A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study

Background: Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation. Methods: This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex® 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded. Results: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m2. Hernia defects were <20 × 20 cm, classified as class I–III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence. Conclusions: The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.

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Radial Head Arthroplasty: Does Ligaments Repair Influence Outcomes? A Minimum Two Years Follow-Up Radiographic Multi-Center Study

10.21203/rs.3.rs-418402/v1 ◽

2021 ◽

Author(s):

Cristina Galavotti ◽

Sara Padovani ◽

Alessandro Nosenzo ◽

Margherita Menozzi ◽

Pietro Maniscalco ◽

...

Keyword(s):

Radial Head ◽

Revision Rate ◽

Radial Head Fracture ◽

Degenerative Changes ◽

Annular Ligament ◽

Radial Head Fractures ◽

Radial Head Arthroplasty ◽

Multi Center Study ◽

Center Study

Abstract Purpose: The current indication for comminuted radial head fractures is radial head arthroplasty (RHA). The main purpose of this study was to investigate any statistical differences in terms of prosthesis revision or removal and radiographic-degenerative changes by comparing patients who underwent RHA and ligaments repair to those who underwent only RHA implant at minimum two-years follow up. The secondary aim was to delineate a trend profile of RHA implants.Methods: All patients who underwent RHA surgery for traumatic pathology between January 2012 and December 2017 were eligible. Two researchers independently and retrospectively reviewed the patients’ charts and collected the following data: type of prosthesis, associated surgical procedures and revision surgery. They also looked for any radiographic sign of prosthesis loosening, overstuffing, capitellar osteopenia, heterotopic ossification and degenerative changes. No clinical evaluation was performed. Results: In six years 124 RHA were implanted (74 Female, 50 Male, mean age 56). The main diagnoses were: terrible-triad, trans-olecranon fracture and isolated radial head fracture. It was found no significant statistical difference between the two groups, nevertheless the cohort of patients that underwent ligaments repair had a lower revision rate in comparison to the other. Suture of the annular ligament seems to be critical. The overall revision rate was 10.5%.Conclusion:This multi-center study found no evidence that ligaments repair, as an associated surgical procedure, improves RHA longevity, except for annular ligament. Nevertheless, it seems to prevent degenerative changes at mid-term follow-up.

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Clinical Characteristics of Pregnant Women With Epilepsy-A Retrospective Multi Center Study

10.21203/rs.3.rs-141288/v1 ◽

2021 ◽

Author(s):

Huan Cheng ◽

Dongyan Wu ◽

Lin Li ◽

Qinyi Fan ◽

Xinghua Tang ◽

...

Keyword(s):

Pregnancy Outcomes ◽

Clinical Characteristics ◽

Adverse Pregnancy Outcomes ◽

Therapeutic Drugs ◽

Anti Epileptic Drug ◽

Adverse Pregnancy ◽

One Year ◽

Multi Center Study ◽

Center Study

Abstract Background: Many women with epilepsy (WWE) become pregnant, so the control of seizures during pregnancy and the use of anti-epileptic drug (AED) may directly affect the outcome of pregnancy. This study retrospectively analyzed seizures, medications and pregnancy outcomes of WWE, in order to provide clinical basis for reasonable management of pregnancy in these women. Methods: Information, including seizures, medications during pregnancy and pregnancy outcomes of WWE, was collected through telephonic follow-up and retrospectively analyzed. Results: Among the 61 WWE, 26 cases had seizures during pregnancy. Among the WWE treated with monotherapy, the most commonly used AEDs were carbamazepine (29.27%), levetiracetam (31.71%) and lamotrigine (14.63%). Nine WWE had adverse pregnancy outcomes. The incidence of adverse pregnancy outcomes in WWE who had seizures within one year before pregnancy was significantly higher than WWE who were seizure-free within one year before pregnancy (c2=5.355, p=0.021). The incidence of adverse pregnancy outcomes in WWE who had seizures during pregnancy was also significantly higher than WWE without seizures during pregnancy (c2=7.155, p=0.007).Conclusions: A small number of WWE had adverse pregnancy outcomes, while the majority of them had relatively stable epilepsy control during pregnancy and gave birth to a healthy offspring. The main therapeutic drugs for WWE are new AEDs, represented by levetiracetam and lamotrigine, and the use of valproate sodium has been significantly reduced. Seizures within one year before pregnancy may be able to predict seizures during pregnancy.

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