Academic Journal
Bio-integrative vs Metallic Screws in Calcaneus Osteotomies: A Non-Inferiority Randomized Clinical Trial
| العنوان: | Bio-integrative vs Metallic Screws in Calcaneus Osteotomies: A Non-Inferiority Randomized Clinical Trial |
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| المؤلفون: | Mansur, Nacime Salomao Barbachan, Carvalho, Kepler A.M., Chinelati, Rogerio Marcio Kajimura, Fayed, Aly M., Schmidt, Eli, Lalevee, Matthieu, Rojas, Edward O., Ehret, Amanda, Chrea, Bopha, de Cesar Netto, Cesar |
| المصدر: | Foot & Ankle Orthopaedics ; volume 8, issue 4 ; ISSN 2473-0114 2473-0114 |
| بيانات النشر: | SAGE Publications |
| سنة النشر: | 2023 |
| الوصف: | Category: Hindfoot; Other Introduction/Purpose: The use of bio-integrative implants in orthopedic surgery is growing exponentially. Advantages, such as reduced implant-related artifact production, lower removal rates, and superior bone interaction, have been advocated. However, while many biomechanical and histological reports could sustain its structural and biological properties, only some clinical studies were produced that could support its use. Therefore, this trial intended to determine the bio-integrative screws' capacity to reach the same clinical and radiographical outcomes of current metallic screws in calcaneus osteotomies. Our main hypothesis was that metallic and bio-integrative screws would not present differences when comparing bone healing and complications. Methods: This was a single center, in parallel groups, randomized non-inferiority clinical trial (NCT05018130) that included patients undergoing a calcaneal sliding osteotomy from November 2021 to January 2023. Patients were randomized in a 1 to 1 ratio by software in the metallic or bio-integrative groups, and allocation occurred after anesthesia was carried out. Surgeries were performed by a single surgeon respecting the same technique, using two canulated 4mm screws, either titanium or fiber, according to the treatment group. The primary outcome was determined by bone using weight-bearing computed tomography (WBCT) in the 6th postoperative week. At least 50% of bone trabeculae crossing the osteotomy site needed to be observed to be considered positive. Secondary outcomes included minor and major complications and bone healing, assessed in the 2nd, 4th, 6th, 12th, 24th, and 48th weeks of follow-up. Two assessors performed readings. Between-group differences were measured with ANOVA and chi-square tests. Results: After twenty-nine patients were assessed initially, 22 subjects were found eligible and included in the study. Groups were similar demographically (ps>0.37), with ten patients allocated to the bio-integrative and 12 to the ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1177/2473011423s00126 |
| DOI: | 10.1177/2473011423S00126 |
| الاتاحة: | https://doi.org/10.1177/2473011423s00126 https://journals.sagepub.com/doi/pdf/10.1177/2473011423S00126 |
| Rights: | https://creativecommons.org/licenses/by-nc/4.0/ |
| رقم الانضمام: | edsbas.4A7D2B0C |
| قاعدة البيانات: | BASE |
| DOI: | 10.1177/2473011423s00126 |
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