Quality of prospective controlled randomized trials regarding platelet-rich plasma injection for osteoarthritis of the knee.

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard for study design and are considered to have the highest level of evidence. The purpose of this study is to evaluate quality of evidence of prospective RCTs that investigated the clinical efficacy of platelet-rich plasma (PRP) treatments for knee osteoarthritis. We hypothesized that a high level of clinical evidence does not correlate with a high-quality scientific study. MATERIAL AND METHODS: A systematic literature search to identified RCTs that evaluated the efficacy of PRP treatments for knee osteoarthritis. Inclusion criteria included studies that contained key terms "Platelet-rich plasma," "PRP", "knee", and "osteoarthritis". Exclusion criteria excluded studies that were not prospective RCTs. Ten RCTs were evaluated by four independent reviewers. The studies were assessed according to the Oxford Levels of Evidence, a modified Coleman Methodology Score, and the revised Consolidated Standards of Reporting Trials (CONSORT) score. RESULTS: Three of the four Observers rated all 10 studies as Level I, while one Observer rated 80% of the studies as Level I. Using the Coleman Methodology Score, the average score for all studies was 58.0 out of 100 points, designating the studies as "fair." Areas of deficiency included clinical effect measurement and intent-to-treat analysis. Using the CONSORT checklist, the average score was 16.9 out of 22 points, designating the studies as "good". Areas of deficiency included inadequate implementation of randomization and interpretation of results. DISCUSSION: Clinicians should critically evaluate research studies regardless of study design. A sophisticated study design and high level of evidence designation does not guarantee quality research. We determined that RCTs for PRP treatment of knee osteoarthritis were not as robust in quality despite their Level I Oxford Level of Evidence rating.

Early internal fixation of open ankle malleolar fractures is not associated with increased complications: case control study.

The timing of definitive fixation of open ankle malleolar fractures is still controversial. This study intended to evaluate the outcome of patients who were managed by immediate definitive fixation in comparison to delayed definitive fixation following open ankle malleolar fractures. This was an IRB approved retrospective case control study of 32 patients who were treated with open reduction and internal fixation (ORIF) for open ankle malleolar fractures at our Level I trauma center 2011-2018. Patients were divided into 2 groups; immediate ORIF group (within 24 hours) and delayed ORIF group (first stage included debridement and external fixator or splinting followed by second stage of delayed ORIF). Outcomes assessed were postoperative complications (wound healing, infection, nonunion). Logistic regression models were used to access the unadjusted and adjusted associations between post- operative complications and selected co factors. The immediate definitive fixation group included 22 patients while the delayed staged fixation group included 10 patients. Gustilo type II and III open fractures were associated with higher complications rate (p-value = 0.012) in both groups. Comparing the 2 groups, There was no increase in complication in the immediate fixation group compared to the delayed group. Complications following open ankle malleolar fractures are usually associated with Gustilo type II and III open fractures. Immediate definitive fixation after adequate debridement was not found to increase complication rate compared to staged management.

Incidence of Cubital Tunnel Syndrome in the U.S. Military Population.

PURPOSE: Cubital tunnel syndrome (CuTS) is the second most common peripheral nerve entrapment syndrome. However, existing epidemiological evidence regarding the estimated incidence of the CuTS disease burden in specific populations is sparse, especially among the U.S. military. The purpose of this study was to describe the demographics and determine the incidence of CuTS among active duty U.S. military service members. METHODS: All first-time occurrences for CuTS among military members were identified using International Classification of Diseases, Ninth Revision, clinical modification code 354.2 for ulnar nerve lesions in the U.S. Defense Medical Epidemiology Database. A multivariable Poisson regression analysis was used to estimate the incidence rate ratio (IRR) per 1,000 person-years and 95% confidence intervals (95% CI), while controlling for sex, race, age, rank, and service. Rate-ratios were calculated using different referent factors based on differences in sex, race, age, rank, and service branch. RESULTS: During the 10-year study period, the total number of incident cases of CuTS was 31,568, and a total of 13,745,456 person-years were documented. The overall unadjusted IRR of CuTS during the study period was 2.3 per 1,000 person-years (95% CI, 2.27-2.33). The 35- to 39-year age group had the highest adjusted IRR of CuTS. In addition, females, Caucasians, and junior enlisted service members showed significantly higher IRRs. CONCLUSIONS: Our study was able to provide baseline epidemiological data on IRRs and influential risk factors in CuTS. We demonstrated an incidence of CuTS that is comparable with previously reported IRRs, which have varied from 0.08 to 8.0 cases per 1,000 person-years. This study also found significantly higher risk for the development of CuTS with increased age and among U.S. Army service members. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

Nanosphere pharmacodynamics improves safety of immunostimulatory cytokine therapy.

Systemic administration of interleukin (IL)-12 induces potent anti-tumor immune responses in preclinical cancer models through the systemic activation of effector immune cells and release of proinflammatory cytokines. IL-12-loaded PLGA nanospheres (IL12ns) are hypothesized to improve therapeutic efficacy and thwart unwanted side effects observed in previous human clinical trials. Through the investigation of peripheral blood and local tissue immune responses in healthy BALB/c mice, the immune-protective pharmacodynamics of IL12ns were suggested. Nanospheres increased pro-inflammatory plasma cytokines/chemokines (IFN-γ, IL-6, TNF-α, and CXCL10) without inducing maladaptive transcriptomic signatures in circulating peripheral immune cells. Gene expression profiling revealed activation of pro-inflammatory signaling pathways in systemic tissues, the likely source of these effector cytokines. These data support that nanosphere pharmacodynamics, including shielding IL-12 from circulating immune cells, depositing peripherally in systemic immune tissues, and then slowly eluting bioactive cytokine, thereafter, are essential to safe immunostimulatory therapy.

Cervical wound dehiscence following internal fixation of the cervical and thoracic spine: a report of three cases.

Background: Wound dehiscence is a known postoperative complication, but in cervical spine surgery it is rare and there is a lack of documented literature. This case report discusses novel complications of wound dehiscence in three patients who were treated with spinous process ostectomies after posterior cervical surgeries. Case Description: In total three cases are reported in these reports. Case one documents the management of a patient with full-thickness cervical wound dehiscence following a cervical paraspinal infection corrected with posterior spinal fixation and fusion. This patient was treated with resection of the prominent spinous processes. Case two documents the management of a patient with an odontoid fracture requiring revision surgery. The patient developed a full-thickness wound dehiscence and was treated with resection of the prominent spinous processes. Case three was a patient suffering from a T9 spinal cord injury who was also treated for multiple vertebral fractures. The patient eventually developed internal cervical wound dehiscence which resulted in removal of the prominent spinous processes. Conclusions: This case report documents the successful treatment of cervical wound dehiscence which is a rare postoperative complication of cervical spinal surgery. This information is valuable as treatment strategies and research into cervical wound dehiscence are limited to a single case report.

Thirty-Day Mortality and Complication Rates in Total Joint Arthroplasty After a Recent COVID-19 Diagnosis: A Retrospective Cohort in the National COVID Cohort Collaborative (N3C).

BACKGROUND: The risk of postoperative complications in patients who had a positive COVID-19 test prior to a total joint arthroplasty (TJA) is unknown. The purpose of this investigation was to study the complications and mortality associated with a recent COVID-19 diagnosis prior to TJA. METHODS: Patients undergoing primary and revision total hip arthroplasties (THAs) or total knee arthroplasties (TKAs) were identified using the National COVID Cohort Collaborative (N3C) Data Enclave. Patients were divided into a COVID-19-positive group (positive polymerase chain reaction [PCR] test, clinical diagnosis, or positive antibody test) and a COVID-19-negative group, and the time from diagnosis was noted. There was no differentiation between severity or acuity of illness available. The postoperative complications reviewed included venous thromboembolism, pneumonia, acute myocardial infarction, readmission rates, and 30-day mortality rates. RESULTS: A total of 85,047 patients who underwent elective TJA were included in this study, and 3,516 patients (4.13%) had had a recent positive COVID-19 diagnosis. Patients diagnosed with COVID-19 at 2 weeks prior to TJA were at increased risk of pneumonia (odds ratio [OR], 2.46), acute myocardial infarction (OR, 2.90), sepsis within 90 days (OR, 2.63), and 30-day mortality (OR, 10.61). CONCLUSIONS: Patients with a recent COVID-19 diagnosis prior to TJA are at greater risk of postoperative complications including 30-day mortality. Our analysis presents critical data that should be considered prior to TJA in patients recently diagnosed with COVID-19. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

Validity of Using the Scratch Collapse Test in the Lower Extremities.

BACKGROUND: The scratch collapse test is a provocative test that has been successfully used for peripheral neuropathies. The elbow is the main testing site, but there may be times when use of the upper extremities is contraindicated. This study sought to determine the sensitivity of using the scratch collapse test on the lower extremity for upper extremity neuropathies. METHODS: One hundred patients with an electromyographically confirmed diagnosis of carpal tunnel or cubital tunnel syndrome were prospectively enrolled. As a control, the scratch collapse test was conducted normally using the elbow as a testing site. After a baseline was established, the test was repeated using eversion of the foot and ankle against an inversion force. RESULTS: Of the 100 study patients, 89 had a positive scratch collapse test on the upper extremity and 84 had a positive test on the lower extremity. In the 51 patients with carpal tunnel syndrome, 45 had a positive test on the upper extremity (sensitivity, 88.2 percent; 95 percent CI, 76.13 to 95.56 percent), and 42 had a positive test of the lower extremity (sensitivity, 82.35 percent; 95 percent CI, 69.13 to 91.60 percent). In the 49 patients with cubital tunnel syndrome, 44 had a positive test on the upper extremity (sensitivity, 89.8 percent; 95 percent CI, 77.77 to 96.6 percent), and 42 had a positive test on the lower extremity (sensitivity, 85.7 percent; 95 percent CI, 72.76 to 94.06 percent). CONCLUSION: There were no statistically significant differences in the sensitivities of the scratch collapse test on the upper or lower extremities, suggesting that the lower extremity could serve as an alternative site for the scratch collapse test. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, II.

Utility of 3-Dimensional Intraoperative Imaging in Pelvic and Acetabular Fractures: A Network Meta-Analysis.

BACKGROUND: Successful surgical management of pelvic ring and acetabular fractures requires technical expertise to achieve an accurate reduction and stable fixation. The use of 3-dimensional (3D) intraoperative imaging (3DIOI) as an assessment tool has led to improved reduction and placement of implants. The purpose of this study was to assess the utility of using 3DIOI in the management of acetabular and pelvic fractures on the basis of outcomes reported in the literature. METHODS: A literature search was performed using PubMed, the Cochrane Database of Systematic Reviews (CDSR), and Google Scholar using key terms. A network meta-analysis conducted using the frequentist approach allowed for statistical analysis of reported outcomes regarding screw position (in mm), fracture reduction (in mm), and complications. RESULTS: A total of 9 studies were included in this analysis. When compared with conventional radiography, the mean radiation dose (in cGy·cm2) was significantly higher in 3DIOI (mean difference, 82.72; 95% confidence interval [CI], 21.83 to 143.61; p = 0.007). Use of 3DIOI yielded a 93% lower risk of developing medical complications (odds ratio [OR], 0.07; 95% CI, 0.02 to 0.35; p = 0.014). Use of 3DIOI yielded higher odds of achieving accurate screw placement (OR, 4.21; 95% CI, 1.44 to 12.32; p = 0.008) and perfect reduction (OR, 2.60; 95% CI, 1.19 to 5.68; p = 0.016). In ranking the imaging modalities, 12 of the 13 parameters analyzed were in favor of 3DIOI over conventional fluoroscopy and 2D navigation imaging. CONCLUSIONS: Current literature supports the use of 3DIOI because of the decreased rates of misplaced implants, malreduced fractures, complications, and subsequent revision operations. The use of 3DIOI allows for improved visualization of pelvic anatomy when repairing pelvic and acetabular fractures, and helps surgeons to achieve favorable surgical outcomes. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Incidence of Pelvic Ring Fractures in the U.S. Military Population.

Introduction  Pelvic ring fractures occur frequently among the elderly population, but some studies demonstrate a bimodal distribution where the incidence is elevated among younger age groups as well. The mechanisms of injury also vary based on age groups. Previous studies are specific to trauma registries and centers, but epidemiological data within the U.S. military are sparse. In the U.S. military population, pelvic ring fractures can be related to high-energy trauma including motor vehicle accidents and combat warfare. The purpose of this study was to determine the incidence of pelvic ring fractures among active duty U.S. military service members between 2006 and 2015, while also describing the demographics associated with the findings. Materials and Methods All data were collected from the U.S. Defense Medical Epidemiology Database (DMED). To calculate the incidence rates, only first-time occurrences for pelvic ring fractures among military members were used. Each point was identified using International Classification of Diseases, Ninth Revision (ICD-9), clinical modification code 808 for "fractures of the pelvis." A multivariate Poisson regression analysis was used to estimate the incidence rate per 1,000 person-years and 95% confidence intervals while controlling for sex, race, age, rank, and service. Rate ratios were calculated using different referent factors based on differences in sex, race, age, rank, and service branch. This study was IRB exempt as all the data used were de-identified patient data from the DMED system. Results Over the 10-year study period, a total of 4,802 incident cases of pelvic ring fractures, and a total of 13,748,429 person-years were documented. The overall incidence rate of pelvic ring fractures was 0.35 per 1,000 person-years. The incidence of pelvic ring fractures was highest among the youngest age group (<20 years) and among the lower-ranking service members. Additionally, other demographic groups such as the White race, female sex, and Army service members showed the highest incidence rates. Conclusion Our study determined baseline epidemiological data on incidence rates of pelvic ring fractures in the U.S. military. Patient demographics may be contributing factors, and the present analysis was able to elucidate associated underlying demographics. We demonstrated that the incidence was highest among the younger age groups, and that incidence rates may be specific to age cohorts. This study also found that lower-ranking service members had the highest incidence in all service branches, suggesting a form of occupational risk. Furthermore, our findings suggest that females, White race groups, and Army enlisted service members show a significantly higher incidence rate and may be at a greater risk. Our findings are important as they broaden the understanding of the patterns of pelvic ring fractures in the U.S. military population and occupational risks associated with this population.