1.Radiographic and Clinical Outcomes of Transverse Process Hook Placement at the Proximal Thoracic Upper Instrumented Vertebra in Adult Spinal Deformity Surgery
Sang Hun LEE ; Micheal RAAD ; Andrew H. KIM ; David B. COHEN ; Khaled M. KEBAISH
Neurospine 2024;21(2):502-509
Objective:
Few studies have reported radiographic and clinical outcomes of transverse process hook (TPH) placement at the proximal thoracic upper instrumented vertebra (UIV) in adult spinal deformity (ASD) surgery. This study aims to investigate radiographic and clinical outcomes of TPH placement at the UIV for ASD surgery.
Methods:
This is a retrospective cohort of 56 patients with ASD (age, 59 ± 13 years; followup, 44 ± 19 months) from Johns Hopkins Hospital, who underwent long posterior spinal fusion to the proximal thoracic spine (T2–5). Visual analogue scale (VAS) for back pain, Oswestry Disability Index (ODI), 36-item Short Form health survey scores, thoracic kyphosis (TK), lumbar lordosis, sacral slope, pelvic tilt, pelvic incidence, proximal junctional kyphosis (PJK) angle, PJK incidence, pattern of PJK, grades of TPH dislodgement, revision surgery, and factors associated with high-grade TPH dislodgement were analyzed.
Results:
VAS for back pain and ODI values improved significantly from preoperatively to final follow-up. Mean change in PJK angle was 12° (range, 0.5°–43°). Twenty patients (36%) developed PJK, of whom 13 had compression fractures at 1 vertebra distal to the UIV (UIV–1). Final TPH position was stable in 42 patients (75%). In most patients (86%), TPH dislodgement did not progress after 6-month postoperative follow-up. Three patients (5.3%) underwent revision surgery to extend the fusion because of symptomatic PJK. Unstable TPH position was associated only with revision surgery and TK.
Conclusion
TPH placement at the proximal thoracic UIV for long fusion showed favorable clinical and radiographic outcomes in terms of the incidence of PJK and mean PJK angle at mean 44-month follow-up. TPHs placed in the proximal thoracic UIV were in stable position in 75% of patients. Compression fracture at UIV–1 was the most common pattern of PJK. PJK angle progression was greater in revision cases and in patients with greater preoperative thoracic kyphosis.
2.Radiographic and Clinical Outcomes of Transverse Process Hook Placement at the Proximal Thoracic Upper Instrumented Vertebra in Adult Spinal Deformity Surgery
Sang Hun LEE ; Micheal RAAD ; Andrew H. KIM ; David B. COHEN ; Khaled M. KEBAISH
Neurospine 2024;21(2):502-509
Objective:
Few studies have reported radiographic and clinical outcomes of transverse process hook (TPH) placement at the proximal thoracic upper instrumented vertebra (UIV) in adult spinal deformity (ASD) surgery. This study aims to investigate radiographic and clinical outcomes of TPH placement at the UIV for ASD surgery.
Methods:
This is a retrospective cohort of 56 patients with ASD (age, 59 ± 13 years; followup, 44 ± 19 months) from Johns Hopkins Hospital, who underwent long posterior spinal fusion to the proximal thoracic spine (T2–5). Visual analogue scale (VAS) for back pain, Oswestry Disability Index (ODI), 36-item Short Form health survey scores, thoracic kyphosis (TK), lumbar lordosis, sacral slope, pelvic tilt, pelvic incidence, proximal junctional kyphosis (PJK) angle, PJK incidence, pattern of PJK, grades of TPH dislodgement, revision surgery, and factors associated with high-grade TPH dislodgement were analyzed.
Results:
VAS for back pain and ODI values improved significantly from preoperatively to final follow-up. Mean change in PJK angle was 12° (range, 0.5°–43°). Twenty patients (36%) developed PJK, of whom 13 had compression fractures at 1 vertebra distal to the UIV (UIV–1). Final TPH position was stable in 42 patients (75%). In most patients (86%), TPH dislodgement did not progress after 6-month postoperative follow-up. Three patients (5.3%) underwent revision surgery to extend the fusion because of symptomatic PJK. Unstable TPH position was associated only with revision surgery and TK.
Conclusion
TPH placement at the proximal thoracic UIV for long fusion showed favorable clinical and radiographic outcomes in terms of the incidence of PJK and mean PJK angle at mean 44-month follow-up. TPHs placed in the proximal thoracic UIV were in stable position in 75% of patients. Compression fracture at UIV–1 was the most common pattern of PJK. PJK angle progression was greater in revision cases and in patients with greater preoperative thoracic kyphosis.
3.Radiographic and Clinical Outcomes of Transverse Process Hook Placement at the Proximal Thoracic Upper Instrumented Vertebra in Adult Spinal Deformity Surgery
Sang Hun LEE ; Micheal RAAD ; Andrew H. KIM ; David B. COHEN ; Khaled M. KEBAISH
Neurospine 2024;21(2):502-509
Objective:
Few studies have reported radiographic and clinical outcomes of transverse process hook (TPH) placement at the proximal thoracic upper instrumented vertebra (UIV) in adult spinal deformity (ASD) surgery. This study aims to investigate radiographic and clinical outcomes of TPH placement at the UIV for ASD surgery.
Methods:
This is a retrospective cohort of 56 patients with ASD (age, 59 ± 13 years; followup, 44 ± 19 months) from Johns Hopkins Hospital, who underwent long posterior spinal fusion to the proximal thoracic spine (T2–5). Visual analogue scale (VAS) for back pain, Oswestry Disability Index (ODI), 36-item Short Form health survey scores, thoracic kyphosis (TK), lumbar lordosis, sacral slope, pelvic tilt, pelvic incidence, proximal junctional kyphosis (PJK) angle, PJK incidence, pattern of PJK, grades of TPH dislodgement, revision surgery, and factors associated with high-grade TPH dislodgement were analyzed.
Results:
VAS for back pain and ODI values improved significantly from preoperatively to final follow-up. Mean change in PJK angle was 12° (range, 0.5°–43°). Twenty patients (36%) developed PJK, of whom 13 had compression fractures at 1 vertebra distal to the UIV (UIV–1). Final TPH position was stable in 42 patients (75%). In most patients (86%), TPH dislodgement did not progress after 6-month postoperative follow-up. Three patients (5.3%) underwent revision surgery to extend the fusion because of symptomatic PJK. Unstable TPH position was associated only with revision surgery and TK.
Conclusion
TPH placement at the proximal thoracic UIV for long fusion showed favorable clinical and radiographic outcomes in terms of the incidence of PJK and mean PJK angle at mean 44-month follow-up. TPHs placed in the proximal thoracic UIV were in stable position in 75% of patients. Compression fracture at UIV–1 was the most common pattern of PJK. PJK angle progression was greater in revision cases and in patients with greater preoperative thoracic kyphosis.
4.Clinical Trial Protocol for ROSELLA:a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer
Alexander B. OLAWAIYE ; Jae-Weon KIM ; Andrea BAGAMERI ; Erin BISHOP ; Anita CHUDECKA-GŁAZ ; Alix DEVAUX ; Laurence GLADIEFF ; Mary E. GORDINIER ; Jacob KORACH ; Michael E. MCCOLLUM ; Linda MILESHKIN ; Bradley J. MONK ; Shibani NICUM ; Angélica NOGUEIRA-RODRIGUES ; Ana OAKNIN ; David M. O’MALLEY ; Mauro ORLANDO ; Lyndah DREILING ; Iulia C. TUDOR ; Domenica LORUSSO
Journal of Gynecologic Oncology 2024;35(4):e111-
Background:
Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population.
Methods
ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18
5.Clinical Trial Protocol for ROSELLA:a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer
Alexander B. OLAWAIYE ; Jae-Weon KIM ; Andrea BAGAMERI ; Erin BISHOP ; Anita CHUDECKA-GŁAZ ; Alix DEVAUX ; Laurence GLADIEFF ; Mary E. GORDINIER ; Jacob KORACH ; Michael E. MCCOLLUM ; Linda MILESHKIN ; Bradley J. MONK ; Shibani NICUM ; Angélica NOGUEIRA-RODRIGUES ; Ana OAKNIN ; David M. O’MALLEY ; Mauro ORLANDO ; Lyndah DREILING ; Iulia C. TUDOR ; Domenica LORUSSO
Journal of Gynecologic Oncology 2024;35(4):e111-
Background:
Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population.
Methods
ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18
6.Radiographic and Clinical Outcomes of Transverse Process Hook Placement at the Proximal Thoracic Upper Instrumented Vertebra in Adult Spinal Deformity Surgery
Sang Hun LEE ; Micheal RAAD ; Andrew H. KIM ; David B. COHEN ; Khaled M. KEBAISH
Neurospine 2024;21(2):502-509
Objective:
Few studies have reported radiographic and clinical outcomes of transverse process hook (TPH) placement at the proximal thoracic upper instrumented vertebra (UIV) in adult spinal deformity (ASD) surgery. This study aims to investigate radiographic and clinical outcomes of TPH placement at the UIV for ASD surgery.
Methods:
This is a retrospective cohort of 56 patients with ASD (age, 59 ± 13 years; followup, 44 ± 19 months) from Johns Hopkins Hospital, who underwent long posterior spinal fusion to the proximal thoracic spine (T2–5). Visual analogue scale (VAS) for back pain, Oswestry Disability Index (ODI), 36-item Short Form health survey scores, thoracic kyphosis (TK), lumbar lordosis, sacral slope, pelvic tilt, pelvic incidence, proximal junctional kyphosis (PJK) angle, PJK incidence, pattern of PJK, grades of TPH dislodgement, revision surgery, and factors associated with high-grade TPH dislodgement were analyzed.
Results:
VAS for back pain and ODI values improved significantly from preoperatively to final follow-up. Mean change in PJK angle was 12° (range, 0.5°–43°). Twenty patients (36%) developed PJK, of whom 13 had compression fractures at 1 vertebra distal to the UIV (UIV–1). Final TPH position was stable in 42 patients (75%). In most patients (86%), TPH dislodgement did not progress after 6-month postoperative follow-up. Three patients (5.3%) underwent revision surgery to extend the fusion because of symptomatic PJK. Unstable TPH position was associated only with revision surgery and TK.
Conclusion
TPH placement at the proximal thoracic UIV for long fusion showed favorable clinical and radiographic outcomes in terms of the incidence of PJK and mean PJK angle at mean 44-month follow-up. TPHs placed in the proximal thoracic UIV were in stable position in 75% of patients. Compression fracture at UIV–1 was the most common pattern of PJK. PJK angle progression was greater in revision cases and in patients with greater preoperative thoracic kyphosis.
7.Clinical Trial Protocol for ROSELLA:a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer
Alexander B. OLAWAIYE ; Jae-Weon KIM ; Andrea BAGAMERI ; Erin BISHOP ; Anita CHUDECKA-GŁAZ ; Alix DEVAUX ; Laurence GLADIEFF ; Mary E. GORDINIER ; Jacob KORACH ; Michael E. MCCOLLUM ; Linda MILESHKIN ; Bradley J. MONK ; Shibani NICUM ; Angélica NOGUEIRA-RODRIGUES ; Ana OAKNIN ; David M. O’MALLEY ; Mauro ORLANDO ; Lyndah DREILING ; Iulia C. TUDOR ; Domenica LORUSSO
Journal of Gynecologic Oncology 2024;35(4):e111-
Background:
Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population.
Methods
ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18
8.Radiographic and Clinical Outcomes of Transverse Process Hook Placement at the Proximal Thoracic Upper Instrumented Vertebra in Adult Spinal Deformity Surgery
Sang Hun LEE ; Micheal RAAD ; Andrew H. KIM ; David B. COHEN ; Khaled M. KEBAISH
Neurospine 2024;21(2):502-509
Objective:
Few studies have reported radiographic and clinical outcomes of transverse process hook (TPH) placement at the proximal thoracic upper instrumented vertebra (UIV) in adult spinal deformity (ASD) surgery. This study aims to investigate radiographic and clinical outcomes of TPH placement at the UIV for ASD surgery.
Methods:
This is a retrospective cohort of 56 patients with ASD (age, 59 ± 13 years; followup, 44 ± 19 months) from Johns Hopkins Hospital, who underwent long posterior spinal fusion to the proximal thoracic spine (T2–5). Visual analogue scale (VAS) for back pain, Oswestry Disability Index (ODI), 36-item Short Form health survey scores, thoracic kyphosis (TK), lumbar lordosis, sacral slope, pelvic tilt, pelvic incidence, proximal junctional kyphosis (PJK) angle, PJK incidence, pattern of PJK, grades of TPH dislodgement, revision surgery, and factors associated with high-grade TPH dislodgement were analyzed.
Results:
VAS for back pain and ODI values improved significantly from preoperatively to final follow-up. Mean change in PJK angle was 12° (range, 0.5°–43°). Twenty patients (36%) developed PJK, of whom 13 had compression fractures at 1 vertebra distal to the UIV (UIV–1). Final TPH position was stable in 42 patients (75%). In most patients (86%), TPH dislodgement did not progress after 6-month postoperative follow-up. Three patients (5.3%) underwent revision surgery to extend the fusion because of symptomatic PJK. Unstable TPH position was associated only with revision surgery and TK.
Conclusion
TPH placement at the proximal thoracic UIV for long fusion showed favorable clinical and radiographic outcomes in terms of the incidence of PJK and mean PJK angle at mean 44-month follow-up. TPHs placed in the proximal thoracic UIV were in stable position in 75% of patients. Compression fracture at UIV–1 was the most common pattern of PJK. PJK angle progression was greater in revision cases and in patients with greater preoperative thoracic kyphosis.
9.Prevalence of incidental distal biceps signal changes on magnetic resonance imaging
Eugene KIM ; Joost T.P. KORTLEVER ; Amanda I. GONZALEZ ; David RING ; Lee M. REICHEL
Clinics in Shoulder and Elbow 2023;26(3):260-266
Background:
Knowledge of the base rate of signal changes consistent with distal biceps tendinopathy on magnetic resonance imaging (MRI) has the potential to influence strategies for diagnosis and treatment of people that present with elbow pain. The aim of this study is to measure the prevalence of distal biceps tendon signal changes on MRIs of the elbow by indication for imaging.
Methods:
MRI data for 1,306 elbows were retrospectively reviewed for mention of signal change in distal biceps tendon. The reports were sorted by indication.
Results:
Signal changes consistent with distal biceps tendinopathy were noted in 197 of 1,306 (15%) patients, including 34% of patients with biceps pain, 14% of patients with unspecified pain, and 8% of patients with a specific non-biceps indication. Distal biceps tendon changes noted on radiology reports were associated with older age, male sex, and radiologists with musculoskeletal fellowship training.
Conclusions
The finding that distal biceps MRI signal changes consistent with tendinopathy are common even in asymptomatic elbows reduces the probability that symptoms correlate with pathology on imaging. The accumulation of signal changes with age, also independent of symptoms, suggests that tendon pathology persists after symptoms resolve, that some degree of distal biceps tendinopathy is common in a human lifetime, and that tendinopathy may often be accommodated without seeking care.Level of evidence: IV.
10.Cohort profile: investigating SARS-CoV-2 infection and the health and psychosocial impact of the COVID-19 pandemic in the Canadian CHILD Cohort
Rilwan AZEEZ ; Larisa LOTOSKI ; Aimée DUBEAU ; Natalie RODRIGUEZ ; Myrtha E. REYNA ; Tyler FREITAS ; Stephanie GOGUEN ; Maria MEDELEANU ; Geoffrey L. WINSOR ; Fiona S. L. BRINKMAN ; Emily E. CAMERON ; Leslie ROOS ; Elinor SIMONS ; Theo J. MORAES ; Piush J. MANDHANE ; Stuart E. TURVEY ; Shelly BOLOTIN ; Kim WRIGHT ; Deborah MCNEIL ; David M. PATRICK ; Jared BULLARD ; Marc-André LANGLOIS ; Corey R. ARNOLD ; Yannick GALIPEAU ; Martin PELCHAT ; Natasha DOUCAS ; Padmaja SUBBARAO ; Meghan B. AZAD
Epidemiology and Health 2023;45(1):e2023091-
The coronavirus disease 2019 (COVID-19) pandemic has affected all Canadian families, with some impacted differently than others. Our study aims to: (1) determine the prevalence and transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among Canadian families, (2) identify predictors of infection susceptibility and severity of SARS-CoV-2, and (3) identify health and psychosocial impacts of the COVID-19 pandemic. This study builds upon the CHILD Cohort Study, an ongoing multi-ethnic general population prospective cohort consisting of 3,454 Canadian families with children born in Vancouver, Edmonton, Manitoba, and Toronto between 2009 and 2012. During the pandemic, CHILD households were invited to participate in the CHILD COVID-19 Add-On Study involving: (1) brief biweekly surveys about COVID-19 symptoms and testing; (2) quarterly questionnaires assessing COVID-19 exposure and testing, vaccination status, physical and mental health, and pandemic-driven life changes; and (3) in-home biological sampling kits to collect blood and stool. In total, 1,462 households (5,378 participants) consented to the CHILD COVID-19 Add-On Study: 2,803 children (mean±standard deviation [SD], 9.0±2.7 years; range, 0-17 years) and 2,576 adults (mean±SD, 43.0±6.5 years; range, 18-85 years). We will leverage the wealth of pre-pandemic CHILD data to identify risk and resilience factors for susceptibility and severity to the direct and indirect pandemic effects. Our short-term findings will inform key stakeholders and knowledge users to shape current and future pandemic responses. Additionally, this study provides a unique resource to study the long-term impacts of the pandemic as the CHILD Cohort Study continues.

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