Comparing human bone screws to metal screws for flatfoot surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the effectiveness of a human allogeneic cortical bone screw, known as Shark Screw®, with a traditional metal/Bio-Tenodesis screw in treating symptomatic flatfoot deformities through medializing calcaneal osteotomy and flexor digitorum longus (FDL) tendon transfer. The study will assess union rates, time to union, complication rates, and patient-reported outcomes using various activity scores over a follow-up period of two years. The goal is to determine if the human bone screw can provide similar or better outcomes without the need for hardware removal post-surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Florian Wenzel-Schwarz, MD — Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising, Vienna, Austria
• Study coordinator: Florian Wenzel-Schwarz, MD
• Email: florian.wenzel-schwarz@oss.at
• Phone: +43180182

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.