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1.
J Bone Joint Surg Am ; 105(Suppl 1): 10-14, 2023 07 19.
Artículo en Inglés | MEDLINE | ID: mdl-37466574

RESUMEN

BACKGROUND: Opioid prescribing in the context of orthopaedic surgery has been recognized as having a critical role in the ongoing opioid epidemic. Given the negative consequences of chronic opioid use, great efforts have been made to reduce both preoperative and postoperative opioid prescribing and consumption in orthopaedic surgery. Musculoskeletal oncology patients represent a unique subset of patients, and there is a paucity of data evaluating perioperative opioid consumption and the risk for chronic use. The objective of the present study was to describe opioid consumption patterns and evaluate predictors of chronic opioid use in musculoskeletal oncology patients undergoing limb-salvage surgery and endoprosthetic reconstruction. METHODS: The present study was a secondary analysis of the recently completed PARITY (Prophylactic Antibiotic Regimens in Tumor Surgery) trial and included musculoskeletal oncology patients undergoing lower-extremity endoprosthetic reconstruction. The primary outcome was the incidence of opioid consumption over the study period. A multivariate binomial logistic regression model was created to explore predictors of chronic opioid consumption at 1 year postoperatively. RESULTS: Overall, 193 (33.6%) of 575 patients were consuming opioids preoperatively. Postoperatively, the number of patients consuming opioids was 82 (16.7%) of 492 at 3 months, 37 (8%) of 460 patients at 6 months, and 28 (6.6%) of 425 patients at 1 year. Of patients consuming opioids preoperatively, 12 (10.2%) of 118 had continued to consume opioids at 1 year postoperatively. The adjusted regression model found that only surgery for metastatic bone disease was predictive of chronic opioid use (odds ratio, 4.90; 95% confidence interval, 1.54 to 15.40; p = 0.007). Preoperative opioid consumption, older age, sex, longer surgical times, reoperation rates, and country of origin were not predictive of chronic use. CONCLUSIONS: Despite a high prevalence of preoperative opioid use, an invasive surgical procedure, and a high rate of reoperation, few patients had continued to consume opioids at 1 year postoperatively. The presence of metastases was associated with chronic opioid use. These results are a substantial departure from the existing orthopaedic literature evaluating other patient populations, and they suggest that specific prescribing guidelines are warranted for musculoskeletal oncology patients. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Neoplasias , Trastornos Relacionados con Opioides , Humanos , Analgésicos Opioides/uso terapéutico , Trastornos Relacionados con Opioides/prevención & control , Dolor Postoperatorio/etiología , Pautas de la Práctica en Medicina , Estudios Retrospectivos
2.
J Bone Joint Surg Am ; 105(Suppl 1): 22-28, 2023 07 19.
Artículo en Inglés | MEDLINE | ID: mdl-37466576

RESUMEN

BACKGROUND: Although the treatment of lower-extremity bone tumors is similar between adult and pediatric patients, differences in outcomes are unknown. Outcomes for lower-extremity oncologic reconstruction have been challenging to study because of the low incidence and heterogeneity in disease and patient characteristics. The PARITY (Prophylactic Antibiotic Regimens in Tumor Surgery) trial is the largest prospective data set assembled to date for patients with lower-extremity bone tumors and presents an opportunity to investigate differences in outcomes between these groups. METHODS: Patient details were acquired from the prospectively collected PARITY trial database. The 1993 Musculoskeletal Tumor Society (MSTS-93) and Toronto Extremity Salvage Score (TESS) questionnaires were administered preoperatively and at 3, 6, and 12 months postoperatively. Continuous outcomes were compared between groups with use of the Student t test, and dichotomous outcomes were compared with use of the Pearson chi-square test. RESULTS: A total of 150 pediatric and 447 adult patients were included. Pediatric patients were more likely than adult patients to have a primary bone tumor (146 of 150 compared with 287 of 447, respectively; p < 0.001) and to have received adjuvant chemotherapy (140 of 149 compared with 195 of 441, respectively; p < 0.001). Reoperation rates were not significantly different between age groups (45 of 105 pediatric patients compared with 106 of 341 adult patients; p ≤ 0.13). Pediatric patients had higher mean MSTS-93 scores (64.7 compared with 53.8 among adult patients; p < 0.001) and TESS (73.4 compared with 60.4 among adult patients; p < 0.001) at baseline, which continued to 1 year postoperatively (mean MSTS-93 score, 82.0 compared with 76.8 among adult patients; p = 0.02; mean TESS, 87.7 compared with 78.6 among adult patients; p < 0.001). Despite the differences in outcomes between cohorts, pediatric and adult patients demonstrated similar improvement in MSTS-93 scores (mean difference, 17.4 and 20.0, respectively; p = 0.48) and TESS (mean difference, 14.1 and 14.7, respectively; p = 0.83) from baseline to 1 year postoperatively. CONCLUSIONS: Pediatric patients had significantly better functional outcomes than adult patients at nearly all of the included postoperative time points; however, pediatric and adult patients showed similar mean improvement in these outcomes at 1 year postoperatively. These findings may be utilized to help guide the postoperative expectations of patients undergoing oncologic reconstruction. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Neoplasias Óseas , Procedimientos de Cirugía Plástica , Adulto , Niño , Humanos , Neoplasias Óseas/cirugía , Neoplasias Óseas/patología , Recuperación del Miembro , Extremidad Inferior/cirugía , Estudios Prospectivos , Resultado del Tratamiento
3.
J Bone Joint Surg Am ; 105(Suppl 1): 41-48, 2023 07 19.
Artículo en Inglés | MEDLINE | ID: mdl-37466579

RESUMEN

BACKGROUND: The specific risk factors for surgical site infection (SSI) in orthopaedic oncology patients undergoing endoprosthetic reconstruction have not previously been evaluated in a large prospective cohort. In the current study, we aimed to define patient- and procedure-specific risk factors for SSI in patients who underwent surgical excision and endoprosthetic reconstruction for lower-extremity bone or soft-tissue tumors using the prospectively collected data of the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. METHODS: PARITY was a multicenter, blinded, randomized controlled trial with a parallel 2-arm design that aimed to determine the effect of a long duration (5 days) versus short duration (24 hours) of postoperative prophylactic antibiotics on the rate of SSI in patients undergoing surgical excision and endoprosthetic reconstruction of the femur or tibia. In this secondary analysis of the PARITY data, a multivariate Cox proportional hazards regression model was constructed to explore predictors of SSI within 1 year postoperatively. RESULTS: A total of 96 (15.9%) of the 604 patients experienced an SSI. Of the 23 variables analyzed in the univariate analysis, 4 variables achieved significance: preoperative diagnosis, operative time, volume of muscle excised, and hospital length of stay (LOS). However, only hospital LOS was found to be independently predictive of SSI in the multivariate regression analysis (hazard ratio per day = 1.03; 95% confidence interval = 1.01 to 1.05; p < 0.001). An omnibus test of model coefficients demonstrated that the model showed significant improvement over the null model (χ2 = 78.04; p < 0.001). No multicollinearity was found. CONCLUSIONS: This secondary analysis of the PARITY study data found that the only independent risk factor for SSI on multivariate analysis was hospital LOS. It may therefore be reasonable for clinicians to consider streamlined discharge plans for orthopaedic oncology patients to potentially reduce the risk of SSI. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Neoplasias , Infección de la Herida Quirúrgica , Humanos , Extremidad Inferior , Estudios Prospectivos , Factores de Riesgo , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/prevención & control
4.
J Bone Joint Surg Am ; 105(Suppl 1): 73-78, 2023 07 19.
Artículo en Inglés | MEDLINE | ID: mdl-37466583

RESUMEN

BACKGROUND: The detection of a surgical site infection (SSI) in patients with metal implants requires a high degree of clinical acumen. The inherent subjectivity of SSI diagnosis poses a challenge in the design of surgical trials because this subjectivity raises concern for outcome assessment bias. Central Adjudication Committees (CACs) are often utilized to minimize the variability in outcome assessment. Little research has been done to determine the reliability of outcome assessment in trials utilizing a CAC. In the present study, we determined the agreement between the study CAC and the clinical site investigators for the primary and secondary outcome assessments. METHODS: The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial was a multicenter, blinded, parallel 2-arm, randomized controlled trial that aimed to determine the effect of a 5-day versus 1-day postoperative prophylactic antibiotic regimen on the rate of SSI in patients undergoing surgical excision of tumors in the femur or tibia. The blinded PARITY CAC adjudicated all primary and secondary outcomes identified during the 1-year study follow-up. In the present secondary analysis, the Cohen kappa statistic was utilized to determine the level of agreement. RESULTS: The primary outcome of SSI diagnosis demonstrated a substantial level of agreement between the CAC and the site investigators (0.699; 95% confidence interval [CI], 0.595 to 0.803]). Categorization of the SSI (i.e., superficial, deep, or organ space) showed moderate agreement (0.470; 95% CI, 0.382 to 0.558). Secondary outcomes such as the types of reoperations and the indication for reoperation typically showed substantial to almost perfect agreement, whereas antibiotic-related complications showed fair agreement (0.241; 95% CI, 0.000 to 0.474). CONCLUSIONS: Although there was a substantial level of agreement between the PARITY CAC and site investigators on the diagnosis of an SSI, as well as typically at least substantial agreement on the causes and types of reoperations, there was less agreement regarding the type of SSI and the occurrence of an antibiotic-related complication. Therefore, the CAC appears to have provided value when adjudicating the depth of infection and when determining the causality of medical complications associated with antibiotics. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Antibacterianos , Infección de la Herida Quirúrgica , Humanos , Antibacterianos/uso terapéutico , Reoperación , Reproducibilidad de los Resultados , Infección de la Herida Quirúrgica/prevención & control , Infección de la Herida Quirúrgica/epidemiología
5.
J Arthroplasty ; 38(11): 2204-2209, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37286053

RESUMEN

BACKGROUND: The influence of socioeconomic status on outcomes following total joint arthroplasty (TJA) in the Canadian single-payer healthcare system is yet to be elucidated. The objective of the present study was to evaluate the impact of socioeconomic status on TJA outcomes. METHODS: This was a retrospective review of 7,304 consecutive TJA (4,456 knees and 2,848 hips) performed between January 1, 2001 and December 31, 2019. The primary independent variable was the average census marginalization index. The primary dependent variable was functional outcome scores. RESULTS: The most marginalized patients in both the hip and knee cohorts had significantly worse preoperative and postoperative functional scores. Patients in the most marginalized quintile (V) showed a decreased odds of achieving a minimal important difference in functional scores at 1-year follow-up (odds ratio [OR] 0.44; 95% confidence interval [CI] [0.20, 0.97], P = .043). Patients in the knee cohort in the most marginalized quintiles (IV and V) had increased odds of being discharged to an inpatient facility with an OR of 2.07 (95% CI [1.06, 4.04], P = .033) and OR of 2.57 (95% CI [1.26, 5.22], P = .009), respectively. Patients in the hip cohort in V quintile (most marginalized) had increased odds of being discharged to an inpatient facility with an OR of 2.24 (95% CI [1.02, 4.96], P = .046). CONCLUSION: Despite being a part of the Canadian universal single-payer healthcare system, the most marginalized patients had worse preoperative and postoperative function, and had increased odds of being discharged to another inpatient facility. LEVEL OF EVIDENCE: IV.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Humanos , Alta del Paciente , Atención de Salud Universal , Canadá , Estudios Retrospectivos , Factores de Riesgo , Complicaciones Posoperatorias
6.
Hip Int ; 33(5): 850-857, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35848126

RESUMEN

BACKGROUND: The use of quadratus lumborum nerve blocks (QLB) for pain control following elective total hip arthroplasty (THA) has increased substantially in recent years. The objective of this systematic review and meta-analysis was to compare outcomes from randomised controlled trials (RCTs) utilising QLBs following elective THA. METHODS: MEDLINE, EMBASE, and Cochrane databases were searched for RCTs perioperative QLBs for THA. Quantitative synthesis was conducted for pain scores, opioid consumption and adverse events. RESULTS: A total of 7 RCTs with 429 patients undergoing THA were included. No differences in pain scores were demonstrated between QLBs and control interventions. Subgroup analysis demonstrated no differences between QLBs and sham procedures or active comparators. No differences in postoperative opioid consumption between QLB and control interventions was found. In trials reporting adverse events, they were rare and similar between groups. Overall, the certainty of the evidence was graded as low or very low. CONCLUSIONS: The current literature suggests that a QLB for THA does not reduce pain or opioid consumption compared to sham or active comparators.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Bloqueo Nervioso , Humanos , Artroplastia de Reemplazo de Cadera/efectos adversos , Analgésicos Opioides/uso terapéutico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Bloqueo Nervioso/métodos , Manejo del Dolor/métodos
7.
Hip Int ; 33(4): 576-582, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35848135

RESUMEN

PURPOSE: Same-day home (SDH) discharge in total joint arthroplasty (TJA) has increased in popularity in recent years. The objective of this study was to evaluate the causes and predictors of failed discharges in planned SDH patients. METHODS: A consecutive cohort of patients who underwent total knee (TKA) or total hip arthroplasty (THA) that were scheduled for SDH discharge between 01 April 2019 and 31 March 2021 were retrospectively reviewed. Patient demographics, causes of failed discharge, perioperative variables, 30-day readmissions and 6-month reoperation rates were collected. Multivariate regression analysis was undertaken to identify independent predictors of failed discharge. RESULTS: The cohort consisted of 527 consecutive patients. 101 (19%) patients failed SDH discharge. The leading causes were postoperative hypotension (20%) and patients who were ineligible for the SDH pathway (19%). 2 individual surgeons, later operative start time (OR 1.3; 95% CI, 1.15-1.55; p = 0.001), ASA class IV (OR 3.4; 95% CI, 1.4-8.2; p = 0.006) and undergoing a THA (OR 2.0; 95% CI, 1.2-3.1, p = 0.004) were independent predictors of failed SDH discharge. No differences in age, BMI, gender, surgical approach or type of anaesthetic were found (p > 0.05). The 30-day readmission or 6-month reoperation were similar between groups (p > 0.05). CONCLUSIONS: Hypotension and inappropriate patient selection were the leading causes of failed SDH discharge. Significant variability existed between individual surgeons failed discharge rates. Patients undergoing a THA, classified as ASA IV or had a later operative start time were all more likely to fail SDH discharge.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Humanos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Artroplastia de Reemplazo de Cadera/efectos adversos , Factores de Riesgo , Alta del Paciente , Estudios Retrospectivos , Canadá , Complicaciones Posoperatorias/etiología , Tiempo de Internación
8.
Curr Oncol ; 29(10): 7598-7606, 2022 10 13.
Artículo en Inglés | MEDLINE | ID: mdl-36290877

RESUMEN

BACKGROUND AND OBJECTIVES: Functional outcomes are important for oncology patients undergoing lower extremity reconstruction. The objective of the current study was to describe patient reported function after surgery and identify predictors of postoperative function in musculoskeletal oncology patients undergoing lower extremity endoprosthetic reconstruction. METHODS: We performed a cohort study with functional outcome data from the recently completed Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. We utilized the 100-point Toronto Extremity Salvage Score (TESS), which was administered pre-operatively and at 3, 6 and 12 months post-operatively. Higher scores indicate better physical functioning, and the minimally important difference is 11 points. We calculated mean functional scores at each timepoint after surgery and developed a logistic regression model to explore predictors of failure to achieve excellent post-operative function (TESS ≥ 80) at 1 year after surgery. RESULTS: The 555 patients included in our cohort showed important functional improvement from pre-surgery to 1 year post-surgery (mean difference 14.9 points, 95%CI 12.2 to 17.6; p < 0.001) and 64% achieved excellent post-operative function. Our adjusted regression model found that poor (TESS 0-39) pre-operative function (odds ratio [OR] 3.3, 95%CI 1.6 to 6.6); absolute risk [AR] 24%, 95%CI 8% to 41.2%), older age (OR per 10-year increase from age 12, 1.32, 95%CI 1.17, 1.49; AR 4.5%, 95%CI 2.4% to 6.6%), and patients undergoing reconstruction for soft-tissue sarcomas (OR 2.3, 95%CI 1.03 to 5.01; AR 15.3%, 95%CI 0.4% to 34.4%), were associated with higher odds of failing to achieve an excellent functional outcome at 1-year follow-up. Patients undergoing reconstruction for giant cell tumors were more likely to achieve an excellent functional outcome post-operatively (OR 0.40, 95%CI 0.17 to 0.95; AR -9.9%, 95%CI -14.4% to -0.7%). CONCLUSIONS: The majority of patients with tumors of the lower extremity undergoing endoprosthetic reconstruction achieved excellent function at 1 year after surgery. Older age, poor pre-operative function, and endoprosthetic reconstruction for soft tissue sarcomas were associated with worse outcomes; reconstruction for giant cell tumors was associated with better post-operative function. LEVEL OF EVIDENCE: Therapeutic Level IV.


Asunto(s)
Tumores de Células Gigantes , Sarcoma , Neoplasias de los Tejidos Blandos , Humanos , Recuperación del Miembro , Estudios de Cohortes , Resultado del Tratamiento , Sarcoma/cirugía , Sarcoma/patología , Extremidad Inferior/cirugía , Extremidad Inferior/patología , Tumores de Células Gigantes/cirugía , Antibacterianos
9.
Bone Joint J ; 104-B(10): 1168-1173, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36177639

RESUMEN

AIMS: The aim of this study was to determine the prevalence and impact of tourniquet use in patients undergoing limb salvage surgery with endoprosthetic reconstruction for a tumour around the knee. METHODS: We retrieved data from the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial; specifically, differences in baseline characteristics, surgical details, and postoperative functional outcomes between patients who had undergone surgery under tourniquet and those who had not. A linear regression model was created to evaluate the impact of tourniquet use on postoperative Toronto Extremity Salvage Scores (TESSs) while controlling for confounding variables. A negative-binomial regression model was constructed to explore predictors of postoperative length of stay (LOS). RESULTS: Of the 604 patients enrolled in the PARITY trial, 421 had tumours around the knee joint, of whom 225 (53%) underwent surgery under tourniquet. The tourniquet group was younger (p = 0.014), more likely to undergo surgery for a tumour of the tibia, and had shorter operating times by a mean of 50 minutes (95% confidence interval 30 to 72; p < 0.001). The adjusted linear regression model found that the use of a tourniquet, a shorter operating time, and a higher baseline TESS independently predicted better function at both three- and six-month follow-up. The negative-binomial regression model showed that tourniquet use, shorter operating time, younger age, and intraoperative tranexamic acid administration independently predicted a shorter LOS in hospital. CONCLUSION: The results of this study show that in patients undergoing resection of a tumour around the knee and endoprosthetic reconstruction, the use of an intraoperative tourniquet is associated with a shorter operating time, a reduced length of stay in hospital, and a better early functional outcome.Cite this article: Bone Joint J 2022;104-B(10):1168-1173.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Neoplasias , Ácido Tranexámico , Antibacterianos , Artroplastia de Reemplazo de Rodilla/métodos , Humanos , Articulación de la Rodilla/cirugía , Neoplasias/cirugía , Torniquetes
12.
J Bone Joint Surg Am ; 104(18): 1659-1666, 2022 09 21.
Artículo en Inglés | MEDLINE | ID: mdl-35809001

RESUMEN

BACKGROUND: Functional outcomes are commonly reported in studies of patients undergoing limb-salvage surgery for the treatment of musculoskeletal tumors; however, interpretation requires knowledge of the smallest amount of improvement that is important to patients: the minimally important difference (MID). We established the MIDs for the Musculoskeletal Tumor Society Rating Scale-93 (MSTS-93) and Toronto Extremity Salvage Score (TESS) for patients with bone tumors undergoing lower-extremity endoprosthetic reconstruction. METHODS: This study was a secondary analysis of the recently completed PARITY (Prophylactic Antibiotic Regimens in Tumor Surgery) study. We used MSTS-93 and TESS data from this trial to calculate (1) the anchor-based MIDs with use of an overall function scale and a receiver operating characteristic curve analysis and (2) the distribution-based MIDs based on one-half of the standard deviation of the change scores from baseline to the 12-month follow-up and one-half the standard deviation of baseline scores. RESULTS: Five hundred and ninety-one patients were available for analysis. The Pearson correlation coefficients for the association between changes in MSTS-93 and TESS scores and changes in the external anchor scores were 0.71 and 0.57, indicating high and moderate correlations. The anchor-based MID was 12 points for the MSTS-93 and 11 points for the TESS. Distribution-based MIDs were larger: 16 to 17 points for the MSTS-93 and 14 points for the TESS. CONCLUSIONS: Two methods for determining MIDs for the MSTS-93 and TESS for patients undergoing lower-extremity endoprosthetic reconstruction for musculoskeletal tumors yielded quantitatively different results. We suggest the use of anchor-based MIDs, which are grounded in changes in functional status that are meaningful to patients. These thresholds can facilitate responder analyses and indicate whether significant differences following interventions are clinically important to patients. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Neoplasias Óseas , Sistema Musculoesquelético , Antibacterianos , Neoplasias Óseas/cirugía , Humanos , Recuperación del Miembro/métodos , Extremidad Inferior/cirugía , Sistema Musculoesquelético/cirugía
13.
Ann Surg Oncol ; 29(12): 7312-7317, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-35864365

RESUMEN

INTRODUCTION: Sarcoma patients undergoing surgical resection and endoprosthetic reconstruction often receive neoadjuvant chemotherapy (NACT). The objective of the current study was to determine if the timing of NACT impacts the rates of surgical site infections (SSI) and reoperations. METHODS: This study was a secondary analysis of the recently published Prophylactic Antibiotic Regimens in Tumor Surgery trial. Patients who underwent NACT, tumor resection, and endoprosthetic reconstruction for a bone or soft tissue sarcoma were included. Multivariate Cox proportional hazards regression models were created to evaluate if NACT timing was predictive of SSI or reoperations. RESULTS: Overall, 216 patients from 39 clinical sites were included in the analysis. The most common diagnosis was osteosarcoma (75%), followed by Ewing's sarcoma (16%). The median time from completion of NACT to surgery was 24 days (interquartile range 15-42 days). Eighty-five (39%) patients underwent surgery within 3 weeks of completing NACT, 78 (36%) underwent surgery 3-6 weeks after completing NACT, and 53 (22%) patients underwent surgery > 6 weeks after completion of NACT. The timing of NACT did not impact SSI rates or reoperation rates. Longer operative time was an independent predictor of both SSI [hazard ratio (HR) per hour of 1.21, 95% confidence interval (CI) 1.07-1.40; p = 0.002] and reoperation rates (HR of 1.15 per hour, 95% CI 1.03-1.28; p = 0.014). CONCLUSION: The timing of surgery following NACT varied considerably. Chemotherapy timing did not impact SSI or reoperations in patients undergoing surgical resection and endoprosthetic reconstruction in sarcoma patients.


Asunto(s)
Neoplasias Óseas , Sarcoma de Ewing , Neoplasias de los Tejidos Blandos , Antibacterianos , Neoplasias Óseas/tratamiento farmacológico , Neoplasias Óseas/patología , Neoplasias Óseas/cirugía , Quimioterapia Adyuvante , Humanos , Extremidad Inferior/patología , Terapia Neoadyuvante , Estudios Retrospectivos
14.
Medicines (Basel) ; 9(3)2022 Feb 28.
Artículo en Inglés | MEDLINE | ID: mdl-35323717

RESUMEN

Background: There has been substantial interest from the pharmaceutical industry to study and develop new biologic agents. Previous studies outside of the biologics field have demonstrated that industry funding has the potential to impact the design and findings of clinical trials. The objective of this study was to evaluate the impact of industry funding on randomized controlled trials (RCTs) that investigated the efficacy of biologic therapies. Methods: A review of all RCTs involving biologic therapies in top impact factor medical journals from January 2018 to December 2020 was performed. The relationship between industry funding and the presence of statistically significant primary outcomes and the use of active comparators were analyzed. Results: Among the 157 RCTs included, 120 (76%) were industry funded and 37 (24%) declared no industry funding. Industry-funded studies were significantly more likely to report a statistically significant positive primary outcome compared to studies without industry funding (85% vs. 67%, χ2 = 5.867, p = 0.015) and were significantly more likely to utilize placebo or no comparator than non-industry-funded trials (78% vs. 49%, χ2 = 4.430, p = 0.035). Conclusions: Industry-funded trials investigating biologic therapies are more likely to yield statistically significant positive outcomes and use placebo comparators when compared to non-industry-funded biologic therapy trials in high-impact medical journals.

15.
J Arthroplasty ; 37(2): 298-302, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34627955

RESUMEN

BACKGROUND: Current literature suggests that 8%-35% of patients undergoing total hip arthroplasty (THA) undergo a subsequent contralateral THA. This study aims to determine if functional outcomes after primary THA predict outcomes in the subsequent primary THA of the contralateral side. METHODS: A retrospective cohort of patients undergoing staged bilateral primary THA was reviewed. The Oxford Hip Score (OHS) was utilized as the functional outcome measurement tool and was assessed preoperatively and at one year postoperatively. The minimal clinically important difference (MCID) was assessed. Based on the first-side THA one-year outcomes, the odds of maintaining an MCID, or not, for the second-side THA were determined. RESULTS: The study cohort consisted of 551 patients and 1102 primary THAs. The average postoperative OHSs were similar after the first and second THA. Patients achieving the MCID with the first-side surgery were 2.6 times (95% confidence interval 1.0 to 6.64, P = .04) more likely to achieve the MCID for the second-side surgery than patients failing to reach the MCID for their first-side surgery. After the first THA, 29 (5.3%) patients failed to reach the predefined MCID for the OHS compared with 54 (9.8%) patients undergoing their second THA (odds ratio: 1.96 [95% confidence interval: 1.23 to 3.1], χ2 = 8.14, P = .005). CONCLUSIONS: Functional outcomes after the first THA are predictive of functional outcomes of the second THA. Patients are more likely to achieve a clinically significant improvement after their first THA related to higher preoperative OHSs before the second THA.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Cadera/efectos adversos , Humanos , Diferencia Mínima Clínicamente Importante , Periodo Posoperatorio , Estudios Retrospectivos , Resultado del Tratamiento
16.
Curr Oncol ; 28(5): 3748-3757, 2021 09 28.
Artículo en Inglés | MEDLINE | ID: mdl-34677238

RESUMEN

The proximal femur is a common location for the development of bony metastatic disease. Metastatic bone disease in this location can cause debilitating pain, pathologic fractures, reduced quality of life, anemia or hypercalcemia. A thorough history, physical examination and preoperative investigations are required to ensure accurate diagnosis and prognosis. The goals of surgical management is to provide pain relief and return to function with a construct that provides stability to allow for immediate weightbearing. Current surgical treatment options include intramedullary nailing, hemiarthroplasty or total hip arthroplasty and endoprosthetic reconstructions. Oligometastatic renal cell carcinoma must be given special consideration as tumor resection and reconstruction has survival benefit. Both tumor and patient characteristics must be taken into account before deciding on the appropriate surgical intervention.


Asunto(s)
Neoplasias Óseas , Calidad de Vida , Neoplasias Óseas/cirugía , Fémur , Humanos , Estudios Retrospectivos , Resultado del Tratamiento
17.
Curr Oncol ; 28(5): 3771-3794, 2021 09 28.
Artículo en Inglés | MEDLINE | ID: mdl-34677240

RESUMEN

AIM: The aim of this study was to systematically assess the risk of bias in osteosarcoma and Ewing's sarcoma (ES) randomized controlled trials (RCT) and to examine the relationships between bias and conflict of interest/industry sponsorship. METHODS: An OVID-MEDLINE search was performed (1976-2019). Using the Cochrane Collaboration guidelines, two reviewers independently assessed the prevalence of risk of bias in different RCT design domains. The relationship between conflicts of interest and industry funding with the frequency of bias was examined. RESULTS: 73 RCTs met inclusion criteria. Prevalence of low-risk bias domains was 47.3%, unclear-risk domains 47.8%, and 4.9% of the domains had a high-risk of bias. Domains with the highest risk of bias were blinding of participants/personnel and outcome assessors, followed by randomization and allocation concealment. Overtime, frequency of unclear-risk of bias domains decreased (χ2 = 5.32, p = 0.02), whilst low and high-risk domains increased (χ2 = 8.13, p = 0.004). Studies with conflicts of interest and industry sponsorships were 4.2 and 3.1 times more likely to have design domains with a high-risk of bias (p < 0.05). CONCLUSION: This study demonstrates that sources of potential bias are prevalent in both osteosarcoma and ES RCTs. Studies with financial conflicts of interest and industry sponsors were significantly more likely to have domains with a high-risk of bias. Improvements in reporting and adherence to proper methodology will reduce the risk of bias and improve the validity of the results of RCTs in osteosarcoma and ES.


Asunto(s)
Sarcoma de Ewing , Sesgo , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Sarcoma de Ewing/epidemiología
18.
Curr Oncol ; 28(3): 1909-1920, 2021 05 19.
Artículo en Inglés | MEDLINE | ID: mdl-34069748

RESUMEN

Synovial sarcomas (SS) represent a unique subset of soft tissue sarcomas (STS) and account for 5-10% of all STS. Synovial sarcoma differs from other STS by the relatively young age at diagnosis and clinical presentation. Synovial sarcomas have unique genomic characteristics and are driven by a pathognomonic t(X;18) chromosomal translocation and subsequent formation of the SS18:SSX fusion oncogenes. Similar to other STS, diagnosis can be obtained from a combination of history, physical examination, magnetic resonance imaging, biopsy and subsequent pathology, immunohistochemistry and molecular analysis. Increasing size, age and tumor grade have been demonstrated to be negative predictive factors for both local disease recurrence and metastasis. Wide surgical excision remains the standard of care for definitive treatment with adjuvant radiation utilized for larger and deeper lesions. There remains controversy surrounding the role of chemotherapy in the treatment of SS and there appears to be survival benefit in certain populations. As the understanding of the molecular and immunologic characteristics of SS evolve, several potential systematic therapies have been proposed.


Asunto(s)
Sarcoma Sinovial , Neoplasias de los Tejidos Blandos , Humanos , Recurrencia Local de Neoplasia , Proteínas de Fusión Oncogénica/genética , Sarcoma Sinovial/diagnóstico , Sarcoma Sinovial/genética , Sarcoma Sinovial/terapia , Translocación Genética
19.
J Arthroplasty ; 36(6): 2219-2222, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33648843

RESUMEN

BACKGROUND: The American Association of Hip and Knee Surgeons (AAHKS) Annual Scientific Meeting is a leading forum for the presentation and dissemination of research regarding the management of hip and knee pathology making research presented at these meetings a representation of the current literature in the field. The purpose of this study was to quantify the level of evidence of podium presentations presented at the AAHKS annual meeting from 2015 to 2019. METHODS: Two reviewers evaluated the abstracts for the available presentations. Basic science and biomechanical studies were excluded from the review. Economic studies that were not able to be evaluated based on the American Academy of Orthopedic Surgeon guidelines were also excluded. The two reviewers then independently evaluated each abstract and assigned a level of evidence (level I-V) based on the American Academy of Orthopedic Surgeon classification scheme. RESULTS: A total of 258 podium presentations were included. In total, 17 (7%) abstracts were graded level I evidence, 57 (22%) were graded level II, 85 (33%) were graded level III, and 98 (38%) were graded level IV (Table 1). There was a significant change in the distribution of the level of evidence of podium presentations over time (χ2 = 24.6, P = .02). The proportion of level I studies has increased between 2015 and 2019 (from 3.9% to 11.8%) with a concomitant decrease in level IV studies (from 42.3% to 21.6%) over that time period. CONCLUSIONS: There has been a significant improvement in the levels of evidence of podium presentations at the AAHKS Annual Meeting from 2015 to 2019.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Ortopedia , Cirujanos , Humanos , Rodilla , Articulación de la Rodilla , Sociedades Médicas , Estados Unidos/epidemiología
20.
J Arthroplasty ; 36(6): 1908-1914, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33648844

RESUMEN

BACKGROUND: The relationship among pain catastrophizing, emotional disorders, and total joint arthroplasty (TJA) outcomes is an emerging area of study. The purpose of this study is to examine the association of these factors with 1-year postoperative pain and functional outcomes. METHODS: A prospective cohort study of preoperative TJA patients using the Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale (HADS-A/HADS-D) was conducted. Postoperative outcomes included Visual Analog Scale (VAS) pain, Oxford, Harris Hip (HHS) and Knee Society (KSS) scores. Median regression was used to assess the pattern of relationship among preoperative clinically relevant catastrophizing (CRC) pain, abnormal HADS, and 1-year postoperative outcomes. RESULTS: We recruited 463 TJA patients, all of which completed 1-year follow-up. At 1 year, CRC-rumination (adjusted median difference 1; 95% confidence interval [CI] 0.31-1.69, P = .005) and abnormal HADS-A (adjusted median difference 1; 95% CI 0.36-1.64, P = .002) were predictors of VAS pain, CRC magnification a predictor of HHS/KSS (adjusted median difference 1.3; 95% CI 5.23-0.11, P = .041), and abnormal HADS-A a predictor of Oxford (adjusted median difference 3.68; 95% CI 1.38-5.99, P = .002). CRC patients demonstrated inferior VAS pain (P = .001), Oxford (P < .0001), and HHS/KSS (P = .025). Abnormal HADS patients demonstrated inferior postoperative VAS (HADS-A, P = .025; HADS-D, P = .030) and Oxford (HADS-A, P = .001; HADS-D, P = .030). However, patients with CRC experienced significant improvement in VAS, Oxford, and HHS/KSS (P < .05) from preoperative to 1 year. Similarly, patients with abnormal HADS showed significant improvement in VAS pain and HHS/KSS (P < .05). CONCLUSION: TJA patients who are anxious, depressed, or pain catastrophizing have inferior preoperative and postoperative pain and function. However, as compared to their preoperative status, clinically significant improvement can be expected following hip/knee arthroplasty.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Catastrofización , Ansiedad , Depresión , Humanos , Dolor Postoperatorio , Estudios Prospectivos , Resultado del Tratamiento
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