Comparing human bone screws to metal screws for flatfoot surgery
Medial Displacement Calcaneal Osteotomy and FDL- Transfer - a Prospective Comparative Study Between Metal/Bio-Tenodesis Screw (Arthrex) and the Human, Allogeneic Cortical Bone Screw (Shark Screw®️, Surgebright-GmbH)
This study is testing if a new human bone screw works as well as a traditional metal screw for treating flatfoot surgery to see if it can help patients recover better without needing to remove the hardware later.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthopedic Hospital Vienna Speising Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05643079 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with symptomatic flatfoot deformities who require surgical intervention and meet specific inclusion criteria.
Not a fit: Patients with a BMI over 40, active infections, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for additional surgeries and complications associated with hardware removal, leading to improved patient satisfaction and outcomes.
How similar studies have performed: Previous studies using allogeneic bone screws have shown promising results, indicating low complication rates and high satisfaction, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.