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

Launched by ORTHOPEDIC HOSPITAL VIENNA SPEISING · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two types of screws used in surgery for flat feet, a condition where the arch of the foot falls. One screw is made from human bone, which could potentially make recovery easier since it doesn’t need to be removed later, while the other is a metal screw. The study aims to find out if the human bone screw works just as well as the metal screw in helping patients heal after surgery. Researchers will compare how well each screw helps the foot heal, the time it takes for the bones to fuse together, any complications that arise, and how patients feel about their foot function after the surgery.

To participate in this study, you must be an adult with specific foot issues and a body mass index (BMI) of less than 40. The trial is open to all genders and involves having surgery, followed by several check-ups over the next two years to assess your recovery. During these visits, you’ll have X-rays and CT scans to monitor the healing process, and you’ll also answer questions about your activity levels. This trial is important for understanding the best options for treating flat feet, so if you think you might be eligible, it could be a great opportunity to contribute to this research.

Gender

ALL

Eligibility criteria

• • 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

Trial Officials