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1.
Orthop J Sports Med ; 12(4): 23259671241245149, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38660019

RESUMO

Background: The ulnar collateral ligament (UCL) is the primary soft tissue stabilizer to valgus stress in the elbow and is placed under this valgus stress during the throwing motion. Although there are known risk factors for UCL injury, it is unknown whether the UCL undergoes adaptive changes in athletes from different climates. Purpose: To compare elbow stress ultrasound (SUS) findings between professional baseball pitchers from warm climates versus cold climates and assess significant differences in adaptive and morphologic changes in the UCL. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Dynamic SUS evaluations were performed over 18 years on the dominant and nondominant arms of 643 professional pitchers from warm and cold climates as determined by the player's country/state of origin. Studies were compared with respect to relative UCL thickness (dominant arm vs nondominant arm), relative glenohumeral joint laxity (joint space distance under stress vs joint space distance at rest), and the presence of morphologic changes such as tears or calcifications. In addition, a subgroup analysis was performed to compare the progression of SUS findings over 3 years in players with sequential yearly data. Results: Players from warmer climates had significantly greater relative UCL thicknesses than players from colder climates (1.75 vs 1.50 mm, respectively; P = .047). There were no differences between these 2 groups in terms of relative ulnohumeral joint laxity (P = .201), presence of morphologic changes (P = .433), 3-year progression of relative UCL thickness (P = .748), or relative joint laxity (P = .904). Conclusion: Professional pitchers from warm climates had a greater side-to-side difference in UCL thickness between the dominant and nondominant arms. This may be due to the potential for year-round throwing among baseball players from warm climates. There was no difference in laxity, thickness progression, laxity progression, or the presence of additional morphologic changes.

2.
Perm J ; : 1-10, 2024 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-38652519

RESUMO

INTRODUCTION: Stoma site incisional hernias (SSIHs) are associated with substantial long-term morbidity, and the rate can be as high as 30% to 40%. Recent efforts using prophylactic mesh reinforcement (PMR) to reduce the development of hernias have shown encouraging outcomes. The objective of this study was to assess the use of prophylactic biosynthetic mesh at the time of stoma reversal on the overall SSIH rate. METHODS: This is an observational retrospective cohort study. A review of 101 consecutive patients who underwent PMR in the retrorectus plane from 2015 to 2020 was compared to 73 consecutive patients who underwent primary stoma closure without mesh from 2011 to 2014. The primary endpoint was the presence of SSIH on clinical examination or computed tomography after ostomy takedown. RESULTS: In total, 174 cases were analyzed with 101 patients in the treatment group (median follow-up 45.2 months) and 73 patients in the control group (median follow-up 43.2 months). There were no major differences in preoperative characteristics between the groups. Fourteen patients developed SSIHs with 1 (1.0%) in the treatment arm and 13 (17.8%) in the control arm (p = 0.001). The majority of stomas were loop ileostomies and end colostomies, and stoma type did not affect hernia rates. On univariate analysis, body mass index (p = 0.029) and chronic kidney disease < 3 (p = 0.003) were independent predictors of hernia formation, while mesh was significantly protective (p = 0.000057). DISCUSSION: PMR with biosynthetic mesh at the time of stoma reversal and closure is an effective procedure to reduce the incidence of SSIHs and does not seem to be associated with an increased risk of complications.

3.
Brain Spine ; 4: 102780, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38510641

RESUMO

Introduction: As the population of elderly patients continues to rise, the number of these individuals presenting with thoracolumbar trauma is expected to increase. Research question: To investigate thoracolumbar fusion outcomes for patients with vertebral fractures as stratified by decade. Secondarily, we examined the variability of cost across age groups by identifying drivers of cost of care. Materials and methods: We queried the United States Nationwide Inpatient Sample(NIS) for adult patients undergoing spinal fusion for thoracolumbar fractures between 2012 and 2017. Patients were stratified by decade 60-69(sexagenarians), 70-79(septuagenarians) and 80-89(octogenarians). Bivariable analysis followed by multivariable regression was performed to assess independent predictors of length of stay(LOS), hospital cost, and discharge disposition. Results: A total of 2767 patients were included, of which 46%(N = 1268) were sexagenarians, 36% septuagenarians and 18%(N = 502) octogenarians. Septuagenarians and octogenarians had shorter LOS compared to sexagenarians(ß = -0.88 days; p = 0.012) and(ß = -1.78; p < 0.001), respectively. LOS was reduced with posterior approach(-2.46 days[95% CI: 3.73-1.19]; p < 0.001), while Hispanic patients had longer LOS(+1.97 [95% CI: 0.81-3.13]; p < 0.001). Septuagenarians had lower total charges $12,185.70(p = 0.040), while the decrease in charges in octogenarians was more significant, with a decrease of $26,016.30(p < 0.001) as compared to sexagenarians. Posterior approach was associated with a decrease of $24,337.90 in total charges(p = 0.026). Septuagenarians and octogenarians had 1.72 higher odds(p < 0.001) and 4.16 higher odds(p < 0.001), respectively, of discharge to a skilled nursing facility. Discussion and conclusions: Healthcare utilization in geriatric thoracolumbar trauma is complex. Cost reductions in the acute hospital setting may be offset by unaccounted costs after discharge. Further research into this phenomenon and observed racial/ethnic disparities must be pursued.

4.
Brain Spine ; 4: 102777, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38465282

RESUMO

Introduction: Given the increasing incidence of traumatic thoracolumbar injuries in recent years, studies have sought to investigate potential risk factors for outcomes in these patients. Research question: The aim of this study was to investigate trends and risk factors for in-hospital mortality after fusion for traumatic thoracolumbar injury. Materials and methods: Patients undergoing thoracolumbar fusion after traumatic injury were queried from the National Inpatient Sample (NIS) from 2012 to 2017. Analysis was performed to identify risk factors for inpatient mortality after surgery. Results: Patients in 2017 were on average older (51.0 vs. 48.5, P = 0.004), had more admitting diagnoses (15.5 vs. 10.7, p < 0.001), were less likely to be White (75.8% vs. 81.2%, p = 0.006), were from a ZIP code with a higher median income quartile (Quartile 1: 31.4% vs. 28.6%, p = 0.011), and were more likely to have Medicare as a primary payer (22.9% vs. 30.1%, p < 0.001). Bivariate analysis of demographics and surgical characteristics demonstrated that patients in the in-hospital mortality group (n = 90) were older (70.2 vs. 49.6, p < 0.001), more likely to be male (74.4% vs. 62.8%, p = 0.031), had a great number of admitted diagnoses (21.3 vs. 12.7, p < 0.001), and were more likely to be insured by Medicare (70.0% vs. 27.0%, p < 0.001). Multivariate regression analysis found age (OR 1.06, p < 0.001) and Black race (OR 3.71, p = 0.007) were independently associated with in-hospital mortality. Conclusion: Our study of nationwide, traumatic thoracolumbar fusion procedures from 2012 to 2017 in the NIS database found older, black patients were at increased risk for in-hospital mortality after surgery.

5.
J Arthroplasty ; 2024 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-38367903

RESUMO

BACKGROUND: Data on sports/physical activity participation following unicompartmental knee arthroplasty (UKA) and patello-femoral arthroplasty (PFA) is variable and limited. The purpose of this study was to assess participations, outcomes, and limitations in sports following UKA and PFA. METHODS: Patients who underwent UKA and PFA at a single institution from 2015 to 2020 were surveyed on sports participation before and after surgery. Data was correlated with perioperative patient characteristics and outcome scores. Among 776 patients surveyed, 356 (50%) patients responded. Of respondents, 296 (83.1%) underwent UKA, 44 (12.6%) underwent PFA, and 16 (4.5%) underwent both UKA/PFA. RESULTS: Activity participation rates were 86.5, 77.3, and 87.5% five years prior, and 70.9, 61.4, and 75% at one year prior to UKA, PFA, and UKA/PFA, respectively. Return to sports rates were 81.6, 64.7, and 62.3% at mean 4.6 years postoperatively, respectively. The most common activities were recreational walking, swimming, cycling, and golf. Patients returned to a similar participation level for low-impact activities, whereas participation decreased for intermediate- and high-impact activities. Patients participating in activities had higher postoperative Knee Injury and Osteoarthritis Outcome Score Joint Replacement (P < .001), 12-Item Short Form Physical Component Score (P = .045) and Mental Component Score (P = .012). Activity restrictions were reported among 25, 36.4, and 25% of UKA, PFA, and UKA/PFA patients, respectively, and were more commonly self-imposed than surgeon-directed. CONCLUSIONS: Though UKA patients' postoperative sports participation may improve compared to one year preoperatively, participation for patients surgically treated for isolated osteoarthritis is decreased compared to 5 years preoperatively and varies among patient subsets.

6.
Artigo em Inglês | MEDLINE | ID: mdl-38420655

RESUMO

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To evaluate how preoperative Oswestry Disability Index (ODI) thresholds might affect minimal clinically important difference (MCID) achievement following lumbar fusion. SUMMARY OF BACKGROUND DATA: As payers invest in alternative payment models, some are suggesting threshold cutoffs of patient reported outcomes (PROMs) in reimbursement approvals for orthopedic procedures. The feasibility of this has not been investigated in spine surgery. MATERIALS/METHODS: We included all adult patients undergoing 1-3 level primary lumbar fusion at a single urban tertiary academic center from 2014-2020. ODI was collected preoperatively and one-year postoperatively. We implemented theoretical threshold cutoffs at increments of 10. MCID was set at 14.3. The percent of patients meeting MCID were determined among patients "approved" or "denied" at each threshold. At each threshold, the positive predictive value (PPV) for MCID attainment was calculated. RESULTS: A total 1,368 patients were included and 62.4% (N=364) achieved MCID. As the ODI thresholds increased, a greater percent of patients in each group reached the MCID. At the lowest ODI threshold, 6.58% (N=90) of patients would be denied, rising to 20.2%, 39.5%, 58.4%, 79.9%, and 91.4% at ODI thresholds of 30, 40, 50, 60, and 70, respectively. The PPV increased from 0.072 among patients with ODI>20 to 0.919 at ODI>70. The number of patients denied a clinical improvement in the denied category per patient achieving the MCID increased at each threshold (ODI>20: 1.96; ODI>30: 2.40; ODI>40: 2.75; ODI>50: 3.03; ODI>60: 3.54; ODI>70: 3.75). CONCLUSION: Patients with poorer preoperative ODI are significantly more likely to achieve MCID following lumbar spine fusion at all ODI thresholds. Setting a preoperative ODI threshold for surgical eligibility will restrict access to patients who may benefit from spine fusion, despite ODI>20 demonstrating the lowest predictive value for MCID achievement.

7.
Arthritis Rheumatol ; 2024 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-38272842

RESUMO

OBJECTIVE: Myositis-associated autoantibodies (MAAs) have been associated with overlap myositis, certain disease manifestations such as interstitial lung disease (ILD), and worse prognosis in the idiopathic inflammatory myopathies. MAAs overall remain largely uncharacterized in patients with juvenile-onset myositis. Moreover, it is unknown whether the number of MAAs is associated with disease severity. METHODS: Patients with juvenile myositis in cross-sectional natural history studies who underwent testing for myositis autoantibodies were included. Demographics, myositis autoantibodies, clinical characteristics, medications received, and outcomes of those with and without MAAs were compared. Multivariable logistic regression was performed to determine whether the number of MAAs detected was associated with severe disease features. RESULTS: Among 551 patients, 36% had an MAA and 13% had more than one MAA. Among those who were MAA positive, there was a higher frequency of overlap myositis (18% vs 5.9%, P < 0.001). MAA positivity was associated with certain clinical features, including Raynaud phenomenon (odds ratio [OR] 2.44, 95% confidence interval [CI] 1.41-4.28) and ILD (OR 3.43, 95% CI 1.75-6.96), as well as a chronic disease course (OR 1.72, 95% CI 1.10-2.72) and mortality (OR 3.76, 95% CI 1.72-8.43). The number of MAAs was also associated with mortality (OR 1.83, 95% CI 1.16-2.86). CONCLUSION: MAAs were prevalent in a large cohort of patients with juvenile myositis. ILD, refractory disease, and mortality were associated with MAA positivity. Prospective studies are needed to determine whether early detection of MAAs may lead to improved outcomes for patients with juvenile myositis.

8.
J Am Acad Orthop Surg ; 32(8): 354-361, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-38271675

RESUMO

INTRODUCTION: Patients presenting with spinal cord injury (SCI) often times have notable deficits or polytrauma and may require urgent decision making for early management. However, their presentation may affect decision-making ability. Although advance care planning (ACP) may help guide spine surgeons as to patient preferences, the rate at which they are available and disparities in ACP completion are still not understood. The objective of this study was to evaluate disparities in the completion of ACP among patients with acute SCI. METHODS: All patients presenting with cervical SCI to the emergency department at an urban, tertiary level I trauma center from 2010 to 2021 were identified from a prospective database of all consults evaluated by the spine service. Each patient's medical record was reviewed to assess for the presence of ACP documents such as living will, power of attorney, or advance directive. Community-level socioeconomic status was assessed using the Distressed Communities Index. Bivariable and multivariable analyses were performed. RESULTS: We identified 424 patients: 104 (24.5%) of whom had ACP. Patients with ACP were older (64.8 versus 56.5 years, P = 0.001), more likely White (78.8% versus 71.9%, P = 0.057), and present with ASIA Impairment Scale grade A SCI (21.2% versus 12.8%, P = 0.054), although the latter two did not reach statistical significance. On multivariable logistic regression, patients residing in at-risk communities were significantly less likely to have ACP documents compared with those in prosperous communities (odds ratio [OR]: 0.29, P = 0.03). Although patients living in distressed communities were less likely to complete ACP compared with those in prosperous communities (OR 0.50, P = 0.066), this did not meet statistical significance. Female patients were also less likely to have ACP (OR: 0.43, P = 0.005). CONCLUSION: Female patients and those from at-risk communities are markedly less likely to complete ACP. Attention to possible disparities during admission and ACP discussions may help ensure that patients of all backgrounds have treatment goals documented.


Assuntos
Planejamento Antecipado de Cuidados , Medula Cervical , Traumatismos da Medula Espinal , Humanos , Feminino , Diretivas Antecipadas , Classe Social , Traumatismos da Medula Espinal/terapia
9.
Am J Sports Med ; 52(1): 224-231, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-38164663

RESUMO

BACKGROUND: The Major League Baseball (MLB) draft is a common route for players to enter professional baseball in the United States. Players taken in earlier rounds are typically higher-performing players. When looking at pitchers specifically, higher performance at the amateur level may be associated with an increased frequency of adaptive change in the throwing elbow. PURPOSE: To determine whether pitchers taken in earlier rounds of the MLB draft have a greater frequency or extent of pathological change in the elbow, as measured by dynamic stress ultrasound. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: Dynamic stress ultrasounds (SUSs) were performed over 18 years on the dominant and nondominant arms of 651 professional pitchers. The 383 drafted players were grouped according to the round in which they were drafted (rounds 1-5, 6-10, 11-20, 21+). Groups were compared with respect to "relative" ulnar collateral ligament (UCL) thickness (dominant-nondominant), relative ulnohumeral joint laxity (joint space distance under stress minus joint space at rest), and the presence of pathology (calcifications, tears, hypoechoic foci, osteophytes). In addition, a subgroup analysis was done to compare the progression of SUS findings over 3 years in players for which data were available. RESULTS: Draft round groups did not differ by age, number of previous spring training, or handedness. Comparing baseline measurements, there was no significant relationship between draft round and relative UCL thickness (P = .932), relative laxity (P = .996), or presence of pathology detectable on SUS (P = .642). However, increased relative UCL thickness was significantly associated with the presence of pathology on SUS (odds ratio, 1.45; 95% CI, 1.26-1.69; P < .001). Longitudinally, there was no significant relationship between draft round and 3-year progression of relative laxity, relative UCL thickness, or clinical progression of pathology. CONCLUSION: Higher-performing pitchers are drafted earlier in the MLB draft. This may be attributable to peak pitch velocity, in-game performance, visibility gained during player showcases, or any number of other sport-specific variables. However, despite this, there was no significant relationship between draft round and adaptive changes to the elbow or specific properties of the UCL on stress ultrasound.


Assuntos
Beisebol , Ligamento Colateral Ulnar , Ligamentos Colaterais , Articulação do Cotovelo , Reconstrução do Ligamento Colateral Ulnar , Humanos , Cotovelo/diagnóstico por imagem , Ligamento Colateral Ulnar/diagnóstico por imagem , Estudos Transversais , Articulação do Cotovelo/diagnóstico por imagem , Articulação do Cotovelo/cirurgia , Ligamentos Colaterais/diagnóstico por imagem , Ligamentos Colaterais/cirurgia
10.
Nat Med ; 30(2): 498-506, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38182785

RESUMO

INTRIGUE was an open-label, phase 3 study in adult patients with advanced gastrointestinal stromal tumor who had disease progression on or intolerance to imatinib and who were randomized to once-daily ripretinib 150 mg or sunitinib 50 mg. In the primary analysis, progression-free survival (PFS) with ripretinib was not superior to sunitinib. In clinical and nonclinical studies, ripretinib and sunitinib have demonstrated differential activity based on the exon location of KIT mutations. Therefore, we hypothesized that mutational analysis using circulating tumor DNA (ctDNA) might provide further insight. In this exploratory analysis (N = 362), baseline peripheral whole blood was analyzed by a 74-gene ctDNA next-generation sequencing-based assay. ctDNA was detected in 280/362 (77%) samples with KIT mutations in 213/362 patients (59%). Imatinib-resistant mutations were found in the KIT ATP-binding pocket (exons 13/14) and activation loop (exons 17/18). Mutational subgroup assessment showed 2 mutually exclusive populations with differential treatment effects. Patients with only KIT exon 11 + 13/14 mutations (ripretinib, n = 21; sunitinib, n = 20) had better PFS with sunitinib versus ripretinib (median, 15.0 versus 4.0 months). Patients with only KIT exon 11 + 17/18 mutations (ripretinib, n = 27; sunitinib, n = 25) had better PFS with ripretinib versus sunitinib (median, 14.2 versus 1.5 months). The results of this exploratory analysis suggest ctDNA sequencing may improve the prediction of the efficacy of single-drug therapies and support further evaluation of ripretinib in patients with KIT exon 11 + 17/18 mutations. ClinicalTrials.gov identifier: NCT03673501.


Assuntos
Antineoplásicos , Neoplasias Gastrointestinais , Tumores do Estroma Gastrointestinal , Naftiridinas , Ureia/análogos & derivados , Adulto , Humanos , Sunitinibe/uso terapêutico , Tumores do Estroma Gastrointestinal/tratamento farmacológico , Tumores do Estroma Gastrointestinal/genética , Tumores do Estroma Gastrointestinal/patologia , Mesilato de Imatinib/uso terapêutico , Resistencia a Medicamentos Antineoplásicos/genética , Biomarcadores , Mutação/genética , Antineoplásicos/uso terapêutico , Proteínas Proto-Oncogênicas c-kit/genética , Proteínas Proto-Oncogênicas c-kit/uso terapêutico , Inibidores de Proteínas Quinases/uso terapêutico , Neoplasias Gastrointestinais/tratamento farmacológico , Neoplasias Gastrointestinais/genética , Neoplasias Gastrointestinais/patologia
11.
Artigo em Inglês | MEDLINE | ID: mdl-38170724

RESUMO

BACKGROUND: The severity of degenerative changes of the hip is known to adversely impact the outcomes of the treatment of femoroacetabular impingement (FAI). Although the operative indications for FAI have expanded to include patients with moderate degrees of hip osteoarthritis, the exact stage of hip osteoarthritis at which surgery for FAI can offer clinical benefits is still uncertain. QUESTIONS/PURPOSES: (1) How does the survivorship free from conversion to THA and survivorship free from revision differ between patients with preexisting Tönnis Grades 2 or 3 changes and those without advanced degenerative changes (Tönnis Grade 0 or 1) after mini-open femoroacetabular osteoplasty? (2) What are the differences in hip-specific and general-health outcome scores between the two groups after mini-open femoroacetabular osteoplasty? METHODS: From December 2003 to April 2019, we treated 901 patients for FAI, and their clinical data were systematically recorded in a longitudinally maintained database. Mini-open femoroacetabular osteoplasty was our preferred surgical approach because of the surgeon's extensive experience with the technique. Among the entire dataset, 6% of patients (51 individuals) had Tönnis Grade 2 or higher hip osteoarthritis, while the remaining 94% (850 patients) had no or mild degenerative changes (Tönnis Grade 0 or 1). In the Tönnis Grade 2 or 3 group, three patients were lost before the minimum 2-year follow-up duration, leaving 4% (48 patients) who qualified for inclusion in the study. For the matched group with Tönnis Grade 0 or 1, 5% (45 patients) were excluded because of incomplete data, and a further 7% (58 patients) were excluded because they did not have 2 years of follow-up, leaving 83% (747 patients) who were eligible for the matching process. Matching was based on patient age (within 1 year), gender, and BMI (within one unit). Matching resulted in the inclusion of 144 randomly selected control patients in this retrospective, comparative study. General indications for femoroacetabular osteoplasty included symptoms of pain and restricted hip motion in young, active patients with signs of FAI evident on physical examination and radiographs. Patient demographics, medical history, radiographic parameters, and intraoperative findings were compared between the two groups to establish baseline differences and identify potential confounding variables. There was no difference in the mean ± standard deviation age between the cohort of interest and control group (39 ± 10 years and 38 ± 11 years, respectively; p = 0.67). There was no difference in the mean follow-up duration (7 ± 3 years versus 8 ± 2 years; p = 0.25) or the preoperative symptomatic period between the study and control groups (2 ± 2 years versus 3 ± 6 years; p = 0.09). There was no difference in the prevalence of dysplasia, slipped capital femoral epiphysis, Perthes disease, or avascular necrosis of the hip between the two groups. Intraoperatively, the groups did not differ in terms of labral repair (65% [31 of 48] versus 78% [113 of 144]; p = 0.08) and labral transplantation (2%; p > 0.99 for both); however, labral resection was performed more frequently in the study group (63% [30 of 48] versus 42% [60 of 144]; p = 0.002). At a minimum of 2 years of follow-up, survivorship free from conversion to THA and survivorship free from revision surgeries, as well as the latest clinical and functional outcome scores (SF-36, Hip Disability and Osteoarthritis Outcome Score, and modified Harris hip score), were compared between groups. RESULTS: Survivorship free from conversion to THA at 5 years was lower among patients with preexisting Tönnis Grades 2 or 3 changes than it was among patients matched for age, gender, and BMI who did not have advanced degenerative changes (Tönnis Grade 0 or 1) after mini-open femoroacetabular osteoplasty (75% [95% confidence interval 64% to 88%] versus 92% [95% CI 87% to 96%]; p < 0.001). No patients in either group underwent reoperation other than conversion to THA. Although the groups did not differ at baseline in terms of their outcomes scores, the group with more visible arthritis had lower postoperative Hip Disability and Osteoarthritis Outcome Scores than the control group (60 ± 21 points versus 86 ± 11 points, mean difference 26 points [95% CI 10 to 41]; p =0.004). There were no other between-group differences in outcome scores after surgery. CONCLUSION: In our study, approximately 25% of patients undergoing mini-open femoroacetabular osteoplasty with Tönnis Grade 2 or higher osteoarthritis underwent conversion to THA within 5 years. Some postoperative functional scores were lower in patients with advanced arthritis than in matched patients with no or mild arthritis. We emphasize the importance of exercising caution when considering femoroacetabular osteoplasty in patients in whom advanced arthritis is already evident at the time of presentation. LEVEL OF EVIDENCE: Level III, therapeutic study.

12.
Future Oncol ; 20(10): 593-601, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37593881

RESUMO

Tenosynovial giant cell tumor (TGCT) is a rare, locally aggressive neoplasm that occurs in the synovium of joints, bursae, or tendon sheaths and is caused by upregulation of the CSF1 gene. Vimseltinib is an oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit the CSF1 receptor. Here, we describe the rationale and design for the phase III MOTION trial (NCT05059262), which aims to evaluate the efficacy and safety of vimseltinib in participants with TGCT not amenable to surgical resection. In part 1, participants are randomized to receive vimseltinib 30 mg twice weekly or matching placebo for ≤24 weeks. Part 2 is a long-term treatment phase in which participants will receive open-label vimseltinib.


Tenosynovial giant cell tumor (or TGCT) is a rare, noncancerous tumor that grows in the soft tissue lining the spaces of joints and bursae (fluid-filled sacs that work to reduce friction in the joints). These tumors are linked to increased levels of a protein called CSF1. While this condition is typically treated with surgery, some patients may not be candidates for surgical removal of the tumor due to factors such as location or complexity of the tumor; therefore, drug treatments are needed to help these patients. Vimseltinib is an investigational oral drug specifically designed to inhibit the receptor to which the CSF1 protein binds. In this article, we describe the rationale and design for a phase III clinical trial that will test how well vimseltinib works in participants with TGCT who are not candidates for surgery. In the first part of the study, participants are randomly assigned to receive vimseltinib 30 mg twice weekly or a matching placebo (inactive substance) for up to 24 weeks. This first part is blinded, so participants will not know if they are receiving vimseltinib or the placebo. The second part of the study is a long-term treatment phase in which all participants will receive vimseltinib (unblinded). Clinical Trial Registration: NCT05059262 (ClinicalTrials.gov).


Assuntos
Tumor de Células Gigantes de Bainha Tendinosa , Humanos , Tumor de Células Gigantes de Bainha Tendinosa/tratamento farmacológico , Tumor de Células Gigantes de Bainha Tendinosa/genética , Inibidores de Proteínas Quinases/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Ensaios Clínicos Fase III como Assunto
13.
Arthritis Rheumatol ; 76(4): 631-637, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38059274

RESUMO

OBJECTIVE: Novel autoantibody specificities including anti-CCAR1 were recently discovered in adult patients with anti-transcriptional intermediary factor (TIF1)-positive dermatomyositis (DM) and were associated with attenuated cancer emergence. The aims of the present study were to examine whether these autoantibodies occur in patients with juvenile-onset DM (JDM) and to determine their associated features. METHODS: Sera from 150 patients with anti-TIF1γ autoantibody-positive JDM in a cross-sectional cohort and 90 juvenile healthy controls were assayed for anti-CCAR1, anti-C1Z1, anti-IMMT, anti-TBL1XR1, and anti-Sp4 autoantibodies. Demographics, myositis autoantibodies, clinical features, medications, outcomes, and HLA-DRB1 and HLA-DQA1 alleles were compared between those with and without these autoantibodies. RESULTS: Any one of the anti-TIF1γ-associated autoantibodies was present in 44 patients (29%) overall, including 25 (17%) with anti-Sp4, 22 (15%) with anti-TBL1XR1, 14 (9%) with anti-CCAR1, 2 (1%) with anti-C1Z1, and 2 (1%) with anti-IMMT autoantibodies. These anti-TIF1γ-associated autoantibodies frequently co-occurred. Patients with any of the anti-TIF1γ-associated autoantibodies had less frequent falling (34% [15] vs. 53% [56], P = 0.032) and lower peak muscle enzymes. None of the patients had cancer. Among White patients, HLA-DRB1*03 was protective against an anti-TIF1γ-associated autoantibody (odds ratio 0.20, 95% confidence interval 0.07-0.52). CONCLUSION: Autoantibodies associated with anti-TIF1γ were found in isolation and in combination among a subset of patients with JDM. Patients with these autoantibodies had less severe muscle disease and were not enriched for HLA-DRB1*03. Additional autoantibodies among patients with positive anti-TIF1γ with JDM likely contribute to the heterogeneity of the anti-TIF1γ serologic subgroup.


Assuntos
Dermatomiosite , Neoplasias , Adulto , Humanos , Análise de Mediação , Cadeias HLA-DRB1 , Autoanticorpos , Estudos Transversais , Imunogenética , Fatores de Risco
14.
Int Orthop ; 48(4): 1023-1030, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37946052

RESUMO

PURPOSE: Joint line (JL) position change in total knee arthroplasty (TKA) may alter knee biomechanics and impact function. The purpose of this study was to compare the change in JL position between robotic-assisted TKA (RA-TKA) and conventional TKA (C-TKA). METHODS: A retrospective, radiographic analysis was conducted of patients who underwent RA-TKA and C-TKA to compare JL position change. JL position was measured in consecutive RA-TKAs and C-TKAs performed by four fellowship-trained arthroplasty surgeons. Statistical analysis was done utilizing t-tests and Mann Whitney U tests, with statistical significance being defined as a p value < 0.05. RESULTS: Six hundred total RA-TKAs and 400 total C-TKAs were included in the analysis. There were no significant differences in patient baseline characteristics such as body mass index, range of motion, and tibiofemoral coronal alignment. RA-TKAs were associated with an average of 0.04 (2.2) mm JL position change, and C-TKAs were associated with an average 0.5 (3.2) mm JL position change (p = 0.030). There were inter-surgeon differences when comparing the change in JL position for RA-TKAs and C-TKAs between the four participating surgeons. CONCLUSION: RA-TKA leads to better preservation of the JL position than C-TKA, and this seems to be dependent on the arthroplasty surgeon's preferences and techniques during TKA. Whether this statistically significant difference is clinically relevant needs to be further investigated.


Assuntos
Artroplastia do Joelho , Prótese do Joelho , Osteoartrite do Joelho , Procedimentos Cirúrgicos Robóticos , Humanos , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Estudos Retrospectivos , Articulação do Joelho/diagnóstico por imagem , Articulação do Joelho/cirurgia , Joelho/cirurgia , Osteoartrite do Joelho/cirurgia
15.
Spine (Phila Pa 1976) ; 49(2): 138-145, 2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-37235801

RESUMO

STUDY DESIGN: Retrospective single-institution cohort. OBJECTIVE: To evaluate the implementation of a commercial bundled payment model in patients undergoing lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: BPCI-A caused significant losses for many physician practices, prompting private payers to establish their own bundled payment models. The feasibility of these private bundles has yet to be evaluated in spine fusion. METHODS: Patients undergoing lumbar fusion from October to December 2018 in BPCI-A before our institution's departure were included for BPCI-A analysis. Private bundle data was collected from 2018 to 2020. Analysis of the transition was conducted among Medicare-aged beneficiaries. Private bundles were grouped by calendar year (Y1, Y2, Y3). Stepwise multivariate linear regression was performed to measure independent predictors of net deficit. RESULTS: The net surplus was the lowest in Y1 ($2,395, P =0.03) but did not differ between our final year in BPCI-A and subsequent years in private bundles (all, P >0.05). AIR and SNF patient discharges decreased significantly in all private bundle years compared with BPCI. Readmissions fell from 10.7% (N=37) in BPCI-A to 4.4% (N=6) in Y2 and 4.5% (N=3) Y3 of private bundles ( P <0.001). Being in Y2 or Y3 was independently associated with a net surplus in comparison to the Y1 (ß: $11,728, P =0.001; ß: $11,643, P =0.002). Postoperatively, length of stay in days (ß: $-2,982, P <0.001), any readmission (ß: -$18,825, P =0.001), and discharge to AIR (ß: $-61,256, P <0.001) or SNF (ß: $-10,497, P =0.058) were all associated with a net deficit. CONCLUSIONS: Nongovernmental bundled payment models can be successfully implemented in lumbar spinal fusion patients. Constant price adjustment is necessary so bundled payments remain financially beneficial to both parties and systems overcome early losses. Private insurers who have more competition than the government may be more willing to provide mutually beneficial situations where cost is reduced for payers and health systems. LEVEL OF EVIDENCE: 3.


Assuntos
Medicare , Fusão Vertebral , Humanos , Idoso , Estados Unidos , Estudos Retrospectivos , Alta do Paciente
16.
Clin Spine Surg ; 37(1): 40-42, 2024 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-37684723

RESUMO

Meta-analyses represent the best available medical evidence. Although a powerful tool, they are not without criticisms since any bias in the original studies are then compounded when they are pooled together for the meta-analysis. Funnel plots provide a useful graphical representation of the presence of bias, and forest plots represent the heterogeneity of findings within studies included in a meta-analysis. The purpose of this review is to help readers interpret these statistical tools to better understand the findings of a meta-analysis.


Assuntos
Viés de Publicação , Humanos , Viés
17.
J Hand Surg Glob Online ; 5(6): 740-743, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38106928

RESUMO

Purpose: There is no consensus regarding optimal closure for trigger finger release (TFR) surgery. The purpose of this study was to compare the number of postoperative visits and complications following TFR closure with nonabsorbable sutures versus those following TFR closure with absorbable sutures and skin glue. The hypothesis was that wound closure with absorbable sutures and glue will result in fewer postoperative visits, while having similar complication rates as that with nonabsorbable sutures. Methods: A retrospective review identified all patients undergoing open TFR over a 3-year period performed by two hand surgery fellowship-trained hand surgeons who adhered to an identical surgical protocol except for incisional closure. Patients were divided into two groups: a control group with nonabsorbable 4-0 monofilament sutures requiring removal ("suture" group) and a study group with buried absorbable 4-0 monofilament sutures not requiring removal as well as skin glue ("glue" group). The data collected included age, sex, number of postoperative visits, wound complications, infections, antibiotic use, prescribed hand therapy, hospital admission, and reoperation. Results: A total of 305 open TFR surgeries in 278 patients were included in the study, with 155 digits in the "suture" group and 150 in the "glue" group. Both groups were similar in age and sex. The "suture" group had significantly more total postoperative visits (185 vs 42, respectively, P < .001) and postoperative visits within the first 2 weeks (155 vs 10, respectively, P < .001) than the "glue" group. Additional postoperative visits beyond 2 weeks of surgery were similar between the two groups. Three (1.9%) patients in the "suture" group and two (1.3%) patients in the "glue" group developed a superficial surgical site infection within 30 days after surgery. Neither had deep infections requiring hospitalization or reoperation. Both groups required similar rates of postoperative hand therapy. Conclusions: Absorbable sutures afford fewer postoperative visits while having a similar complication rate as nonabsorbable sutures requiring removal. Type of study/level of evidence: Therapeutic IV.

19.
Eur J Cancer ; 192: 113245, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37598656

RESUMO

PURPOSE: In the INTRIGUE trial, ripretinib showed no significant difference versus sunitinib in progression-free survival for patients with advanced gastrointestinal stromal tumour (GIST) previously treated with imatinib. We compared the impact of these treatments on health-related quality of life (HRQoL). PATIENTS AND METHODS: Patients were randomised 1:1 to once-daily ripretinib 150 mg or once-daily sunitinib 50 mg (4 weeks on/2 weeks off). Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer-30 (EORTC QLQ-C30) questionnaire at day (D)1, and D29 of all cycles until treatment discontinuation. Change from baseline was calculated. Time without symptoms or toxicity (TWiST) was estimated as the mean number of days without progression, death, or grade ≥3 treatment-emergent adverse events per patient over 1 year of follow-up. RESULTS: Questionnaire completion at baseline was 88.1% (199/226) for ripretinib and 87.7% (199/227) for sunitinib and remained high for enrolled patients throughout treatment. Patients receiving sunitinib demonstrated within-cycle variation in self-reported HRQoL, corresponding to the on/off dosing regimen. Patients receiving ripretinib reported better HRQoL at D29 assessments than patients receiving sunitinib on all scales except constipation. HRQoL was similar between treatments at D1 assessments, following 2 weeks without treatment for sunitinib patients. TWiST was greater for ripretinib patients (173 versus 126 days). CONCLUSION: Patients receiving ripretinib experienced better HRQoL than patients receiving sunitinib during the dosing period and similar HRQoL to patients who had not received sunitinib for 2 weeks for all QLQ-C30 domains except constipation. Ripretinib may provide clinically meaningful benefit to patients with advanced GIST previously treated with imatinib.


Assuntos
Tumores do Estroma Gastrointestinal , Humanos , Sunitinibe/efeitos adversos , Tumores do Estroma Gastrointestinal/tratamento farmacológico , Mesilato de Imatinib/efeitos adversos , Qualidade de Vida , Medidas de Resultados Relatados pelo Paciente , Constipação Intestinal/induzido quimicamente
20.
Pediatr Rheumatol Online J ; 21(1): 76, 2023 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-37525200

RESUMO

BACKGROUND AND OBJECTIVE: Evidence for the treatment of multisystem inflammatory syndrome in children (MIS-C) is lacking. Anakinra, which targets IL-1-mediated inflammation, is reserved for refractory cases of MIS-C; however, its use in the treatment of MIS-C is not clearly established. PATIENTS AND METHODS: To examine a role for anakinra in MIS-C, we performed a single center observational cohort study of all MIS-C patients diagnosed at our children's hospital from May 15 to November 15, 2020. Demographics, clinical features, diagnostic testing, and cardiac function parameters were compared between MIS-C patients treated with intravenous immunoglobulin (IVIG) monotherapy and IVIG with anakinra (IVIG + anakinra). RESULTS: Among 46 patients with confirmed MIS-C, 32 (70%) were in the IVIG + anakinra group, of which 9 (28%) were also given corticosteroids (CS). No patients were treated with anakinra alone. MIS-C patients in the IVIG + anakinra group were enriched in a CV shock phenotype (p = 0.02), and those with CV shock were treated with higher doses of anakinra for a longer duration. Furthermore, MIS-C patients in the IVIG + anakinra group exhibited improvements in fever and cardiac function with or without CS. No significant adverse events were observed, and no differences in IL-1ß levels were found among MIS-C patients in the IVIG + anakinra group. CONCLUSIONS: Anakinra treatment, which was co-administered with IVIG primarily in patients with severe MIS-C, was associated with improvements in fever and cardiac function, and demonstrated a favorable side-effect profile. These findings suggest a role for adjunctive anakinra in the treatment of severe MIS-C.


Assuntos
COVID-19 , Proteína Antagonista do Receptor de Interleucina 1 , Humanos , Proteína Antagonista do Receptor de Interleucina 1/efeitos adversos , Imunoglobulinas Intravenosas/efeitos adversos , Síndrome de Resposta Inflamatória Sistêmica/tratamento farmacológico , Febre
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