Electrodiagnostic severity does not predict short- to midterm outcomes of cubital tunnel release surgery.

HYPOTHESIS: This study aimed to explore the prognostic value of electrodiagnostic studies (EDS) to clarify their utility in clinical practice prior to cubital tunnel release surgery and to identify patient factors associated with patient-reported functional improvement after surgery. Our hypothesis was that patients with severe preoperative findings on EDS will tend to experience less functional improvement after surgery given the extent of ulnar nerve compressive injury. METHODS: Patients with cubital tunnel syndrome and preoperative electrodiagnostic data treated from 2012 to 2022 with cubital tunnel release were assessed regarding demographic information, preoperative physical examination findings, EDS findings, postoperative complications, and patient-reported outcomes. Short- to midterm quick Disabilities of the Arm, Shoulder, and Hand questionnaire (qDASH) scores were collected for all patients for further evaluation of preoperative EDS data. Patients were grouped into those who had met the minimal clinically important difference (MCID) in delta qDASH at short- to midterm follow-up and those who did not. EDS data included sensory nerve onset latency, peak latency, amplitude, conduction velocity, as well as motor nerve latency, velocity, and amplitude. Electromyographic (EMG) studies were also reviewed, which included data pertaining to fibrillations, presence of abnormal fasciculation, positive sharp waves, variation in insertional activity, motor unit activity, duration of activity, and presence of increasing polymorphisms. RESULTS: Of the 257 patients included, 160 (62.0%) were found to meet the MCID for short- to midterm qDASH scores. There were no significant differences between patients who did or did not meet the MCID regarding baseline demographics, comorbidities, preoperative examination findings, and operative technique. Patients who met MCID tended to have lower complication (3.80% vs. 7.20%, P = .248) and revision (0.60% vs. 4.10%, P = .069) rates, but these findings were not statistically significant. The cubital tunnel severity as determined by the EDS was similar between cohorts (14.1% vs. 14.3%, P = .498). Analysis of EMG testing showed there were no significant differences in preoperative, short- to midterm qDASH, or delta short- to midterm qDASH scores for patients with or without abnormal EMG findings. Multivariate regression suggested that only age (P = .003) was associated with larger delta qDASH scores. CONCLUSION: Patient-reported preoperative disease severity may predict the expected postoperative change in ulnar nerve functional improvement, and EDS may not have prognostic value for patients undergoing cubital tunnel decompression. Therefore, physicians may suggest surgical treatment without positive EDS findings and still expect postoperative improvement in functional outcomes.

A novel classification of intraoperative ulnar nerve instability to aid transposition surgery.

HYPOTHESIS: The purpose of this study was to compare inter- and intraobserver agreement of a novel intraoperative subluxation classification for patients undergoing ulnar nerve surgery at the elbow. We hypothesize there will be strong inter- and intraobserver agreement of the 4-category classification system, and reviewers will have substantial confidence while reviewing the classification system. METHODS: Four blinded fellowship-trained orthopedic hand surgeons reviewed 25 videos in total on 2 separate viewings, 21 days apart. Variables collected were ulnar subluxation classification (A, B, C, or D) and a confidence metric. Subsequent to primary data collection, classification grading was stratified into A/B or C/D subgroups for further analysis. Cohen κ scores were used to evaluate all variables collected in this study. The interpretation of κ scores included ≤0.0 as no agreement, 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41-0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.0 as almost perfect agreement. RESULTS: Interobserver agreement of subluxation classification as a 4-category scale demonstrated a moderate agreement on first viewing, second viewing, and when both viewings were combined (κ = 0.51, 0.51, and 0.51 respectively). Seventy-five percent (3 of 4) of reviewers had moderate intraobserver agreement for ulnar nerve subluxation classification, whereas 1 reviewer had substantial intraobserver classification (κ = 0.72). Overall, there was high confidence in 65% of classification scores in the second round of viewing, which improved from 58% in the first viewing round. When ulnar subluxation classification selections were regrouped into classes A/B or C/D, 100% of reviewers had substantial interobserver (κ = 0.74-0.75) and substantial to almost perfect intraobserver (κ = 0.71-0.91) agreement. CONCLUSIONS: The 4-category classification was reproducible within and between reviewers. Agreement appeared to increase when simplifying the classification to 2 categories, which may provide guidance to surgical decision making. The validation of a reproducible classification scheme for intraoperative ulnar subluxation may aid with decision making and further postoperative outcomes research.

The Effects of Preoperative Administration of Erythropoietin in Pediatric Patients Undergoing Cranial Vault Remodeling for Craniosynostosis.

BACKGROUND AND PURPOSE: Over 90% of patients undergoing cranial vault remodeling for craniosynostosis receive blood transfusions to compensate for intraoperative blood loss. However, transfusions are not without risk and can lead to allergic and immune transfusion reactions as well as rare cases of infectious transmissions. Preoperative use of erythropoietin in cranial vault remodeling has been demonstrated to be safe and to reduce transfusion requirements in prior studies. This study's purpose is to add to the body of data supporting the safe use of a protocolized erythropoietin alfa regimen before cranial vault remodeling and strip craniectomy procedures with decreased blood transfusion requirements and other favorable outcomes. METHODS: A retrospective chart review was performed on patients who underwent cranial vault remodeling between 2006 and 2021 at our tertiary care center. Two groups were identified: in the first, preoperative erythropoietin was administered under protocol; and in the second, preoperative erythropoietin was not administered. The groups were compared with respect to age, perioperative hemoglobin levels, estimated blood loss during surgery, packed red blood cell transfusion volume, length of hospital stay, and length of surgery. RESULTS: Demographics were not significantly different in terms of age, weight, diagnosis, gender, and type of procedure. Patients who were administered preoperative erythropoietin were found to have significantly increased preoperative hemoglobin levels (13.6 versus 12.3 g/dL), as well as decreased estimated intraoperative blood loss (376 versus 1099 mL), the volume of packed red blood cells transfused (316 versus 897 mL), length of hospital stay, and length of surgery. Postoperative hemoglobin levels were not found to be significantly different. CONCLUSIONS: In this study, preoperative administration of erythropoietin with elemental iron was beneficial for patients undergoing cranial vault remodeling for craniosynostosis. Specifically, it decreased the need for red blood cell transfusion, intraoperative blood loss, and length of hospital stay. No adverse events were recorded in the treatment arm. Further studies may include a separate group administered iron alone.

Interpreting Meta-Analyses: A Guide to Funnel and Forest Plots.

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

Triceps Tendon Reattachment Using Mini Plates and Screws After Failure of Olecranon Avulsion Fracture Fixation in Osteoporotic Bone: A Case Report.

This is a case report of an 85-year-old woman with osteopenia who underwent olecranon avulsion fracture repair with supplemental triceps tendon repair following a fall on an outstretched arm. The initial procedure failed due to osteoporotic bone quality and an atraumatic disruption of the olecranon fracture fixation. The patient subsequently underwent further surgical intervention with an olecranon avulsion fracture excision and a novel triceps tendon repair technique using plate augmentation and fiber tape. Surgeons may consider this novel approach as an initial treatment for elderly patients with osteopenia or osteoporosis undergoing olecranon avulsion fracture fixation, to prevent the failure and consequent revision surgery.

Pickleball- and Paddleball-Related Injuries in the Lower Extremity: Description, Treatment Options, and Return to Play.

Background Pickleball and paddleball are the fastest-growing sports in the United States. However, there are limited studies on the types of lower extremity injuries and treatment options in an outpatient clinic setting. Hypothesis/purpose This study reports the incidence rate, treatments, and return-to-play (RTP) outcomes for patients presenting to a single orthopedic outpatient center with pickleball- and paddleball-related lower extremity injuries. Study design This study is a retrospective case series, with level IV evidence. Methods A database search of our multispecialty electronic medical record (EMR) system from 2015 to 2023 identified 166 patients with outpatient pickleball- and paddleball-related lower extremity injuries. The retrospective data were reviewed for patient demographics, injury type, mechanism of injury, surgical or non-surgical treatment, and return-to-play recommendations. Results We observed that the majority of the patients with pickleball- and paddleball-related injuries in the lower extremities were over 60 years of age, with more males. Additionally, most injuries encountered were ankle sprain/strain from a twisting mechanism, which was treated non-surgically. Additionally, a significant number of patients suffered an Achilles tendon rupture (12.0%), which was treated surgically with an Achilles tendon repair (88.1%), accounting for the most common surgical treatment performed in this study. Of the 166 patients who were seen and treated, 68 (40.9%) returned to play, and 93 (56.3%) were lost to follow-up. Conclusion Most of these injuries were seen in the older population and caused by a sprain or strain due to sudden changes in direction, which were treated non-surgically. The most common surgical treatment was an Achilles tendon repair due to an Achilles tendon rupture. Although a relatively good number of patients were cleared to return to play, some patients were lost to follow-up. Meanwhile, some patients were advised to stop playing pickleball or paddleball due to the severity of their injuries. As this sport continues to rise in popularity and with the incidence rate of lower extremity injuries increasing over time, orthopedic surgeons should be aware of the types of injuries, treatment options, and outcomes, as well as ways to advise patients on prevention. Therefore, further research on the standard treatments and outcomes of pickleball- and paddleball-related injuries in the lower extremities is encouraged.

A Longitudinal Evaluation of Coronavirus Disease 2019 and Its Effects on Spinal Decompressions With or Without Fusion.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: The objectives were to (1) compare the safety of spine surgery before and after the emergence of coronavirus disease 2019 (COVID-19) and (2) determine whether patients with a history of COVID-19 were at increased risk of adverse events. SUMMARY AND BACKGROUND DATA: The COVID-19 pandemic had a tremendous impact on several health care services. In spine surgery, elective cases were canceled and patients received delayed care due to the uncertainty of disease transmission and surgical outcomes. As new coronavirus variants arise, health care systems require guidance on how to provide optimal patient care to all those in need of our services. PATIENTS AND METHODS: A retrospective review of patients undergoing spine surgery between January 1, 2019 and June 30, 2021 was performed. Patients were split into pre-COVID or post-COVID cohorts based on local government guidelines. Inpatient complications, 90-day readmission, and 90-day mortality were compared between groups. Secondary analysis included multiple logistic regression to determine independent predictors of each outcome. RESULTS: A total of 2976 patients were included for analysis with 1701 patients designated as pre-COVID and 1275 as post-COVID. The pre-COVID cohort had fewer patients undergoing revision surgery (16.8% vs 21.9%, P < 0.001) and a lower home discharge rate (84.5% vs 88.2%, P = 0.008). Inpatient complication (9.9% vs 9.2%, P = 0.562), inpatient mortality (0.1% vs 0.2%, P = 0.193), 90-day readmission (3.4% vs 3.2%, P = 0.828), and 90-day mortality rates (0.8% vs 0.8%, P = 0.902) were similar between groups. Patients with positive COVID-19 tests before surgery had similar complication rates (7.7% vs 6.1%, P = 1.000) as those without a positive test documented. CONCLUSIONS: After the emergence of COVID-19, patients undergoing spine surgery had a greater number of medical comorbidities, but similar rates of inpatient complications, readmission, and mortality. Prior COVID-19 infection was not associated with an increased risk of postsurgical complications or mortality. LEVEL OF EVIDENCE: Level III.

A Comparison of Clinical Outcomes Between Anterior Cervical Discectomy and Fusion Versus Posterior Cervical Laminoplasty for Multilevel Cervical Myelopathy.

STUDY DESIGN: Retrospective Cohort. OBJECTIVE: To compare patient-reported outcomes and surgical outcomes after anterior cervical discectomy and fusion (ACDF) versus cervical laminoplasty for multilevel cervical spondylotic myelopathy. BACKGROUND: Treatment options for multilevel cervical spondylotic myelopathy include ACDF and cervical laminoplasty. Given that the literature has been mixed regarding the optimal approach, especially in patients without kyphosis, there is a need for additional studies investigating outcomes between ACDF and cervical laminoplasty. METHODS: A retrospective review was conducted of adult patients undergoing 3 or 4-level surgery. Patients with preoperative kyphosis based on C2-C7 Cobb angles were excluded. The electronic medical record and institutional databases were reviewed for baseline characteristics, surgical outcomes, and patient-reported outcomes. RESULTS: A total of 101 patients who underwent ACDF and 52 patients who underwent laminoplasty were included in the study. The laminoplasty cohort had a higher overall Charlson Comorbidity Index (3.10 ± 1.43 vs 2.39 ± 1.57, P = 0.011). Both groups had a comparable number of levels decompressed, C2-C7 lordosis, and diagnosis of myelopathy versus myeloradiculopathy. Patients who underwent laminoplasty had a longer length of stay (2.04 ± 1.15 vs 1.48 ± 0.70, P = 0.003) but readmission, complication, and revision rates were similar. Both groups had similar improvement in myelopathy scores (∆modified Japanese Orthopedic Association: 1.11 ± 3.09 vs 1.06 ± 3.37, P = 0.639). ACDF had greater improvement in Neck Disability Index (∆Neck Disability Index: -11.66 ± 19.2 vs -1.13 ± 11.2, P < 0.001), neck pain (∆Visual Analog Scale-neck: -2.69 ± 2.78 vs -0.83 ± 2.55, P = 0.003), and arm pain (∆Visual Analog Scale-arm: -2.47 ± 3.15 vs -0.48 ± 3.19, P = 0.010). These findings persisted in multivariate analysis except for Neck Disability Index. CONCLUSION: ACDF and cervical laminoplasty appear equally efficacious at halting myelopathic progression. However, patients who underwent ACDF had greater improvements in arm pain at 1 year postoperatively. Longitudinal studies evaluating the efficacy of laminoplasty to mitigate adjacent segment disease are indicated to establish a robust risk-benefit assessment for these 2 procedures. LEVEL OF EVIDENCE: III.

Lower Extremity Somatosensory Evoked Potentials Predict Functional Outcomes in Complete Traumatic Cervical Spinal Cord Injury.

BACKGROUND: Traumatic cervical spinal cord injury (tCSCI) is often a debilitating injury, making early prognosis important for medical and surgical planning. Currently, the best early predictors of prognosis are physical examination, imaging studies, and patient demographics. Despite these factors, patient outcomes continue to vary significantly. The purpose of this study was to evaluate the prognostic value of somatosensory evoked potentials (SSEPs) with functional outcomes in tCSCI patients. METHODS: A retrospective study was conducted on prospectively collected data from 2 academic institutions. Patients 18 years and older who had tCSCI and underwent posterior cervical decompression and stabilization with intraoperative neuromonitoring were reviewed. The outcomes of interest were the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade and ASIA motor score at follow-up. Outcomes measures were assessed via student t-tests, chi-squared tests, and multivariable regression analysis. RESULTS: A total of 79 patients were included. In complete injuries, detectable lower extremity SSEPs were associated with higher ASIA motor scores at follow-up (P = 0.002), greater increases in ASIA motor scores at follow-up (P = 0.009), and a greater likelihood of clinically important improvement in ASIA motor score (P = 0.024). Incomplete, AIS grade C injuries has higher rates of grade conversion (P = 0.019) and clinically important improvement in ASIA motor score (P = 0.010), compared to AIS grade A or B injuries. CONCLUSIONS: The detection of lower extremity SSEP signals during initial surgical treatment of tCSCI is associated with greater improvement in ASIA motor scores postoperatively. The association is most applicable to patients with complete injury.

Preoperative Electrodiagnostic Study Findings Differ Between Patients With Double-crush Syndrome and Carpal Tunnel Syndrome: A Propensity Matched Analysis.

INTRODUCTION: Double-crush syndrome (DCS) represents a condition that involves peripheral nerve compression in combination with spinal nerve root impingement. The purpose of this study was to compare electrodiagnostic study (EDS) results in patients undergoing carpal tunnel release (CTR) for carpal tunnel syndrome with those undergoing both CTR and anterior cervical diskectomy and fusion for DCS. METHODS: Patients receiving an isolated CTR were compared with those undergoing CTR and anterior cervical diskectomy and fusion within two years of CTR. The latter group was defined as our DCS cohort. Electrodiagnostic study results were collected which included sensory and motor nerve conduction data as well as electromyogram (EMG) findings. All electrodiagnostic studies were done before CTR in both sets of patients. RESULTS: Fifty-four patients with DCS and 137 CTR-only patients were included. Patients with DCS were found to have decreased sensory onset latency (3.51 vs 4.01; P = 0.015) and peak latency (4.25 vs 5.17; P = 0.004) compared with the CTR-only patients. Patients with DCS had slower wrist motor velocity (30.5 vs 47.7; P = 0.012), decreased elbow motor latency (9.62 vs 10.6; P = 0.015), and faster elbow motor velocity (56.0 vs 49.4; P = 0.031). EMG results showed that patients with DCS were more likely to have positive findings in the biceps (31.9% vs 1.96%; P < 0.001) and triceps (24.4% vs 2.97%; P < 0.001), but not abductor pollicis brevis (APB) (45.7% vs 37.9%; P = 0.459). CONCLUSION: We identified changes on EDS between patients with and without DCS. In patients with DCS, sensory nerve studies showed shorter peak and onset latency than in CTR-only patients. Interestingly, DCS and CTR-only patients had different patterns of wrist and elbow motor nerve conduction. Providers observing positive EMG findings proximal to the APB should raise their suspicion for possible cervical radiculopathy and when present with carpal tunnel syndrome-like symptoms, should also consider DCS in their diagnostic differential.

Physical and Psychological Impact of Scar Cosmesis after Cervical Spine Fusion Surgery.

INTRODUCTION: Patients' and surgeons' perceptions of cutaneous scarring can vary, causing unpleasant physical and psychological outcomes. This study aims to bridge the current scientific literature gap and understand the impact of patient-perceived scar cosmesis after anterior and posterior cervical spine surgery. METHODS: Retrospective review of patients ≥18 years old who underwent anterior or posterior cervical spine surgery from 2017 to 2022 at a large, urban academic group. To select patients with adequate time for surgical scar maturation, only patients who were greater than six months post-surgery were included. The SCAR-Q survey, a surgical scar assessment tool, was administered to patients to assess patient perceptions of scar symptomatology, appearance, and psychosocial impact. Scores range from 0 to 100, with 100 as the best outcome. An additional 5-item Likert scale question was administered to assess overall surgical satisfaction. RESULTS: All 854 respondents who completed the survey were stratified into two groups"Unsatisfied vs Satisfied." Patients who were "unsatisfied" with their surgery had the lowest outcome scores for SCAR-Q appearance, symptom, and psychosocial scores than those who were "satisfied" (p<0.001). Females had significantly higher/"more favorable" responses for SCAR-Q Appearance (77.5 vs. 82.8 p<0.001) and Psychosocial (87.4 vs. 94.3 p<0.001) scores compared to males. Regression analysis performed for each component score showed that increases in all three component scores were significant in patients in the satisfied group. CONCLUSIONS: Our study demonstrates that cervical spine surgery patients unsatisfied with their surgical outcome have lower scar-related scores, highlighting the impact of cosmetic closure and appearance.

Surgeon Estimations of Acetabular Cup Orientation Using Intraoperative Fluoroscopic Imagining Are Unreliable.

Background: Accurate acetabular cup orientation is associated with decreased revision rates and improved outcomes of primary total hip arthroplasty. This study assesses surgeon's ability to estimate both the acetabular component inclination and anteversion angles via intraoperative fluoroscopy (IF) images. Methods: We surveyed orthopedic surgeons to estimate acetabular component inclination and anteversion based on 20 IF images of total hip arthroplasty through a direct anterior approach. Postoperative computed-tomography scans were used to calculate the true inclination and anteversion component angles. The absolute difference between the true and estimated values was calculated to determine the mean and standard deviation of the survey results. Interrater reliability was determined through interclass correlation coefficients. Results: A majority of surgeons preferred the direct anterior approach (83.3%) and utilized IF during surgery (70%). Surgeons surveyed were on average 5.9° away from the true value of inclination (standard deviation = 4.7) and 8.8° away from the true value of anteversion (standard deviation = 6.0). Respondents were within 5° of both inclination and anteversion in 19.7% of cases, and within 10° in 57.3% of cases. All surgeons were determined to have poor reliability in estimating anteversion (interclass correlation coefficient < 0.5). Only 2 surgeons were determined to have moderate reliability when estimating inclination. Conclusions: Surgeons, when solely relying on IF for the estimation of anteversion and inclination, are unreliable. Utilization of other techniques in conjunction with IF would improve observer reliability.

Clinical Outcomes Following Open Olecranon Bursa Excision for Septic and Aseptic Olecranon Bursitis: An Observational Study.

Background and objective Olecranon bursitis (aseptic or septic) is caused by inflammation in the bursal tissue. While it is typically managed with conservative measures, refractory cases may indicate surgical intervention. There is currently limited research about outcomes following bursal excision for both septic and aseptic etiologies. In light of this, the purpose of this study was to determine if patients experienced improvement following surgical olecranon bursa excision and to compare outcomes between septic and aseptic forms. Materials and methods A retrospective review was performed involving patients who underwent olecranon bursa excision from 2014 to 2021. Demographic data, patient characteristics, surgical data, and outcome-related data were collected from the medical records. Patients were classified into subgroups based on the type of olecranon bursitis (septic or aseptic). Preoperative and one-year postoperative 12-item short-form survey (SF-12) results and range of motion (ROM) outcomes were evaluated for the entire cohort as well as the subgroups. Results We included 61 patients in our study and found significant improvement in the Physical Component Scale 12 (PCS-12) score for all patients (42.0 vs. 45.5, p=0.010) following surgery. However, based on subgroup analysis, the aseptic group improved in PCS-12 following surgery (41.5 vs. 46.8, p<0.001), but the septic group did not (43.6 vs. 40.5, p=0.277). No improvements were found in the Mental Component Scale 12 (MCS-12) scores following surgery in either group. Eighteen of the 61 patients experienced postoperative complications (29.5%), but only 6.5% required a second surgical procedure. Specifically, 14 of the 18 complications occurred in the aseptic group while two septic and two aseptic patients required additional surgeries. Elbow ROM did not change significantly after surgery but more patients were found to have full ROM postoperatively (83.0% to 91.8%, p=0.228). Conclusion Our findings suggest that patients with refractory olecranon bursitis, particularly if aseptic, tend to gain significant physical health benefits from open bursectomy.

Arthroscopic Treatment of Shoulder Stiffness With Rotator Cuff Repair Yields Similar Outcomes to Isolated Rotator Cuff Repair.

Purpose: To compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR). Methods: Patients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result. Results: A total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P = .005 to P = .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P = .005) and external rotation (7.13° vs 1.65°; P = .031) ROM than the control group. Conclusions: Operative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores. Level of Evidence: Level III retrospective comparative study.

Modified Frailty Index as a Predictor of Postoperative Complications and Patient-Reported Outcomes after Posterior Cervical Decompression and Fusion.

STUDY DESIGN: A retrospective cohort study. PURPOSE: To determine whether the 11-item modified frailty index (mFI) is associated with readmission rates, complication rates, revision rates, or differences in patient-reported outcome measures (PROMs) for patients undergoing posterior cervical decompression and fusion (PCDF). OVERVIEW OF LITERATURE: mFI incorporates preexisting medical comorbidities and dependency status to determine physiological reserve. Based on previous literature, it may be used as a predictive tool for identifying postoperative clinical and surgical outcomes. METHODS: Patients undergoing elective PCDF at our urban academic medical center from 2014 to 2020 were included. Patients were categorized by mFI scores (0-0.08, 0.09-0.17, 0.18-0.26, and ≥0.27). Univariate statistics compared demographics, comorbidities, and clinical/surgical outcomes. Multiple linear regression analysis evaluated the magnitude of improvement in PROMs at 1 year. RESULTS: A total of 165 patients were included and grouped by mFI scores: 0 (n=36), 0.09 (n=62), 0.18 (n=42), and ≥0.27 (n=30). The severe frailty group (mFI ≥0.27) was significantly more likely to be diabetic (p <0.001) and have a greater Elixhauser comorbidity index (p =0.001). They also had worse baseline Physical Component Score-12 (PCS-12) (p =0.011) and modified Japanese Orthopaedic Association (mJOA) (p =0.012) scores and worse 1-year postoperative PCS-12 (p =0.008) and mJOA (p =0.001) scores. On regression analysis, an mFI score of 0.18 was an independent predictor of greater improvement in ΔVisual Analog Scale neck (ß =-2.26, p =0.022) and ΔVAS arm (ß =-1.76, p =0.042). Regardless of frailty status, patients had similar 90-day readmission rates (p =0.752), complication rates (p =0.223), and revision rates (p =0.814), but patients with severe frailty were more likely to have longer hospital length of stay (p =0.006) and require non-home discharge (p <0.001). CONCLUSIONS: Similar improvements across most PROMs can be expected irrespective of the frailty status of patients undergoing PCDF. Complication rates, 90-day readmission rates, and revision rates are not significantly different when stratified by frailty status. However, patients with severe frailty are more likely to have longer hospital stays and require non-home discharge.

Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act.

INTRODUCTION: Demographic factors contribute markedly to orthopaedic surgery outcomes. However, women and minorities have been historically excluded from clinical trials. The United States passed the Safety and Innovation Act (Food and Drug Administration Safety and Innovation Act [FDA-SIA]) in 2012 to increase study diversity and mandate reporting of certain demographics. The purpose of this study was to investigate demographic reporting and analysis among high-risk orthopaedic medical device trials and evaluate the effectiveness of the FDA-SIA in increasing diversity of study enrollment. METHODS: The premarket approval database was queried for all original submissions approved by the Orthopedic Advisory Committee from January 1, 2003, to July 1, 2022. Study demographics were recorded. Weighted means of race, ethnicity, and sex were compared before and after FDA-SIA implementation with the US population. RESULTS: We identified 51 orthopaedic trials with unique study data. Most Food and Drug Administration device trials reported age (98.0%) and sex (96.1%), but only 49.0% and 37.3% reported race and ethnicity, respectively. Only 23 studies analyzed sex, six analyzed race, and two analyzed ethnicity. Compared with the US population, participants were overwhelmingly White (91.36% vs. 61.63%, P < 0.001) with a significant underrepresentation of Black (3.65% vs. 12.41%, P = 0.008), Asian (0.86% vs. 4.8%, P = 0.030), and Hispanic participants (3.02% vs. 18.73%, P < 0.001) before 2013. The FDA-SIA increased female patient enrollment (58.99% vs. 47.96%, P = 0.021) but did not increase the enrollment of racial or ethnic minorities. CONCLUSION: Despite efforts to increase the generalizability of studies within the FDA-SIA, orthopaedic medical devices still fail to enroll diverse populations and provide demographic subgroup analysis. The study populations within these trials do not represent the populations for whom these devices will be indicated in the community. The federal government must play a stronger role in mandating study diversity, enforcing appropriate statistical analysis of the demographic subgroups, and executing measures to ensure compliance. LEVEL OF EVIDENCE: I.

Evaluating Nonoperative Treatment for Low Back Pain in the Presence of Modic Changes: A Systematic Review.

OBJECTIVE: The objective of this study was to summarize and assess the current literature evaluating nonoperative treatments for patients with Modic changes (MCs) and low back pain (LBP). METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The PubMed database was searched from its inception until May 1, 2022 for studies evaluating MC and clinical outcomes. Key findings, treatment details, and patient information were extracted from included studies. Study quality was assessed using the Newcastle-Ottawa Scale. RESULTS: Eighteen studies were included in this review, encompassing a total of 2452 patients, 1713 of whom displayed baseline MC. Seventy-eight percent of studies were high quality. Of included studies, 2 evaluated antibiotics, 5 evaluated steroid injections, 6 evaluated conservative therapies, and 5 evaluated other treatment modalities. Antibiotics and bisphosphonates improved treatment in patients with MC. Patients with MC without disc herniation benefited from conservative therapy, while those with Type I Modic changes and disc herniation experienced poorer improvement. Significant variability exists in reported outcomes following steroid injections. CONCLUSIONS: Nonoperative therapy may provide patients with MC with significant benefits. Patients may benefit from therapies not traditionally utilized for LBP such as antibiotics or bisphosphonates, but conservative therapy is not recommended for patients with concomitant MC and disc herniation. The large variation in follow-up times and outcome measures contributes to significant heterogeneity in studies and inability to predict long-term patient outcomes. More long-term studies are needed to assess nonoperative treatments for LBP in patients with MC.

Effect of Preoperative Marijuana on Patient Outcomes and Opioid Use after Lumbar Decompression.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: Our study aims to analyze the effect of preoperative marijuana use on outcomes and postoperative opioid use in patients who have undergone lumbar decompression without fusion. METHODS: All patients >18 years of age who underwent lumbar decompression from 2017-2022 with documented preoperative marijuana use at our academic institution were retrospectively identified. A 3:1 propensity match incorporating demographics, procedure type, and levels decompressed was performed to compare preoperative marijuana users and non-users. 1-year preoperative and postoperative opioid consumption in milligrams of morphine equivalents and postoperative outcomes including readmissions, reoperations, and complications, were obtained. A multivariate regression model was performed to measure the effect of marijuana use on the likelihood of a spine reoperation. RESULTS: Of the 340 included patients, 85 were preoperative marijuana users. There were no significant differences in medical complications, 90-day readmissions, or opioid consumption preoperatively or postoperatively (P > .05). We identified a trend towards patients who used marijuana having more reoperations for any cause (20.0% vs 11.37%, P = .067). Multivariate logistic regression analysis suggested that preoperative marijuana use was a significant predictor of all-spine reoperations (OR = 2.06, P = .036). CONCLUSIONS: In lumbar decompression patients, preoperative marijuana use does not impact opioid consumption, readmissions, or medical complications, but is a significant predictor of future postoperative reoperations. Additional research is necessary to further explore the role of marijuana use in spine surgery.

Are Clinical or Surgical Outcomes Different Based on Whether the Same Surgeon or Hospital System Performs the Spine Revision?

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To determine the effects of discontinuity in care by changing surgeons, health systems, or increased time to revision surgery on revision spine fusion surgical outcomes and patient-reported outcomes. SUMMARY OF BACKGROUND INFORMATION: Patients undergoing revision spine fusion experience worse outcomes than those undergoing primary lumbar surgery. Those requiring complex revisions are often transferred to tertiary or quaternary referral centers under the assumption that those institutions may be more accustomed at performing those procedures. However, there remains a paucity of literature assessing the impact of discontinuity of care in revision spinal fusions. METHODS: Patients who underwent revision 1-3 level lumbar spine fusion 2011-2021 were grouped based on (1) revision performed by the index surgeon versus a different surgeon, (2) revision performed within the same versus different hospital system as the index procedure, and (3) length of time from index procedure. Multivariate regression for outcomes controlled for confounding differences. RESULTS: A total of 776 revision surgeries were included. An increased time interval between the index procedure and the revision surgery was predictive of a lower risk for subsequent revision procedure (odds ratio: 0.57, P =0.022). Revision surgeries performed by the same surgeon predicted a reduced length of hospital stay (ß: -0.14, P =0.001). Neither time to revision nor undergoing by the same surgeon or same practice predicted 90-day readmission rates. Patients are less likely to report meaningful improvement in Mental Component Score-12 or Physical Component Score-12 if revision surgery was performed at a different hospital system. CONCLUSIONS: Patients who have revision lumbar fusions have similar clinical outcomes regardless of whether their surgeon performed the index procedure. However, continuity of care with the same surgeon may reduce hospital length of stay and associated health care costs. The length of time between primary and revision surgery does not significantly impact patient-reported outcomes. LEVEL OF EVIDENCE: Level III.