Safety and efficacy of cement augmentation with fenestrated pedicle screws for tumor-related spinal instability

OBJECTIVE Achieving rigid spinal fixation can be challenging in patients with cancer-related instability, as factors such as osteopenia, radiation, and immunosuppression adversely affect bone quality. Augmenting pedicle screws with cement is a strategy to overcome construct failure. This study aimed to assess the safety and efficacy of cement augmentation with fenestrated pedicle screws in patients undergoing posterior, open thoracolumbar surgery for spinal metastases. METHODS A retrospective review was performed for patients who underwent surgery for cancer-related spine instability from 2016 to 2019 at the Massachusetts General Hospital. Patient demographics, surgical details, radiographic characteristics, patterns of cement extravasation, complications, and prospectively collected Patient-Reported Outcomes Measurement Information System Pain Interference and Pain Intensity scores were analyzed using descriptive statistics. Logistic regression was performed to determine factors associated with cement extravasation. RESULTS Sixty-nine patients underwent open posterior surgery with a total of 502 cement-augmented screws (mean 7.8 screws per construct). The median follow-up period for those who survived past 90 days was 25.3 months (IQR 10.8–34.6 months). Thirteen patients (18.8%) either died within 90 days or were lost to follow-up. Postoperative CT was performed to assess the instrumentation and patterns of cement extravasation. There was no screw loosening, pullout, or failure. The rate of cement extravasation was 28.9% (145/502), most commonly through the segmental veins (77/145, 53.1%). Screws breaching the lateral border of the pedicle but with fenestrations within the vertebral body were associated with a higher risk of leakage through the segmental veins compared with screws without any breach (OR 8.77, 95% CI 2.84–29.79; p < 0.001). Cement extravasation did not cause symptoms except in 1 patient who developed a symptomatic thoracic radiculopathy requiring decompression. There was 1 case of asymptomatic pulmonary cement embolism. Patients experienced significant pain improvement at the 3-month follow-up, with decreases in Pain Interference (mean change 15.8, 95% CI 14.5–17.1; p < 0.001) and Pain Intensity (mean change 28.5, 95% CI 26.7–30.4; p < 0.001). CONCLUSIONS Cement augmentation through fenestrated pedicle screws is a safe and effective option for spine stabilization in the cancer population. The risk of clinically significant adverse events from cement extravasation is very low.

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A Comparison of Functional and Radiographic Outcomes following Microfracture with Extracellular Matrix Augmentation versus Osteochondral Autograft Transplantation for the Treatment of Medium-Sized Osteochondral Lesions of the Talus

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120s00387 ◽

2020 ◽

Vol 8 (7_suppl6) ◽

pp. 2325967120S0038

Author(s):

Carolyn Sofka ◽

Taylor Cabe ◽

Jonathan Deland ◽

Mark Drakos ◽

Karan Patel

Keyword(s):

Extracellular Matrix ◽

Physical Health ◽

Pain Intensity ◽

Physical Function ◽

Patient Group ◽

Pain Interference ◽

Osteochondral Lesions ◽

Postoperative Change ◽

Patient Reported

Objectives: The aim of this study is to directly compare clinical outcomes following the treatment of medium-sized osteochondral lesions of the talus (OLTs) using a microfracture technique augmented with Extracellular Matrix and Bone Marrow Aspirate Concentrate (MFX) versus OAT to determine which treatment is superior for medium-sized lesions. Methods: Patients treated for an OLT between 2015 and 2018 by a single surgeon, fellowship-trained in sports medicine and foot and ankle, were screened for this study. Retrospective chart review determined treatment, lesion size, lesion location, concurrent injuries, and demographic information. Patients at a minimum of 12 months follow-up, treated with MFX or OAT, and lesions sized 80-165mm2 were eligible for inclusion. All surgical repairs were augmented with an adjuvant mixture of micronized cartilage extracellular matrix and bone marrow aspirate concentrate (ECM-BMAC). Patient-reported functional outcomes were collected through our institution’s prospective Registry database. Patients treated prior to March 2016 were administered preoperative Foot and Ankle Outcome Score questionnaires. Those treated after this date were administered preoperative Physical Function, Pain Interference, Global Physical Health, Global Mental Health, Depression, and Pain Intensity Patient-Reported Outcome Information System (PROMIS) domains. Both FAOS and PROMIS were administered postoperatively. Postoperative MRIs were assessed using a modified magnetic resonance observation of cartilage repair tissue (MOCART) score. Student’s paired and two-group t-tests were used to evaluate for statistically significant pre-to-postoperative change and differences between procedure groups (p less than 0.05). Results: Twenty-seven patients treated with MFX (age range, 14-58) and twenty-three patients treated using OAT (age range, 22-64) were identified. All OAT patients received a single-plug transplantation. The final average lesion size ± standard deviation (SD) for patients treated with MFX was 115.44mm2± 22.51 (range, 156-80mm2) and 121.78mm2± 23.98 (range, 165-80mm2) for those treated using OAT (p=0.34). On average, functional outcome scores improved pre-to-postoperatively across all scales within both groups. Statistically significant improvements were detected in PROMIS Physical Function (Δ=8.32, p=0.01), Pain Interference (Δ=-7.15, p=0.02), Global Physical Health (Δ=5.87, p=0.03), and Pain Intensity (Δ=-7.06, p=0.05) domains for the MFX cohort. For the OAT patient group, significant pre-to-postoperative change was seen in the FAOS subcategories of Pain (Δ=28.70, p=0.03), Sports Activities (Δ=43.12, p<0.01), and Quality of Life (Δ=43.75, p=0.01); overall FAOS score (Δ=29.93, p=0.01); and PROMIS Physical Function (Δ=13.66, p=0.01), Pain Interference (Δ=-14.58, p<0.01), Global Physical Health (Δ=12.2, p=0.01), Depression (Δ=-4.13, p=0.02), and Pain Intensity (Δ=-16.56, p=0.02) domains. On average, with the exception of the postoperative Sports Activities subscale, postoperative FAOS and pre-to-postoperative change in FAOS were higher and greater in the OAT patient group. Similarly, on average, the OAT group had better PROMIS t-scores indicating higher function or less pain and greater pre-to-postoperative change in each PROMIS domain. The OAT cohort’s average postoperative Pain Interference t-score (± SD) of 43.09 (± 5.81) and Depression t-score of 40.06 (± 6.84) were significantly lower than their respective counterparts in the MFX cohort: 50.08 (± 9.47) for Pain Interference and 48.09 (± 7.86) in Depression. (Table 1) Finally, the mean overall MOCART score was 55.67 (± 24.11) within the MFX cohort, average follow-up 15.29 months, and 71 (± 15.60) within the OAT cohort average follow-up 15.8 months. This difference was also statistically significant (p=0.04). Conclusion: The OAT group had a higher MOCART score indicating the use of a single osteochondral autograft plug may result in better structural repair than microfracture abrasion chondroplasty augmented with a mixture of adjuvant ECM-BMAC. In addition, higher average FAOS scores, better average PROMIS t-scores, and greater pre-to-postoperative change in the OAT patient group indicate functional results may be better in this group as well. Specifically, significantly lower Pain Interference and Depression domains and significantly higher Global Mental Health scores indicate patients treated using OAT experience less pain and better psychological benefits postoperatively compared to patients treated using MFX. These results suggest filling the lesion with transplanted autograft bone and native, hyaline cartilage may perform better than and the biomechanically inferior fibrocartilage produced following microfracture even when augmented with adjuvant therapy. OAT may result in better overall clinical outcomes, specifically in a population of patients with medium sized lesions (range, 80 mm2 -165 mm2).

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Utility of Cement Augmentation via Percutaneous Fenestrated Pedicle Screws for Stabilization of Cancer-Related Spinal Instability

Operative Neurosurgery ◽

10.1093/ons/opy186 ◽

2018 ◽

Vol 16 (5) ◽

pp. 593-599 ◽

Cited By ~ 11

Author(s):

Ori Barzilai ◽

Lily McLaughlin ◽

Eric Lis ◽

Anne S Reiner ◽

Mark H Bilsky ◽

...

Keyword(s):

Chart Review ◽

Pedicle Screws ◽

Postoperative Mortality ◽

Cement Augmentation ◽

Radiographic Evaluation ◽

Spinal Instability ◽

Systemic Complications ◽

Patient Reported ◽

Cement Extravasation

Abstract BACKGROUND Cancer patients experience pathological fractures and the typical poor bone quality frequently complicates stabilization. Methods for overcoming screw failure include utilization of fenestrated screws that permit the injection of bone cement into the vertebral body to augment fixation. OBJECTIVE To evaluate the safety and efficacy of cement augmentation via fenestrated screws. METHODS A retrospective chart review of patients with neoplastic spinal instability who underwent percutaneous instrumented stabilization with cement augmentation using fenestrated pedicle screws. Patient demographic and treatment data and intraoperative and postoperative complications were evaluated by chart review and radiographic evaluation. Prospectively collected patient reported outcomes (PRO) were evaluated at short (2- <6 mo) and long term (6-12 mo). RESULTS Cement augmentation was performed in 216 fenestrated pedicle screws in 53 patients. Three patients required reoperation. One patient had an asymptomatic screw fracture at 6 mo postoperatively that did not require intervention. No cases of lucency around the pedicle screws, rod fractures, or cement extravasation into the spinal canal were observed. Eight cases of asymptomatic, radiographically-detected venous extravasation were found. Systemic complications included a pulmonary cement embolism, a lower extremity deep vein thrombosis, and a postoperative mortality secondary to pulmonary failure from widespread metastatic pulmonary infiltration. Significant improvement in PRO measures was found in short- and long-term analysis. CONCLUSION Cement augmentation of pedicle screws is an effective method to enhance the durability of spinal constructs in the cancer population. Risks include cement extravasation into draining blood vessels, but risk of clinically significant extravasation appears to be exceedingly low.

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Minimally Invasive Technique for PMMA Augmentation of Fenestrated Screws

The Scientific World JOURNAL ◽

10.1155/2015/979186 ◽

2015 ◽

Vol 2015 ◽

pp. 1-7 ◽

Cited By ~ 3

Author(s):

Jan-Helge Klingler ◽

Christoph Scholz ◽

Evangelos Kogias ◽

Ronen Sircar ◽

Marie T. Krüger ◽

...

Keyword(s):

Minimally Invasive ◽

Pedicle Screws ◽

Cement Augmentation ◽

Minimally Invasive Technique ◽

Invasive Technique ◽

Injection Technique ◽

Screw Loosening ◽

Optimal Injection ◽

Cement Extravasation

Purpose. To describe the minimally invasive technique for cement augmentation of cannulated and fenestrated screws using an injection cannula as well as to report its safety and efficacy.Methods. A total of 157 cannulated and fenestrated pedicle screws had been cement-augmented during minimally invasive posterior screw-rod spondylodesis in 35 patients from January to December 2012. Retrospective evaluation of cement extravasation and screw loosening was carried out in postoperative plain radiographs and thin-sliced triplanar computed tomography scans.Results. Twenty-seven, largely prevertebral cement extravasations were detected in 157 screws (17.2%). None of the cement extravasations was causing a clinical sequela like a new neurological deficit. One screw loosening was noted (0.6%) after a mean follow-up of 12.8 months. We observed no cementation-associated complication like pulmonary embolism or hemodynamic insufficiency.Conclusions. The presented minimally invasive cement augmentation technique using an injection cannula facilitates convenient and safe cement delivery through polyaxial cannulated and fenestrated screws during minimally invasive screw-rod spondylodesis. Nevertheless, the optimal injection technique and design of fenestrated screws have yet to be identified. This trial is registered with German Clinical TrialsDRKS00006726.

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Patient-Reported Outcomes Demonstrate The Value Of Non-Operative And Operative Orthopedic Treatments And Predict The Odds Of Improvement With Surgery

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000047 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0000

Author(s):

Andrew Haskell ◽

Todd S. Kim

Keyword(s):

Pain Intensity ◽

Patient Reported Outcomes ◽

Pain Interference ◽

Surgical Patients ◽

Final Visit ◽

Adaptive Tests ◽

Item Banks ◽

Patient Reported ◽

Computer Adaptive Tests ◽

Better Than

Category: Outcomes Measurement Introduction/Purpose: The importance of patient reported outcomes (PROs) has become increasingly recognized as an important tool to measure our clinical value. The National Institute of Health (NIH) created the Patient-Reported Outcomes Measurement Information System (PROMIS), a series of validated item banks, to help clinicians and researches measure key clinical domains. The PROMIS computer adaptive tests (CAT) may be administered with minimal resources or administrative burden. This study describes the results of administering computer adaptive tests (CAT) to every patient in a high volume Orthopedic Surgery practice. We test the hypotheses that both non-operative treatment and operative treatments improve PRO scores. Furthermore, we test the hypothesis that preoperative scores in these domains may be used to predict chances of improvement after surgery. Methods: The PROMIS CAT was administered prospectively for all patients as part of standard clinic intake and recorded in the patient’s electronic medical record (EMR) at each clinic visit. The PROMIS item banks are normalized to mean 50±10 for the US population. De-identified data was retrospectively extracted from the EMR including PROMIS scores, demographic information, as well as surgery specific information. As of this submission, 1688 PROMIS CATs from March 2015 to September 2016 have been analyzed. Data for initial and final clinic visits, as well as for the final preoperative visit for patients who had surgery, are compared using Wilcoxon Matched Pairs Test for paired samples and Mann-Whitney U Test for unpaired samples. Linear regression is used to assess the association of initial values to change in value after treatment. The effect of stratified initial clinic domain value on odds of improving with surgery is assessed using Analysis of Variance. Results: Non-surgical and surgical patients present with similar pain intensity (49.6±7.9 vs. 49.4±7.8). Surgical patients do not improve prior to surgery, but both improve by their final visit (45.7±7.5, 43.7±8.8, p<0.05). Non-surgical and surgical patients present with similar pain interference (60.0±8.4 vs. 60.3±8.9). Surgical patients do not improve prior to surgery, but both improve by their final visit (56.9±8.8, 54.3±9.4, p<0.05). For surgical patients, change in pain intensity and pain interference correlate with initial values (R2 0.32 and 0.27, p<0.05). The percentage whose pain intensity improves after surgery when initial value is over one SD worse than mean is 96%, within one SD worse than mean is 81%, within one SD better than mean is 56%, and over one SD better than mean is 40% (p<0.05). Conclusion: Both non-operative and operative orthopedic treatments improve patient reported pain intensity and pain interference. For patients that have surgery, patients that present with more severe symptoms tend to improve more with surgery. Furthermore, the odds of improving after surgery can be calculated based on preoperative PRO scores. This may allow surgeons to counsel patients about the potential benefits of surgery with personalized precision that is currently unavailable. Measuring PROs using PROMIS CATs demonstrates the value of both non-operative and operative Orthopedic Surgery care for our patients. Preoperative PRO scores may predict the odds of successful surgical intervention.

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Association Between Baseline PROMIS Scores, Patient-Provider Communication Factors, and Musculoskeletal Health Literacy on Patient and Surgeon Expectations in Foot and Ankle Surgery

Foot & Ankle International ◽

10.1177/1071100720959017 ◽

2020 ◽

pp. 107110072095901

Author(s):

Aoife MacMahon ◽

Elizabeth A. Cody ◽

Kristin Caolo ◽

Jensen K. Henry ◽

Mark C. Drakos ◽

...

Keyword(s):

Health Literacy ◽

Pain Intensity ◽

Physical Function ◽

Mental Status ◽

Patient Perceptions ◽

Pain Interference ◽

Foot And Ankle ◽

Musculoskeletal Health ◽

Ankle Surgery ◽

Patient Reported

Background: Various factors may affect differences between patient and surgeon expectations. This study aimed to assess associations between patient-reported physical and mental status, patient-surgeon communication, and musculoskeletal health literacy with differences in patient and surgeon expectations of foot and ankle surgery. Methods: Two hundred two patients scheduled to undergo foot or ankle surgery at an academic hospital were enrolled. Preoperatively, patients and surgeons completed the Hospital for Special Surgery Foot & Ankle Surgery Expectations Survey. Patients also completed Patient-Reported Outcomes Measurement Information System (PROMIS) scores in Physical Function, Pain Interference, Pain Intensity, Depression, and Global Health. Patient-surgeon communication and musculoskeletal health literacy were assessed via the modified Patients’ Perceived Involvement in Care Scale (PICS) and Literacy in Musculoskeletal Problems (LiMP) questionnaire, respectively. Results: Greater differences in patient and surgeon overall expectations scores were associated with worse scores in Physical Function ( P = .003), Pain Interference ( P = .001), Pain Intensity ( P = .009), Global Physical Health ( P < .001), and Depression ( P = .009). A greater difference in the number of expectations between patients and surgeons was associated with all of the above ( P ≤ .003) and with worse Global Mental Health ( P = .003). Patient perceptions of higher surgeons’ partnership building were associated with a greater number of patient than surgeon expectations ( P = .017). There were no associations found between musculoskeletal health literacy and differences in expectations. Conclusion: Worse baseline patient physical and mental status and higher patient perceptions of provider partnership building were associated with higher patient than surgeon expectations. It may be beneficial for surgeons to set more realistic expectations with patients who have greater disability and in those whom they have stronger partnerships with. Further studies are warranted to understand how modifications in patient and surgeon interactions and patient health literacy affect agreement in expectations of foot and ankle surgery. Level of Evidence: Level II, prospective comparative series.

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ODI Cannot Account for All Variation in PROMIS Scores in Patients With Thoracolumbar Disorders

Global Spine Journal ◽

10.1177/2192568219851478 ◽

2019 ◽

Vol 10 (4) ◽

pp. 399-405

Author(s):

Peter G. Passias ◽

Samantha R. Horn ◽

Frank A. Segreto ◽

Cole A. Bortz ◽

Katherine E. Pierce ◽

...

Keyword(s):

Linear Regression ◽

Pain Intensity ◽

Physical Function ◽

Social Life ◽

Thoracolumbar Spine ◽

Pain Interference ◽

Pain Intensity Score ◽

Low Back ◽

Patient Reported ◽

The Relationship

Study Design: Retrospective review of single institution. Objective: To assess the relationship between Patient-Reported Outcomes Measurement Information System (PROMIS) and Oswestry Disability Index (ODI) scores in thoracolumbar patients. Methods: Included: Patients ≥18 years with a thoracolumbar spine condition (spinal stenosis, disc herniation, low back pain, disc degeneration, spondylolysis). Bivariate correlations assessed the linear relationships between ODI and PROMIS (Physical Function, Pain Intensity, and Pain Interference). Correlation cutoffs assessed patients with high and low correlation between ODI and PROMIS. Linear regression predicted the relationship of ODI to PROMIS. Results: A total of 206 patients (age 53.7 ± 16.6 years, 49.5% female) were included. ODI correlated with PROMIS Physical Function ( r = −0.763, P < .001), Pain Interference ( r = 0.800, P < .001), and Pain Intensity ( r = 0.706, P < .001). ODI strongly predicted PROMIS for Physical Function ( R2 = 0.58, P < .001), Pain Intensity ( R2 = 0.50, P < .001), and Pain Interference ( R2 = 0.64, P < .001); however, there is variability in PROMIS that ODI cannot account for. ODI questions about sitting and sleeping were weakly correlated across the 3 PROMIS domains. Linear regression showed overall ODI score as accounting for 58.3% ( R2 = 0.583) of the variance in PROMIS Physical Function, 63.9% ( R2 = 0.639) of the variance in Pain Interference score, and 49.9% ( R2 = 0.499) of the variance in Pain Intensity score. Conclusions: There is a large amount of variability with PROMIS that cannot be accounted for with ODI. ODI questions regarding walking, social life, and lifting ability correlate strongly with PROMIS while sitting, standing, and sleeping do not. These results reinforce the utility of PROMIS as a valid assessment for low back disability, while indicating the need for further evaluation of the factors responsible for variation between PROMIS and ODI.

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#MadelungDeformity: Insights Into a Rare Congenital Difference Using Social Media

Hand ◽

10.1177/15589447211054133 ◽

2021 ◽

pp. 155894472110541

Author(s):

Abbas Peymani ◽

Max M. Lokhorst ◽

Austin D. Chen ◽

Chantal M.A.M. van der Horst ◽

Bernard T. Lee ◽

...

Keyword(s):

Social Media ◽

Pain Intensity ◽

Upper Extremity ◽

Peer Relationships ◽

Well Being ◽

Global Perspective ◽

Pain Interference ◽

Measurement Information ◽

Madelung Deformity ◽

Patient Reported

Background Madelung deformity is a rare congenital hand difference with little known regarding the patient perspective. In this cross-sectional survey study, we harnessed the global reach of social media to understand the clinical spectrum of Madelung deformity and its impact on physical, mental, and social health. Methods A survey was developed based on a previously published protocol and multiple Patient-Reported Outcomes Measurement Information System (PROMIS) short forms. The survey was distributed on several Madelung deformity communities on Facebook and Instagram. T-scores were calculated, interpreted, and compared between patients who underwent surgery and those who did not. Correlations between scores were calculated using the Spearman rank correlation coefficient. Results Mean PROMIS scores for adults were as follows: pain intensity, 4.9 ± 2.8; pain interference, 57.6 ± 10.0; upper extremity, 35.2 ± 8.1; depression, 53.8 ± 11.1; anxiety, 55.4 ± 11.4; and ability to participate in social roles and activities, 42.5 ± 7.7. Mean scores for children were as follows: pain intensity, 5.0 ± 2.8; pain interference, 55.7 ± 11.3; upper extremity function, 24.6 ± 10.4; depressive symptoms, 57.7 ± 11.3; anxiety, 57.3 ± 11.9; and peer relationships, 42.2 ± 10.3. Conclusions Madelung deformity has significant effects on patients’ physical, mental, and social well-being, even after surgical treatment. Using social media, we were able to compensate for Madelung deformity’s rarity by engaging an international audience, demonstrating the feasibility to conduct research through it, and providing a global perspective of the disease entity.

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Long-term follow-up of the use of maintenance antibiotic therapy for chronic antibiotic-dependent pouchitis

Frontline Gastroenterology ◽

10.1136/flgastro-2017-100913 ◽

2018 ◽

Vol 9 (2) ◽

pp. 154-158 ◽

Cited By ~ 9

Author(s):

Jonathan P Segal ◽

Stephanie X Poo ◽

Simon D McLaughlin ◽

Omar D Faiz ◽

Susan K Clark ◽

...

Keyword(s):

Side Effects ◽

Antibiotic Therapy ◽

Antibiotic Use ◽

Safety And Efficacy ◽

Pouch Failure ◽

Patient Reported ◽

Long Term Follow Up ◽

Term Maintenance

ObjectiveRestorative proctolectomy is considered the procedure of choice in patients with ulcerative colitis who have failed medical therapy. Chronic pouchitis occurs in 10%–15% of patients, which often require long-term antibiotics to alleviate symptoms. Safety and efficacy of long-term maintenance antibiotics for chronic pouchitis has yet to be established. We aimed to assess the long-term safety and efficacy of maintenance antibiotic therapy for chronic pouchitis.DesignThis was an observational study. We followed up patients who were diagnosed with chronic antibiotic-dependent pouchitis.SettingData were collected from our single specialist pouch centre.PatientsPatients with chronic antibiotic-dependent pouchitis who had been maintained on antibiotics continuously for at least 1 year with a least one follow-up visit.Main outcome measureDevelopment of pouch failure defined by the need for an ileostomy, patient-reported side effects of antibiotics and development of antibiotic resistance found on stool coliform testing.ResultsLong-term use of antibiotics achieve remission in 21% of patients over a median follow-up of 102 (range 9–125). Pouch failure in association with chronic pouchitis after a median follow-up of 8.5 years occurred in 18%. Side effects of long-term antibiotic use occurred in 28% of patients, with resistance to antibiotics from at least one stool sample occurring in 78% patients.ConclusionsAlthough the use of antibiotics in chronic pouchitis may be justified, the use of long-term antibiotics must be weighed against potential complications associated with pouchitis and antibiotics.

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Effect of abiraterone acetate (AA) on patient-reported pain in metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel: Results of longitudinal sensitivity analyses.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.9618 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 9618-9618 ◽

Cited By ~ 2

Author(s):

Yanni Hao ◽

Charles S. Cleeland ◽

Dennis Gagnon ◽

Derek Espindle ◽

Arturo Molina ◽

...

Keyword(s):

Missing Data ◽

Pain Intensity ◽

Short Form ◽

Mixed Effects ◽

Pain Interference ◽

Sensitivity Analyses ◽

Repeated Measure ◽

Patient Reported ◽

Pain Outcomes ◽

The Impact

9618 Background: The COU-AA-301 phase 3 trial showed that AA + prednisone (P) improved overall survival in mCRPC patients (pts) post-docetaxel. Compared with P alone, AA + P also had significant benefits on patient-reported pain. Here we describe post hoc sensitivity analyses of pain data from that trial, using different methods to compensate for the potential impact of missing data. Methods: Pts with mCRPC progressing after docetaxel-based chemotherapy were randomized 2:1 to AA + P or placebo + P. Pain intensity and interference of pain with daily activities were assessed with the Brief Pain Inventory-Short Form (BPI-SF) questionnaire at baseline, Day 15 of Cycle 1, and Day 1 of each 28-day treatment cycle thereafter until treatment discontinuation. The effect of treatment on BPI-SF scores was analyzed using repeated measure mixed-effects (RMM) models, piecewise linear mixed-effects (PWLME) models, and joint mixed-effects and log time-to-dropout (JMEL) models. RMM and PWMLE models assumed missing data (due to death, study dropout, or administrative issues) to be missing at random, the JMEL model to be missing not at random. Model results were compared between treatment arms. Results: 797 pts were randomized to AA + P, and 398 to P only. RMM model estimates suggested statistically significant (p < 0.05) differences in change from baseline for pain intensity and pain interference scores in favor of AA + P at the majority of study visits through cycle 11. PWLME models yielded significantly smaller areas under the curve (AUCs) for AA + P vs P for pain intensity (p = 0.0031) and pain interference (p = 0.0006); smaller AUCs reflect better pain outcomes. Results using JMEL models were nearly identical to those with PWLME models, with AUCs for AA + P significantly smaller than for P alone for pain intensity (p = 0.0031) and pain interference (p = 0.0007). Conclusions: Using various modeling methods that assess the impact of missing data, AA + P showed superior patterns of pain outcomes over time compared with P only in mCRPC pts refractory to docetaxel. These results support the previously reported pain benefits of AA + P over P alone from the same trial. Clinical trial information: NCT00638690.

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The Influence of Preoperative Deformity Severity in Postoperative Patient Reported Outcomes in Adult Acquired Flatfoot

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00028 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0002

Author(s):

Bopha Chrea ◽

Cesar de Cesar Netto ◽

Jonathan H. Garfinkel ◽

Jonathan Day ◽

Guilherme H. Saito ◽

...

Keyword(s):

Mental Health ◽

Pain Intensity ◽

Subtalar Joint ◽

Patient Reported Outcomes ◽

Global Mental Health ◽

Multivariate Regression Analysis ◽

Pain Interference ◽

T Score ◽

Metatarsal Angle ◽

Patient Reported

Category: Ankle; Hindfoot; Other Introduction/Purpose: Adult acquired flatfoot deformity (AAFD) is a complex deformity. Previous work has demonstrated correlation between postoperative foot alignment and patient-reported outcomes. While this work has provided essential targets for surgeons performing flatfoot reconstruction, there is an absence of data that would enable surgeons to predict which patients are likely to have greater or less improvement after surgery based on their preoperative deformity. Conventional radiographs alone may not provide enough detail to isolate individual elements of the deformity. Weightbearing CT (WBCT) allows for far more precise analysis in this regard. We hypothesized that there would be a set of parameters defining preoperative alignment on WBCT that would predict which patients are at risk for a lower magnitude of postoperative improvement in patient-reported outcomes (PROs). Methods: In this retrospective IRB-approved study, patients that underwent surgical flatfoot reconstruction after having a preoperative standing WBCT were identified. Preoperative WBCT images were evaluated by two independent/blinded observers. Multiple parameters related to preoperative alignment and AAFD severity were measured in the sagittal, coronal and transverse planes. Parameters measured included talus-first metatarsal angle; distances between the floor and the navicular, medial cuneiform and cuboid; subtalar joint horizontal angle; superior talar - inferior talar angle; subtalar joint subluxation; talonavicular uncoverage angle; hindfoot moment arm (HMA); and foot and ankle offset (FAO). Prospectively collected data regarding preoperative and postoperative PROs was evaluated. Six PROs components were assessed: physical function; pain interference, pain intensity, global mental health, global physical health and depression. Multivariate regression analysis and a partition prediction model were used to assess the correlation between preoperative alignment and improvement in PROs. P-values of less than 0.05 were considered significant. Results: A total of 51 patients with a preoperative WBCT and postoperative PROs scores were identified and included. Demographic data is shown in Table 1. Multivariate regression analysis demonstrated that preoperative alignment significantly correlated with improvement in three out six components of PROs: pain interference, pain intensity and global mental health. The strongest predictor of improvement in PROMIS physical function t-score was medial cuneiform to floor distance, for pain interference t-score: cuboid to floor distance, for pain intensity: subtalar joint subluxation, for depression t-score: superior talar - inferior talar angle, and for global physical and mental health t-scores: sagittal talus-first metatarsal angle. Conclusion: Our analysis yielded readily identifiable cutoffs for WBCT measurements, where values above or below were correlated with significant differences in the magnitude of PRO score change. Interestingly, measures of sagittal plane collapse and hindfoot valgus were the most predictive of score changes. This data provides useful information for surgeons counseling patients prior to flatfoot reconstruction. Future work using this data to develop prediction models for postoperative outcomes would be valuable, as would studies using WBCT to evaluate the relationship between postoperative corrected alignment and PROs. Complete results are shown in the attached Table.

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