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Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw

Recruitingn/aAges 18 Years - anyAllOrthopedic Hospital Vienna Speising
NCT05643079 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal/Bio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone. The main questions it aims to answer are: * Can the human bone screw achieve union rates like the metal/Bio-Tenodesis screw? * Is the time to union similar between the different screws? * Is the complication rate similar between the different screws? * Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compare

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📋 Eligibility rules (as published)
Inclusion Criteria * Indication for the use of a metal/Bio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with FDL transfer. * BMI\< 40 kg/m² Exclusion Criteria: * Insufficient knowledge of German * Alcohol and drug abuse * Pregnant woman or nursing mother * Foreseeable compliance problems * Neoplastic diseases, malignant bone tumors, rheumatoid arthritis * Active osteomyelitis * History of foot surgery * Advanced osteoarthritis of the lower ankle joint * Ulcerations in the skin of the surgical area * Immunosuppressive medications that cannot be discontinued * BMI \>40
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What it tests

  • medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with metal/Bio-Tenodesis screws
  • medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with Shark Screws®
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Where

1 site
Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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