About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Insufficient knowledge of German
Alcohol and drug abuse
Pregnant woman or nursing mother
Foreseeable compliance problems
Trial design
Treatments tested in this trial
- 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®