Actively Recruiting
Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw
Led by Orthopedic Hospital Vienna Speising · Updated on 2025-03-20
40
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 compared patient groups? Participants will have * the surgery * follow-ups at 6 weeks, 6 months, 1 and 2 years. * X-rays are performed at each follow up. * CT-scans are performed after 6 months. * activity scores are collected at the follow up after 6 months, 1 year and 2 years.
CONDITIONS
Official Title
Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for the use of a metal/Bio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with FDL transfer
- Body mass index (BMI) less than 40 kg/m²
You will not qualify if you...
- 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
- Body mass index (BMI) greater than 40
AI-Screening
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Trial Site Locations
Total: 1 location
1
Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising
Vienna, Austria, 1130
Actively Recruiting
Research Team
F
Florian Wenzel-Schwarz, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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