level IV.

A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects

BACKGROUND CONTEXTA previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSETo evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTINGCost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLEA multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURESCost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODSThe primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTSThe updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of −9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONSThis updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

Does Wound VAC Temporization Offer Patient-Reported Outcomes Similar to Single-Stage Excision Reconstruction After Myxofibrosarcoma Resection?

Vacuum-assisted closure (VAC) temporization is a promising technique to achieve local control in aggressive soft tissue sarcomas. Despite its previously reported efficacy, adoption of VAC temporization remains limited, primarily due to the scarce literature on patient-reported outcomes (PROs) supporting its efficacy. This study compared the postoperative PROs after VAC temporization or single-stage (SS) excision and reconstruction for patients undergoing surgical resection for myxofibrosarcoma management. A retrospective analysis of myxofibrosarcoma patients who underwent surgical resections at our institution from 2016 to 2022 was performed. Postoperative PROs collected prospectively for those treated with VAC temporization or SS excision/reconstruction were compared using a visual analog scale (VAS) for pain and three Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires: Global Health Short-Form Mental (SF Mental), Global Health Short-Form Physical (SF Physical), and Physical Function Short-Form 10a (SF 10a). Absolute and differential (postoperative minus preoperative) scores at the 1-month, 3-month, 6-month, 1-year, and 2-year time points were compared. The analysis included 79 patients (47 treated with VAC temporization and 32 treated with SS excision/reconstruction). All outcomes were similar between the groups except for physical function 1 year after surgery, in which the differential PROMIS SF 10a scores were higher in the SS group (p = 0.001). All the remaining absolute and differential PROMIS and VAS pain scores were similar between the groups at all time points. Postoperative complications did not differ between the groups. The PROs for physical and mental health, physical function, and pain were similar between the myxofibrosarcoma patients who had VAC temporization and those who had SS excision/reconstruction after surgical resection.

Effect of Baseline Veterans RAND-12 Mental Composite Score on Postoperative Patient-Reported Outcome Measures for Cervical Disk Replacement.

Retrospective review. To examine the effect of baseline Veterans RAND-12 (VR-12) Mental Composite Score (MCS) on clinical outcomes in patients undergoing cervical disk replacement (CDR) for herniated disk. Few studies in spine surgery have evaluated the impact of preoperative VR-12 MCS on postoperative outcomes in patients undergoing CDR. Patients undergoing CDR for herniated disk were separated into 2 cohorts based on the VR-12 MCS standardized mean: VR-12 MCS<50 (worse mental health) and VR-12 MCS≥50 (better mental health). Patient-reported outcome measures of VR-12 MCS, VR-12 Physical Composite Score, Short Form-12 (SF-12) MCS, SF-12 Physical Composite Score, Patient-Reported Outcomes Measurement Information System Physical Function, Patient Health Questionnaire-9 (PHQ-9), Visual Analog Scale (VAS) Neck Pain, VAS Arm Pain, and Neck Disability Index were collected at preoperative and up to 2-year postoperative time points. In all, 109 patients were identified, with 50 patients in the worse mental health cohort. The worse mental health cohort reported inferior patient-reported outcome measures in all domains at preoperative, 6-week postoperative, and final postoperative time points. For 6-week postoperative improvement, the worse mental health cohort reported greater improvement for VR-12 MCS, SF-12 MCS, and PHQ-9. For final postoperative improvement, the worse mental health cohort reported greater improvement in VR-12 MCS and SF-12 MCS. Minimum clinically important difference achievement rates were higher in the worse mental health cohort for VR-12 MCS, SF-12 MCS, and PHQ-9. Patients undergoing cervical disk replacement for herniated disk with worse baseline mental health reported inferior clinical outcomes in mental health, physical function, pain, and disability outcomes throughout the postoperative period. Patients with worse baseline mental health demonstrated greater clinically meaningful improvement in mental health. In cervical disk replacement patients, those with worse baseline mental health may report inferior postoperative clinical outcomes but experience greater rates of tangible improvement in mental health.

Clinically significant outcome thresholds and rates of achievement by shoulder arthroplasty type and preoperative diagnosis

BackgroundClinically significant outcome (CSO) benchmarks have been previously established for shoulder arthroplasty by assimilating preoperative diagnoses and arthroplasty types. The purpose of this study was to establish unique CSO thresholds and compare the time-to-achievement of these for reverse shoulder arthroplasty (RSA) for osteoarthritis (GHOA), RSA for rotator cuff arthropathy (RCA), and total shoulder arthroplasty (TSA) for GHOA. Materials & MethodsConsecutive patients who underwent elective RSA for GHOA, TSA for GHOA, or RSA for RCA between February 2015 and May 2020, with 2-year minimum follow-up, were retrospectively identified from a prospectively maintained single surgeon registry. The American Shoulder and Elbow Surgeons (ASES) score was administered preoperatively and postoperatively at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year timepoints. Satisfaction and subjective overall improvement anchor questionnaires were administered at the time of final follow-up. Distribution-based methods was used to calculate the Minimal Clinically Important Difference (MCID), and anchor-based methods were used to calculate the Substantial Clinical Benefit (SCB) and the Patient Acceptable Symptom State (PASS) for each patient group. Median time to achievement, individual incidence of achievement at each time point, and cumulative incidence of achievement calculated using Kaplan-Meier survival curve analysis with interval censoring were compared between groups for each CSO. Cox-regression analyses were also performed to determine which patient factors were significantly associated with early or delayed achievement of CSOs. ResultsThere were 471 patients eligible for study analysis: 276 RSA for GHOA, 107 TSA for GHOA, 88 RSA for RCA. The calculated MCID, SCB, and PASS scores differed for each group. There were no significant differences in median time to achievement of any CSO between groups. Log-rank testing revealed that cumulative achievements significantly differed between groups for MCID (P = 0.014) but not for SCB (P = 0.053) or PASS (P = 0.620). On cox regression analysis, TSA patients had earlier achievement of SCB, whereas TSA and RSA for GHOA patients had earlier achievement of MCID. At two-years, a significantly higher percentage of RSA for GHOA patients achieved MCID and SCB compared to RSA for RCA (MCID:100%, 95.5%, P = 0.003, SCB:94.6%, 86.4%, P = 0.036). ConclusionCalculated CSO thresholds differ according to preoperative diagnosis and shoulder arthroplasty type. Patients undergoing TSA and RSA for GHOA achieve CSOs earlier than RSA for RCA patients, and a significantly higher percentage of RSA for GHOA patients achieve CSOs by 2 years compared to RSA for RCA patients.

Anatomical and Functional Outcomes with Prompt versus Delayed Initiation of Anti-VEGF in Exudative Age-Related Macular Degeneration.

To investigate the correlation between time from diagnosis of treatment-naïve exudative age-related macular degeneration (AMD) to the introduction of anti-VEGF treatment and anatomical and functional outcomes. Retrospective cohort study. Included were treatment-naïve exudative AMD patients who presented to a single tertiary medical center between 2012 and 2018. All patients were treated within the first 30 days of their diagnosis with three monthly intravitreal injections of bevacizumab. Patients were divided into three groups: group 1 (prompt anti-VEGF) were injected with bevacizumab within ten days, group 2 (intermediate anti-VEGF) within 11-20 days, and group 3 (delayed anti-VEGF) within 21-30 days from diagnosis. Baseline characteristics and clinical outcomes were compared up to two years from treatment. 146 eyes of 146 patients were included. Sixty-eight patients were in the prompt anti-VEGF group, 31 in the intermediate anti-VEGF group, and 47 in the delayed anti-VEGF group. Following the induction phase of three intravitreal bevacizumab injections, the mean central subfield macular thickness (328.0 ± 115.4 µm vs. 364.6 ± 127.2 µm vs. 337.7 ± 150.1 µm, p = 0.432) and the best-corrected visual acuity (0.47 ± 0.38 vs. 0.59 ± 0.48 vs. 0.47 ± 0.44 logMAR units, p = 0.458) were comparable between the prompt, intermediate and delayed anti-VEGF groups. Anatomical and functional outcomes, treatment burden, number of relapses and eyes with second-line anti-VEGF therapy were comparable between the groups at both 1-year and 2-year timepoints. Our real-world evidence data emphasize that even if anti-VEGF induction cannot be initiated promptly within ten days from diagnosis of naïve exudative AMD, the visual and anatomical prognosis of the patients may not worsen if the treatment is started within one month of diagnosis.